Food Safety: Experiences of Four Countries in Consolidating Their Food
Safety Systems (Letter Report, 04/20/99, GAO/RCED-99-80).

Pursuant to a congressional request, GAO reviewed the experiences of
foreign countries that are consolidating their food safety
responsibilities, focusing on the: (1) reasons for and approaches taken
to consolidation, the costs and savings, if any, associated with
consolidation, and efforts to assess the effectiveness of the revised
food safety systems; and (2) lessons that the United States might learn
from these countries' experiences in consolidating their food safety
functions.

GAO noted that: (1) the reasons the four countries have consolidated, or
are in the process of consolidating, their organizational
responsibilities for food safety activities differed, as did the
approaches they took; (2) however, all four countries had similar views
regarding the costs and benefits of consolidation and the need to
evaluate their consolidation efforts; (3) in deciding to consolidate
food safety responsibilities, two of the countries--Great Britain and
Ireland--were responding to public concerns about the safety of their
food supplies and chose to consolidate responsibilities in the agencies
that report to their ministers of health; (4) the other two
countries--Canada and Denmark--were more concerned about program
effectiveness and cost savings and consolidated activities in agencies
that report to their ministers of agriculture, who already control most
of the food safety resources; (5) all four countries are incurring
short-term start-up costs in establishing their new agencies but are
expecting long-term benefits in terms of money saved, more food safety
for the money spent, and better assurance of food safety; (6) none of
the countries had developed performance measures and data early in the
consolidation process to assess the effectiveness of their new systems;
(7) foreign officials identified several common lessons from their
experiences that they believe could be broadly applicable to any U.S.
consolidation effort; (8) in all four countries, a consensus had to be
developed on the need to consolidate food safety responsibilities; (9)
certain management initiatives were needed to establish any new agency;
(10) adequate funding for start-up costs was also necessary; (11)
furthermore, to help ensure the new agencies' early success, critical
operational concerns, such as having the flexibility to shift program
resources to the highest food safety priorities, establishing a common
organizational culture, and ensuring openness in the decisionmaking
process, were important factors that had to be addressed; and (12)
evaluation criteria and mechanisms need to be established early in the
process in order to assess the new agency's performance.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-99-80
     TITLE:  Food Safety: Experiences of Four Countries in
	     Consolidating Their Food Safety Systems
      DATE:  04/20/99
   SUBJECT:  Food industry
	     Contaminated foods
	     Health hazards
	     Safety standards
	     Consumer protection
	     Performance measures
	     Centralization
	     Safety regulation
	     Foreign governments
	     Reengineering (management)
IDENTIFIER:  Canada
	     Great Britain
	     Denmark
	     Ireland

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FOOD SAFETY: Experiences of Four Countries in Consolidating Their
Food Safety Systems GAO/RCED-99-80 United States General
Accounting Office

GAO Report to the Chairman, Permanent Subcommittee on
Investigations,

Committee on Governmental Affairs, U. S. Senate

April 1999 FOOD SAFETY Experiences of Four Countries in
Consolidating Their Food Safety Systems

GAO/RCED-99-80

  GAO/RCED-99-80

GAO United States General Accounting Office

Washington, D. C. 20548 Resources, Community, and Economic
Development Division

B-281971 April 20, 1999 The Honorable Susan M. Collins Chairman,
Permanent Subcommittee

on Investigations Committee on Governmental Affairs United States
Senate

Dear Madam Chairman: Outbreaks of foodborne illnesses have raised
questions about the safety of the U. S. food supply and the
inherent weaknesses of the fragmented federal food safety system.
The U. S. Department of Agriculture's (USDA) Food Safety and
Inspection Service has regulatory responsibility for ensuring the
safety of meat, poultry, and some egg products, while the
Department of Health and Human Services' Food and Drug
Administration has regulatory responsibility for all other food
products. Both these agencies inspect domestic and imported food.
In addition, other federal agencies have food safety programs or
responsibilities. As we have reported on many occasions, this
fragmented system impedes the government's ability to efficiently
and effectively oversee the safety of the food supply. 1
Consequently, we have recommended consolidating federal food
safety activities. In August 1998, the National Academy of
Sciences also recommended consolidating food safety functions and
suggested a number of approaches that could be considered,
including a single food safety agency. Shortly after the National
Academy issued its report, the President established a Council on
Food Safety, which was to review and report on the Academy's
report in 1999.

To supplement the National Academy's study, you asked us to review
the experiences of foreign countries that are consolidating their
food safety responsibilities. Specifically, we (1) examined the
reasons for and approaches taken to consolidation, the costs and
savings, if any, associated with consolidation, and efforts to
assess the effectiveness of the revised food safety systems and
(2) identified the lessons that the United States might learn from
these countries' experiences in consolidating their food safety
functions. We visited three countries Canada, Denmark, and Ireland
which have consolidated their food safety responsibilities, and
one country Great Britain which is in the process of consolidating
its food safety responsibilities. These four

1 See Related GAO Products.

GAO/RCED-99-80 Four Countries' Experiences Page 1

B-281971

countries' food safety systems are discussed in detail in
appendixes I through IV.

Results in Brief The reasons the four countries have consolidated,
or are in the process of consolidating, their organizational
responsibilities for food safety activities

differed, as did the approaches they took. However, all four
countries had similar views regarding the costs and benefits of
consolidation and the need to evaluate their consolidation
efforts. In deciding to consolidate food safety responsibilities,
two of the countries Great Britain and Ireland were responding to
public concerns about the safety of their food supplies and chose
to consolidate responsibilities in the agencies that report to
their ministers of health. The other two countries Canada and
Denmark were more concerned about program effectiveness and cost
savings and consolidated activities in agencies that report to
their ministers of agriculture, who already control most of the
food safety resources. All four countries are incurring short-
term start- up costs in establishing their new agencies but are
expecting long- term benefits in terms of money saved, more food
safety for the money spent, and/ or better assurance of food
safety. None of the countries had developed performance measures
and data early in the consolidation process to assess the
effectiveness of its new system.

Foreign officials identified several common lessons from their
experiences that they believe could be broadly applicable to any
U. S. consolidation effort. In all four countries, a consensus had
to be developed on the need to consolidate food safety
responsibilities. Certain management initiatives, such as strong
leadership and a dedicated start- up group to begin agency
operations, were needed to establish any new agency. Adequate
funding for start- up costs was also necessary. Furthermore, to
help ensure the new agencies' early success, critical operational
concerns, such as having the flexibility to shift program
resources to the highest food safety priorities, establishing a
common organizational culture, and ensuring openness in the
decision- making process were important factors that had to be
addressed. And finally, evaluation criteria and mechanisms need to
be established early in the process in order to assess the new
agency's performance.

Background Foodborne illness in the United States is extensive and
costly. Estimates of the incidence of foodborne illness range from
6.5 million to 81 million

cases each year and result in 500 to 9,100 deaths. These illnesses
cost the

GAO/RCED-99-80 Four Countries' Experiences Page 2

B-281971

nation between $7 billion and $37 billion annually in medical and
productivity losses. 2

Multiple agencies share the responsibility for regulating food
safety in the United States 12 different federal agencies in six
federal entities are involved. Our past reviews have shown
inconsistencies and differences between agencies' approaches and
enforcement authorities that undercut overall efforts to ensure a
safe food supply. 3 As such, we have recommended implementing a
uniform, risk- based inspection system and a single food safety
agency to help correct the problems created by this fragmented
system.

Fragmentation is not unique to the United States. Food safety
officials in each of the four countries we visited maintained that
similar fragmentation existed in their systems prior to
consolidation. For example, before consolidation, the Danish food-
processing sector encompassed seven laws, about 125 regulations,
and more than 30 federal agencies and local offices overseeing
food safety activities. Prior to Ireland's consolidation, more
than 50 agencies shared food safety responsibilities.

The four countries have recently completed or are still in the
process of consolidating their activities. Specifically:

 Canada decided in 1996 to consolidate its food inspection
activities into a single new agency. The new agency the Canadian
Food Inspection Agency officially began operations in April 1997.
However, the responsibility for setting health standards for food
safety remained with Health Canada.  Denmark phased in the
consolidation of its food safety activities,

beginning in 1995, by combining the Ministry of Agriculture and
the Ministry of Fisheries into a single ministry the Ministry of
Agriculture and Fisheries. In December 1996, Denmark moved the
food safety inspections conducted by its Health Ministry into the
Ministry of Agriculture and Fisheries The new consolidated agency
is called the Ministry of Food, Agriculture, and Fisheries. The
district and local inspection offices of the old ministries are
being reorganized into 11 regional inspection offices within the
new Ministry. Once this reorganization takes place, the
consolidation will be complete.

2 Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96,
May 8, 1996). 3 Food Safety and Quality: Uniform, Risk- Based
Inspection System Needed to Ensure Safe Food Supply (GAO/RCED-92-
152, June 26, 1992), Food Safety: A Unified, Risk- Based System
Needed to Enhance Food Safety (GAO/RCED-94-71, Nov. 4, 1993), and
Food Safety: Fundamental Changes Needed to Improve Food Safety
(GAO/RCED-97-249R, Sept. 9, 1997).

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 Great Britain is in the process of consolidating its food safety
activities. In September 1997, the Ministry of Agriculture,
Fisheries and Food and the Department of Health set up a work
group composed of staff from both agencies known as the Joint Food
Safety and Standards Group to plan the consolidation. In January
1998, the government formally proposed consolidating all food
safety responsibilities under a new agency to be known as the Food
Standards Agency. Final legislation establishing this agency had
not been enacted as of January 1999. However, the British
government expects Parliament to act on the new agency this year.
Ireland approved the consolidation all of its food safety
responsibilities

under the umbrella of the Food Safety Authority of Ireland in July
1998. This Authority officially assumed its responsibilities in
January 1999.

The three European countries that we visited are members of the
European Union and thus in some instances must follow Union
directives. 4 The European Commission, which is a regulatory body
of the Union, recently made organizational changes that emphasized
consumer protection in its food safety policy. The Commission has
brought together certain responsibilities for consumer protection
and public health for food into a single organization Directorate
General XXIV which reports to the Commissioner for Consumer Policy
and Health Protection. In addition, Directorate General XXIV is
responsible for the relevant scientific committees in the food
safety area. According to several of the European food safety
officials with whom we met, these changes have made it easier for
them to consolidate food safety responsibilities and to reorient
newly consolidated agencies toward consumer protection.

Foreign Countries' Approaches To, and Preliminary Results Of,
Consolidating Food Safety Activities

The four countries we visited had different reasons for
consolidating their food safety activities, and therefore their
approaches to reorganizing food safety responsibilities also
differed. All four countries are incurring short- term costs while
expecting long- term benefits. None had developed performance
measures and data early in the process to assess the effectiveness
of their new systems.

Reasons For, and Responsibilities Of, New Food Safety Agencies

The decisions to consolidate food safety responsibilities in the
four countries we examined were based on each country's recent
food safety history and economic considerations, among other
things. Great Britain

4 The European Union is a collection of 15 member nations, whose
objectives are to promote European economic and social progress,
assert the European identity, and introduce a European citizenship
for the nationals of the member states.

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B-281971

and Ireland chose or plan to have their newly consolidated food
safety activities report to their ministers for health. In Canada,
the new agency reports directly to the Minister for Agriculture.
Denmark combined food safety activities with agricultural and
fisheries activities, creating a new ministry.

According to British food safety stakeholders, 5 the British plan
to consolidate food safety activities into a single agency the
Food Standards Agency in the Department of Health was largely a
result of the government's perceived mishandling of the Bovine
Spongiform Encephalopathy (BSE) outbreak. 6 In Great Britain, as
of February 1, 1999, the BSE outbreak has resulted in 35 human
deaths from a new variant of Creutzfeldt- Jakob disease and has
hurt the country's cattle industry: 3.7 million of Britain's 10
million cattle had to be destroyed. BSE has also had an adverse
impact on the British beef export industry because the European
Union banned the trading of British beef among member nations.
Cattle producers have suffered large losses in the value of their
animals because of depressed markets. Other industries affected by
the BSE outbreak include slaughterhouses, auctioneers, truckers,
and beef export firms. According to several food safety
stakeholders, it was widely perceived that the fragmented and
decentralized food safety system divided between several central
government departments, such as the Ministry of Agriculture,
Fisheries and Food and the Department of Health, as well as local
authorities allowed this outbreak to occur. Some of the
stakeholders were particularly concerned with the Ministry of
Agriculture, Fisheries and Food's dual responsibilities to promote
agriculture and the food industry as well as to regulate food
safety.

Consequently, during the 1997 election campaign for Parliament,
the then candidate, and now prime minister, called for
consolidating food safety responsibilities and for greater
openness in the decision- making process about food safety. The
public also demanded the consolidation of the food safety system
as well as its removal from the Ministry of Agriculture, Fisheries
and Food. As of January 1999, British food safety officials and
other stakeholders remained committed to consolidating all
activities related to food, including, among other things, the
management of nutrition, food safety, chemical, and other
additives, genetically modified

5 Throughout this report we use the term stakeholders to mean the
food industry (farmers and food processors), consumer groups, and
affected government organizations and their employee unions. 6
BSE, commonly known as mad cow disease, is one in a category of
neurological disorders called transmissible spongiform
encephalopathies. The human nervous system disorder Creutzfeldt-
Jakob disease is among these transmissible spongiform diseases,
and the crisis in Britain began when a new variant of Creutzfeldt-
Jakob disease was discovered in association with mad cow disease.

GAO/RCED-99-80 Four Countries' Experiences Page 5

B-281971

organisms, and meat hygiene and dairy inspections. The
consolidated agency will report to the Secretary of State for
Health the cabinet minister responsible for health. The enactment
of the Food Standards Agency's enabling legislation has been
delayed while budgetary and other issues are being addressed. In
the interim, the government established the Joint Food Safety and
Standards Group, which is jointly managed by the Ministry of
Agriculture, Fisheries and Food and the Department of Health.

Similarly in Ireland, outbreaks of foodborne illness and the
potential economic consequences of real or perceived unsafe food
products provided the impetus for the consolidation of food safety
responsibilities into a single agency in July 1998 the Food Safety
Authority of Ireland. Irish food safety officials said that a
succession of high- profile outbreaks of foodborne illnesses
throughout the world, such as the BSE outbreak in Great Britain
and the E. coli outbreak in Scotland, shook consumer confidence in
the safety of food and in the ability of regulatory agencies to
protect the public. In 1998, roughly 80 head of Irish cattle out
of about 7 million head in total were found to be infected with
BSE. These developments signaled not only a public health concern
but also a potentially devastating economic problem because
Ireland exports about 90 percent of the meat it produces.
According to Irish food safety officials, these developments also
served to highlight the difficulties that the Department of
Agriculture and Food faced in trying to carry out the dual mission
of protecting consumers and promoting the food industry.

In July 1998, Ireland enacted legislation that (1) created the
Food Safety Authority of Ireland, (2) made the Authority
responsible for overseeing food safety activities, and (3) had the
Authority report to the Minister of Health and Children. The
legislation provided the Authority with the power to consolidate
all food safety activities into a single agency. In exercising
their new duties, as a first step, the Authority entered into
service contracts with federal and local agencies to continue
their food safety inspections and other activities. These
contracts include mutually agreed- upon objectives and milestones.
Preconsolidation funding arrangements were maintained. That is,
the Parliament provides funds to agencies, which make resources
available to fulfill their obligations with the Authority.
According to Authority officials, if the service contracts are not
satisfactorily performed, the Authority will initiate efforts to
place all food safety activities under its direct control. The
Authority received 6.5 million Irish pounds ($ 10 million in U. S.
dollars) in its first year budget 1.5 million Irish pounds for
start- up costs and 5.0 million Irish pounds for coordinating
inspection services and new educational

GAO/RCED-99-80 Four Countries' Experiences Page 6

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programs. The Authority took official charge of food safety on
January 1, 1999. 7

In contrast to Great Britain and Ireland, Canada initiated changes
to its food safety activities to improve effectiveness and reduce
costs. Canada did not face a loss of public confidence as did
Great Britain and Ireland, but in the early 1990s, it faced a
budgetary crisis and sought ways to reduce federal expenditures.
By combining the various elements of its food inspection services,
Canada expected to save about 13 percent of its food inspection
budget, or $44 million Canadian per year, ($ 29 million in U. S.
dollars) and improve the effectiveness of its inspection programs.
In April 1997, the Canadian Food Inspection Agency began
operations. While national food safety standards continue to be
set by Health Canada Canada's Department of Health all federal
food inspections are the responsibility of the new food inspection
agency, which is also responsible for animal and plant health
inspections. The new agency has the status of a departmental
corporation under the Financial Administration Act, which provides
the agency with the authority to raise and retain funds from its
activities. In addition, from the outset the agency has had
separate employer status, which has enabled it to create its own
personnel system. The new agency reports directly to the Minister
of Agriculture and Agri- Food Canada Canada's department of
agriculture.

Denmark also launched changes to its food safety system to achieve
greater efficiency and effectiveness. In 1996, at the request of
food safety stakeholders, Denmark sought to strengthen its efforts
with respect to food safety and food quality by consolidating food
safety activities in the newly created Ministry of Food,
Agriculture, and Fisheries. Denmark's aims were to simplify food
safety administration, control, and legislation, believing that
such reforms would lead to a more efficient and effective food
safety system and provide assurances of the quality of Danish food
products, many of which are exported. For example, prior to
consolidation, three Danish ministries Health, Agriculture, and
Fisheries, each with its own local food safety structure shared
responsibilities for implementing food safety laws. According to
the Permanent Secretary of the new ministry, the results of this
fragmented approach included extensive overlapping
responsibilities in some areas and gaps in coverage in other
areas; inconsistent food safety inspections; and inefficient use
of

7 Under the Good Friday Agreement between Northern Ireland and the
Republic of Ireland, there is to be an all- island food safety
promotion body. Some functions of the Food Safety Authority of
Ireland will be transferred to this promotion body and will be
undertaken on an all- Ireland basis. These activities will include
food safety promotion, food alerts, surveillance of food- related
illnesses, and laboratory services.

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B-281971

food safety resources. The Permanent Secretary and all other
stakeholders in Denmark believe that consolidating food safety
responsibilities will address these concerns.

Countries Expect Long- Term Benefits but Are Incurring Start- Up
Costs

Officials in the four countries we visited anticipated start- up
costs with the consolidation of food safety activities. These
costs are in addition to the ongoing operational costs.
Specifically, the new, consolidated agencies require additional
funding to establish a fully operational food safety system,
including such overhead costs as computers and telephones. While
the countries may have similar start- up activities, their costs
cannot be compared because of differences in the size of the
countries, the food safety activities that will be included in
these new approaches, and the infrastructure already in place
before these new efforts were launched. In Denmark, the start- up
cost was about 120 million kroner ($ 18 million in U. S. dollars,
or about 3 percent of Denmark's food safety budget). Canadian
officials estimated that their start- up costs were about $25
million Canadian dollars ($ 17 million in U. S. dollars, or about
7 percent of Canada's food safety budget). British food safety
officials estimate that Great Britain will spend 30 million pounds
($ 49 million in U. S. dollars, or about 25 percent of the British
food safety budget) for start- up over a 3- year period. According
to Irish food safety officials, the Food Safety Authority of
Ireland's start- up costs were about 1.5 million Irish pounds ($ 2
million in U. S. dollars). However, the start- up costs as a
percentage of the total food safety budget could not be estimated.
Canadian labor officials also noted less obvious costs, such as
brief losses in productivity shortly before and immediately after
consolidation.

Over the long term, however, food safety stakeholders in all four
of the countries we visited believe that the benefits of
consolidating food safety activities will outweigh the additional
costs. Through a more effective, streamlined approach, these
officials believe, consolidated food safety agencies offer
opportunities to enhance consumer protection and to improve
working relationships with the food industry. Specifically, these
officials believe that consolidating food safety activities would

 improve service delivery by providing a single contact for
consumer and industry clients;  reduce overlap and the duplication
of services;  improve or reduce the need to coordinate food safety
activities, thereby

enhancing the efficiency and effectiveness of food safety
regulation;

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B-281971

 provide more comprehensive oversight of food safety from farm to
table; and  enhance food safety, thereby providing continued
access to international

markets for producers and processors. 8 None of the Four Countries
Has Developed Data for Evaluating the Effectiveness of
Consolidation

Food safety officials in all four countries said that their main
priority to date has been to consolidate food safety activities.
Nevertheless, they believe that evaluation is an important
function. For example, in Canada, the legislation that created the
Canadian Food Inspection Agency calls for performance measures.
The Canadian inspection agency's first business plan for 1999
acknowledges the need to establish measures to evaluate the
agency's performance. In Denmark, beginning in 1999, government
officials said they plan to start using public health information,
including foodborne illness data, to evaluate the effectiveness of
the new organization. Great Britain has published a commitment to
develop performance measures by the time the new agency begins
operations. Ireland plans to introduce a system of monitoring its
service contracts but has not yet determined when it would
evaluate the Authority.

Lessons the Four Countries Learned From Their Experiences

Officials in the four countries identified several lessons that
can be learned from their consolidation experiences. One of the
most important is developing a consensus on the need to reform the
food safety system. Other lessons learned include the importance
of (1) strong leadership; (2) dedicated start- up groups; (3)
additional start- up funding; (4) organizational flexibility; (5)
personnel integration strategies; (6) open decision- making; and
(7) evaluation criteria. These lessons are discussed below.

Consensus on the Need for Change. Officials believe that achieving
consolidation requires strong support among stakeholders. This
includes agreement not only on the need for a new system but also
on its scope and configuration. Each of the four countries began
with a highly fragmented and decentralized system. While food
safety officials in these countries believe that these
decentralized approaches were less than optimal, some stakeholders
hesitated to embrace the new consolidated agencies.

In Great Britain and Ireland, the health and economic threats
posed by outbreaks of foodborne illnesses served as strong
incentives for change.

8 All four of the countries we visited depend to some extent on
food exports for their economic well- being. Officials believe
that greater assurances of food safety should allow them to
maintain current international markets and could actually improve
their access to these markets.

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Although Ireland has already begun functioning under its new food
safety system, as of January 1999, Great Britain had not yet
passed enabling legislation. Food safety officials anticipate
parliamentary action during the current session. The delay in
Great Britain is occurring not because consensus is lacking about
the need for consolidation but because (1) it has been difficult
for stakeholders to arrive at a consensus on how to fund the new
system and (2) Parliament has been occupied with a full slate of
other pressing matters, such as the reform of the House of Lords.
Although the government favors imposing some forms of user fees on
the food industry to help pay for the new system, industry and
some consumer groups generally oppose such fees. Industry groups
oppose them because of the additional costs they would add to
production. The consumer groups with which we met oppose user fees
because they fear such fees could lead to dependence on the food
industry for funding and to a conflict of interest within the new
food standards agency.

In Denmark and Canada, concerns about program effectiveness and
budgetary savings drove the changes. In Denmark, food industry and
consumer groups requested the government to reorganize the food
safety system. In a letter to the Prime Minister, these groups
called for consolidating the food safety system to improve the
effectiveness of inspections. They believed that an efficient food
safety system would help Denmark maintain its reputation for high-
quality, safe foods especially for export markets. In Canada,
officials said that initial support for a consolidated food safety
approach was considerable, but food safety inspector unions
presented some opposition in the hearings before Parliament.
However, even this opposition faded once the new inspection agency
became operational and its advantages became apparent.

Strong leadership. Two of the four countries we visited relied
upon strong leadership to get their new agencies started and to
overcome initial bureaucratic opposition to change. In Ireland, a
director was appointed early in the process to oversee the
establishment of the Food Safety Authority of Ireland. The
director has been able to work effectively with consumers,
industry representatives, and government officials to establish
the new agency's agenda. The Authority gained credibility and
support with the early appointment of its director, a well- known
and respected medical doctor and veterinarian. Even before the new
agency became fully operational, its director became Ireland's
spokesperson on food safety issues. In speaking out on these
issues, the new director was viewed as advocating consumer
protection while being fair to industry. In Denmark, the Permanent
Secretary of the new ministry led the reorganization of its

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B-281971

food safety system. As of January 1999, Great Britain had not yet
had a single individual in charge of the proposed new agency.
Canadian officials noted that the Canadian Food Inspection
Agency's first president was not appointed until late 1996, after
many transition decisions had already been made. However, they
also pointed out that each of the Canadian ministers involved in
the transition provided strong leadership and support to the
start- up group.

Dedicated start- up groups. In Canada and Ireland, dedicated
start- up groups helped ensure that the new agencies began
operations in a timely fashion. For example, Canada recruited
seven key officials from agencies that would be affected by the
consolidation to lay the groundwork for the food inspection
agency. Throughout the period leading up to the creation of
Canada's food inspection agency, the affected departments made a
commitment to free these key officials from day- to- day
operations so they could focus on creating the new agency. In
addition, these key officials obtained the financial and human
resources they needed because they had management's full support.
In Great Britain, the Ministry of Agriculture, Fisheries and Food
and the Department of Health established the Joint Food Safety and
Standards Group, which brought together those parts of the two
agencies likely to form the core of a consolidated food safety
agency. As of January 1999, Great Britain had resolved many of the
major issues regarding the creation of the Food Standards Agency,
except the funding issue described earlier. Denmark did not rely
on a start- up group because it consolidated food safety
responsibilities in phases.

Additional start- up funding. Funding for start- up activities in
the three countries that have consolidated their food safety
activities was handled differently, but all three found that they
needed additional funds. For example, these countries had to
operate dual systems (while the new systems were being brought on
line, the old system had to continue to operate); purchase new
equipment and office space; and standardize procedures from the
different agencies involved in the consolidation. Irish officials
told us that one of the keys to their early success has been
having adequate start- up funds available. By contrast, Canadian
officials told us that they anticipated from the outset that they
would have to request more start- up funds than the amount
originally allocated. Indeed, they did request additional
assistance from the Parliament. For example, the new inspection
agency became legally responsible for its own staffing system on
April 1, 1998, a year after the agency officially opened its
doors. According to Canadian officials, the delay in creating the
new personnel system occurred, at least in part, because they had
underestimated the

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funding and expertise required to develop and implement such a
system. In Denmark, officials also noted the importance of
additional funding for consolidation. They said they could more
effectively manage additional start- up funds by phasing in food
safety consolidation over several years.

Organizational flexibility. Food safety officials in all four
countries said that the new agency should have sufficient
organizational flexibility to shift resources to the areas of
greatest risk. For example, the new Canadian and Danish agencies
can move resources from one area to another, such as moving
inspectors when risk assessments indicate such movements are
needed. In Ireland, officials said that the service contract
arrangement may impede the agencies' ability to move resources to
respond to new or increasing risks. As such, Irish food safety
officials told us that they plan to evaluate the service contract
arrangement in about 3 years. If, at the end of that time, the
Authority believes that the service contract system does not
adequately ensure the safety of the food supply, it would then
move to control all food safety resources. Currently, within its
service agreement context, the Authority can only request that
other agencies shift their resource allocations.

Personnel integration strategies. Integrating all of the new
agency's personnel into a new organizational culture is important
to ensuring its success, according to officials in two of the four
countries we visited. For example, Canada recognized the need to
integrate its inspection staff and to develop a new and distinct
organizational culture and identity. As a result, the new agency's
management devoted considerable time to obtain staff input on the
agency's core mission and values. These consultations continue
today to assist mangers in charting the agency's future. In
Denmark, the new agency was formed from three separate ministries
agriculture, health, and fisheries each with its own culture and
procedures and with staff located in different offices. In order
to successfully blend these disparate groups, Denmark adopted an
incremental approach in which existing agencies were consolidated
over a 4- year period ending in 1999. According to Danish
officials, this strategy for integrating personnel has made the
new food safety agency much more cohesive, and therefore more
effective, than their previous system.

Open decision- making. Openness in the new agencies' decisions and
decision- making process is essential in order to maintain
consensus and public confidence, according to officials in three
of the four countries visited. To achieve openness, the new
agencies will bring consumer protection groups into the decision-
making process and will publicize food

GAO/RCED-99-80 Four Countries' Experiences Page 12

B-281971

safety concerns. This approach is significantly different from
previous government practices. Historically, in Great Britain and
Ireland, the public was not always informed about the bases for
food safety decisions and the processes by which these decisions
were reached. Denmark has a similar history regarding decisions on
meat products. According to officials in these countries, this
lack of openness has fueled public cynicism and mistrust,
especially during outbreaks of foodborne illnesses. For example,
during the BSE outbreak in Great Britain, consumer groups believed
that the Ministry of Agriculture, Fisheries and Food withheld
information from the public regarding the extent of the disease
among the nation's cattle herds as well as information on the
severity of the BSE threat to humans. All three European countries
have made commitments to have open and transparent decision-
making processes in their new food safety agencies.

Evaluation criteria. The ability to evaluate the new consolidated
system should be built in as early as possible in a new agency's
development. Officials in three of the four countries believe that
a new agency's goals and the criteria for evaluating the agency's
progress towards these goals should be defined. Some of the
criteria suggested for measuring the effectiveness of a new agency
include (1) downward trends in the incidence of foodborne
illnesses, (2) increases in the level of confidence the public has
in the new agency, and (3) an a reduction in bacterial levels on
food products, such as meat and poultry. However, no single
criterion should be relied upon exclusively to measure the
effectiveness of a new agency's approaches; rather, a combination
of measures should be used. In evaluating the Canadian Food
Inspection Agency's first year of operations, the Canadian Auditor
General found that agency lacked specific performance expectations
and therefore concluded that it was difficult to determine what
the Agency was trying to achieve. As discussed earlier, both
Canada and Denmark plan to begin developing criteria for and
measuring the effectiveness of their consolidation efforts in
1999.

Comments From the Four Countries Visited

We provided a draft of this report to the food safety agencies of
Canada, Denmark, Great Britain, and Ireland. Overall, officials
for these agencies commented that the draft report was accurate
and useful. They also made a number of technical suggestions,
which we incorporated as appropriate.

We conducted our review from May 1998 through March 1999 in
accordance with generally accepted government auditing standards.
To identify foreign countries that could be changing their food
safety

GAO/RCED-99-80 Four Countries' Experiences Page 13

B-281971

responsibilities, we contacted the embassies of 16 foreign
countries that officials in the Food and Drug Administration and
the U. S. Department of Agriculture's the Food Safety and
Inspection Service and the Foreign Agriculture Service identified
as possibly making changes in their food safety structures. 9 To
(1) determine the reasons for and approaches taken to make
changes; the costs and savings, if any, associated with the
organizational change; and efforts to assess the effectiveness of
the new systems and (2) identify the lessons that the United
States might learn from these countries' experiences, we visited
four countries that were making such changes Canada, Denmark,
Great Britain, and Ireland. We interviewed food safety officials
as well as government officials in the ministries of health,
agriculture, and treasury. We also interviewed representatives
from the countries' food industry, consumer groups, farmers, and
government employee unions. Additionally, we reviewed each
nation's laws and regulations governing food safety, as well as
documents concerning the consolidation of food safety
responsibilities. See appendix V for a list of the organizations
we met with in each country.

As agreed with your office, unless you publicly announce its
contents earlier, we plan no further distribution of this report
until 30 days from the date of this letter. At that time we will
send copies to congressional committees with jurisdiction over
food safety issues; the Embassies of Canada, Denmark, Great
Britain, and Ireland; Dan Glickman, the Secretary of Agriculture;
Donna E. Shalala, the Secretary of Health and Human Services; and
other interested parties. We will also make copies available to
others on request.

9 These 16 countries are Australia, Canada, Denmark, France,
Germany, Great Britain, Hungary, Ireland, Japan, New Zealand,
Norway, Poland, Portugal, Russia, Spain, and Sweden. None of these
countries are decentralizing their food safety systems.

GAO/RCED-99-80 Four Countries' Experiences Page 14

B-281971

If you have any questions about this report please contact me at
(202) 512- 5138. Major contributors to this report are listed in
appendix VI.

Sincerely yours, Lawrence J. Dyckman Director, Food and

Agriculture Issues

GAO/RCED-99-80 Four Countries' Experiences Page 15

Contents Letter 1 Appendix I Canada's Food Safety System

18 Reasons for Consolidating Food Safety Inspection

Responsibilities 18

Responsibilities in the Old and New Food Safety Systems 18 Funding
and Personnel Under the New Agency 22

Appendix II Denmark's Food Safety System

24 Reasons for Consolidating Food Safety Responsibilities 24
Responsibilities in the Old and New Food Safety Systems 24 Funding
and Personnel Under the New Agency 28

Appendix III Great Britain's Food Safety System

30 Reasons for Consolidating Food Safety Responsibilities 30
Responsibilities of the Current and Proposed Food Safety

Systems 31

Funding and Personnel Under the New Agency 34 Appendix IV
Ireland's Food Safety System

36 Reasons for Consolidating Food Safety Responsibilities 36
Responsibilities of the Old and New Food Safety Systems 37 Funding
and Personnel Under the New Agency 38

Appendix V List of Stakeholders by Country

40 Appendix VI Major Contributors to This Report

42 Related GAO Products 44 Tables Table I. 1: Canada's Food
Inspection System Prior to

Consolidation 19

Table I. 2: Canada's Food Inspection System After Consolidation 21

GAO/RCED-99-80 Four Countries' Experiences Page 16

Contents

Figures Figure II. 1: Denmark's Food Safety System Prior to
Consolidation 26 Figure II. 2: Denmark's Food Safety System After
Consolidation 28

Figure III. 1: Key Features of the Current Food Safety System in
Great Britain

32

Abbreviations

BSE Bovine Spongiform Encephalopathy GAO U. S. General Accounting
Office USDA U. S. Department of Agriculture

GAO/RCED-99-80 Four Countries' Experiences Page 17

Appendix I Canada's Food Safety System

Canada decided in 1996 to consolidate its food safety inspection
functions. The Canadian Food Inspection Agency began operations in
April 1997.

Reasons for Consolidating Food Safety Inspection Responsibilities

Canada consolidated its food inspection activities largely in
response to budgetary pressures and calls from government and
industry to operate more efficiently and effectively. Prior to the
creation of the new agency, three separate departments performed
activities related to food safety, which lead to duplication and
overlap in many areas. According to a 1998 report by the Canadian
Auditor General, in the early 1990s, the government reviewed
programs to determine more efficient and effective approaches to
delivering government service. These reviews were conducted in
large part because of serious deficit and debt problems, as well
as changing public perceptions and expectations about the role and
performance of government. Following these reviews, the government
initiated changes in at least four areas, including food
inspection, and began to introduce alternative ways of providing
services. All of the Canadian food safety stakeholders with whom
we met agreed that this emphasis on alternative ways of doing
business helped address budget problems, improved program
efficiency and effectiveness, reduced duplication and overlap, and
helped create the right environment in which to consolidate
responsibilities for food safety inspections.

Responsibilities in the Old and New Food Safety Systems

Prior to the creation of the new Canadian Food Inspection Agency,
three departments Agriculture and Agri- Food Canada, Health
Canada, and the Department of Fisheries and Oceans provided
inspection and related services for food safety, animal and plant
health, and agricultural inputs, that is, animal feed, seed, and
fertilizer. Generally, Health Canada was responsible for ensuring
the health and safety of all food in Canada. Health Canada
typically evaluated and set standards for food safety, managed
crises caused by outbreaks of foodborne illnesses, issued recalls,
conducted domestic product inspections, investigated consumer
complaints, and audited Agriculture and Agri- Food Canada's and
the Department of Fisheries and Oceans' efforts to ensure
compliance with food safety standards. Agriculture and Agri- Food
Canada and the Department of Fisheries had health and safety
responsibilities for the food products under their jurisdiction.
For example, Agriculture set meat and poultry standards for
international trade and domestic commerce; registered feed, seed,
and fertilizer products; inspected imported and domestic products,
such as meat, poultry, dairy, fruits, and vegetables; and reviewed
the labeling and processing of products. Fisheries registered

GAO/RCED-99-80 Four Countries' Experiences Page 18

Appendix I Canada's Food Safety System

seafood establishments, which traded interprovincially and
internationally (87 percent of fish products are exported), as
well as these establishments' suppliers. Fisheries also inspected
exports and vessels as well as all mollusk and shellfish.
Agriculture and Fisheries also promoted the use of the food
products whose safety they regulate. Table I. 1 shows the
responsibilities under Canada's previously decentralized food
inspection system.

Table I. 1: Canada's Food Inspection System Prior to Consolidation
Health Canada Agriculture and Agri- Food Canada Fisheries and
Oceans Canada

Evaluation and standard setting for food safety

Research Risk assessment and risk management Crisis management and
product recalls Compliance and enforcement including inspection of
imports and domestic products, and nonfederally registered
establishments

Complaints investigation Audits of Agriculture and Agri- Food
Canada and the Department of Fisheries and Oceans

Laboratory and diagnostic support Evaluation and standard setting
for

trade and commerce Risk assessment and risk management
Registration of establishments that trade interprovincially and
internationally and their suppliers; feed, seed, and fertilizer
products

Compliance and enforcement including inspection of domestic and
imported products and registered establishments

Export certification Animal and plant disease control Laboratory
support for commodities Labeling, process review Complaints
investigation

Evaluation and standard setting for trade and commerce

Development and application of quality management practices

Risk assessment and risk management Registration Compliance and
enforcement including inspection of domestic and imported
products, registered establishments and nonregistered fisherman
packers

Molluscan and shellfish inspection Export certification for fish
products Contaminant monitoring Vessel inspection Compliants
investigations Laboratory analysis of fish and fish products

The new system consolidates food inspection activities into one
agency, thus integrating the delivery of inspection and quarantine
services currently provided by Agriculture and Agri- Food Canada,
Health Canada, and the Department of Fisheries and Oceans. The new
inspection agency provides all inspection services related to food
safety, economic fraud, trade- related requirements, and animal
and plant health programs. Its primary responsibility is to
enforce standards pertaining to food safety and animal and plant
health. To accomplish this task, it, among other things, registers
processing plants, inspects domestic and imported foods,

GAO/RCED-99-80 Four Countries' Experiences Page 19

Appendix I Canada's Food Safety System

certifies exports, and quarantines selected imported food
products. The new agency's role also includes identifying and
evaluating risk management options; conducting assessments for
animal and plant health; setting standards for trade and commerce;
developing risk- based inspection systems; investigating outbreaks
of foodborne illness; conducting enforcement actions; and
coordinating emergency responses. The responsibilities for setting
food safety standards, risk assessment, and analytical testing
research and audit have been reinforced but remain with Health
Canada. Table I. 2 shows each organization's new responsibilities
in the current system.

GAO/RCED-99-80 Four Countries' Experiences Page 20

Appendix I Canada's Food Safety System

Table I. 2: Canada's Food Inspection System After Consolidation
Canadian Food Inspection Agency Agriculture and Agri- Food

Canada Health Canada Fisheries and Oceans Canada

Moved from Health: Inspect imports and domestic products,
nonfederally registered establishments

Laboratory and diagnostic support Crisis management and product
recalls

No role. Evaluation and standard setting for food safety

Research Risk assessment and risk management

Assess the effectiveness of the new agency's food safety programs

No role. Moved from Agriculture: Register establishments that
trade interprovincially and internationally and their suppliers;
feed, seed, and fertilizer products

Compliance and enforcement including inspection of domestic and
imported products, and registered establishments

Animal and plant disease control Export certification Moved from
Fisheries: Registration

Compliance and enforcement including inspection of domestic and
imported products, registered establishments and nonregistered
fisherman packers

Export certification for fish and fish products

Vessel inspection Laboratory analyses for fish and fish products

The Canadian Food Inspection Agency is a departmental corporation
under the Financial Administration Act. The new agency is headed
by a President, who reports to the Minister of Agriculture and
Agri- Food. The minister, in turn, reports to Parliament on food
safety inspection activities. The Minister of Health reports to
Parliament on setting human food safety

GAO/RCED-99-80 Four Countries' Experiences Page 21

Appendix I Canada's Food Safety System

standards and policies and assessing the effectiveness of the new
agency's activities.

Funding and Personnel Under the New Agency

The new agency, although supported largely through general tax
revenues, has the power to raise and retain funds from its
activities. For fiscal year 1998, the new agency had a budget of
about $355 million Canadian dollars ($ 238 million in U. S.
dollars), which included about $25 million in start- up funds and
about $330 million ($ 221 million in U. S. dollars) in
appropriations. Canadian officials expect the food safety agency's
budgets to decline over the next 3 years, from about $330 million
this year to about $311 million ($ 208 million in U. S. dollars)
in fiscal year 2000, about $304 million ($ 204 million in U. S.
dollars) in fiscal year 2001, and about $299 million ($ 200
million in U. S. dollars) in fiscal year 2002. While most
government departments are funded annually through parliamentary
appropriations, the new agency has the authority to spend its
annual appropriation over 24 months. According to officials of the
new agency, this more flexible funding authority should allow the
new agency to access funds over an extended period, providing for
unplanned cash flows or other unforeseen expenses. Unlike most
other federal departments, the new agency is allowed to raise a
portion of its annual budget by assessing user fees. In 1998, the
Canadian Auditor General estimated that in its first year of
operation, the new agency raised about 12 percent of its budget
through user fees.

With respect to personnel, the agency's enabling legislation
created a management and accountability framework that provides
the new agency with some flexibility to replace traditional
departmental approaches. For example, the new agency received
separate employer status. That is, it has been delegated the
authority to establish its own human resource management system,
negotiate collective bargaining agreements with unions, and
establish terms and conditions of employment. (Traditionally such
authority is the responsibility of the Treasury Board roughly
equivalent to a combination of the U. S. Department of the
Treasury, the Office of Personnel Management, and the Office of
Management and Budget). Thus, the new agency can work with unions
to create a more flexible work environment, such as changing
inspectors' duty hours or work- site assignments. In its first
year of operation, the agency reduced the number of union
bargaining units from 19 to 4, thereby creating a more streamlined
and efficient process.

GAO/RCED-99-80 Four Countries' Experiences Page 22

Appendix I Canada's Food Safety System

Under the new system, existing departments provided the full- time
equivalent of 4,500 staff years to the new agency. Of the total,
Agriculture and Agri- Food Canada contributed over 86 percent;
Health Canada, just over 3 percent; and the Department of
Fisheries and Oceans, about 9 percent. The new agency operates
programs in all 10 provinces and the Canadian territories. It has
about 4,200 regional staff; 185 field offices; 408 third- party
establishments, such as slaughterhouses; and 22 laboratories and
research facilities. It will have a regional structure with four
centers of operation and 18 regions.

GAO/RCED-99-80 Four Countries' Experiences Page 23

Appendix II Denmark's Food Safety System

Denmark phased in its operations over about 4 years, completing
the consolidation in 1999. Its food safety system is housed in the
new Ministry of Food, Agriculture, and Fisheries.

Reasons for Consolidating Food Safety Responsibilities

Denmark reorganized its food safety responsibilities to address
problems in the coordination and integration of services. Prior to
1995, at the beginning of the consolidation process, three Danish
ministries shared responsibilities for implementing food safety
laws. According to the Permanent Secretary of the new ministry,
this fragmented approach resulted in extensive overlaps of
responsibilities in some areas and gaps in coverage in other
areas; inconsistent food safety inspections; and inefficient
utilization of food safety resources.

The chairman of the Danish National Academy of Sciences said that
in 1995 the Academy reported that to improve the efficiency of
food safety, Denmark's food safety system needed to be
reorganized. The goal of the proposed reorganization was to
simplify food safety legislation, administration, and control,
with the belief that such reforms would lead to a more efficient
and effective food safety system, and provide assurances that the
high quality of Danish food products would continue. The Danish
Academy recommended that a new consolidated agency include all of
the activities related to food safety and adopt a consumer
protection orientation. The Academy also noted that by
consolidating food safety activities, the government could (1)
take advantage of new risk- based inspection schemes, such as the
Hazard Analysis and Critical Control Point system; (2) move
resources to areas presenting greater risk; (3) improve
international and European Union interactions; and (4) improve the
uniformity and consistency of local inspections. Finally, the
Academy's report concluded that the new agency should be based in
the agriculture and fisheries ministry.

In a May 1996 letter to the Prime Minister, representatives of
Denmark's consumers, farmers, and food industries also requested
that the government reorganize the food safety system. In their
letter, these stakeholders endorsed the concept of a consolidated
food safety system to improve food inspections.

Responsibilities in the Old and New Food Safety Systems

Before consolidation, the three Danish ministries shared food
safety responsibilities; each agency had its own headquarters and
field staff. The Ministry of Health set food safety standards for
local inspectors who inspected food processing plants, warehouses,
and local retail stores. The

GAO/RCED-99-80 Four Countries' Experiences Page 24

Appendix II Denmark's Food Safety System

Ministry of Agriculture was responsible for, among other things,
inspecting meat and poultry processing plants. The Ministry of
Fisheries was responsible for the safety of all fish and seafood,
including fishing vessels and processing plants. Figure II. 1
shows Denmark's food safety system prior to consolidation.

GAO/RCED-99-80 Four Countries' Experiences Page 25

Appendix II Denmark's Food Safety System

Figure II. 1: Denmark's Food Safety System Prior to Consolidation

Legislation, directives, regulations Parliament European

Union Ministry

of Health

Ministry of Agriculture

Ministry of Fisheries

National Food Agency

Veterinary Services Fisheries

Inspection Plant

Directorate 32 local control units 5 districts 6

inspectorates 6 districts Retail shops

Food processors

Fishing vessels

1st part of consolidation combined the ministries of Agriculture
and of Fisheries

GAO/RCED-99-80 Four Countries' Experiences Page 26

Appendix II Denmark's Food Safety System

In 1995, the Danish government combined the Ministry of
Agriculture and the Ministry of Fisheries and their respective
responsibilities into a single ministry the Ministry of
Agriculture and Fisheries. In December 1996, the Danish government
took a second step by moving the food safety activities of the
Ministry of Health into the Ministry of Agriculture and Fisheries,
and renamed the resulting organization the Ministry for Food,
Agriculture, and Fisheries. The goal of this reorganization was to
enhance the safety of food from its origins in the soil or sea to
the table of the consumers. Danish food safety officials believe
that with this approach there is a clear advantage for all
sectors, including consumers, retailers, processors, farmers, and
fishermen.

In July 1997, under the Ministry of Food, Agriculture, and
Fisheries, the Danish government organized food safety into three
subunits the Danish Veterinary and Food Administration, the Danish
Plant Directorate, and the Danish Directorate for Fisheries. The
Danish Veterinary and Food Administration is responsible for (1)
ensuring that consumers have healthy food, including meats as well
as fruits and vegetables; (2) protecting consumers against
misinformation; (3) monitoring and controlling animal diseases
that can be transferred to humans; (4) inspecting meat at all the
processing plants; (5) ensuring the safety and quality of fish
imports and exports; and (6) coordinating the activities of other
food safety agencies. The Administration is also the controlling
authority for veterinarians, animal medicines, and compliance with
animal protection rules. As of January 1999, the Administration
was continuing the last phase of the consolidation by reorganizing
the local and district offices.

The Danish Plant Directorate responsibilities include the quality
of vegetable products, plant health, environmental regulations for
agricultural production, and farmers' subsidies. It inspects seeds
and cereals, feed and fertilizers, fruit and vegetables, and other
plant and forestry seeds. It uses sampling and laboratory tests as
well as farm visits to inspect processing plants and farms.

The Danish Directorate for Fisheries is responsible for, among
other things, inspections of fresh waters and coastal areas,
including fish farms. Figure II. 2 shows Denmark's food safety
system after consolidation.

GAO/RCED-99-80 Four Countries' Experiences Page 27

Appendix II Denmark's Food Safety System

Figure II. 2: Denmark's Food Safety System After Consolidation

The Ministry for Food, Agriculture, and Fisheries Parliament
European

Union 11 Regional Inspection offices Plant

Directorate Retail Food

processors Fishing

vessels Veterinary

and Food Administration

Directorate for Fisheries Department Assisstant

Secretary

Funding and Personnel Under the New Agency

The total budget for the Ministry of Food, Agriculture, and
Fisheries for calendar year 1999 is about 13.5 billion kroner ($ 2
billion in U. S. dollars). This total represents around 4.75
billion kroner in appropriations and 8.7 billion kroner in
European Union subsidies. The Ministry also received about 120
million kroner for start- up costs.

GAO/RCED-99-80 Four Countries' Experiences Page 28

Appendix II Denmark's Food Safety System

Altogether, the Ministry of Food, Agriculture, and Fisheries has
4,952 staff. The Ministry has a central administrative staff of
195. The Danish Veterinary and Food Administration has 1,400
employees 435 in central offices, 795 at slaughterhouses, and 170
in laboratories, border inspection posts, and in the food safety
units. The Plant Directorate has a staff of 510 located throughout
the country. The Fisheries Directorate has a staff of 325 75 in
central offices, 150 in land- based inspection offices, and 100 on
vessels. The remaining 2,522 staff are engaged in various
agricultural promotion programs and research activities. The final
phase of the consolidation will bring about 520 employees from
local food inspection units into the Veterinary and Food
Administration.

Danish food safety officials stated that they do not anticipate
any savings in costs or personnel under the new organization.
However, they believe that food safety inspections will be more
consistent, resulting in a more efficient and effective food
safety system.

GAO/RCED-99-80 Four Countries' Experiences Page 29

Appendix III Great Britain's Food Safety System

As of January 1999, the Food Standards Agency had not been
formally established, but British food safety officials and other
stakeholders said they remained committed to its creation.
According to the Deputy Head of the Joint Food Safety and
Standards Group, a draft bill to create the new agency was
published for comment on January 27, 1999, and officials expect
the Parliament to take action during the current legislative
session.

Reasons for Consolidating Food Safety Responsibilities

Loss of public confidence in Great Britain's food safety system
and acknowledged weaknesses that contributed to serious outbreaks
of foodborne illnesses have made the creation of a new food safety
system a government priority. Public confidence in the food safety
system has eroded over the past 10 years in the face of several
serious outbreaks of foodborne illnesses. Surveys of the British
public in the mid- 1990s showed that concern focused on four
areas: the microbial safety of food, 10 the chemical safety of
food, the safety of genetically modified organisms and novel foods
and processes, and the nutritional quality of the diet.

Many public interest groups and the chairs of expert scientific
committees, as well as companies in the food processing,
producing, and retailing fields, believe that the current system
has real failings. According to these experts and government
studies, Great Britain's food safety system is fragmented and
lacks coordination among the different organizations involved in
setting food policy and in monitoring and controlling food safety.
That is, there are considerable overlaps and gaps between the
Ministry of Agriculture, Fisheries and Food; the Department of
Health; and the other departments dealing with food safety issues.
Other concerns identified included (1) too many institutional
barriers to promoting food safety at different points in the food
chain; (2) a lack of a clear strategy and structure for monitoring
the surveillance of chemical food safety, and (3) inconsistent
enforcement of food safety laws throughout Great Britain.

The fact that the Ministry of Agriculture, Fisheries and Food
promotes the economic interests of the food industry while being
charged with protecting public health was also identified as a
serious shortcoming of the system. Inevitably, there were
perceived conflicts between concerns for food safety and the
economic interests of some industry sectors. These conflicts have
been handled within the Ministry of Agriculture, Fisheries and
Food and are often perceived to be conducted in semi- secrecy.
Many food safety decisions have been met with widespread
skepticism, if not

10 Microbial pathogens are harmful bacteria, viruses, and
parasites that are transmitted by foods and foodborne outbreaks.

GAO/RCED-99-80 Four Countries' Experiences Page 30

Appendix III Great Britain's Food Safety System

suspicion, because of a perceived conflict of interest and the
relative secrecy of deliberations.

In September 1997, the Ministry of Agriculture, Fisheries and Food
and the Department of Health set up the Joint Food Safety and
Standards Group. This group brought together those parts of the
two departments that are likely to form the operational core of a
consolidated food safety agency. In January 1998, the government
proposed consolidating food safety responsibilities in a new
agency known as the Food Standards Agency. Despite widespread and
continuing support for the proposed agency, Parliament did not
enact enabling legislation for it during its 1997- 98 session,
because of, among other things, concerns over how to fund the new
agency and difficulty in obtaining time on the legislative
calendar. Nevertheless, the government has taken other steps to
strengthen the handling of food safety issues, such as making a
greater effort to ensure that information about food safety and
human health is presented more clearly and more comprehensively to
the public.

Responsibilities of the Current and Proposed Food Safety Systems

The framework for most food legislation in Great Britain derives
from the 1990 Food Safety Act, which brought together and updated
all food legislation into one comprehensive document and
implemented some European Union legislative requirements. In Great
Britain, responsibility for food standards and food safety is
divided among several national government departments, the
environmental health and trading standards departments of local
authorities, and a number of other bodies. Figure III. 1 displays
the key features of the current food safety structure in Great
Britain.

GAO/RCED-99-80 Four Countries' Experiences Page 31

Appendix III Great Britain's Food Safety System

Figure III. 1: Key Features of the Current Food Safety System in
Great Britain

Parliament The Government

Chemist The Ministry

of Agriculture, Fisheries and

Food Department

of Health

Public Health Laboratory

Service Central Science Laboratory

Meat Hygiene Service

Regional public health

laboratories Veterinary

Medicines Directorate

Privately owned public

analysts Local authorities Environmental

health officers

Trading standards departments

Public analysts Expert

advisory committees

Veterinary Laboratories

Agency Pesticides

Safety Directorate

Local Authority Coordinating

Body on Food and Trading Standards

Prior to the creation of the Joint Food Safety and Standards Group
in September 1997, the Ministry of Agriculture, Fisheries and Food
was the lead department on food standards, the chemical safety of
food, labeling, and food technology. Within the Ministry, various
subunits at headquarters and in regional offices were responsible
for specific aspects of food safety.

GAO/RCED-99-80 Four Countries' Experiences Page 32

Appendix III Great Britain's Food Safety System

The Veterinary Laboratories Agency provided the Ministry with
advice on how animal health can affect human health. The
Pesticides Safety Directorate was responsible for evaluating and
approving the use of pesticides and implementing post- approval
controls. The Central Science Laboratory provided a wide range of
scientific services and scientific support to policy work. The
Meat Hygiene Service, established in 1995, provided meat
inspection services to licensed meat premises and enforced hygiene
and welfare laws in slaughterhouses. The Veterinary Medicines
Directorate evaluated and approved veterinary medicines and
maintained surveillance of, and monitored suspected adverse
reactions to, residues in meat and animal products.

Furthermore, the Department of Health took the lead on issues of
food hygiene, microbiological food safety, and nutrition. A number
of subunits handled specific aspects of the Department's
responsibilities. For example, the Public Health Laboratory
Service, in partnership with its regional offices and local
environmental health departments, was responsible for most
laboratory analysis concerning the microbiological safety of food.
The Department of Health also had some enforcement
responsibilities, although enforcement is predominantly a local
function. Most of the food safety activities previously performed
by the Ministry of Agriculture, Fisheries and Food and the
Department of Health are now being carried out by the joint group.

District and county councils are responsible for enforcing most
food safety laws and regulations. Port health authorities and
local environmental health departments have an enforcement
responsibility with regard to enforcing food sanitation laws. The
Trading Standards Departments usually within County Councils
enforce food standards and labeling of food nutritional content.
Coordination of local authorities' enforcement of food issues is
the responsibility of the Local Authorities Coordination Body on
Food and Trading Standards, which provides advice and guidance for
enforcement authorities and advises the central government on
enforcement issues. This body also acts as the nation's liaison
for transborder food safety problems in the European Union.

Under the proposed new system, the new Food Standards Agency will
assume most of Great Britain's food safety responsibilities and
attempt to address past weaknesses. The Agency will be accountable
to Parliament through the Secretary of State for Health. 11
According to the government's

11 The new safety agency will also report to the Health Ministers
of Scotland, Wales, and Northern Ireland.

GAO/RCED-99-80 Four Countries' Experiences Page 33

Appendix III Great Britain's Food Safety System

proposal, the new agency will be responsible for (1) formulating
policy and advising the government on the need for legislation on
all aspects of food safety and standards, as well as on certain
aspects of nutrition; (2) providing information and educational
material for the public on food matters; (3) working closely with
government departments to protect the public, particularly in
areas such as nutrition and farming practices; and (4)
commissioning research and surveillance across the full range of
its activities.

As envisioned, the Food Standards Agency will assume the
responsibilities of the Ministry of Agriculture, Fisheries and
Food and the Department of Health in ensuring the safety of the
whole food chain, from farm to table. The new Agency will have key
roles at the farm level, with powers to prevent contaminated food
from entering the food chain and to control animal diseases that
could be passed through the food chain. At the processing level,
the new agency will also have considerable authority because it
will take over the Meat Hygiene Service and thus be responsible
for inspecting and licensing fresh meat plants and for
implementing measures to prevent the transmission of Bovine
Spongiform Encephalopathy (BSE). At the consumer level, the Agency
will have responsibility for all matters concerning food
additives, chemical contaminants, and the labeling of food to
ensure that consumers are not misled with regard to its content.

Although the Food Standards Agency will not take over the existing
enforcement responsibilities of local authorities and local
outbreaks will continue to be managed locally, it will set
standards for enforcement and will have the power to take action
directly to protect the public. In addition, it will take a
leading role in coordinating responses with central and local
authorities in the event of a national food emergency, such as the
recent BSE crisis.

Funding and Personnel Under the New Agency

The Deputy Group Head of the Joint Group estimated the start- up
cost for the new agency will be about 30 million pounds ($ 49
million in U. S. dollars) spread over a 3- year period, and the
operating cost for the new agency will be about 120 million pounds
($ 196 million in U. S. dollars) annually. The local governments
will spend 130 million pounds ($ 212 million in U. S. dollars)
annually on food safety.

While staffing levels have not yet been officially determined, the
officials of the joint group estimate that about 500 staff will be
employed at

GAO/RCED-99-80 Four Countries' Experiences Page 34

Appendix III Great Britain's Food Safety System

headquarters and about 1,700 in the Meat Hygiene Service. A
governing body composed of a chairperson and no more than 12
independent members will run the new agency. Governing members are
to be appointed on the basis of their professional reputation and
expertise, bringing a broad balance of relevant skills,
experience, and independence to the new agency. In addition,
members are to act collectively in the public interest; rather
than to represent any particular sector or interest group. Current
plans call for a majority of the members to be drawn from public
interest backgrounds. The governing body will be empowered to
publish any of the advice it gives the government.

GAO/RCED-99-80 Four Countries' Experiences Page 35

Appendix IV Ireland's Food Safety System

In July 1998, the Irish government enacted legislation creating
the Food Safety Authority of Ireland. The Authority assumed all
responsibility for food safety in January 1999.

Reasons for Consolidating Food Safety Responsibilities

For many years Irish consumers have been warned about the dangers
of using unpasteurized milk, the need for proper hygiene in the
home, and the necessity of proper cooking to ensure food safety.
However, a succession of high- profile outbreaks of foodborne
illnesses throughout the world, such as the Bovine Spongiform
Encephalopathy outbreak in Great Britain, shook consumer
confidence in the safety of food and in the ability of regulatory
agencies to protect the public. In 1996, 21 elderly people died in
a Scottish nursing home as a result of eating meat tainted with
the E. coli O157 H: 7 bacterium. Also in 1996, a European survey
indicated that antibiotic residues in Irish pork were among the
highest in Europe. These incidents undermined consumers'
confidence in the Irish food industry and in the Irish regulatory
agencies; the public began to respond to vague reassurances with
skepticism. According to Irish officials, these outbreaks also
helped to highlight the difficulties that the Department of
Agriculture and Food faced in trying to carry out its dual mission
of protecting consumers and promoting the food industry. Consumers
seemed to regard the incidence of foodborne illnesses as equally
the fault of the government and the food industry.

Avoiding serious outbreaks of foodborne illness and maintaining a
strong food safety system are extremely important for Ireland's
economy for two reasons. First, according to officials in the
Irish Department of Agriculture and Food, roughly 90 percent of
the country's food is produced for export. For example,
Agriculture officials estimated that roughly 9 out of every 10
cows worth about $3.7 billion are exported annually. Agriculture
officials feared that any serious outbreak of a foodborne illness
could effectively close many export markets, thereby depriving
Ireland of foreign trade. Furthermore, Agriculture officials were
concerned that Irish exports could decline, even without a major
outbreak, if trading partners lost confidence in the Irish food
safety system and thus in the safety of Irish food. Second,
Ireland's economy also depends heavily on tourism. To the extent
that outbreaks of foodborne illnesses, or the threat of outbreaks,
dampen tourism, serious economic harm could follow.

By early 1997, the Irish government believed that addressing the
country's food safety concerns could wait no longer. In addition
to food related illnesses, other concerns, such as the
availability of genetically modified

GAO/RCED-99-80 Four Countries' Experiences Page 36

Appendix IV Ireland's Food Safety System

food and food irradiation, caused concern among much of the Irish
population. Irish food safety officials believed that any threat
to the food supply, whether real or potential, required a response
that was sufficient to calm domestic and international markets.
The Irish government established a start- up group the Food Safety
Authority on January 1, 1998, and enacted legislation to create
the Authority on July 2, 1998. The Authority assumed full control
of the food safety system on January 1, 1999.

Responsibilities of the Old and New Food Safety Systems

Prior to the creation of the Authority, food safety was fragmented
across more than 50 entities, including 6 major government
departments, 33 local authorities, and 8 regional health boards.
The Department of Agriculture and Food inspects farms,
slaughterhouses, and deboning and trimming halls for compliance
with food processing regulations. Local and county governments, as
well as the Ministers of Environment; Public Enterprise; Marine;
and Trade, Enterprise, and Employment, have various other food
safety responsibilities. For example, Ireland has eight Health
Boards that have local food safety authority, such as inspecting
retail and catering outlets as well as butcher shops and some food
processing plants.

According to Irish food safety officials, in 1996, the government
established an interdepartmental committee to advise Parliament on
how the various food safety agencies could be best coordinated. In
early 1997, this committee recommended establishing the Food
Safety Authority of Ireland as a regulator of regulators. That is,
the responsibility for food safety would remain with existing
agencies, but the Authority would audit these agencies and have a
voice in setting and maintaining standards as well as in the
promotion of good practices.

However, a new government elected in mid- 1997 came to office
believing that the Authority should be directly accountable for
all food safety functions. The new government envisioned an
Authority that would take over all functions related to food
safety and food hygiene from existing agencies, providing
consumers with protection from illnesses related to unsafe food.
The Authority was to be independent and science- based and provide
for full farm- to- fork traceability. Original plans for creating
the Authority included transferring all relevant staff to the new
agency.

However, personnel issues precluded the wholesale transferring of
staff to the new Authority. Roughly 2,000 staff, spread across the
50- plus agencies

GAO/RCED-99-80 Four Countries' Experiences Page 37

Appendix IV Ireland's Food Safety System

deliver food safety services throughout the country. It is common
for such staff to have other duties, in addition to food safety
responsibilities. Officials found it impossible under these
circumstances to transfer food safety personnel to the Authority
without disrupting other, sometimes unrelated, programs. The
solution was to have the Authority and existing agencies enter
into contractual agreements, called service contracts, which were
to specify food safety activities.

In October 1998, the Authority began negotiating the terms and
conditions of these contracts with the existing agencies.
According to Authority officials, the first contracts took effect
in March 1999. The contracts include objectives that the Authority
wants the agencies to meet, as well as the time frame within which
they should be met. Current plans call for existing funding
arrangements to be maintained, that is, agencies will continue to
receive appropriations from the Parliament. Agencies are then
expected to make sufficient resources available to meet service
contract obligations. The Authority is to publish the details of
the service contracts and introduce a system to monitor agencies'
compliance. If agencies do not satisfactorily perform their
agreed- upon responsibilities, the Authority is to report to the
Minister for Health and Children, which will arrange for such
reports to be sent to Parliament.

Although the Authority will also have an enforcement role, its
main function will be to foster, through education and promotion,
a food safety culture at all stages of the food chain, from
production to final use by the consumer. One of the Authority's
key objectives is to bring about acceptance of the notion that the
primary responsibility for food safety rests with the food
industry and consumers, not the government. The Authority's
enforcement responsibilities are also to be carried out through
service contracts with the departments of Agriculture and Health
and include the inspection, approval, licensing, and registration
of food premises and equipment and laboratory analysis.

Funding and Personnel Under the New Agency

According to Authority officials, for fiscal year 1999, the Food
Safety Authority of Ireland has a budget of about 6.5 million
Irish pounds ($ 9 million in U. S. dollars). Of this amount about
1.5 million pounds ($ 2 million in U. S. dollars) was for start-
up operations, and another 5.0 million pounds ($ 7 million in U.
S. dollars) is for the coordination of inspection services and new
educational programs.

GAO/RCED-99-80 Four Countries' Experiences Page 38

Appendix IV Ireland's Food Safety System

The Authority's organizational structure includes the Board, a
Scientific Committee, a Consultative Council, and a Chief
Executive. The 10- member Board provides strategic direction for
the Authority, acting as a forum in which the work of its various
structural elements is harmonized. To help ensure that the
Authority maintains a consumer protection focus, food industry
representatives are precluded from serving on the Board. The
Scientific Committee has 15 members, all appointed by the Minister
for Health and Children, and all with eminent scientific
qualifications and experience to ensure the broadest possible
range of expertise. As of January 1999, the Committee had the
assistance of 85 scientists involved in 6 subcommittees and 10
working groups. The role of the Scientific Committee is to assist
and advise the Board on matters pertaining to scientific or
technical questions, food inspection and nutrition. The Board also
receives advice from the Consultative Council a body that includes
consumers as well as food industry representatives. The Council
has 24 members, 12 appointed by the Department of Health and
Children and 12 by the Board.

The Chief Executive reports to the Board and is ultimately
responsible for the implementation of policies and the achievement
of the Authority's goals. According to Authority officials, there
will be 60 staff to coordinate about 2,000 staff performing the
food safety inspections and other activities through the service
agreements. The Authority is divided into four divisions. The
Technical and Scientific Division develops policy and sets
standards, priorities, quality levels, and procedures for
technical and scientific issues. It serves the research needs of
the Scientific Committee and its subcommittees. In addition, it
collects and assesses surveillance data on foodborne illnesses.

The Operations Division focuses on enforcement by overseeing the
service contracts' implementation. The Operations Division
coordinates, controls, and harmonizes all activities under these
contracts. It also carries out an audit program throughout the
food chain to help ensure compliance with the Authority's
decisions on standards and processes.

The Communications, Education, and Information Division develops
and implements policy on communications, education, and
information for consumers, enforcement officers, public health
professionals, and others in the food chain.

The Corporate Services Division develops and implements
accounting, human resources, information technology, and legal
services.

GAO/RCED-99-80 Four Countries' Experiences Page 39

Appendix V List of Stakeholders by Country

Canada Agricultural Union Agriculture and Agri- Food Canada
Canadian Food Inspection Agency Canadian Meat Council Consumers
Association of Canada Fisheries and Oceans Canada Fisheries
Council of Canada Health Canada Office of Auditor General of
Canada Treasury Board of Canada

Denmark Agricultural Council of Denmark Copenhagen Food Control
Unit Consumer Council Danish Dairy Board Danish Farmers Union
Danish Poultry Association Danish Veterinary Association
Federation of Danish Pig Producers

and Slaughterhouses Ministry of Food, Agriculture and Fisheries
Steff- Houlberg Processors

Great Britain Consumers' Association Department of Health
Department of the Treasury Food, Drink, and Tobacco Federation;

Transport and General Workers Union Federation of Fresh Meat
Wholesalers Joint Food Safety and Standards Group Ministry of
Agriculture, Fisheries and Food National Consumer Council National
Farmers' Union National Food Alliance

GAO/RCED-99-80 Four Countries' Experiences Page 40

Appendix V List of Stakeholders by Country

Northern Foods, plc Sea Fish Industry Authority

Ireland Avonmore Waterford Group, plc Agriculture and Food
Development Authority,

National Food Centre Department of Agriculture and Food Department
of Health and Children Food Safety Authority of Ireland Food,
Drink, and Tobacco Federation RDS  Consumer Advocates Super Quinn
Supermarket

GAO/RCED-99-80 Four Countries' Experiences Page 41

Appendix VI Major Contributors to This Report

Keith Oleson, Assistant Director Eugene Wisnoski, Evaluator- in-
Charge John M. Nicholson, Jr . Carol Herrnstadt Shulman

GAO/RCED-99-80 Four Countries' Experiences Page 42

GAO/RCED-99-80 Four Countries' Experiences Page 43

Related GAO Products Food Safety: Opportunities to Redirect
Federal Resources and Funds Can Enhance Effectiveness (GAO/RCED-
98-224, Aug. 6, 1998).

Food Safety: Fundamental Changes Needed to Improve Food Safety
(GAO/RCED-97-249R, Sept. 9, 1997).

Food Safety: New Initiatives Would Fundamentally Alter the
Existing System (GAO/RCED-96-81, Mar. 27, 1996).

Food Safety and Quality: Uniform, Risk- Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26,
1992).

Food Safety and Quality: Who Does What in the Federal Government
(GAO/RCED-90-19A & B, Dec. 21, 1990).

(150653) GAO/RCED-99-80 Four Countries' Experiences Page 44

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