Food Safety
Experiences of Seven Countries in Consolidating Their Food Safety Systems Gao ID: GAO-05-212 February 22, 2005The safety and quality of the U.S. food supply are governed by a complex system that is administered by 15 agencies. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), have primary responsibility for food safety. Many legislative proposals have been made to consolidate the U.S. food safety system, but to date no other action has been taken. Several countries have taken steps to streamline and consolidate their food safety systems. In 1999, we reported on the initial experiences of four of these countries--Canada, Denmark, Ireland, and the United Kingdom. Since then, additional countries, including Germany, the Netherlands, and New Zealand, have undertaken consolidations. This report describes the approaches and challenges these countries faced in consolidating food safety functions, including the benefits and costs cited by government officials and other stakeholders. In commenting on a draft of this report, HHS and USDA said that the countries' consolidation experiences have limited applicability to the U.S. food safety system because the countries are much smaller than the United States. The two agencies believe that they are working together effectively to ensure the safety of the food supply.
In consolidating their food safety systems, the seven countries we examined--Canada, Denmark, Germany, Ireland, the Netherlands, New Zealand, and the United Kingdom--varied in their approaches and the extent to which they consolidated. However, the countries' approaches were similar in one respect--each established a single agency to lead food safety management or enforcement of food safety legislation. These countries had two primary reasons for consolidating their food safety systems--public concern about the safety of the food supply and the need to improve program effectiveness and efficiency. Countries faced challenges in (1) deciding whether to place the agency within the existing health or agriculture ministry or establish it as a stand-alone agency while also determining what responsibilities the new agency would have and (2) helping employees adjust to the new agency's culture and support its priorities. Although none of the countries has analyzed the results of its consolidation, government officials consistently stated that the net effect of their country's consolidation has been or will likely be beneficial. Officials in most countries stated their new food safety agencies incurred consolidation start-up costs. However, in each country, government officials believe that consolidation costs have been or will likely be exceeded by the benefits. These officials and food industry and consumer stakeholders cited significant qualitative improvements in the effectiveness or efficiency of their food safety systems. These improvements include less overlap in inspections, greater clarity in responsibilities, and more consistent or timely enforcement of food safety laws and regulations. In addition to these qualitative benefits, officials from three countries, Canada, Denmark, and the Netherlands, identified areas where they believe financial savings may be achieved as a result of consolidation. For example, in the Netherlands officials said that reduced duplication in food safety inspections would likely result in decreased food safety spending and that they anticipate savings from an expected 25 percent reduction in administrative and management personnel. Although the seven countries we reviewed are much smaller than the United States, they are also high-income countries where consumers have very high expectations for food safety. Consequently, we believe that the countries' experiences in consolidating food safety systems can offer useful information to U.S. policymakers.
GAO-05-212, Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems
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Report to Congressional Requesters:
February 2005:
FOOD SAFETY:
Experiences of Seven Countries in Consolidating Their Food Safety
Systems:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-212]:
GAO Highlights:
Highlights of GAO-05-212, a report to congressional requesters:
Why GAO Did This Study:
The safety and quality of the U.S. food supply are governed by a
complex system that is administered by 15 agencies. The U.S. Department
of Agriculture (USDA) and the Food and Drug Administration (FDA),
within the Department of Health and Human Services (HHS), have primary
responsibility for food safety. Many legislative proposals have been
made to consolidate the U.S. food safety system, but to date no other
action has been taken. Several countries have taken steps to streamline
and consolidate their food safety systems. In 1999, we reported on the
initial experiences of four of these countries”Canada, Denmark,
Ireland, and the United Kingdom. Since then, additional countries,
including Germany, the Netherlands, and New Zealand, have undertaken
consolidations.
This report describes the approaches and challenges these countries
faced in consolidating food safety functions, including the benefits
and costs cited by government officials and other stakeholders. In
commenting on a draft of this report, HHS and USDA said that the
countries‘ consolidation experiences have limited applicability to the
U.S. food safety system because the countries are much smaller than the
United States. The two agencies believe that they are working together
effectively to ensure the safety of the food supply.
What GAO Found:
In consolidating their food safety systems, the seven countries we
examined ”Canada, Denmark, Germany, Ireland, the Netherlands, New
Zealand, and the United Kingdom”varied in their approaches and the
extent to which they consolidated. However, the countries‘ approaches
were similar in one respect”each established a single agency to lead
food safety management or enforcement of food safety legislation. These
countries had two primary reasons for consolidating their food safety
systems”public concern about the safety of the food supply and the need
to improve program effectiveness and efficiency. Countries faced
challenges in (1) deciding whether to place the agency within the
existing health or agriculture ministry or establish it as a stand-
alone agency while also determining what responsibilities the new
agency would have and (2) helping employees adjust to the new agency‘s
culture and support its priorities.
Although none of the countries has analyzed the results of its
consolidation, government officials consistently stated that the net
effect of their country‘s consolidation has been or will likely be
beneficial. Officials in most countries stated their new food safety
agencies incurred consolidation start-up costs. However, in each
country, government officials believe that consolidation costs have
been or will likely be exceeded by the benefits. These officials and
food industry and consumer stakeholders cited significant qualitative
improvements in the effectiveness or efficiency of their food safety
systems. These improvements include less overlap in inspections,
greater clarity in responsibilities, and more consistent or timely
enforcement of food safety laws and regulations. In addition to these
qualitative benefits, officials from three countries, Canada, Denmark,
and the Netherlands, identified areas where they believe financial
savings may be achieved as a result of consolidation. For example, in
the Netherlands officials said that reduced duplication in food safety
inspections would likely result in decreased food safety spending and
that they anticipate savings from an expected 25 percent reduction in
administrative and management personnel.
Although the seven countries we reviewed are much smaller than the
United States, they are also high-income countries where consumers have
very high expectations for food safety. Consequently, we believe that
the countries‘ experiences in consolidating food safety systems can
offer useful information to U.S. policymakers.
www.gao.gov/cgi-bin/getrpt?GAO-05-212.
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:
Countries Have Taken Various Consolidation Approaches, and Officials
and Stakeholders Cited Challenges and Costs but Believe Food Safety
Systems Are Now More Effective:
Concluding Observations:
Comments from the Seven Countries Examined:
Agency Comments and Our Evaluation:
Appendixes:
Appendix I: Scope and Methodology:
Appendix II: Canada's Food Safety System Consolidation:
Appendix III: Denmark's Food Safety System Consolidation:
Appendix IV: Germany's Food Safety System Consolidation:
Appendix V: Ireland's Food Safety System Consolidation:
Appendix VI: The Netherlands' Food Safety System Consolidation:
Appendix VII: New Zealand's Food Safety System Consolidation:
Appendix VIII: The United Kingdom's Food Safety System Consolidation:
Appendix IX: Comments from the Department of Health and Human Services:
Appendix X: Comments from the U.S. Department of Agriculture:
Appendix XI: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Staff Acknowledgments:
Table:
Table 1: Comparison of Selected Countries' Population, Gross Domestic
Product (GDP), Total Food Consumption, per Capita GDP, and Spending for
Food as a Percentage of Total Spending:
Figures:
Figure 1: U.S. Federal Agencies' Food Safety Responsibilities:
Figure 2: Improvements in Food Safety Operations Cited by Government
Officials or Stakeholders:
Figure 3: Summary of Canada's Food Safety System Consolidation:
Figure 4: Summary of Denmark's Food Safety System Consolidation:
Figure 5: Summary of Germany's Food Safety System Consolidation:
Figure 6: Summary of Ireland's Food Safety System Consolidation:
Figure 7: Summary of the Netherlands' Food Safety System Consolidation:
Figure 8: Summary of New Zealand's Food Safety System Consolidation:
Figure 9: Summary of the United Kingdom's Food Safety System
Consolidation:
Figure 10: Food Safety Authority of Ireland's Organization:
Figure 11: The Netherlands' 2001 Food Safety System Organization:
Figure 12: The Netherlands' 2002 and 2003 Food Safety System
Organization:
Abbreviations:
AMS: Agricultural Marketing Service:
APHIS: Animal and Plant Health Inspection Service:
ARS: Agricultural Research Service:
BSE: bovine spongiform encephalopathy:
CDC: Centers for Disease Control and Prevention:
CFIA: Canadian Food Inspection Agency:
DVFA: Danish Veterinary and Food Administration:
EFSA: European Food Safety Authority:
EPA: Environmental Protection Agency:
EU: European Union:
FDA: Food and Drug Administration:
FSA: Food Standards Agency:
FSAI: Food Safety Authority of Ireland:
FSIS: Food Safety and Inspection Service:
GDP: gross domestic product:
HHS: U.S. Department of Health and Human Services:
KvW: Inspectorate for Health Protection and Veterinary Public Health:
NMFS: National Marine Fisheries Service:
NZFSA: New Zealand Food Safety Agency:
RVV: National Inspection Service for Livestock and Meat:
USDA: U.S. Department of Agriculture:
VWA: The Food and Consumer Product Safety Authority:
Letter February 22, 2005:
The Honorable George V. Voinovich:
Chairman:
The Honorable Daniel K. Akaka:
Ranking Member:
Subcommittee on Oversight, Government Management, the Federal Workforce
and the District of Columbia:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Richard Durbin:
United States Senate:
As we have previously reported, the federal food safety system in the
United States emerged piecemeal, over many decades, typically in
response to particular health threats or economic crises. The result is
a fragmented legal and organizational structure that gives
responsibility for specific food commodities to different agencies and
provides them with significantly different authorities to enforce food
safety laws. In fiscal year 2003, the principal federal agencies with
food safety responsibilities spent nearly $1.7 billion to ensure the
safety and quality of the U.S. food supply.
Many legislative proposals have been made to reform existing laws and
consolidate the U.S. food safety system, but to date no action has been
taken. Most recently, in 2004, parallel Senate and House bills proposed
combining the food safety regulatory programs of the U.S. Department of
Agriculture (USDA) and the Food and Drug Administration (FDA), within
the Department of Health and Human Services (HHS), and the voluntary
seafood inspection program operated by the Department of Commerce.
Several countries have taken steps to streamline and consolidate food
safety functions. In 1999, we reported on the experiences of four
countries--Canada, Denmark, Ireland, and the United Kingdom--that were
consolidating their food safety systems.[Footnote 1] In response to
your interest in learning about these and other countries' experiences
with consolidation, we updated information on the countries covered in
the 1999 report and included information on three other countries that
have also undertaken consolidation efforts--Germany, the Netherlands,
and New Zealand. This report describes the approaches these seven
countries have taken in consolidating food safety functions, the
challenges they faced, and the results of the countries' efforts,
including benefits and costs cited by government officials and industry
or consumer stakeholders.
To develop this information, we examined the seven countries' efforts
to streamline and consolidate their food safety systems,[Footnote 2]
including the benefits and costs that resulted, as cited by government
officials.[Footnote 3] We conducted structured interviews with senior
government officials from food safety, agriculture, and health agencies
and with representatives of food industry and consumer organizations,
reviewed and analyzed the documents they provided, and reviewed World
Health Organization and GAO reports. We also met with European Union
(EU) food safety officials to discuss how the EU's food legislation is
affecting its member countries' decisions to consolidate, as well as
how the EU interacts with food safety agencies in member
countries.[Footnote 4] The information on countries' food safety
systems in this report, including descriptions of laws, is based almost
exclusively on interviews with and documentation provided by high-level
food safety officials as well as food industry or consumer stakeholders
from the seven countries we examined. Most of the information we
obtained was qualitative. To the extent possible, we corroborated the
qualitative information provided by government officials by
interviewing food industry and consumer organization stakeholders. We
obtained very limited quantitative information. We asked government
officials questions intended to help us assess the reliability of the
quantitative information they provided, but we could not determine the
reliability of most of this information because of constraints on the
amount of time the countries' food safety officials could devote to our
study. Although we could not assess the quantitative information's
reliability, we are reporting it in order to provide descriptive
information that will inform policymakers in the United States about
the various approaches, challenges, and benefits that countries'
officials identified to us regarding their consolidation efforts.
Appendix I provides more information on our scope and methodology. We
conducted our work from April 2004 through December 2004 in accordance
with generally accepted government auditing standards.
Results in Brief:
The seven countries we examined have taken various approaches to
consolidate their food safety systems. Each of the seven countries we
reviewed established a single agency to lead food safety management or
enforcement of food safety legislation and modified existing food
safety laws, although their approaches and the extent to which they
consolidated differed. For example, Denmark centralized its system by
creating a new federal agency in which it consolidated almost all the
food safety functions and activities, including inspections, which were
previously distributed among several government agencies. In contrast,
Germany's new agency functions as a coordinating body to lead food
safety management and formulate general administrative rules to guide
the implementation of national food safety laws by the German federal
states.[Footnote 5] The German federal states continue to be
responsible for overseeing food inspections performed by local
governments. The two major factors motivating countries to consolidate
their food safety systems were public concern about food safety and a
need to improve program effectiveness and efficiency. For example, in
the United Kingdom, consolidation occurred primarily in response to a
loss of consumer confidence resulting from the outbreak of mad cow
disease, and in Canada, consolidation was intended to achieve greater
program effectiveness and reduce expenditures. A third important
motivating factor for the EU countries has been the need to comply with
recently adopted EU legislation. These EU changes aim to harmonize and
simplify its food safety legislation and to create a single,
transparent set of food safety rules that is applicable to all EU
member countries.
In reorganizing their food safety systems, several countries cited
challenges in two areas. First, many countries had to consider whether
to place the new agency within the existing health or agriculture
ministry or establish it as a stand-alone agency while also determining
what responsibilities the new agency would have. For example, Ireland
chose to place its new food safety agency in its existing Department of
Health and Children, in part, to separate food safety responsibility
from the promotion of the food industry, which is the responsibility of
the Department of Agriculture and Food. On the other hand, to separate
food safety regulation from political pressures, New Zealand
established a semi-autonomous food safety agency. A second challenge,
cited by officials in several countries, was helping employees
assimilate into the new agency's culture and support its priorities. To
foster the development of a common organizational culture, food agency
officials in Denmark moved employees to centralized locations and held
monthly meetings to familiarize them with the mission and culture of
the organization.
Although none of the countries has formally analyzed its consolidation
results, the government officials and stakeholders we interviewed in
each of the seven countries stated that the overall effect of
consolidation has been or will likely be positive. None of the
countries has conducted an analysis to compare the effectiveness and
efficiency of its consolidated food safety system with that of the
previous system. For example, officials stated they could not determine
whether their country's consolidation had reduced foodborne illness
because consolidation was only one of many factors that could influence
the frequency of foodborne illness. Furthermore, it may be too early to
fully assess the benefits of consolidation for several of the countries
because their new food safety structures have been functioning for 3
years or less. Although limited, some information on costs and benefits
was available. As expected, most countries incurred start-up costs in
reorganizing. These expenditures were used for purposes such as
acquiring buildings and purchasing laboratory equipment. Some countries
experienced a temporary reduction in the quantity of food safety
activities performed due to consolidation-related disruptions. However,
government officials in each of the seven countries believe that these
consolidation costs have been or will likely be exceeded by the
benefits. Specifically, these officials, as well as stakeholders in
each country, consistently stated that consolidation of their food
safety systems has led to significant qualitative improvements in food
safety operations that enhance effectiveness or efficiency. For
example, government officials and stakeholders cited such benefits as
reduced overlap in inspections, more targeted inspections based on food
safety risk, more consistent or timely enforcement of food safety laws
and regulations, and greater clarity in responsibilities. Government
officials in Canada, the Netherlands, and Denmark stated that some cost
savings may be achieved as a result of changes that have already taken
place or are expected from planned changes needed to complete their
consolidation efforts. For example, in the Netherlands officials said
that reduced duplication in food safety inspections would likely result
in decreased food safety spending. Dutch officials also said that they
anticipate savings to be derived from an expected 25 percent reduction
in administrative and management personnel and from selling excess
property.
In commenting on a draft of this report, HHS and USDA stated that they
are working together effectively to ensure food safety and pointed out
limitations related to the information available for our study. For
example, both agencies said the report does not contain cost-benefit
analyses of countries' consolidations, and USDA said the report does
not have information on causal relationships between consolidation and
quantifiable public health benefits, such as changes in the incidence
of foodborne illness. They also said that these countries'
consolidation experiences have or may have limited applicability to the
U.S. food safety system because the countries have smaller food and
agriculture industries than the United States. Our report clearly
acknowledges that the countries provided limited quantitative data on
the costs and benefits of consolidation and points out that the
information presented is based on structured interviews with high-level
officials, documentation they provided, and interviews with food
industry or consumer stakeholders from each of the seven countries we
reviewed. As our report states, government officials, as well as food
industry and consumer stakeholders, consistently stated that
consolidation of their food safety systems has led to significant
improvements in food safety operations that enhance effectiveness and
efficiency. In addition, our report clearly states that the countries
we reviewed are smaller than the United States, but it also notes that,
similar to the United States, they are high-income countries where
consumers have high expectations for food safety. Consequently, we
believe this report provides useful information on countries'
experiences, particularly with regard to the qualitative improvements
in food safety operations cited by government officials.
Background:
While the U.S. food supply is generally safe, each year, according to a
Centers for Disease Control and Prevention (CDC) estimate, tens of
millions of Americans become ill and thousands die from eating unsafe
food. Furthermore, USDA's Economic Research Service has estimated that
the costs associated with foodborne illnesses are about $7 billion,
including medical costs and productivity losses from missed work.
The safety and quality of the U.S. food supply is governed by a complex
system that is administered by 15 agencies. The principal federal
agencies with food safety responsibilities operate under numerous
statutes underpinning the federal framework for ensuring the safety and
quality of the food supply in the United States. These laws give the
agencies different regulatory and enforcement authorities, and about 70
interagency agreements aim to coordinate the combined food safety
oversight responsibilities of the various agencies. The federal system
is supplemented by the states, which have their own statutes,
regulations, and agencies for regulating and inspecting the safety and
quality of food products.
USDA and FDA have primary responsibility for ensuring the safety of
foods. USDA's Food Safety and Inspection Service regulates meat,
poultry, and certain egg products, and FDA regulates the safety of all
other foods, including milk, seafood, and fruits and vegetables. The
Environmental Protection Agency (EPA) sets limits on the amount of
pesticide residues that are allowed in food, and the National Marine
Fisheries Service within the Department of Commerce provides fee-for-
service inspections to ensure the safety and/or quality of commercial
seafood. Similarly, USDA's Agricultural Marketing Service (AMS)
performs food quality assurance inspections that include food safety
elements. In addition to their established food safety
responsibilities, USDA, FDA, and EPA, along with the Department of
Homeland Security, have begun to address food security.[Footnote 6]
Figure 1 summarizes the 15 agencies and their food safety
responsibilities.
Figure 1: U.S. Federal Agencies' Food Safety Responsibilities:
[See PDF for image]
[A] According to USDA, AMS has no statutory authority in the area of
food safety. However, AMS 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 attack. 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 direction on how to protect the U.S. food supply from
deliberate contamination.
[End of figure]
Many proposals have been made to consolidate the U.S. food safety
system, but to date no action has been taken. Several bills introduced
in the Congress, reports by the National Academy of Sciences and the
National Commission on the Public Service, and several of our reports
and testimonies have proposed consolidation of the U.S. food safety
system. For example, in 2001, parallel Senate and House bills proposed
consolidating inspections and other food safety responsibilities in a
single independent agency. In 2004, legislation was again introduced in
the Senate and the House to establish a single food safety agency to
protect public health, ensure food safety, and improve research and
food security. This proposed legislation would combine the two food
safety regulatory programs of USDA and FDA, along with a voluntary
seafood inspection program operated by the Department of Commerce. The
proposed new food safety program would have been based on a
comprehensive analysis of the hazards associated with different foods
and their processing and would require, among other things, the
enforcement of the adoption of process controls in food establishments
as well as the establishment and enforcement of science-based standards.
In 1998, the National Academy of Sciences recommended integrating the
U.S. food safety system and suggested several options, including a
single food safety agency.[Footnote 7] More recently, the National
Commission on the Public Service recommended that government programs
that are designed to achieve similar outcomes be combined into one
agency and that agencies with similar or related missions be combined
into large departments.[Footnote 8] The Commission chairman testified
before a House subcommittee that important health and safety
protections fail when responsibility for regulation is dispersed among
several departments, as is the case with the U.S. food safety system.
The division of responsibility among several government agencies
responsible for food safety is not unique to the United States. Food
safety officials in the countries we selected for this review said they
faced similar divisions of responsibilities and that their countries'
reorganizations were intended to address this problem.
Although the seven countries whose food safety systems we reviewed are
much smaller in population than the United States, they, like the
United States, are high-income countries[Footnote 9] where consumers
have very high expectations for food safety. Table 1 presents data on
population, size of economy, food expenditures, and consumer spending
for food as a percentage of total consumer spending for the seven
countries and the United States. The table shows that U.S. consumers'
spending on food as a percentage of their total spending is somewhat
similar to that of the other seven countries, ranging from about 10
percent in the United States to over 16 percent in Ireland and the
United Kingdom. In general, high-income countries tend to spend a
smaller percentage of their income on food than low-income countries.
For instance, in low-income countries consumers' spending for food
often exceeds 50 percent of their total spending.[Footnote 10]
Table 1: Comparison of Selected Countries' Population, Gross Domestic
Product (GDP), Total Food Consumption, per Capita GDP, and Spending for
Food as a Percentage of Total Spending:
Country: Canada;
Population[A]: (2004): 32,507,874;
Size of economy (2003 GDP[B]): (dollars in millions): $834,390;
Total food consumption[C]: (2003): (dollars in millions): $45,375;
Per capita GDP[D]: (2003): $27,097;
Spending for food as a percentage of total spending[E]: 11.68%.
Country: Denmark;
Population[A]: (2004): 5,413,392;
Size of economy (2003 GDP[B]): (dollars in millions): $212,404;
Total food consumption[C]: (2003): (dollars in millions): $12,430;
Per capita GDP[D]: (2003): 39,497;
Spending for food as a percentage of total spending[E]: 14.02%.
Country: Germany;
Population[A]: (2004): 82,424,609;
Size of economy (2003 GDP[B]): (dollars in millions): $2,400,655;
Total food consumption[C]: (2003): (dollars in millions): $162,251;
Per capita GDP[D]: (2003): $29,137;
Spending for food as a percentage of total spending[E]: 13.09%.
Country: Ireland;
Population[A]: (2004): 3,969,558;
Size of economy (2003 GDP[B]): (dollars in millions): $148,553;
Total food consumption[C]: (2003): (dollars in millions): $5,018;
Per capita GDP[D]: (2003): $38,864;
Spending for food as a percentage of total spending[E]: 16.59%.
Country: Netherlands;
Population[A]: (2004): 16,318,199;
Size of economy (2003 GDP[B]): (dollars in millions): $511,556;
Total food consumption[C]: (2003): (dollars in millions): $27,659;
Per capita GDP[D]: (2003): $31,759;
Spending for food as a percentage of total spending[E]: 13.29%.
Country: New Zealand;
Population[A]: (2004): 3,993,817;
Size of economy (2003 GDP[B]): (dollars in millions): $76,256;
Total food consumption[C]: (2003): (dollars in millions): $5,525;
Per capita GDP[D]: (2003): $19,350;
Spending for food as a percentage of total spending[E]: 15.19%.
Country: United Kingdom;
Population[A]: (2004): 60,270,708;
Size of economy (2003 GDP[B]): (dollars in millions): $1,794,858;
Total food consumption[C]: (2003): (dollars in millions): $104,550;
Per capita GDP[D]: (2003): $30,355;
Spending for food as a percentage of total spending[E]: 16.37%.
Country: United States;
Population[A]: (2004): 293,027,571;
Size of economy (2003 GDP[B]): (dollars in millions): $10,881,609;
Total food consumption[C]: (2003): (dollars in millions): $564,040;
Per capita GDP[D]: (2003): $36,924;
Spending for food as a percentage of total spending[E]: 9.73%.
Source: GAO using various sources cited below.
Note: For each data source, the table shows most recent year available
from the source.
[A] Central Intelligence Agency, The World Factbook, Field Listing-
Population, July 2004 estimates, ([Hyperlink,
http://www.cia.gov/cia/publications/factbook/fields/2119.html]).
[B] World Development Indicators database, World Bank, September 2004
World Bank, [Hyperlink,
http://www.worldbank.org/data/databytopic/GDP.pdf]. Gross Domestic
Product is the market value of the goods and services produced by labor
and property located in a particular country.
[C] Consumer expenditure amounts, except for the United States, are
from national statistical offices/OECD/Eurostat/Euromonitor for 2003.
The amount for 2003 for the United States is from the Economic Research
Service, USDA. All amounts are for expenditures of food and
nonalcoholic beverages brought into the home.
[D] United Nations, Department of Economics and Statistics Division,
Indicators on Income and Economic Activity. All amounts are for 2003
and were last updated in December 2004.
[E] ERS/USDA Data - International Food Consumption Patterns,
[Hyperlink, http://www.ers.usda.gov/data/InternationalFoodDemand]. Food
budget shares are estimated across 114 countries using 1996 data for
nine major consumption groups and eight food subgroups including bread
and cereals; meat; fish; dairy products; fats and oils; fruit and
vegetables; beverages and tobacco; and other food products.
[End of table]
Most of the countries we selected for this review are members of the
EU[Footnote 11] and, as such, must abide by EU food safety legislation.
The development and implementation of EU food safety legislation is the
responsibility of the Health and Consumer Protection Directorate
General. In 2002, to respond to consumer concerns about the safety of
the food supply, the EU created a new independent food safety
institution, the European Food Safety Authority (EFSA), which is
responsible for providing independent, scientific advice on all matters
linked to food and animal feed safety. The tasks performed by EFSA
include communicating with the public on food safety matters and
providing risk assessments to the European Commission, the European
Parliament, and the EU Member States.
In addition to creating EFSA in April 2004, the EU adopted additional,
comprehensive food safety legislation[Footnote 12] that becomes
effective, in large part, on January 1, 2006. Together with the earlier
regulation establishing EFSA, the legislation is intended to create a
single, transparent set of EU food safety rules applicable to all food,
including animal and nonanimal products. The legislation covers the
entire food supply chain from production to consumption and places more
requirements on EU member nations. It identifies specific food safety
objectives and, unlike much of the EU's previous food safety
legislation, specifies the methods by which those objectives must be
achieved. For example, it requires food business operators to adopt
specific hygiene measures and a permanent procedure or procedures based
on Hazard Analysis and Critical Control Point principles.[Footnote 13]
Moreover, the legislation requires that each EU country establish and
implement an official food and animal feed control plan by January 1,
2007. Thereafter, an annual report on the implementation of this
national control plan must be submitted. To carry out its official
controls over food and animal feed, a country must designate
responsible entities. If a country has more than one responsible
entity, it must ensure effective coordination between these entities.
According to a paper presented at a 2004 international forum for food
safety regulators, in recent years many EU countries have chosen to
establish a national food safety authority, but the establishment of
such an authority is not obligatory.[Footnote 14]
Countries Have Taken Various Consolidation Approaches, and Officials
and Stakeholders Cited Challenges and Costs but Believe Food Safety
Systems Are Now More Effective:
The seven countries we examined had two primary reasons for
reorganizing and consolidating their food safety systems, took various
approaches, and often faced similar challenges. While the extent to
which countries consolidated their food safety systems varied
considerably, each country established a single agency to lead food
safety management or enforcement of food safety legislation.[Footnote
15] Although most countries incurred some consolidation start-up costs,
government officials, as well as food industry and consumer
stakeholders, generally agree that consolidation has led to significant
qualitative improvements in the effectiveness or efficiency of their
food safety systems. Our ability to evaluate these improvements and
other information officials provided was limited because none of the
countries has conducted an analysis to measure the effectiveness and
efficiency of its consolidated food safety system relative to that of
the previous system. In some cases, it may be too early to fully assess
the benefits of the countries' consolidations.
The seven countries whose reorganizations we reviewed consolidated
their food safety systems primarily to improve program effectiveness
and efficiency or to respond to public concern about food safety.
According to a 1998 National Research Council report,[Footnote 16] an
effective food safety system protects and improves the public health by
ensuring that foods meet science-based safety standards through the
integrated activities of the public and private sectors. This report
also addresses efficiency, stating the greatest strides in ensuring
food safety from production to consumption can be made through a
scientific risk-based system that ensures that surveillance,
regulatory, and research resources are allocated to maximize
effectiveness. Public concern about food safety became an important
issue in several industrialized countries during the 1990s when bovine
spongiform encephalopathy (BSE), commonly known as mad cow disease, was
confirmed in large numbers of cattle.[Footnote 17] In addition to
improving effectiveness and efficiency and responding to public concern
about food safety, some EU countries were further prompted to
consolidate by the need to comply with recently approved EU food safety
legislation that becomes effective, in large part, January 1, 2006. The
new legislation places more requirements on EU member countries. For
example, each EU member country will be required to submit and annually
update a plan for the implementation of the new law and to report
annually on the implementation of that plan.
Regarding consolidation approaches, each country established a single
agency to lead food safety management or enforcement of food safety
legislation. Each country modified its existing legal framework to give
legal authority and responsibility to the new food safety agency.
However, countries' approaches in consolidating their food safety
systems varied, particularly with respect to how comprehensively food
safety functions were consolidated. For example, Denmark centralized
its system by creating a new federal agency in which it consolidated
almost all its food safety functions and activities, including food
inspections, which were previously distributed among several federal
and local government agencies. On the other hand, in Germany, which
established a new lead food safety agency, the 16 federal states
continue to be responsible for oversight of food inspections performed
by local governments. Germany's new food safety agency functions as a
coordinating body to lead food safety management, including formulation
of general administrative rules to guide the federal states'
implementation of national food safety laws.
In reorganizing their food safety systems, officials from several
countries cited challenges in two areas. First, many countries faced a
similar decision regarding whether to place the new agency within the
existing health or agriculture ministry or establish it as a stand-
alone agency while also determining what responsibilities the new
agency would have. A second challenge, cited by officials in several
countries, was helping employees assimilate into the new agency's
culture and support its priorities.
Although countries have not formally analyzed consolidation results,
the government officials and stakeholders we interviewed in each of the
seven countries cited improvements in food safety system operations and
stated that the net effect of consolidation has been or will likely be
positive. None of the countries has conducted an analysis to measure
the effectiveness and efficiency of its consolidated food safety system
relative to that of the previous system. For example, officials stated
that they could not determine whether their country's consolidation had
resulted in public health benefits, such as reduced foodborne illness,
because consolidation was only one of many factors that could affect
the frequency of foodborne illness. Furthermore, it may be too early to
fully assess the benefits of consolidation for several of the
countries, as their countries' new food safety structures have been
functioning for 3 years or less. Although limited, some information on
costs and benefits was available. As expected, most countries incurred
start-up costs, which included, for example, the acquisition of
buildings and purchases of laboratory equipment. Some countries
experienced a temporary reduction in the quantity of food safety
activities performed due to consolidation-related disruptions. However,
government officials in each of the seven countries believe the
benefits of their consolidations have exceeded or will likely exceed
the costs. In particular, these officials, as well as food industry and
consumer stakeholders in each country, consistently stated that
consolidation of their food safety systems has led to significant
qualitative improvements in food safety operations that enhance
effectiveness or efficiency. These improvements include the reduction
of overlapping food safety activities, such as inspections of food
establishments by various agencies. (Figure 2 summarizes each country's
improvements in food safety operations as cited by government
officials, food industry stakeholders, or consumer stakeholders.)
Moreover, government officials in Canada, the Netherlands, and Denmark
stated that some cost savings may be achieved as a result of changes
that have already taken place or are expected from planned changes
needed to complete their consolidation efforts.
Figure 2: Improvements in Food Safety Operations Cited by Government
Officials or Stakeholders:
[See PDF for image]
Note: The improvements listed are based on structured interviews with
food safety officials and food industry and consumer stakeholders.
[End of figure]
Figures 3 through 9 show summary information on each country's reasons
for consolidation, entities responsible for food safety before and
after consolidation, challenges, and start-up[Footnote 18] and other
consolidation-related costs, as well as examples of consolidation
benefits. This information was provided by government officials and
food industry or consumer stakeholders. For more detailed information
on each country, see appendixes II through VIII.
Figure 3: Summary of Canada's Food Safety System Consolidation:
[See PDF for image]
[A] The Canadian Food Inspection Agency is also responsible for food
quality assurance inspections and animal and plant disease control.
[B] Health Canada's responsibilities include research, risk assessment
and standard setting in relation to the nutritional quality of foods
marketed in Canada.
[C] An international review supported this assessment, stating the
investigation was comprehensive, thorough, and timely. In addition,
food industry stakeholders said the government's response to BSE was
very effective.
[End of figure]
Figure 4: Summary of Denmark's Food Safety System Consolidation:
[See PDF for image]
[End of figure]
Figure 5: Summary of Germany's Food Safety System Consolidation:
[See PDF for image]
[A] Research has found that acrylamide, a carcinogen, may be formed in
starch-containing foods when they are baked or fried.
[End of figure]
Figure 6: Summary of Ireland's Food Safety System Consolidation:
[See PDF for image]
[A] Ireland's start-up costs as a percentage of its total food safety
budget could not be estimated.
[End of figure]
Figure 7: Summary of the Netherlands' Food Safety System Consolidation:
[See PDF for image]
[A] The Netherlands plans to merge its two inspection offices into one
national inspection office within its food safety agency, the Food and
Consumer Product Safety Authority.
[End of figure]
Figure 8: Summary of New Zealand's Food Safety System Consolidation:
[See PDF for image]
[A] The Trans-Tasman Mutual Recognition Arrangement is an arrangement
between the Commonwealth, State and Territory Governments of Australia
and the Government of New Zealand. According to its 1998 guide, the
Arrangement allows goods to be traded freely between New Zealand and
Australia.
[B] New Zealand has not compiled information on its total 2002 food
safety spending because several entities had food safety
responsibilities. According to officials, NZFSA's fiscal year 2004-2005
budget is about $78 million New Zealand (about $53 million U.S.).
[End of figure]
Figure 9: Summary of the United Kingdom's Food Safety System
Consolidation:
[See PDF for image]
[A] According to an FSA official, reserve powers range from providing
help and guidance by directing the way in which the local authority
operates to performing the local authority's services.
[End of figure]
Concluding Observations:
Although different in many respects, the seven countries' experiences
provide information on the reform and consolidation of food safety
systems that can be useful to U.S. policymakers. While the seven
countries had to overcome challenges, their experiences show that
reforming and streamlining food safety systems is possible when a
consensus exists among government agencies, the food industry, and
consumer organizations. As we learned from food safety officials and
industry and consumer stakeholders in each country we reviewed, such
reforms may result in benefits such as reducing overlaps in food safety
inspections and basing the frequency of inspections on the risks posed
by specific products. We have reported in the past that the federal
food safety system in the United States could benefit from statutory
and organizational reforms. As Congress and other policymakers consider
the advantages and disadvantages of streamlining multiple existing food
safety statutes into a uniform and risk-based framework and whether to
consolidate federal food safety functions under a single agency, these
countries' lessons may offer useful information.
Comments from the Seven Countries Examined:
We provided relevant excerpts from a draft of this report to officials
of food safety agencies in Canada, Denmark, Germany, Ireland, the
Netherlands, New Zealand, and the United Kingdom for their review. The
officials either replied that they had no technical comments or
provided technical corrections, which we incorporated into the report
as appropriate.
Agency Comments and Our Evaluation:
Although this report does not evaluate HHS's or USDA's food safety
programs and, therefore, makes no recommendations to the agencies, we
provided a draft copy to HHS and USDA for review and comment. In
commenting on this report, both HHS and USDA stated that U.S. food
safety agencies are working together effectively.
HHS noted that our report provides limited quantitative data on the
results of each country's consolidation. The report clearly states that
the information presented was obtained primarily through structured
interviews with high-level government officials and food industry and
consumer stakeholders from each of the seven countries we reviewed. In
addition, our report acknowledges that these officials provided limited
quantitative data; when it was provided to us, we included it in the
report. Our report also acknowledges that none of the countries has
conducted a formal analysis to compare the effectiveness and efficiency
of its consolidated food safety system with that of the previous
system. HHS also commented that the countries included in our report
have smaller food and agriculture industries than the United States. We
agree, and our report highlights such differences in table 1, which
shows that the seven countries have smaller economies and less total
food consumption than the United States. Our report also points out,
however, that these countries are similar to the United States in that
they are high-income countries where consumers have high expectations
for food safety. Finally, HHS commented that the report does not
identify the agencies that are responsible for foodborne illness
surveillance in each of the countries we reviewed. We have added a
footnote to indicate that the report does not contain that information.
HHS also provided technical comments, which we have incorporated in the
report as appropriate. HHS's comments are presented in appendix IX.
In its comments, USDA stated that the report does not contain rigorous
cost-benefit analyses or quantitative data on the public health effects
of the countries' consolidations, such as changes in foodborne illness
rates. Our report clearly acknowledges that we obtained limited
quantitative information and that none of the countries has conducted
an analysis to compare the effectiveness and efficiency of its
consolidated food safety system with that of the previous system.
Specifically, with regard to the effect of consolidation on public
health benefits, the report states that officials told us they could
not determine whether their country's consolidation had reduced
foodborne illness because consolidation was one of many factors that
could influence the frequency of foodborne illness. USDA also stated
that the report does not contain quantitative data on reorganization
costs. This statement is incorrect. All but one of the seven countries
provided information on the costs of reorganization, which the report
presents in figures 3 through 9. Similar to HHS, USDA commented that
the countries we reviewed have much smaller populations and also differ
from the United States in climate and agricultural production. Our
report identifies differences of this type in table 1. The report
points out, however, that these countries and the United States have at
least one important similarity: they are high-income countries where
consumers have high expectations for food safety. As a result, we
believe the consolidation experiences of the countries reviewed have
applicability to the United States. USDA also provided technical
comments, which we incorporated into the report as appropriate. USDA's
comments are included in appendix X.
We are sending copies of this report to the appropriate congressional
committees, the Secretaries of Agriculture and of Health and Human
Services, and other interested parties. We will also make copies
available to others upon request. 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 about this report, please call
me at (202) 512-3841. Key contributors to this report are listed in
appendix XI.
Signed by:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
[End of section]
Appendixes:
Appendix I: Scope and Methodology:
This report describes the approaches the seven countries have taken in
consolidating food safety functions, the challenges they faced, and the
results of the countries' efforts, including benefits and costs cited
by government officials and industry or consumer stakeholders.
For the purposes of this report, we defined consolidation as the
transfer of responsibility and resources for performing a food safety
function from two or more agencies to a single agency.
To identify countries that have consolidated their food safety systems,
we interviewed USDA and FDA officials, reviewed a 2001World Health
Organization report on how countries have organized their food safety
systems,[Footnote 19] and reviewed the Internet sites of countries'
food safety agencies. We selected a judgmental sample of seven
countries for our review based on the following criteria: USDA and FDA
officials agreed that these countries have consolidated, the countries
have high per capita income, and the countries have consolidated
functions of their food safety system within the last 10 years.
To address our objective, we examined the seven countries' efforts to
streamline and consolidate their food safety systems, including the
benefits and costs that resulted, as cited by government officials. We
conducted structured interviews with senior government officials from
food safety agencies and with representatives of food industry or
consumer organizations in each country, reviewed and analyzed the
documents they provided, and reviewed World Health Organization and GAO
reports. We also met with European Union (EU) food safety officials to
discuss how the EU's food legislation is affecting its member
countries' decisions to consolidate, as well as how the EU interacts
with food safety agencies in member countries.
The information on countries' food safety systems in this report,
including descriptions of laws,[Footnote 20] is based almost
exclusively on interviews with and documentation provided by high-level
food safety officials as well as food industry or consumer stakeholders
from the seven countries we examined. Most of the information we
obtained was qualitative. To the extent possible, we corroborated the
qualitative information provided by government officials by
interviewing food industry and consumer organization stakeholders. We
obtained very limited quantitative information. We asked government
officials questions intended to help us assess the reliability of the
quantitative information they provided, but we could not determine the
reliability of most of this information because of constraints on the
amount of time the countries' food safety officials could devote to our
study. Although we could not assess the quantitative information's
reliability, we are reporting it in order to provide descriptive
information to inform policymakers in the United States about the
various approaches, challenges, and benefits that countries' officials
identified to us regarding their consolidation efforts.
The data in table 2 on selected countries' population, gross domestic
product, food consumption, income, and consumer spending were used for
background purposes and were not verified.
We conducted our work from April 2004 through December 2004 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: Canada's Food Safety System Consolidation:
In 1997, Canada consolidated its food inspection activities with the
creation of the Canadian Food Inspection Agency. Food safety standard
setting, research, and risk assessment were consolidated within Health
Canada.
Reasons for Consolidating Food Safety Responsibilities:
Canada consolidated its food safety system to (1) improve effectiveness
by making inspections and enforcement more consistent, clarifying
responsibilities, and enhancing reporting to the Canadian parliament,
(2) improve efficiency by reducing duplication and overlap in food
safety activities, and (3) reduce federal spending.
Responsibilities and Structure Before and After Consolidation:
Before Canada consolidated its food safety system, its food safety
inspection, food policy, and risk assessment responsibilities were
shared by three separate entities--Health Canada, Agriculture and Agri-
Food Canada, and Fisheries and Oceans Canada.
In 1997, the Canadian parliament approved the Canadian Food Inspection
Agency (CFIA) Act. All food safety inspection activities were assigned
to CFIA, a separate regulatory agency whose president reports to the
Minister of Agriculture and Agri-Food Canada. CFIA is responsible for
all food safety inspections and related activities, including
inspections of imported and domestic products, export certifications,
laboratory and diagnostic support, crisis management, and product
recalls. CFIA is also responsible for food quality assurance
inspections and animal health and plant disease control. Canada has
adopted a comprehensive farm-to-table approach to food safety
responsibilities.
Public health policy and standard-setting responsibilities including
research, risk assessment, and setting limits on the amount of a
substance allowed in a food product, were consolidated within Health
Canada.[Footnote 21] With the placement of food safety inspections and
related activities in CFIA and risk assessment in Health Canada,
inspection responsibilities were separated from risk assessment to
allow for an independent scientific risk assessment process.
Legislation:
In 1997, the Canadian Food Inspection Agency Act created the agency and
gave it authority to implement existing food safety laws. Additional
legislative reform intended to increase the food safety system's
effectiveness and efficiency beyond the gains already achieved was
introduced in the Canadian parliament in November 2004.[Footnote 22]
According to CFIA, under this proposed legislation, the authorities for
CFIA inspectors contained in eight commodity-specific laws would be
strengthened and made consistent. In addition, the law would give CFIA
additional inspection and enforcement authorities to protect the food
supply, such as the authority to hold products while awaiting test
results.
Challenges:
CFIA faced a challenge in helping staff adjust to a new organization as
its work force combined former employees from the health, agriculture,
and fisheries departments. According to officials, several senior
officials retired when CFIA was being formed. As a result, the agency
temporarily had less experience at the management level than would have
been optimal. Canadian officials told us it is important to plan for
the merging of organizational cultures and to bring the new work force
into a dialogue on the new organization's vision and objectives.
Employee unions were initially concerned that the consolidation would
lead to privatization of the food safety work force. According to a
CFIA official, these concerns decreased substantially when the work
force realized privatization was not planned. In addition, the official
stated that labor relations have improved because unions now only have
to interact with one food safety inspection agency instead of three.
In addition, assignment of responsibilities was a major obstacle during
the implementation phase of Canada's consolidation. To address this
challenge, Health Canada and CFIA jointly developed a food safety
functions matrix to clearly define responsibilities.
Annual Expenditures and Number of Employees:
According to a senior official, CFIA's fiscal year 2003 food safety
spending was $360 million Canadian ($232 million U.S.). Spending for
all of its activities--food safety, animal health, and plant
protection--was $517 million Canadian ($334 million U.S.). User fees
assessed on food establishments financed a portion of this spending.
These user fees for food inspections have been frozen at about $40
million Canadian (about $26 million U.S.) since 1997 and in fiscal year
2003 accounted for about 11 percent of CFIA's food safety spending.
According to a Health Canada official, the fiscal year 2004 budget for
Health Canada's food program was about $42 million Canadian ($31
million U.S.).
Reducing spending was one of Canada's objectives in consolidating its
food safety system. A senior CFIA official stated that during the
agency's first two years, fiscal years 1997 and 1998, the consolidation
reduced food safety operating expenditures by 10 percent relative to
preconsolidation food safety spending.[Footnote 23] The official based
this statement on his knowledge of food safety operating expenditures
before and after the consolidation. The official noted that Canada has
not performed an analysis on the effect of its consolidation on food
safety expenditures. According to the official, such an analysis would
be difficult because (1) the last audited preconsolidation
quantification of food safety expenditures was published in a 1994
report by Canada's Office of the Auditor General and (2) in fiscal year
1997, when the CFIA was formed, food safety, animal health, and plant
health expenditures were not separated in financial reports. The agency
began separating these expenditures in financial reports beginning in
fiscal year 2000.
According to the CFIA official, CFIA's work force consisted of about
5,300 employees in fiscal year 2003. According to a Health Canada
official, the Health Canada food program had approximately 400 staff in
fiscal year 2004.
Stakeholder Reaction:
The food industry stakeholders we interviewed were consistently
supportive of Canada's consolidation. Among the consolidation-related
benefits they cited were improved communications, particularly with
respect to food recalls; easier interaction with regulators through
having a single contact for enforcement and compliance; fewer
inspectors visiting processing plants; clarification of
responsibilities; and increased consistency in the enforcement of food
safety laws.
While expressing overall support for the consolidation, representatives
of some food industry organizations cited a need for more timely
decision making. For example, representatives of one organization said
their member companies, which, they said, often have more technical
expertise than the government authorities on specific matters,
sometimes have to wait too long for a decision on a food safety
question and lose commercial opportunities as a result. In addition,
some industry representatives said Health Canada's setting of standards
should better reflect CFIA's ability to enforce the standards.
[End of section]
Appendix III: Denmark's Food Safety System Consolidation:
In 1997, Denmark consolidated its food safety system with the creation
of the Danish Veterinary and Food Administration.
Reasons for Consolidating Food Safety Responsibilities:
Denmark consolidated its food safety system to (1) improve
effectiveness in several areas, including communications with consumers
and consistency of inspections and (2) improve efficiency in numerous
ways, such as by moving resources to areas that present higher risks
and reducing overlaps in responsibilities.
Responsibilities and Structure Before and After Consolidation:
Before Denmark consolidated its food safety system, responsibilities
for inspections were shared by multiple entities, including the
Ministry of Agriculture, the Ministry of Fisheries, and a large number
of municipalities. Standard-setting responsibilities were shared by the
Ministry of Health, the Ministry of Agriculture, and the Ministry of
Fisheries.
In 1997, the Danish government consolidated the multiple agencies'
activities into the Danish Veterinary and Food Administration (DVFA),
an agency of the newly formed Ministry of Food, Agriculture, and
Fisheries. Inspections were consolidated within the DVFA in 1999 and
2000. In August 2004, as part of a governmental reorganization, the
Danish Veterinary and Food Administration was moved to the newly
created Ministry of Family and Consumer Affairs.
The DVFA is responsible for almost all food safety responsibilities.
For logistical reasons, a few duties were not moved to the new agency
in 1999 and 2000. These remaining duties are with the Plant
Directorate, which is responsible for animal feed inspections, and the
Directorate for Fisheries, which is responsible for inspections of fish
on ships. These two agencies are in the Ministry of Food, Agriculture,
and Fisheries. According to officials, the DVFA has farm-to-table food
safety responsibilities.
Denmark has separated risk management and risk assessment. The Danish
Institute for Food and Veterinary Research, a separate institute within
the DVFA, is responsible for research and risk assessment.
Legislation:
The Danish Food Act, adopted in 1998, reformed Danish food safety law
by replacing seven existing food laws with this single law. The
legislation harmonizes the regulation of food of animal origin and
other food, and, according to Danish officials, it is very similar to
EU food legislation.
Challenges:
Officials said when bringing employees from several agencies into a new
organization, it is important to establish a common culture. The
consolidation involved over 2,000 employees, including about 500
municipal inspectors who were moved to the DVFA. To foster the
development of a common organizational culture, food agency officials
moved employees to centralized locations and established online
discussion groups to familiarize employees with the mission and culture
of the organization. In addition, the division heads in the regional
offices held monthly meetings with employees.
Moreover, officials stressed the need to have adequate funding for
start-up costs.
Annual Budget and Number of Employees:
According to officials, DVFA's budget for 2004 was 856 million Danish
kroner (about $142 million U.S.). About 61 percent of this planned
spending was to be financed by user fees assessed on food
establishments. User fees finance nearly all meat inspections.
Officials stated that DVFA had about 2,000 employees (1,820 full-time
equivalents) in 2004.
Stakeholder Reaction:
The food industry and consumer organization representatives we
interviewed told us their organizations supported the proposed
consolidation and continue to support it. They stated that the
consolidation has improved the food safety system's effectiveness.
Improvements cited include more consistent enforcement of food safety
regulations, reduced overlap in inspections, streamlined
communications, clearer responsibilities, and improved service delivery
as a result of having a single contact. For example, a food industry
representative stated that having a single contact leaves no doubt
about which authority to approach when a problem or question arises. In
addition, the representative said Denmark's salmonella control program
is an example of a situation where the consolidation's clearer
responsibilities have been beneficial.[Footnote 24] Without the
consolidation, said the representative, this program probably would
have experienced conflicts between the health and agriculture
ministries and would not have been as successful.
User fees are also an important consideration for the Danish food
industry. As noted earlier, Danish food companies finance a significant
portion of DVFA's spending through payment of user fees. According to
industry officials, the payment of these fees motivated the food
industry to support reforms in the Danish food safety system that would
hold down inspection costs.
According to a consumer organization representative, the consolidation
made food safety inspections and enforcement of laws and regulations
more consistent. Before the consolidation, the representative said,
many municipal food safety entities had insufficient expertise and
resources and the central government's oversight of municipal food
safety entities was uneven. In addition, the representative stated that
the consolidation had facilitated the development of DVFA's online
system to report the results of inspections. The representative
believes having access to inspection reports has contributed to Danish
consumers' continued high confidence in the safety of their food.
[End of section]
Appendix IV: Germany's Food Safety System Consolidation:
The German parliament approved the creation of the Federal Office of
Consumer Protection and Food Safety and the Federal Institute for Risk
Assessment in 2002.
Reasons for Consolidating Food Safety Responsibilities:
Germany consolidated its food safety system in response to public
concerns about food safety stemming from the discovery of BSE in 2000
and other food safety problems. An additional objective was improved
compliance with EU food safety legislation.
Responsibilities and Structure Before and After Consolidation:
Before Germany consolidated its food safety system, responsibilities
for research, risk assessment, and communication were shared by the
Federal Ministry of Health and the Federal Ministry of Food,
Agriculture and Forestry.[Footnote 25] Responsibilities for
implementation of federal legislation and oversight of inspections were
shared by the sixteen federal German states, and inspections were
performed by municipalities and other local governments.
In 2002, the creation of two new food safety agencies was approved by
the German Parliament. Both of the new agencies are in the Federal
Ministry of Consumer Protection, Food, and Agriculture.
The Federal Office of Consumer Protection and Food Safety, a
coordinating body, is responsible for leading food safety risk
management. It serves as Germany's contact point with the European
Commission, including (1) acting as a coordinator for Food and
Veterinary Office audits of compliance with EU food safety legislation
and (2) implementing in Germany the European rapid alert system for
consumer health protection and food safety. In addition, this agency's
responsibilities include coordinating food safety surveillance at the
federal level and formulating general administrative rules to guide the
implementation of national food safety laws by the German federal
states. The federal states continue to be responsible for
implementation of food safety legislation and oversight of food
inspections performed by local governments.
The other new food safety agency is the Federal Institute for Risk
Assessment, whose responsibilities include providing impartial
scientific advice and support for the law-making activities and
policies of the federal government in all fields concerning food safety
and consumer health protection, except for animal diseases. The Federal
Institute for Risk Assessment performs risk assessments and
communicates risk assessment results to the general public. According
to officials, this agency was created to separate risk assessments from
decision making. The purpose of this separation was to increase public
confidence in risk assessments by distancing these assessments from
possible political interference.
A chronology of the consolidation of Germany's food safety system
follows:
* November 2000--The detection of BSE in German cattle and other food
safety issues undermined consumer confidence in the food safety system.
* July 2001--The Federal Performance Commissioner's Report, a study of
the German food safety system, was produced by a German national audit
office task force. The report's three main recommendations were to (1)
reorganize the Federal Ministry of Consumer Protection, Food, and
Agriculture, (2) establish a coordinating body within the federal
government, and (3) establish a scientific unit to perform risk
assessments.
* December 2001--In response to the task force report's second and
third recommendations, administrative guidance issued by the Federal
Ministry of Consumer Protection, Food, and Agriculture established the
Federal Office of Consumer Protection and Food Safety and the Federal
Institute for Risk Assessment as "institutes."
* August 2002--The German parliament approved the Consumer Health
Protection and Food Safety Restructuring Act, authorizing the creation
of these two new food safety agencies.
* November 2002--The Consumer Health Protection and Food Safety
Restructuring Act took effect.
* December 2003--The Federal Office of Consumer Protection and Food
Safety presented the federal states with a draft general administrative
regulation that would harmonize their food safety controls. As of
October 2004, German officials expected these regulations to take
effect in January 2005.
Legislation:
The Consumer Health Protection and Food Safety Restructuring Act, which
took effect in November 2002, separated the fields of risk management
and risk assessment by authorizing the creation of Germany's two new
food safety agencies.
Challenges:
According to officials, negotiations between the federal government and
the federal states concerning reform of food safety law have been
complicated, as some reforms that would give the federal government
increased authority would require constitutional changes.
Annual Budget and Number of Employees:
According to officials, the Federal Office of Consumer Protection and
Food Safety's budgeted spending for 2004 was 25 million euros (about
$31 million U.S.), and the budgeted 2004 spending for the Federal
Institute for Risk Assessment was 47 million euros (about $58 million
U.S.).
In 2004, according to officials, the Federal Office of Consumer
Protection and Food Safety had about 350 employees, and the Federal
Institute for Risk Assessment had about 540 staff.
Stakeholder Reaction:
The German food industry and consumer organization stakeholders we
contacted support the consolidation.
According to a representative of a major food industry organization,
the German food industry supports the creation of the Federal Office of
Consumer Protection and Food Safety because it has increased
coordination of the federal states' food safety activities and has
improved Germany's ability to respond to potential food safety crises.
In addition, to further improve Germany's ability to prevent potential
food safety crises and in view of impending EU legislation, the food
industry advocates increasing the Federal Office of Consumer Protection
and Food Safety's authority to coordinate the federal states' food
safety activities, thus enabling increased harmonization of food safety
standards and control procedures across states. Moreover, the food
industry representative stated that the separation of risk assessment
and risk management has given the food safety system more credibility
in the view of the public and industry.
A representative of the consumer organization we contacted stated that
the consolidation has made the food safety system more effective. In
addition, the representative stated that the consolidation has
increased German consumers' confidence, but added that German consumers
continue to have less confidence than consumers in other European
countries. The consumer organization favors giving the Federal Office
of Consumer Protection and Food Safety increased authority.
[End of section]
Appendix V: Ireland's Food Safety System Consolidation:
In 1998, the Irish government enacted legislation creating the Food
Safety Authority of Ireland. The Authority assumed all responsibility
for food safety in July 1999.
Reasons for Consolidating Food Safety Responsibilities:
Officials stated that Ireland consolidated responsibility for food
safety and food law enforcement within a single national agency to
address public concern about food safety stemming from food scares and
the detection of BSE in Ireland. Maintaining a strong food safety
system is also extremely important for Ireland's economy for several
reasons. According to senior food safety officials, roughly 90 percent
of the country's meat and 75 percent of food is produced for export. If
trading partners lost confidence in the food safety system, thus losing
confidence in the food, exports could decline--even without a major
outbreak. In addition, Ireland's economy depends heavily on tourism,
and outbreaks of foodborne illnesses could affect tourism and cause
serious harm to the economy. Furthermore, when BSE was found in Irish
cattle in the 1990's, Irish consumption of meat declined as consumers
questioned the effectiveness of the Department of Agriculture and Food,
which was responsible for inspections of abattoirs, meatpacking plants,
and farms. Also, some consumers perceived that the Department favored
the interests of the food industry over consumer protection.
Responsibilities and Structures Before and After Consolidation:
According to officials, before the consolidation of Ireland's food
safety system, food safety functions were the responsibility of over 50
entities across the government, including six government departments,
33 local authorities, and eight regional health boards, with no central
government authority to coordinate all of these entities. The
Department of Agriculture and Food, inspected farms, slaughterhouses,
and meat processing facilities for compliance with food safety
regulations and was also responsible for the promotion of the
agriculture industry. Local governments and regional authorities (e.g.,
health boards) had various other food safety responsibilities, such as
inspecting meat plants producing for the home market, production and
processing of food of nonanimal origin and the retail and catering
sectors. In addition, multiple agencies were tasked with enforcing food
safety legislation with no central accountability system in place to
ensure that food safety legislation was being properly enforced or to
coordinate food safety functions and activities across the food supply
chain.
As a result of a series of food scares in the 1990s, the Irish
government undertook a review of its food safety system in 1996 to
assure the safety and quality of their food products. The government's
review eventually led to the establishment of a lead food safety
agency. The government established an interdepartmental committee to
advise the Irish parliament on how the various food safety entities
could best be coordinated. In early 1997, this committee recommended
establishing a Food Safety Authority of Ireland. Under this
recommendation, the responsibility for implementation of food safety
laws would have remained with the existing agencies. The Authority
would have audited these agencies and had a voice in setting and
maintaining standards as well as in promoting good practices. Before
this recommendation was enacted, a new government took office after an
election in mid-1997. The new government believed that the Authority
should be directly accountable for all food safety functions, including
enforcement of food legislation. This proposal led to the establishment
of the Food Safety Authority of Ireland (FSAI), formally established in
law under the Food Safety Authority of Ireland Act, 1998, and beginning
its official operation in January 1999. The legislation which
established the FSAI provides for the transfer of all relevant staff to
the new agency. Alternatively it provides that the FSAI can enter into
a service contract with existing agencies for the enforcement of food
legislation. As the likely personnel issues surrounding the smooth
transfer of staff would have delayed commencement of FSAI's food safety
enforcement role, the service contract mechanism was used. At the time,
roughly 2,000 staff, spread across more than 50 agencies, delivered
food safety services throughout the country. Many staff had duties in
addition to food safety responsibilities and therefore officials found
it difficult to transfer "food safety" personnel to the Authority
without disrupting other programs.
FSAI is an independent, science-based body that reports to the
Department of Health and Children.[Footnote 26] According to officials,
the government deliberately placed the FSAI under the auspices of the
Department of Health and Children rather than the Department of
Agriculture and Food, as the former's focus is on consumer health and
protection, whereas the latter is associated with industry and trade
development and promotion.
A Board of 10 members, appointed by the Minister of Health and
Children, governs FSAI although a chief executive officer leads day-to-
day operations.[Footnote 27] In addition, the agency has a 15 member
scientific committee that assists and advises the Board. See figure 10.
Figure 10: Food Safety Authority of Ireland's Organization:
[See PDF for image]
[End of figure]
FSAI is the single regulatory authority with responsibility for
enforcing food safety legislation in Ireland. This responsibility is
managed through service contracts with agencies performing food safety
activities. FSAI has the responsibility to monitor and audit these
agencies to determine how well they fulfill the tasks laid out in their
service contracts. FSAI meets formally at least three times a year with
each agency's liaison to facilitate monitoring of the service
contracts, and began auditing the agencies on their performance in
fulfilling their service contracts, in the second half of
2004.[Footnote 28]
FSAI has risk assessment, risk management, and risk communication
responsibilities, including setting standards according to the
scientific advice (put forth by the scientific committee), making risk
management decisions with the agencies that are responsible for
conducting food safety inspection and enforcement, and communicating
risks to consumers, the food industry, and public health professionals.
According to officials, FSAI's responsibility for food law enforcement
begins when food or animals are transported from the farm. In the
fisheries and aquaculture sector, it has responsibility for food law at
the level of primary production. However, feed safety and animal
welfare are outside its jurisdiction.
Procedures are in place to deal with food scares and food crises,
should they emerge. Such crisis measures include a 24-hour emergency
number, where local authorities can contact FSAI, as well as a
memorandum of understanding between FSAI and all the agencies with food
safety functions on how to coordinate during a crisis. In addition,
FSAI is the national contact for the EU's rapid alert food safety
system.
Legislation:
According to senior food safety officials, legislative reform of
Ireland's food safety laws was minor. The Food Safety Authority of
Ireland Act, 1998, as well as establishing FSAI, also transferred
authority for enforcement of existing food legislation and setting food
safety and hygiene standards to FSAI. Although food law in Ireland
dates back to the 1800's, most of Ireland's national food legislation
today is derived from Ireland's EU membership.
Challenges:
According to officials, in deciding where to place the new food safety
agency within the government, Ireland chose to place it under its
existing Department of Health and Children specifically to separate
food safety responsibilities from food and agriculture promotion
efforts, which is the responsibility of the Department of Agriculture
and Food.
In addition, food safety agency officials had the overall role of
bringing about the general understanding that the primary
responsibility for food safety rests with the food industry. According
to senior officials, FSAI works with all stakeholders towards this end.
Industry stakeholders we spoke with stated they are now aware that they
have such a responsibility. This change was, in part, due to the FSAI
holding open forums with shellfish farmers, caterers, industry groups,
and other stakeholders. The forums discussed problems and solutions, as
well as advocated partnerships.
Annual expenditures and number of employees:
FSAI officials estimated that FSAI spends 9.4 million euros (about
$11.6 million U.S.) on food safety activities annually. Government
departments, such as the Department of Agriculture and Food, still
retain responsibility for policy and legislation and have separate
budgets.
In 2004, FSAI had 82 employees.
Stakeholder Reaction:
According to industry stakeholders, FSAI has been successful in making
the concerns and desires of consumers and retailers on food safety
matters a higher priority than they were before the consolidation and
making food safety a higher priority for industry by fostering open
communication. Industry representatives stated these changes have been
positive for industry. For example, stakeholders also stated that their
positive relationship with FSAI has allowed industry organizations to
be informed about discussions at the EU level and subsequently voice
their position to FSAI on issues discussed at this level. A report
published in October 2003 on industry attitudes toward food safety
stated that 910 of 1,300 industry representatives surveyed (70 percent)
considered food safer than it had been 10 years earlier.[Footnote 29]
A consumer organization stakeholder cited several examples of why
consumers support Ireland's consolidation of its food safety system.
For example, the official stated that FSAI is a single contact point
for consumers when food safety concerns or questions arise. Moreover,
the official said, the consolidation and creation of FSAI added
accountability to food safety in Ireland, which did not exist before.
As a result, said the official, consumers are more confident in the
safety of the food supply, as well as more aware and knowledgeable
about food safety. A report published in October 2003 on consumers
attitudes toward food safety stated that more than half of 800 adult
consumers (53 percent) surveyed considered food safer than it had been
10 years earlier.[Footnote 30]
[End of section]
Appendix VI: The Netherlands' Food Safety System Consolidation:
In 2002, the Netherlands moved an inspection office from the health
ministry and an inspection office from the agriculture ministry to its
new food safety agency, the Food and Consumer Product Safety Authority.
According to Dutch officials, further consolidation is to occur by
January 1, 2006, when the merger of the two inspection offices is to be
completed.
Reasons for Consolidating Food Safety Responsibilities:
A need to reduce overlap and improve coordination among the Dutch
government's multiple food safety entities, as well as public concern
about food safety stemming from the dioxin contamination of animal
feed,[Footnote 31] BSE, and other animal diseases triggered the
Netherlands' decision to restructure its food safety system. Officials
noted that the need to comply with recently adopted EU legislation also
motivated the Netherlands' consolidation.
Responsibilities and Structure Before and After Consolidation:
Before the Netherlands consolidated its food safety agencies in 2002,
the country maintained two food safety inspection offices, each located
in a different ministry. The Inspectorate for Health Protection and
Veterinary Public Health (KvW) was in the Ministry of Public Health,
Welfare and Sports. The National Inspection Service for Livestock and
Meat (RVV) was in the Ministry of Agriculture, Nature and Food Quality.
According to a senior food safety official, having food safety
responsibilities divided between two different ministries caused
overlap within the Netherlands' food safety system. For example, both
ministries had responsibilities for inspecting slaughterhouse
facilities. Officials stated that communications between the two
inspection agencies needed to be streamlined and duplication of
inspection efforts needed to be reduced.
In 2001, before beginning its 2002 consolidation, the Netherlands tried
to address the problems associated with having two inspection offices
by creating the Netherlands Food Authority, a small team of scientists
who monitored the work of the two inspection offices, KvW and RVV. (See
fig. 11 below.) However, according to officials, by 2002, both the
Dutch parliament and consumer organizations wanted more guarantees for
food safety inspections than could be offered by the Netherlands Food
Authority. Therefore, in July 2002, the Netherlands converted the
Netherlands Food Authority into a new food safety agency, the Food and
Consumer Product Safety Authority, and placed both the RVV and KvW
within the new agency. Initially, the Food and Consumer Product Safety
Authority was housed under the Ministry of Public Health, Welfare and
Sports, but in 2003 it was moved to the Ministry of Agriculture, Nature
and Food Quality. (See fig. 12 below.) According to officials, moving
the new food safety agency to the agricultural ministry increased its
prominence.
Figure 11: The Netherlands' 2001 Food Safety System Organization:
[See PDF for image]
[End of figure]
Figure 12: The Netherlands' 2002 and 2003 Food Safety System
Organization:
[See PDF for image]
[End of figure]
According to officials, the Food and Consumer Product Safety
Authority's core responsibilities cover three areas: (1) risk
assessment and research--to identify and analyze potential threats to
the safety of food and consumer products; (2) enforcement--to ensure
compliance with legislation for meat, food, and consumer products,
which may include nonfood items; and (3) risk communication--to provide
information concerning risk and risk reduction, based on accurate and
reliable data. The agency's enforcement responsibilities include food,
animal health, and animal welfare inspections.[Footnote 32]
Senior food safety officials stated that the Netherlands' consolidation
efforts are not complete. According to officials, the two inspection
offices will be merged into one by 2006. This single inspection office
will consist of inspectors responsible for inspecting several types of
food products. The Food and Consumer Product Safety Authority has begun
training current inspectors in anticipation of this merger.
Legislation:
According to an agency document, the Food and Consumer Product Safety
Authority derives its responsibilities from various sources, including
the Food and Consumer Product Safety Authority Organization Decree,
dated July 10, 2002. To accomplish the move of inspection offices, the
RVV and the KvW, within the Netherlands food safety system, officials
stated that no major legal changes or new laws were needed. Only minor
revisions in some laws, such as changing the name of the organization
responsible, were necessary.
Challenges:
Officials in the Netherlands faced three challenges in changing the
country's food safety system. First, the government had to decide what
responsibilities and authorities the new food safety agency would have.
Second, as discussed above, the government had to decide which ministry
the new food safety agency would be placed in. The third challenge was
an increase in employee attrition. For example, an official stated that
attrition increased when the Food and Consumer Product Safety Authority
was moved from the Ministry of Public Health, Welfare and Sports to the
Ministry of Agriculture, Nature and Food Quality.
Annual Budget and Number of Employees:
According to officials, in 2004, the Food and Consumer Product Safety
Authority's budget was 188 million euros (about $232 million U.S.), and
the agency's workforce consisted of about 2,700 full-time equivalents.
Officials also told us that the workforce would decrease to about 1,800
full-time equivalents by January 2006. Among the factors causing this
reduction are the partial privatization of meat inspections and the
reorganization and reduction of administrative and management personnel.
Stakeholder Reaction:
Representatives of the fruit and vegetable, dairy, and livestock and
meat industries all stated that their operations were not affected by
the consolidation in the Netherlands' food safety system. However, they
all stated that the change was beneficial for consumers in that it
clarified that the Food and Consumer Product Safety Authority was the
responsible agency for food safety functions. The Food and Consumer
Product Safety Authority performed a study of Dutch consumers'
confidence in the safety of food in 2002 and 2003. The study results
show that consumers in both years had high confidence in food safety.
In addition, one industry representative explained that as a result of
moving the two inspection offices into a single agency, the two offices
now have common goals.
[End of section]
Appendix VII: New Zealand's Food Safety System Consolidation:
The New Zealand Food Safety Authority was established in July 2002.
Reasons for Consolidating Food Safety Responsibilities:
According to officials, the New Zealand Food Safety Authority (NZFSA)
was established in July 2002 to improve the effectiveness of New
Zealand's food safety system by coordinating and harmonizing food
safety efforts. Specifically, New Zealand wanted to address
inconsistencies between the methods used in the Ministry of Agriculture
and Forestry's export food safety program and the Ministry of Health's
domestic food safety program.
Responsibilities and Structure Before and After Consolidation:
Before the consolidation, the Ministry of Agriculture and Forestry had
food safety responsibilities for agricultural production, meat and
dairy processing, food exports, and registration of agricultural
compounds and veterinary medicines. The Ministry of Health was
responsible for addressing health issues, as well as ensuring the
safety of food sold on the domestic market, including imported food.
According to officials, to address inconsistencies between the two
ministries' food programs, New Zealand's government consolidated food
safety responsibilities of the two ministries into one semi-autonomous
body attached to the Ministry of Agriculture and Forestry.
NZFSA is now New Zealand's controlling authority for domestic food
safety and imports and exports of food and food-related products. It is
responsible for administering legislation covering food for sale on the
domestic market; primary processing of animal products and official
assurances related to their export; exports of plant products; food
imports; and the regulation of agricultural compounds, such as
pesticides and fertilizers, as well as veterinary medicines. NZFSA has
farm-to-table responsibilities--from primary production through
processing to retailers, importing, and exporting, as well as
responsibility for consumer education. According to officials, the
export program's purposes are to maintain and increase exports while
providing assurances of food safety and keeping compliance costs under
control. NZFSA's organization includes a verification agency, which
audits animal product facilities to verify that exporters are following
agreed processes. According to officials, about 280 of NZFSA's
approximately 480 employees are in the verification agency.
In addition, New Zealand and Australia share a trans-Tasman independent
agency established under Australian law, the Food Standards Australia
New Zealand, that develops food standards for composition, labeling,
and contaminants that apply to all foods produced or imported for sale
in New Zealand.[Footnote 33]
Legislation:
Officials stated that existing food safety legislation required only
very minor modification to create the New Zealand Food Safety Authority
and authorize it to regulate food safety. However, officials stated
that the total domestic food regulatory program is currently under
review, and it was expected that quite extensive change would be needed
as an outcome of this review. Legislative change is expected in late
fiscal year 2005-2006.
Challenges:
According to officials, adjustment to a new organizational culture was
somewhat challenging for some employees. They said some employees from
the larger organizations, particularly employees from the Ministry of
Health, had difficulty assimilating into the culture of the new agency.
Approximately 100 employees moved from the Ministry of Agriculture and
Forestry, and 12 staff moved from the Ministry of Health into the new
food safety agency. A second challenge for officials was deciding where
within the government the agency would be located. NZFSA was
established as a semi-autonomous body attached to the Ministry of
Agriculture and Forestry. According to officials, its semi-autonomous
status is intended to provide a level of separation from producers
sought by the New Zealand public. In addition, the government had to
decide whether to move certain food-related responsibilities to the new
agency. For example, responsibility for human nutrition was kept at the
Ministry of Health.
Annual Budget and Number of Employees:
According to officials, NZFSA's budget for the fiscal year that ended
June 30, 2004, was approximately $78 million New Zealand (about $53
million U.S.). A portion of NZFSA's spending is financed by user fees
assessed on industry for a range of regulator-provided services,
including export certification, export audit arrangements, and market
access efforts. Officials stated that NZFSA had approximately 480
employees in 2004.
Stakeholder Reaction:
According to a consumer organization representative, before the
creation of NZFSA, consumers were dissatisfied with the low priority
both ministries placed on food safety. According to this
representative, consumer organizations advocated changes in the food
safety system, including the creation of a single agency dedicated to
food safety.
In 2003, about one year after its creation, NZFSA commissioned a study
conducted by an independent research organization to provide benchmark
information on food safety issues among New Zealand's general public.
The study revealed that a majority of respondents considered food
safety standards to be improving, although concerns remain about
specific foods, such as chicken; food outlets; and other food-related
issues, including salmonella. Only one-third of the survey's
respondents stated that they were confident in the level of monitoring
and enforcement of food safety standards. Despite these concerns,
officials of a consumer organization stated that the creation of NZFSA
was a very positive step that was strongly supported by consumers, and
that the agency was too new for consumer confidence levels to have
significantly increased at the time of the survey.
An official representing a food industry organization in New Zealand
stated that the organization, along with others, had advocated the
establishment of a single food safety agency for years. The official
stated the previous system was piecemeal and inefficient, due to
coordination problems associated with two ministries having food safety
responsibilities and neither ministry placing a high priority on food
safety. As a result of the establishment of NZFSA, the industry is more
confident in how the nation handles food safety. One official stated
that as a result of the consolidation, the use of available resources
for food safety activities is more efficient because food safety
resources are located in one agency instead of fragmented between two
ministries. In addition, the official stated that consumer confidence
levels have improved due to an increase in the government's
responsiveness to food safety crises. According to the official, NZFSA
has a responsive network that quickly delivers information to notify
the public of food safety issues. Finally, the official stated that
NZFSA has significantly improved transparency and remains committed to
ongoing discussions with its many stakeholder groups. For example, in
responding to reports of increased iodine levels in children, NZFSA
began discussions immediately with endocrinologists, other doctors, and
with food industry representatives to address the issue.
[End of section]
Appendix VIII: The United Kingdom's Food Safety System Consolidation:
In 1999, the Queen, by and with the consent of Parliament, enacted
legislation to establish the independent Food Standards Agency, which
went into effect on April 1, 2000.
Reasons for Consolidating Food Safety Responsibilities:
Officials stated that the United Kingdom consolidated its food safety
system due to a loss of public confidence in food safety, which largely
resulted from the government's perceived mishandling of BSE. By early
1999, the human form of BSE, variant Creutzfeldt-Jakob disease, had
caused 35 deaths. It was widely perceived that the fragmented and
decentralized food safety system allowed this outbreak to occur.
According to a consumer organization representative, consumers believed
that the Ministry of Agriculture, Fisheries, and Food--which had dual
responsibilities to promote the agricultural and food industry as well
as to regulate food safety--favored industry over consumers in making
decisions related to food safety.
Responsibilities and Structure Before and After Consolidation:
Before the reorganization of the United Kingdom's food safety system in
2000, food safety responsibilities were divided among several central
government departments, such as the Ministry of Agriculture, Fisheries,
and Food and the Department of Health, as well as local authorities.
The Meat Hygiene Service, a subunit of the Ministry of Agriculture,
Fisheries, and Food was responsible for meat inspections, including
enforcing hygiene in slaughterhouses. Other food inspections, conducted
by local authorities, received no oversight from the central government.
In 1999, to address public concerns, the Parliament passed the Food
Standards Act of 1999 to establish the independent Food Standards
Agency (FSA) as the country's lead food safety agency. Officials stated
that the core groups of employees that started with FSA were from the
Ministry of Agriculture, Fisheries, and Food and the Department of
Health. The Meat Hygiene Service was moved out of the Ministry of
Agriculture, Fisheries, and Food and placed within FSA.[Footnote 34] In
addition, FSA was granted audit authority over local enforcement.
According to officials, FSA is responsible for scientific risk
assessments, risk management, standard setting, education, and public
outreach. In addition, its subunit, the Meat Hygiene Service, is
responsible for meat inspections. For other foods, FSA forms inspection
policy and audits local inspection authorities. Fruit, crops, and
animal feed are also within its jurisdiction. FSA has no agricultural
or food promotion responsibilities.
FSA has the powers of an agency in a ministry, but is not part of a
ministry. However, according to officials, the agency is held
accountable to the Westminster Parliament and devolved administrations
in Scotland, Wales, and Northern Ireland through Health Ministers.
An independent Board that consists of a Chairman, a Deputy Chair, and
up to 12 other members appointed to act collectively in the public
interest, manage the FSA. The Board's Chairman, who is appointed by the
Secretary of State for Health; Scottish Ministers; the National
Assembly for Wales; and the Department of Health, Social Services and
Public Safety in Northern Ireland, determines food policy and holds
discussions on policy issues in public meetings.
Legislation:
The Food Standards Act of 1999 established the FSA. It classifies the
FSA as an independent nonministerial government department and defines
the agency's functions and powers, including its function to monitor
and audit the performance of local authorities and where necessary to
exercise reserve powers[Footnote 35] over local authorities.
Challenges:
The United Kingdom's main challenge in consolidating was deciding which
responsibilities to place in the new food safety agency. The government
had to decide whether to (1) separate or combine food safety and
nutrition, (2) include the Meat Hygiene Service within the new agency,
and (3) include nonmeat inspections as a responsibility of the new
agency or to sustain that authority with the local governments.
Decisions on these issues were made after several debates in Parliament
and considerable discussion among government officials and stakeholders
from the food industry and consumer organizations.
An additional challenge cited by FSA officials was to avoid duplication
of efforts during the establishment of FSA and the termination of the
Ministry of Agriculture, Fisheries, and Food. To address this
challenge, a joint interim group was created to help reduce such
duplication of efforts.
Annual Budget and Number of Employees:
According to officials, FSA's annual budget is approximately 130
million pounds sterling (about $220 million U.S.); most of that amount
is allocated for meat inspections. The food industry pays FSA about 30
million pounds sterling (about $51 million U.S.) annually in user fees
for inspections.
Officials stated that FSA's workforce consists of approximately 3,000
employees.[Footnote 36]
Stakeholder Reaction:
A consumer stakeholder stated that the establishment of FSA was an
improvement to the food safety system because the agency has made the
system more open and transparent than it was before the consolidation.
Surveys of consumer attitudes on particular areas of the food safety
system have been conducted, but no survey has been conducted to measure
the confidence level of consumers for the entire food safety system.
For example, this stakeholder stated that surveys conducted by a
consumer association concluded that meat is still a concern for
consumers, but the association has not conducted a survey to determine
confidence levels over the entire food chain. The same consumer
stakeholder also stated that FSA has increased public education about
food safety.
Industry stakeholders agreed that the establishment of a single,
independent food safety agency has increased consumer confidence. A
stakeholder stated that the most significant result of the
consolidation was a shift from an industry focus to a consumer focus on
food safety matters. Stakeholders also said transparency regarding the
government's oversight of food safety matters has greatly increased. In
addition, one stakeholder noted that the consolidation resulted in
increased accountability within the food safety system. However,
industry stakeholders cited dissatisfaction with the new agency's
reporting on the testing of food products. One stakeholder stated that
FSA collects product samples, tests them, and reports results without
consulting companies. Another stated that the agency comments on food
product studies before they are actually completed.
[End of section]
Appendix IX: Comments from the Department of Health and Human Services:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Office of Inspector General:
Washington, D.C. 20201:
FEB 1 2005:
Mr. Robert A. Robinson:
Managing Director, Natural Resources and 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-
Experiences of Seven Countries in Consolidating Their Food Safety
Systems" (GAO-05-212). 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.
COMMENTS OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES ON THE U.S.
GOVERNMENT ACCOUNTABILITY OFFICE'S DRAFT REPORT, "FOOD SAFETY-
EXPERIENCES OF SEVEN COUNTRIES IN CONSOLIDATING THEIR FOOD SAFETY
SYSTEMS" (GAO-05-212):
We appreciate the opportunity to review and comment on the U.S.
Government Accountability Office's (GAO) draft report.
The GAO draft report states that the decision and results by each
country for such consolidation and/or reorganization are not well
substantiated by quantitative data or evidence. The report does cite
some anecdotal or qualitative remarks on "perceived" benefits. For
example, a statement is given that the reorganization achieved more
timely response but no data to show how much the time of response
changed or improved. However, it would have been instructive to know
the cost/benefit rationale to undertake such reorganization and all of
the necessary steps to complete the transition, over what period of
time, total cost and number of personnel to accomplish.
In using these countries as a reference point for consolidation of food
safety programs, it should also be pointed out that each of the
countries studied represent a much smaller food and agriculture
industry than we have here in the U.S. Therefore, the scalability of
any conclusions, based on these experiences, would need to be assessed
with that in mind.
In 2002, the Bush Administration looked into the issue of consolidating
food safety agencies, particularly Department of Health and Human
Services, Food and Drug Administration and the U.S. Department of
Agriculture/Food Safety and Inspection Service, 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 current and recent
Administrations have strived to develop a central framework without
reorganizing many different organizations, agencies, and departments.
Largely, this has been accomplished through interagency councils,
workgroups, scientific partnerships, and coordinated budget activities.
HHS believes that the current food safety system is working. Federal
agencies with food safety authorities are working together effectively.
The American food supply continues to be among the safest in the world.
The term "surveillance" needs to be clarified. The Centers for Disease
Control is described on page 9 (Figure 1: U.S. Federal Agencies' Food
Safety Responsibilities) as being responsible for "Protecting the
nation's public health, including foodborne illness surveillance."
However, the report focuses on surveillance of the food supply, not of
people and illness. Identifying where surveillance and investigation of
foodborne illnesses reside in the seven countries will help avoid the
misinterpretation that ALL food-related activities were shifted into
the consolidated agencies described. For example, human disease
surveillance for foodborne diseases, such as Salmonella or E. coli
0157, is conducted by the Health Department, not the Food Safety
Authority, in Denmark, Germany, and the Netherlands. If GAO did not
collect information on which agency is responsible for human foodborne
disease surveillance after consolidation, a special note should be made
in the report.
[End of section]
Appendix X: Comments from the U.S. Department of Agriculture:
United States Department of Agriculture:
Food Safety and Inspection Service:
Washington, D.C. 20250
FEB 4 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 specific comments from the U.S. Department of
Agriculture (USDA) on the Government Accountability Office (GAO) draft
report entitled, "FOOD SAFETY: Experiences of Seven Countries in
Consolidating Their Food Safety Systems." The Department appreciates
the opportunity to comment on this draft report.
From a public health regulatory standpoint, we are primarily interested
in whether consolidation of food safety systems resulted in a
measurable benefit to public health. Unfortunately your study did not
determine whether consolidation or reorganization in these foreign
countries had reduced foodborne illness rates for any of the countries
included in the study. The report does not contain rigorous cost-
benefit analyses to support the claimed or implied benefits. We had
hoped that the report would contain quantitative data including
foodborne illness rates, pathogen levels in regulatory samples,
operating efficiencies obtained from consolidation, and reorganization
costs. Additionally, the report does not contain an analysis to compare
the effectiveness and efficiency of the consolidated food safety
systems with those of the previous systems.
During the course of the audit, we noted differences between the U.S.
and the countries identified in this report. The seven countries whose
food safety systems you reviewed are much smaller in population than
the United States. Because of differences in climate and agricultural
production, it may not be possible to compare food safety systems of
these other countries to our own. Because of these issues we believe
that the report's observations have limited applicability to the U.S.
food safety agencies.
USDA plays an integral role in ensuring the safety of the nation's food
supply. For example, as a partner in the U.S. food safety effort, the
Food Safety and Inspection Service maintains a strong working
relationship and open communication with other public health agencies.
Our agencies continue to demonstrate the active cooperation,
communication, and coordination on public health issues to effectively
and seamlessly ensure the safety of the nation's food supply.
Effective communication and coordination is the best way to ensure that
the safety and security of all food products are being considered in
the farm to table continuum. The USDA believes the existing system is
working. The American food supply continues to be among the safest in
the world.
Sincerely,
Signed by:
Dr. Barbara J. Masters:
Acting Administrator:
Enclosure:
[End of section]
Appendix XI: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Robert A. Robinson, (202) 512-3841;
Maria Cristina Gobin, (202) 512-8418;
Gary Brown, (404) 679-1954:
Staff Acknowledgments:
In addition to those named above, major contributors to this report
were Lawrence J. Dyckman and Kelli Ann Walther. Nancy Crothers, Barbara
El Osta, Michele Fejfar, and Amy Webbink also made key contributions to
this report.
(360460):
FOOTNOTES
[1] GAO, Food Safety: Experiences of Four Countries in Consolidating
Their Food Safety Systems, GAO/RCED-99-80 (Washington, D.C.: Apr. 20,
1999).
[2] For the purposes of this report, we defined consolidation as the
transfer of responsibility and resources for performing a food safety
function from two or more agencies to a single agency.
[3] In examining countries' food safety systems, we did not obtain
information on agencies that are responsible for foodborne illness
surveillance for each of the seven countries.
[4] Five of the countries whose systems we studied, Denmark, Germany,
Ireland, the Netherlands, and the United Kingdom, are members of the
European Union.
[5] The Federal Republic of Germany consists of 16 federal states,
known as länder. Under Germany's federal structure, the federal states
have responsibilities that include the implementation of food safety
laws.
[6] For the purposes of this report, we defined food security as
distinct from food safety in that food security refers to the
vulnerability of a nation's food supply to deliberate actions that
contaminate food or reduce the available quantity of food.
[7] Ensuring Safe Food From Production to Consumption, Institute of
Medicine, National Research Council (Washington, D.C.: National Academy
Press, 1998).
[8] Urgent Business For America: Revitalizing the Federal Government
For the 21st Century, Report of the National Commission on the Public
Service (Washington, D.C., 2003).
[9] All seven countries, as well as the United States, are in the World
Bank's high-income category.
[10] For all of the 114 countries analyzed in a recent USDA Economic
Research Service study, consumer spending on food as a percentage of
total spending ranged from nearly 74 percent of the total budget in
Azerbaijan to just below 10 percent in the United States. James Seale,
Jr., Anita Regmi, and Jason Bernstein, "International Evidence on Food
Consumption Patterns," Technical Bulletin Number 1904, Economic
Research Service, USDA, October 2003.
[11] The EU is a treaty-based institutional framework that defines and
manages economic and political cooperation among its 25 member
countries. EU member countries have reached EU-wide agreement in
certain policy areas, including food safety, and operate as a single
economic market.
[12] According to EU officials, the legislative package includes
Regulation (EC) No. 852/2004 of the European Parliament and of the
Council of 29 April 2004 on the hygiene of foodstuffs; Regulation (EC)
No. 882/2004 of the European Parliament and of the Council of 29 April
2004 on official controls performed to ensure the verification of
compliance with feed and food law and animal health and animal welfare
rules; Regulation (EC) No. 853/2004 of the European Parliament and of
the Council of 29 April 2004 laying down specific hygiene rules for
food of animal origin; Regulation (EC) No. 854/2004 of the European
Parliament and of the Council of 29 April 2004 laying down specific
rules for the organization of official controls on products of animal
origin intended for human consumption; and Directive 2004/41/EC of the
European Parliament and of the Council of 21 April 2004 repealing
certain directives concerning food hygiene and health conditions for
the production and placing on the market of certain products of animal
origin intended for human consumption and amending Council Directives
89/662/EEC and 92/118/EEC and Council Decision 95/408/EC.
[13] Hazard Analysis and Critical Control Point principles are risk-
based and make industry, rather than government inspectors, responsible
for identifying steps in food production where food safety hazards are
most likely to occur and for establishing controls that prevent or
reduce such hazards.
[14] "European Food Safety Control Systems: New Perspectives on a
Harmonized Legal Basis" (paper presented at the Second Food and
Agriculture Organization of the United Nations/World Health
Organization Global Forum for Food Safety Regulators, October 2004).
[15] The Netherlands established a lead agency to enforce food safety
legislation. The other six countries established a lead agency for risk
management. Risk management is the process, distinct from risk
assessment, of weighing policy alternatives, in consultation with all
interested parties, considering risk assessment and other factors
relevant for the health protection of consumers and for the promotion
of fair trade practices, and, if needed, selecting appropriate
prevention and control options. However, some countries, such as
Germany, have separated responsibility for risk assessment--the
scientifically based process consisting of hazard identification,
hazard characterization, exposure assessment, and risk
characterization--from risk management by placing risk management and
risk assessment responsibilities in separate entities.
[16] Ensuring Safe Food From Production to Consumption, National
Research Council (Washington, D.C.: 1998).
[17] BSE is an always fatal, neurodegenerative disease that has been
found in cattle in numerous countries. Cattle contract the disease
through animal feed that contains protein derived from the remains of
diseased animals. Scientists generally believe an equally fatal disease
in humans--known as variant Creutzfeldt-Jacob Disease (vCJD)--is linked
to eating beef from cattle infected with BSE.
[18] In consolidating their food safety systems, six of the seven
countries incurred start-up costs in addition to ongoing operational
costs. In these countries, the newly created consolidated food safety
agencies needed additional funding to establish a fully operational
food safety system. Although some countries provided documentation
regarding these start-up costs, we were not able to determine the
reliability of this information.
[19] World Health Organization, Improved Coordination and Harmonization
of National Food Safety Control Services (World Health Organization
Regional Office for Europe, Copenhagen, Denmark, 2001).
[20] We did not perform independent analysis of those laws or attempt
to independently assess their intent.
[21] Health Canada's responsibilities include research, risk assessment
and standard setting in relation to the nutritional quality of foods
marketed in Canada. For example, Health Canada is responsible for
nutrition labeling, health claims, and nutrient content claims.
[22] The CFIA Enforcement Act was introduced in the Canadian Parliament
on November 26, 2004.
[23] The official also noted that since fiscal year 1998,CFIA's total
expenditures for all of its activities--food safety, animal health, and
plant protection--have increased, but said this increased spending was
not related to the consolidation and attributed the increase to higher
food production, exports, and consumption, as well as increased
spending in response to threats from new animal and plant diseases and
pests. While some of these new plant pests and animal diseases, such as
BSE, are food safety issues, others, such as foot-and-mouth disease, an
animal disease, and the Asian long-horned beetle, an insect that harms
trees, are not related to food safety.
[24] Salmonella bacteria, sometimes present in meat, are a source of
foodborne illness in humans.
[25] The Federal Environment Ministry had responsibility for industrial
contaminants, such as dioxin, in food. It continues to have this
responsibility.
[26] According to officials, FSAI maintains independence due to its
clear separation from the food industry. Section 10 of the Food Safety
Authority of Ireland Act, 1998 states: "The Authority shall, subject to
this Act, be independent in the exercise of its functions."
[27] Members of the Board are primarily from academia or public health
fields.
[28] Each service contract is valid for 3 years, at the conclusion of
which it is revised and renewed.
[29] FSAI's Food Safety Consultative Council conducted the survey. The
results were published in October 2003 in a report entitled "Industry
Attitudes to Food Safety in Ireland."
[30] "Consumer Attitudes to Food Safety in Ireland," based on a survey
by FSAI's Food Safety Consultative Council, was published in October
2003.
[31] In 1999, dioxin, a potential carcinogen, was found in animal feed
in Europe. To protect consumer health, the European Commission adopted
measures to remove poultry, pigs, and cattle suspected of having eaten
contaminated feed from the food supply chain.
[32] According to officials, producers have the primary responsibility
for product quality.
[33] Food Standards Australia New Zealand was established by the
Australian Food Standards Australia New Zealand Act 1991.
[34] In June 2001, the Department for Environment, Food, and Rural
Affairs (DEFRA) was created. Its responsibilities include on-farm
issues, such as animal welfare and the safety of animal feed, as well
as promotion of agriculture and the food industry. According to
officials, elements of the Ministry of Agriculture, Fisheries, and
Food, which no longer exists, were moved to FSA (1999 to 2000) and
DEFRA (2001).
[35] According to an FSA official, reserve powers range from providing
help and guidance by directing the way in which the local authority
operates to performing the local authority's services.
[36] According to officials, about 2,500 of these employees are with
the Meat Hygiene Service.
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