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entitled 'Food Safety: Selected Countries' Systems Can Offer Insights 
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Report to Congressional Requesters: 

United States Government Accountability Office: 
GAO: 

June 2008: 

Food Safety: 

Selected Countries' Systems Can Offer Insights into Ensuring Import 
Safety and Responding to Foodborne Illness: 

Food Safety: 

GAO-08-794: 

GAO Highlights: 

Highlights of GAO-08-794, a report to congressional requesters. 

Why GAO Did This Study: 

Like other nations, the United States faces growing food safety 
challenges resulting from at least three major trends. First, imported 
food makes up a growing share of the food supply. Second, consumers are 
increasingly eating foods that are raw or have had minimal processing 
and that are often associated with foodborne illness. Third, changing 
demographic patterns mean that more of the U.S. population is, and 
increasingly will be, susceptible to foodborne illness. In 2005, GAO 
reported on the approaches and challenges seven countries faced in 
reorganizing and consolidating food safety functions. Since then, the 
European Union (EU) has taken on a larger role in overseeing food 
safety within its 27 member states. 

GAO was asked to describe how the EU, Canada, Germany, Ireland, Japan, 
the Netherlands, and the United Kingdom (1) ensure the safety of 
imported food, (2) respond to recent outbreaks of foodborne illness, 
and (3) measure the effectiveness of their reorganized approach to food 
safety. GAO also asked experts in these countries and the EU to 
identify emerging food safety challenges that they expect to face over 
the next decade. In doing this work, GAO did not evaluate the 
countries’ management of their food safety systems or explicitly 
compare their efforts with those of the United States. 

What GAO Found: 

The countries GAO examined have a comprehensive approach to ensuring 
the safety of imported food. Specifically, they focus on the entire 
food supply chain, from “farm to table;” place primary responsibility 
for food safety on producers; separate risk assessment and risk 
management; use a risk-based inspection system; and take steps to 
ensure that certain food imports meet equivalent safety standards. 
Under the “farm to table” approach, for example, food safety laws cover 
every stage of the food production process, starting with how animals 
are raised and ending when food reaches the consumer. All countries GAO 
reviewed focus import inspections on the foods likeliest to pose the 
greatest risk. The EU, for example, requires that all imports of live 
animals and products of animal origin—which are considered high 
risk—enter the EU through approved border inspection posts. 

Several of the selected countries reported that three elements of their 
food safety systems are critical in helping them respond to outbreaks 
of foodborne illnesses. These elements are traceback procedures, 
cooperative arrangements between government veterinarians and public 
health officials, and mandatory recall authority. In EU member states, 
all food must be traceable “one step forward and one step back” so 
industry and government can quickly track any food products to minimize 
harm to public health and reduce the economic impact on industry. Food 
and feed business operators must be able to document the names and 
addresses of the supplier and customer, as well as the nature of the 
product and date of delivery. Officials in several countries told GAO 
that mandatory recall authority—the legal authority to remove, or 
require another party to remove, a product from the market—is rarely 
used but is an important part of the food safety system because it is 
the last stop in the supply chain. 

None of the selected countries has evaluated the impact of its 
reorganized food safety system, although several track certain 
indicators, such as the number of inspections, enforcement actions, and 
foodborne illnesses. However, some countries’ national audit offices 
(GAO’s counterparts) have evaluated specific aspects of their 
countries’ food safety systems. For example, the UK audit office found 
that the country’s Food Standards Agency had improved public 
confidence, a stated objective. The EU’s Food and Veterinary Office has 
conducted numerous reviews of aspects of all EU countries’ food safety 
systems and identified areas needing improvement. Most of the selected 
countries use proxy measures, such as public opinion surveys, to assess 
their effectiveness. Public opinion in several countries has improved 
in recent years. Countries’ industry and consumer stakeholders also 
generally had positive views of the reorganized food safety systems. 

Experts identified food safety challenges that they expect to face over 
the next decade. These include climate change; demographic change, with 
increases elderly people and immigration; and new types of foods, such 
as ready-to-eat salads, that may result in more incidents of foodborne 
illness. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-794]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Selected Countries Have a Comprehensive, Risk-Based Approach to Import 
Safety: 

Selected Countries and the EU Cite Key Elements of Food Systems as 
Critical to Effectively Responding to Outbreaks of Foodborne Illness: 

The Selected Countries Have Not Evaluated Their Reorganized Food Safety 
Systems, but Proxy Measures Indicate Improvements: 

Food Safety Officials in Other Countries Identified Issues of Future 
Concern: 

Appendix I: Country and EU Profiles: 

Appendix II: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Reasons for Consolidating Food Safety Responsibilities: 

Table 2. Risk Assessment and Risk Management Bodies in Selected 
Countries: 

Table 3: Emerging Food Safety Challenges Identified by Various Foreign 
Food Safety Officials: 

Table 4: Major EU Laws, Regulations, and Directives: 

Abbreviations: 

BSE: bovine spongiform encephalopathy: 

BVL: Federal Office of Consumer Protection and Food Safety: 

CFIA: Canadian Food Inspection Agency: 

DAFF: Department of Agriculture, Fisheries, and Food: 

DG-SANCO: Directorate General for Health and Consumer Protection: 

EC: European Commission: 

ECDC: European Centre for Disease Prevention and Control: 

EEA: European Economic Area: 

EFSA: European Food Safety Authority: 

EPA: Environmental Protection Agency: 

EU: European Union: 

FDA: Food and Drug Administration: 

FSAI: Food Safety Authority of Ireland: 

FSC: Food Safety Commission: 

FVO: Food and Veterinary Office: 

GDP: gross domestic product: 

HACCP: Hazard Analysis and Critical Control Point: 

HC: Health Canada: 

HPA: Health Protection Agency: 

HPSC: Health Protection Surveillance Centre: 

MAFF: Ministry of Agriculture, Forestry, and Fisheries: 

MHLW: Ministry of Health, Labor, and Welfare: 

NMFS: National Marine Fisheries Service: 

RFID: Radio-Frequency Identification: 

RIVM: National Institute for Public Health and the Environment: 

SALSA: Safe Food for Local Suppliers Association: 

SPS: Sanitary and Phytosanitary: 

TRACES: Trade Control and Expert System: 

UK: United Kingdom: 

USDA: U.S. Department of Agriculture: 

VWA: Food and Consumer Product Safety Authority: 

WTO: World Trade Organization: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

June 10, 2008: 

The Honorable Richard J. Durbin: 
United States Senate: 

The Honorable Rosa L. DeLauro: 
Chair: 
Subcommittee on Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies: 
Committee on Appropriations: 
House of Representatives: 

Like other nations, the United States faces growing food safety 
challenges resulting from at least three major trends. First, imported 
food makes up a growing share of the food supply. According to an 
analysis by the U.S. Department of Agriculture (USDA), the dollar value 
of agricultural imports to the United States for consumption increased 
by about 53 percent in just 4 years, from $46 billion in fiscal year 
2003 to $70 billion in fiscal year 2007. The United States also trades 
with more than 150 countries and territories, with food products coming 
into more than 300 U.S. ports. USDA estimates that approximately 60 
percent of the fresh fruits and vegetables consumed in the United 
States is imported, as is 75 percent of the seafood. Second, we are 
increasingly eating foods that are consumed raw or with minimal 
processing and that are often associated with foodborne illness. For 
example, according to USDA, leafy greens such as spinach are the 
category of produce most likely to be associated with an outbreak, and 
the average consumer ate 2.4 pounds of fresh spinach in 2005--a 180 
percent increase over 1992. Third, changing demographic patterns mean 
that more of the U.S. population is, and increasingly will be, 
susceptible to foodborne illness. The U.S. population is aging, and 
older people tend to be more vulnerable to foodborne illness than 
younger ones. The risk of severe and life-threatening symptoms from 
infections caused by foodborne pathogens is also higher for young 
children, pregnant women, and immune-compromised individuals. According 
to the Food and Drug Administration (FDA), these groups make up about 
20 to 25 percent of the U.S. population. 

Recent outbreaks of foodborne illness have focused public attention on 
the increasing potential for widespread dissemination of contaminated 
products. For example, beginning in September 2006, the United States 
experienced an outbreak of E. coli associated with the consumption of 
tainted spinach grown in California; this outbreak resulted in 
confirmed illnesses and deaths. Widespread outbreaks of other foodborne 
illnesses, such as Salmonella, have also occurred from contaminated 
peanut butter and tomatoes. In addition, there have been problems with 
certain meat products, resulting in recalls (which in the United States 
are nonmandatory). Although the number of recalls has declined in 
recent years, the quantity of meat and poultry recalled has increased 
sharply. Meat and poultry product recalls declined from 125 in 2002 to 
58 in 2007. However, 2 of the 6 biggest meat recalls in U.S. history 
occurred in a 6-month period, between October 2007 and February 2008. 

In the United States, 15 different federal agencies are responsible for 
food safety. Two agencies, USDA and FDA, have primary responsibility. 
USDA is responsible for the safety of meat, poultry, and certain egg 
products, while FDA is responsible for the safety of virtually all 
other foods, including milk, seafood, and fruits and vegetables. Food 
safety responsibility is further divided among the 50 states, which may 
have their own statutes, regulations, and agencies for regulating and 
inspecting the safety and quality of food products. Over the past 30 
years, we have detailed problems with the current fragmented federal 
food safety system and reported that the system has caused inconsistent 
oversight, ineffective coordination, and inefficient use of resources. 
This fragmentation calls into question whether the government can plan 
more strategically to inspect food production processes, identify and 
react more quickly to outbreaks of foodborne illness, and focus on 
promoting the safety and integrity of the nation's food supply. This 
fragmentation is the key reason that we added federal oversight of food 
safety to our High-Risk Series in January 2007 and called for a 
governmentwide examination of the food safety system.[Footnote 1] We 
recommended, among other things, that Congress enact comprehensive, 
uniform, and risk-based food safety legislation and commission the 
National Academy of Sciences or a blue ribbon panel to conduct a 
detailed analysis of alternative organizational structures for food 
safety. 

In 2005, we reported on the approaches and challenges seven countries 
faced in consolidating food safety functions.[Footnote 2] These 
countries were Canada, Denmark, Germany, Ireland, the Netherlands, New 
Zealand, and the United Kingdom (UK). Some of these countries 
reorganized their food safety systems in response to public concern 
about the safety of the food supply during outbreaks of bovine 
spongiform encephalopathy (BSE, also known as mad cow disease) and, in 
the case of the European countries, widespread dioxin contamination in 
chicken products during the 1990s. Some countries--notably Canada, 
Denmark, and New Zealand--reorganized to improve the overall 
effectiveness of their systems. Since our 2005 report, the food safety 
system of the European Union (EU) has been fully integrated and is 
regulated by legislation that applies to all 27 member states. Japan 
also reorganized part of its food safety system in 2003, creating a new 
agency, the Food Safety Commission, to assess the health risks 
associated with food. Even with updated measures in place, however, it 
is not possible to totally eliminate all foodborne pathogens from the 
food supply. For example, incidents of E. coli have increased slightly 
in the EU over the past 10 years, and in early 2008, a number of 
Japanese citizens became seriously ill after eating frozen dumplings 
imported from China that contained a dangerous level of pesticides. 

In this context, you asked us to describe (1) how 6 countries (Canada, 
Germany, Ireland, Japan, the Netherlands, and the UK) that have 
reorganized their food safety systems and the EU ensure the safety of 
imported food, (2) what these countries and the EU consider to be the 
most critical elements in helping them respond to recent outbreaks of 
foodborne illness, and (3) how they measure the effectiveness of their 
reorganized food safety systems, as well as how effective the 
reorganized systems have been in minimizing harm to public health from 
outbreaks of foodborne illness. In addition, we asked experts in these 
6 countries and the EU to identify what they consider to be some of the 
most important emerging food safety challenges they expect to face over 
the next decade. 

To address these questions, we collected and reviewed laws and 
directives, and analyzed agencies' annual reports, performance reports, 
strategic plans, official brochures, and guidance documents on policies 
and procedures from these 6 countries and the EU. We also met with food 
safety officials, industry experts, and consumer advocacy 
representatives in Belgium (for the EU), Canada, Germany, Ireland, 
Japan, the Netherlands, and the UK. Canada, Germany, Ireland, the 
Netherlands, and the UK were selected because we had reviewed those 
countries in our 2005 report. They were selected then because they had 
reorganized their food safety systems within the past 10 years and, 
like the United States, had high per capita income, and their consumers 
had high expectations for food safety. We added Japan because it also 
has a high per capita income and recently reorganized part of its food 
safety system. We added the EU because of its major role in 
coordinating member countries' food safety activities. In this report, 
we refer to the changes to their food safety systems that the selected 
countries have made as reorganization. In describing the changes to 
systems of Canada, Germany, Ireland, the Netherlands, and the UK, 
however, we use the countries' term, which is consolidation. 

After we collected the information, we prepared appendixes that 
described each country's and the EU's food safety system. We then sent 
the draft appendixes to officials in those countries for review and 
comment. We received comments from at least one agency (food safety or 
public health) in 6 of the selected countries. Japan did not provide 
comments. After receiving their feedback and making revisions, where 
appropriate, we sent the appendixes to representatives of the various 
countries' national audit offices. We also sent copies of the report to 
the Department of Agriculture, the Department of State, the Food and 
Drug Administration, and the Office of the U.S. Trade Representative 
for their review; we incorporated their comments as appropriate. 

The information on countries' food safety systems in this report, 
including descriptions of laws, is based largely on interviews with and 
documentation provided by food safety officials as well as food 
industry or consumer stakeholders from the countries we examined. Most 
of the information obtained was qualitative. We did not compare any 
elements of these countries' systems to the United States' system-- 
although in some cases, country officials told us that aspects of their 
food safety systems were similar to aspects of the U.S. system--and we 
did not independently evaluate the effectiveness of any of the programs 
or systems described. We also did not independently verify the foreign 
laws and directives discussed. Instead, we relied on our discussions 
with foreign officials and the documents we collected. We recognize 
that the selected countries have much smaller populations and also 
differ from the United States in climate and agricultural production as 
well as in organizational structure. However, these countries and the 
United States have at least one important similarity: All are high- 
income countries where consumers have high expectations for food 
safety. We conducted our work from July 2007 to June 2008 in accordance 
with generally accepted government auditing standards. Those standards 
require that we plan and perform the work to obtain sufficient, 
appropriate evidence to provide a reasonable basis for our findings and 
conclusions based on our objectives. We believe that the evidence 
obtained provides a reasonable basis for our findings and conclusions 
based on our objectives. Detailed information on each country's and the 
EU's food safety systems can be found in appendix I. In this report, 
when we refer to selected countries, we mean the 6 countries named 
above and the EU. Of the 6 countries, 4--Germany, Ireland, the 
Netherlands, and the UK--are EU member states. 

Results in Brief: 

The selected countries have a comprehensive, risk-based approach to 
ensuring the safety of imported food. Specifically, they focus on the 
entire food supply chain, from "farm to table;" place primary 
responsibility for food safety on food producers with the government 
providing oversight; separate risk assessment and risk management; 
employ a risk-based inspection system; and take steps to ensure that 
certain food imports meet equivalent food safety standards. More 
specifically, we found the following: 

* Farm-to-table oversight. Under this approach, the entire food 
production process is regulated, starting with how animals are raised 
on the farm and ending when food reaches the final consumer. For 
example, according to EU sources, under the EU's integrated farm-to- 
table approach, food and feed laws cover all stages of production, 
processing, and distribution. The laws also cover imported products 
from the primary production of a food, through its storage, transport, 
sale, or supply to the final consumer and, where relevant, the 
importation, production, manufacture, storage, transport, distribution, 
sale, and supply of feed. We were told that this is a comprehensive and 
integrated approach that focuses on the prevention of problems 
throughout the food chain. 

* Producer responsibility. The burden for food safety in most of the 
selected countries lies primarily with food producers, rather than with 
inspectors, although inspectors play an active role in overseeing 
compliance. This principle applies to both domestic and imported 
products. We were told that like the farm-to-table concept, producer 
accountability is a proactive approach that focuses on prevention. 

* Separate risk assessment and risk management. To create independent 
safeguards, the EU and some countries created separate agencies for (1) 
risk assessment--scientific evaluation of all known and potential 
adverse health effects resulting from foodborne hazards--and (2) risk 
management--the process for weighing policy alternatives to accept or 
minimize assessed risks and select appropriate responses. In addition, 
some of the countries also separated their risk management agencies 
from those that promote industry in order to ensure independence. For 
example, before they reorganized, risk management in Ireland, Japan, 
and the UK had been conducted by the same agency that oversaw 
agricultural production, and consumers perceived that these dual 
responsibilities presented conflicting priorities. 

* Risk-based inspection systems. The selected countries focus their 
inspection of imports on the foods most likely to pose the greatest 
risk. A risk-based approach is critical in light of the volume of 
products in the food supply. The EU, for example, requires that all 
imports of live animals and products of animal origin--which are 
considered high risk--enter the EU through approved border inspection 
posts. These shipments cannot clear the port without veterinary 
approval. Shipments containing products the EU considers lower risk, 
such as fruits, vegetables, cereals, and spices, must meet less 
stringent requirements. The EU and Japan require that importers bear 
the cost of disposing of or reinspecting noncompliant food products. 

* Certain food imports must meet equivalent safety standards. Each of 
the selected countries takes steps to ensure that certain types of 
food--most often, meat or animal products--meet equivalent food safety 
standards. Japan also has specific arrangements with some governments 
to certify exports of certain high-risk products. According to Japanese 
officials, under a Japanese-Chinese agreement, for example, the Chinese 
government certifies Chinese spinach processors, who in turn oversee 
the practices of local farmers and test the product at three stages of 
production. Chinese authorities then conduct preshipment tests on the 
spinach before exporting, confirming that the exporter has observed the 
proper procedures on pesticide management. The spinach may be inspected 
again once it arrives in Japanese ports. 

Several of the selected countries generally reported that three 
elements of their food safety systems are critical in helping them 
respond to outbreaks of foodborne illnesses. These elements include 
traceback procedures, cooperative arrangements between government 
veterinarians and public health officials, and mandatory recall 
authority. 

* Traceback procedures. All food and feed must be traceable "one step 
forward and one step back" in EU member states so industry and 
governments can quickly track any questionable food or feed products to 
minimize harm to public health and reduce the economic impact on 
industry. Food and feed business operators must be able to document the 
names and addresses of the supplier and customer, as well as the nature 
of the product and date of delivery. They are also required to have in 
place systems and procedures that allow for this information to be made 
available to government officials on demand. Exporters in trading 
partner (non-EU) countries do not need to meet this requirement, except 
under certain circumstances, but EU importers should be able to 
identify their direct supplier in trading partner countries. In 
addition, the selected countries also have mandatory animal 
identification programs for certain livestock species. 

* Cooperation between government veterinarians and public health 
officials. In light of highly pathogenic avian influenza, BSE, and 
recognition of the connection between animal and human diseases, such 
cooperation has been critical in tracking the source of zoonotic 
(animal-to-human) diseases in some countries. For example, in the UK, 
the Veterinary Laboratories Agency has several memorandums of 
understanding with the Health Protection Agency, the UK agency that 
monitors outbreaks of infectious diseases, to conduct research. The 
agencies also support joint efforts to standardize laboratory methods 
and databases. The Veterinary Laboratories Agency can also assist in 
cases where a direct or indirect animal source is suspected in 
outbreaks of zoonotic diseases and where veterinary investigation or 
intervention could help reduce risks to the public. For example, 
according to UK officials, during the investigation of a 2004 outbreak 
of an antibiotic-resistant strain of Salmonella among cattle on an 
English farm, rapid communication of test results and epidemiological 
information between the Health Protection Agency and the Veterinary 
Laboratories Agency led to containment of the outbreak before it could 
spread to humans. 

* Mandatory recall authority. Officials in several countries told us 
that mandatory recall authority--the legal authority to remove, or 
require another party to remove--a product from the market is rarely 
used. However, according to a Canadian industry representative, this 
authority is an important part of the food safety system because it is 
the last stop in the supply chain. Moreover, as Canadian government 
officials indicated, they rarely need to exercise mandatory recall 
authority because the threat of such a recall generally prompts food 
suppliers to remove products from the market. 

None of the selected countries had conducted a comprehensive evaluation 
of its reorganized food safety system, but most countries track certain 
indicators, such as the number of inspections conducted, the number of 
enforcement actions taken, and the number of foodborne illness 
outbreaks. However, most of the selected countries have assessed 
specific aspects of their food safety systems. For example, some of the 
countries' national audit offices had evaluated specific aspects of 
their countries' food safety systems, and Health Canada has assessed 
some elements of the Canadian system. In the EU, the Food and 
Veterinary Office has conducted numerous reviews of certain aspects of 
member countries' food safety systems. For example, in June 2005, the 
office assessed the import control system and four operating border 
inspection posts in Germany. It found that import controls were 
generally applied correctly in the posts visited, with only minor 
shortcomings. However, the office also found that supervision of 
imports that do not comply with EU regulations was inadequate, 
traceability was not reliable, and exit of these noncompliant products 
from the EU was not ensured. It also found that there were significant 
deficiencies at some of the border inspection facilities. As a result 
of the audit, Germany took steps to address the shortcomings. Most of 
these countries also use proxy measures, such as consumer surveys, to 
assess their effectiveness, and the public impression of food safety 
has improved in several countries in recent years. Finally, 
stakeholders we interviewed cited the benefits of their country's 
reorganized food safety system. 

Experts in the selected countries identified a number of challenges 
related to food safety that they expect to face over the next decade, 
with climate change the most frequently identified challenge. 
Specifically, they indicated that climate change may result in an 
increase in foodborne pathogens that thrive in warmer conditions, such 
as the Vibrio bacterium in oysters. Furthermore, some officials 
expressed concern that their populations are aging, and older people 
are more vulnerable to foodborne illness than younger ones. 
Additionally, the emergence of new types of foods--for example, ready- 
to-eat foods, including those that do not require cooking and therefore 
may retain pathogens--may result in illness. 

Background: 

In the United States, USDA and FDA have primary responsibility for 
ensuring the safety of domestic and imported foods. USDA is responsible 
for the safety of meat, poultry, and certain egg products and for 
performing certain food quality inspections and certifications that 
include food safety elements. FDA is responsible for the safety of all 
other foods, including milk, seafood, and fruits and vegetables. In 
addition, the Environmental Protection Agency (EPA) sets limits on the 
amount of pesticide residues that are allowed in food, and the National 
Marine Fisheries Service (NMFS) within the Department of Commerce 
provides fee-for-service inspections of seafood safety and quality. The 
Department of Homeland Security is responsible for coordinating 
agencies' food security activities, including at U.S. borders. The U.S. 
Centers for Disease Control and Prevention is responsible for 
monitoring, identifying, and investigating foodborne disease problems 
and for working with FDA, NMFS, USDA, state and local public health 
departments, universities, and industry to develop control methods. 

In January 2007, we added the federal oversight of food safety to our 
High-Risk Series, which is intended to raise the priority and 
visibility of government programs that are in need of broad-based 
transformation to achieve greater economy, efficiency, effectiveness, 
accountability, and sustainability. Over the past 30 years, we have 
detailed problems with the current fragmented federal food safety 
system and reported that the system has caused inconsistent oversight, 
ineffective coordination, and inefficient use of resources, all of 
which suggest that the federal oversight of food safety should be 
designated as a high-risk area. The fragmented nature of the federal 
food oversight system raises the question of whether the government can 
plan more strategically to inspect food production processes, identify 
and react more quickly to outbreaks of foodborne illnesses, and focus 
on promoting the safety and integrity of the nation's food supply. 

As in the United States, government agencies in other countries also 
share responsibility for their nation's food safety. In February 2005, 
we reported on the experiences of several countries in reorganizing 
their food safety systems. Food safety officials in the countries we 
selected said they faced similar divisions of responsibilities and that 
their countries' reorganizations were intended to address this problem. 
The countries streamlined and consolidated their food safety functions, 
establishing a single agency to lead food safety management or 
enforcement of food safety legislation. Table 1 lists the reasons each 
country gave for consolidating its food safety responsibilities. 

Table 1: Reasons for Consolidating Food Safety Responsibilities: 

Canada: 
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. 

Denmark: 
Denmark consolidated its food safety system to improve effectiveness 
(e.g., communication with consumers and consistency of inspections) and 
to improve efficiency (e.g., move resources to high-risk areas and 
reduce overlaps in responsibilities). 

Germany: 
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. 

Ireland: 
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. Also, some consumers perceived that 
the ministry that was responsible for inspecting farms and meatpacking 
plants had favored the interests of the food industry over consumer 
protection. 

The Netherlands: 
The Netherlands consolidated its food safety system out of 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, BSE, and 
other animal diseases. Officials noted that the need to comply with 
recently adopted EU legislation also motivated the Netherlands' 
consolidation. 

New Zealand: 
New Zealand consolidated its food safety system to improve 
effectiveness in several areas, including coordination within the food 
safety system, and to eliminate inconsistencies in the country's 
oversight of domestic food, imports, and exports. 

The UK: 
Officials stated that the UK 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 the BSE outbreak. 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. 

Source: [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-212]. 

[End of table] 

Although the 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 whose consumers have very high 
expectations for food safety. 

Most of the countries we selected for this review are members of the EU 
and, as such, are subject to applicable requirements of EU food safety 
legislation. The development and implementation of EU food safety 
legislation is the responsibility of the Brussels-based Directorate 
General for Health and Consumer Protection (referred to by its French 
acronym, DG-SANCO). In 2002 the EU also created a new independent food 
safety institution, the European Food Safety Authority (EFSA), which is 
responsible for providing independent scientific advice on all matters 
related to food and animal feed safety. In April 2004, the EU adopted 
additional, comprehensive food safety legislation that became effective 
on January 1, 2006. Together with the earlier regulation establishing 
EFSA, the legislation was intended to create a single, transparent set 
of EU food safety rules applicable to both animal and nonanimal 
products. Since that time, individual EU countries have worked to bring 
their national food safety laws in line with EU requirements--a process 
referred to as harmonization. 

These selected countries also face the challenge of foodborne illness 
caused by known hazards as well as new threats. To address these 
challenges, the United States and other countries have undertaken 
certain measures to protect human health. These measures include the 
use of a science-based safety system for certain food products, known 
as Hazard Analysis and Critical Control Point (HACCP), and the 
requirement that exporting nations meet food safety standards similar 
to the importing country's own standards. A HACCP system is designed to 
improve the safety of food by having industry identify and control 
biological, chemical, and physical hazards in products before they 
enter the market. In the United States, USDA established HACCP 
requirements for meat and poultry establishments in 1996. FDA 
implemented similar HACCP requirements for seafood in 1997 and for 
juice in 2002. Under the HACCP system, processing firms must identify 
hazards that are reasonably likely to occur and must develop and 
implement plans to control those hazards. HACCP systems, under USDA and 
FDA regulations, are not required for other stages of production, such 
as on the farm. In general, the federal food safety regulation begins 
at the point of processing, rather than on the farm itself. 

With regard to equivalent food safety standards between countries, the 
Agreement on the Application of Sanitary and Phytosanitary Measures-- 
entered into force with the establishment of the World Trade 
Organization (WTO) on January 1, 1995--affirms that member countries 
are allowed to adopt and enforce measures necessary to protect human, 
animal, or plant life or health, provided, among other things, the 
measures are based and maintained on scientific principles and 
evidence, do not arbitrarily or unjustifiably discriminate among WTO 
members, and are not applied in a manner that would constitute a 
disguised restriction on international trade. In turn, member countries 
are expected to accept the sanitary or phytosanitary measures of other 
member countries as equivalent if the exporting member objectively 
demonstrates that its measures achieve the importing member's 
appropriate level of sanitary or phytosanitary protection. Members are 
encouraged to use relevant international standards and work toward 
harmonization--that is, the adoption of common sanitary or 
phytosanitary measures--to facilitate trade. Consistent with the 
principles of the sanitary and phytosanitary agreement, many countries 
use equivalency agreements to certify that their food safety systems 
are equivalent to those of the country importing products. All 
countries in our review are parties to the WTO and to the Agreement on 
the Application of Sanitary and Phytosanitary Measures. 

In response to these increasing challenges, FDA and other U.S. agencies 
recently released plans that discuss the oversight of food safety. In 
November 2007, FDA released its Food Protection Plan, which sets forth 
FDA's framework for overseeing the safety of food.[Footnote 3] 
Concurrently, a 12-agency working group presented to the President its 
Action Plan for Import Safety, which contains, among other things, 
recommendations for improving the safety of food imports entering the 
United States.[Footnote 4] Both plans spell out numerous actions FDA 
plans or is requesting authority to take to enhance food safety, 
including writing new food protection guidelines for industry and 
helping foreign countries improve their regulatory systems. 

Selected Countries Have a Comprehensive, Risk-Based Approach to Import 
Safety: 

The selected countries have a comprehensive, risk-based approach to 
ensuring the safety of imported food that focuses on the entire food 
supply chain, from "farm to table." The selected countries emphasize 
prevention, placing primary responsibility for food safety on food 
producers, with government bodies providing oversight. Some of these 
countries separate risk analysis and risk management, and some also 
separate food safety from the promotion of agricultural trade. Each 
country also employs a risk-based inspection system so that foods with 
increased risk receive the most attention. The selected countries also 
take steps to ensure certain food imports meet equivalent food safety 
standards. 

The Selected Countries' Food Safety Systems Are Based on Farm-To-Table 
Oversight: 

The selected countries have generally adopted a farm-to-table approach, 
under which the entire food production process is regulated, starting 
with how animals are raised on the farm and ending when food reaches 
the final consumer. Farm-to-table oversight in the selected countries 
applies to both domestic and imported foods. We were told that farm-to- 
table is a comprehensive and integrated approach that focuses on 
prevention of problems throughout the food chain. In the EU, for 
example, according to EU sources, food and feed laws under this 
approach (referred to in the EU as "farm to fork") cover all stages of 
production (including farming), processing, and distribution. According 
to these sources, EU laws also cover imported products from the primary 
production of a food, through its storage, transport, sale, or supply 
to the final consumer and, where relevant, the importation, production, 
manufacture, storage, transport, distribution, sale, and supply of 
feed. Individual EU member states, through their bodies charged with 
food safety oversight (referred to as competent authorities), ensure 
surveillance and control of food and feed operators, and the European 
Commission (EC--the administrative, implementing, and enforcement body 
of the EU) tests the performance of member states' control capacities 
through audits and inspections. Farms and food producers in non-EU 
countries that export to the EU must observe the same safety standards 
that apply in the EU in order to export their products. 

Canada also takes a farm-to-table approach to food safety to safeguard 
not just the food supply but also the plants and animals upon which 
safe food depends. Products subject to inspection by the Canadian Food 
Inspection Agency range from agricultural inputs, such as seeds, feeds, 
and fertilizers; to fresh foods, including meat, fish, eggs, grains, 
dairy products, fruit and vegetables; and prepared and packaged foods. 
The government also works with commodity sectors to develop and review 
food safety plans. At the consumer end of the spectrum, the food safety 
agency educates Canadians about safe food-handling practices and 
various food safety risks through its Web site, food safety fact 
sheets, and the Canadian Partnership for Consumer Food Safety 
Education, a group of industry, consumer, and government organizations 
that jointly develop and implement a national program to educate 
consumers on how to safely handle food. Moreover, in December 2007, 
Canada's Prime Minister announced the new Food and Consumer Product 
Safety Action Plan aimed at strengthening and modernizing Canada's 
safety system for health, consumer, and food products. The plan 
responds to changes in trade, industry supply chains, and consumer 
buying patterns. Under the plan, the government will implement programs 
focused on prevention, targeting highest risks, and promoting rapid 
response. Among other things, the initiative will involve working with 
industries, provinces, and territories to implement preventive food 
safety control measures along the food chain. 

Like the EU and Canada, Japan takes a farm-to-table approach (referred 
to there as a "food chain" approach) to food safety. According to the 
Japanese Food Safety Commission, Japanese law stipulates that food 
safety be ensured at each stage of the food production process and 
apportions responsibility for food safety among the national 
government, the local governments, food operators, and consumers. 
(Consumers are responsible for improving their knowledge and 
understanding of food safety and expressing their opinions about 
policies to ensure food safety. One of the ways they can educate 
themselves about food safety is by paying close attention to food 
labels, and according to USDA's Foreign Agricultural Service, the 
Japanese government has recently introduced initiatives to strengthen 
food labeling requirements.) At the national level, the Ministry of 
Agriculture, Forestry, and Fisheries oversees primary production 
processes, including animal health and the use of agricultural 
chemicals, and the Ministry of Health, Labor, and Welfare oversees the 
processing and distribution stages. Moreover, with regard to imports, 
the ministry develops a monitoring plan each year for imports that 
prescribes measures for ensuring food safety in three stages: (1) in 
the exporting countries, (2) at entry into Japan, and (3) during 
internal distribution. 

Producers in Most of the Selected Countries Are Responsible for Food 
Safety: 

The burden for ensuring food safety in most of the selected countries 
lies primarily with food producers, rather than with inspectors, 
although inspectors play an active role in overseeing compliance. This 
principle applies to both domestic and imported products. We were told 
that like the farm-to-table concept, producer accountability is a 
proactive approach that focuses on prevention. 

According to EU sources, for example, food and feed operators have 
primary responsibility for food safety, while member states provide 
oversight over these operators at all stages of production. Business 
operators are responsible for the food and animal feed (such as cattle 
fodder or pet food) that they produce, transport, store, or sell. They 
must (1) be able to rapidly identify any supplier or consignee, (2) 
immediately inform the competent authorities if they have a reason to 
believe their food or feed is not safe, (3) immediately withdraw a 
product from the market if they have reason to believe the product is 
not safe, (4) apply HACCP principles in their processes and ensure that 
controls are applied at critical points,[Footnote 5] and (5) cooperate 
with the competent authorities in actions taken to reduce risk. The 
competent authority in each member state is responsible for monitoring 
producers to ensure that they are meeting these obligations. The EU 
Food and Veterinary Office then assesses the performance of the member 
states' competent authorities, countries aspiring to join the EU, and 
non-EU countries intending to export to the EU to verify the 
effectiveness of national control systems for enforcing EU requirements 
in the areas of food safety, animal health and welfare, and plant 
health. 

In Japan, business operators who produce, import, sell, or conduct 
other business for fertilizers, agricultural chemicals, feed, feed 
additives, veterinary medicines, and other agricultural products bear 
primary responsibility for ensuring food safety when conducting their 
business activities. These operators are also responsible for providing 
accurate and appropriate information on their products and for 
cooperating with policies implemented by the national and local 
governments. The national government is responsible for formulating and 
implementing policies to ensure food safety. With regard to imports, 
the burden of compliance with Japanese food safety regulation lies with 
importers, but the Japanese government (specifically, the Ministry of 
Health, Labor, and Welfare) further ensures compliance through a high 
level of import monitoring. In 2006, for example, Japan reported that 
its inspectors examined 11 percent of declared products coming into its 
ports. 

Some producers in selected countries have commented that placing 
responsibility on them is generally positive. One industry 
representative, for example, told us that, "farmers and producers can 
no longer hide behind meat inspectors." An industry representative from 
another country said that, because producers are concerned with 
protecting their name brands, greater accountability makes them 
proactive. A consumer representative from a third country echoed this 
view, stating that importers are bearing more responsibility for 
ensuring the safety of their food imports because they are aware of the 
damages--financial and image-related--that violations cause to their 
business. 

Producer Responsibility: The Case of EU Feed Suppliers: 

Feed suppliers in the EU must apply HACCP principles, register with 
their national competent authorities to help ensure traceability, and 
comply with specific microbiological criteria, such as for levels of 
Salmonella, molds, and yeast. The competent authorities in each country 
approve certain feed operators (i.e., those manufacturing and/or 
selling certain feed additives) by visiting the facility before they 
start up any activity to ensure that the operators meet the 
requirements of the legislation, and once the operator is approved, the 
competent authority provides oversight and imposes penalties for 
noncompliance. The EU Food and Veterinary Office, in turn, inspects the 
competent authorities’ oversight and provides recommendations when 
there are shortcomings. It also inspects countries aspiring to join the 
EU, and non-EU countries intending to export to the EU, to verify the 
effectiveness of their national control systems to implement EU 
standards in the areas of food safety, animal health and welfare, and 
plant health. As for imported feed, importers must ensure that their 
feed meets EU standards. 

Some Countries Separate Risk Assessment from Risk Management: 

To create independent safeguards, some of the selected countries 
created separate agencies for (1) risk assessment--scientific 
evaluation of all known and potential adverse health effects resulting 
from foodborne hazards--and (2) risk management--the process for 
weighing policy alternatives to accept or minimize assessed risks and 
to select appropriate responses. The EU, for example, created the 
European Food Safety Agency to conduct risk assessment, while Japan 
created the Food Safety Commission for this purpose. Germany created 
the Federal Institute for Risk Assessment to assess risks and the 
Federal Office of Consumer Protection and Food Safety to lead food 
safety risk management. This office also coordinates food safety 
surveillance at the federal level. (The 16 individual German states are 
responsible for food safety legislation and oversight of food 
inspections performed by local governments.) Canada consolidated 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, in one agency, Health Canada. 
Table 2 provides the names of the risk assessment and risk management 
bodies in each of the selected countries. 

Table 2: Risk Assessment and Risk Management Bodies in Selected 
Countries: 

Country: Canada; 
Risk assessment body: Health Canada; 
Risk management body: Canadian Food Inspection Agency. 

Country: EU; 
Risk assessment body: European Food Safety Agency; 
Risk management body: Risks are managed by individual EU member states. 

Country: Germany; 
Risk assessment body: Federal Institute for Risk Assessment; 
Risk management body: The Federal Office of Consumer Protection and 
Food Safety (coordinating body)[A]. 

Country: Ireland; 
Risk assessment body: Science Committee of the Food Safety Authority of 
Ireland[B]; 
Risk management body: Food Safety Authority of Ireland. 

Country: Japan; 
Risk assessment body: Food Safety Commission[C]; 
Risk management body: Ministry of Health, Labor, and Welfare and 
Ministry of Agriculture, Forestry, and Fisheries. 

Country: The Netherlands; 
Risk assessment body: National Institute for Public Health and the 
Environment[D]; 
Risk management body: Food and Consumer Product Safety Authority. 

Country: The UK; 
Risk assessment body: Food Standards Agency[E]; 
Risk management body: Food Standards Agency. 

Sources: Canada, EU, Germany, Ireland, Japan, the Netherlands, and the 
UK. 

Notes: 

[A] Germany's 16 federal states are responsible for overseeing 
compliance with the law, and as such, they are in charge of food and 
feed safety, animal health and welfare, and plant health. The Federal 
Office of Consumer Protection and Food Safety coordinates--but does not 
oversee--the activities of the federal states in these areas. 

[B] In Ireland, a Scientific Committee was established in 2000 to aid 
the Food Safety Authority of Ireland in risk assessment. The committee 
is made up of scientists from a variety of disciplines whose work for 
the authority is voluntary. 

[C] In 2003, Japan established the Food Safety Commission as a Cabinet- 
level agency responsible for conducting neutral, scientific risk 
assessments related to food safety, including the use of food 
additives, pesticide residues, and the presence of illness-causing 
bacteria, and other issues. The commission became a fully functioning, 
independent agency in 2005. Previously, the two ministries responsible 
for managing food safety--the Ministry of Health, Labor, and Welfare 
and the Ministry of Agriculture, Forestry, and Fisheries--conducted 
their own scientific risk assessments. While the Food Safety Commission 
now assesses risks, the two ministries are responsible for managing 
these risks. 

[D] The Food and Consumer Product Safety Authority's Office of Risk 
Assessment commissions the National Institute for Public Health and the 
Environment to conduct risk assessments on its behalf. 

[E] The Food Standards Agency also receives advice from 10 scientific 
committees that provide input, as needed, on various food-related 
risks. 

[End of table] 

Some countries have also separated their risk management agencies from 
those that promote industry in order to ensure independence. For 
example, Ireland and the UK, as part of their restructuring several 
years ago, took risk management away from their ministries of 
agriculture, which consumers perceived as favoring the food industry 
over consumer protection. Similarly, prior to Japan's 2003 food safety 
system restructuring, the Food Agency within the Ministry of 
Agriculture, Forestry, and Fisheries, which was responsible for food 
safety, was managed in collaboration with industrial promotion bureaus 
within the ministry; the Food Agency was abolished when the Food Safety 
Commission was created. 

Inspections of Imports Are Based on Risk, and in the EU and Japan, 
Importers Bear Some Costs: 

The selected countries base their inspections of imports on the degree 
of risk presented by particular food types, and the EU and Japan 
require that importers bear the cost of disposing of or reinspecting 
noncompliant food products. Live animals and animal products, such as 
meat, milk, and fish, are among those that present the highest level of 
risks because they can transmit serious human and animal diseases. In 
addition, certain plant products, such as nuts, wheat, corn, beans, 
rice, and certain spices can present high levels of risks because they 
may be contaminated by aflatoxins--toxins produced by mold that can 
damage the liver and may lead to liver cancer. Fruits and vegetables 
may also be considered high risk if they contain unacceptably high 
levels of pesticide residues. Risk may also be considered high if a 
product is traded in large quantities or if a product or the area it 
comes from is known to be susceptible to particular plant or animal 
diseases. 

According to the EU, it has shifted its focus from regular, but random, 
sampling to paying attention to the sources of greatest risk. If the 
risk of a given food product is not known or quantified, the EU applies 
what it refers to as the "precautionary principle:" If there are 
reasonable grounds for suspecting a problem, the commission acts to 
limit the risk. The EU asserts that it does not necessarily need to 
wait for proof that there really is a risk. 

The EU requires that all imports of live animals and products of animal 
origin enter the EU only through certain border inspection posts-- 
airports, rail stations, and deepwater ports--of which there are about 
300. The posts, which are under the authority of each member state's 
official veterinary services, must be notified in advance of the 
presentation of such consignments; these consignments must undergo an 
official veterinary check at the post. A member state's customs service 
cannot release consignments unless they have passed through veterinary 
controls. When a consignment arrives at a border inspection post 
accompanied by the correct health certification, three types of checks 
will be carried out: 

* Documentary--for all consignments, inspectors review the accompanying 
documents. 

* Identity--for all consignments, inspectors verify that the identity 
of the goods corresponds fully with the veterinary documents supplied. 

* Physical--for a percentage of consignments, depending on the type of 
animal product and the country of origin, inspectors physically inspect 
the consignments to ensure they do not pose a threat to public and 
animal health. According to EU officials, EU legislation also specifies 
a minimum number of physical checks to be carried out per product group 
(e.g., meat, fish, or dairy) by each member state. A physical 
inspection may also involve taking samples for laboratory tests. 

When all tests and checks are satisfactory, the consignment is issued a 
Common Veterinary Entry Document and is placed on the EU market. 

If a consignment does not comply with EU requirements, it may be 
rejected. In these cases, EU officials negotiate with the owner of the 
consignment and the country of dispatch, where appropriate, about 
whether to destroy the product, to retreat it for uses other than the 
human food chain, or to return it. Food or feed business operators or 
their representatives are responsible for the consignment and are 
liable for any costs incurred by the competent authorities to destroy 
or redispatch it. 

When consignments are not in compliance, all other border inspection 
posts are notified through the EU's Rapid Alert System for Food and 
Feed (rapid alert system), an electronic notification system managed by 
DG-SANCO in Brussels. The system alerts all EU member countries of a 
potential food problem, including either a direct or an indirect risk 
to human health from food or feed. The rapid alert network involves all 
member states, the European Community, and the European Food Safety 
Authority, as well as the non-EU countries of Iceland, Liechtenstein, 
and Norway. Each participating country has a rapid alert system contact 
point to collect information on national notifications and enter them 
into the database. The exchange of information allows participating 
states to immediately ascertain whether they are also affected by a 
problem and take appropriate measures. Since all EU border posts are 
connected electronically, problems at any one border can quickly be 
announced to all other border posts via the rapid alert system. Future 
imports from the same exporting country are then scrutinized more 
closely. 

The EU also maintains a list of food products of nonanimal origin that 
may represent a human health risk. Cereals and nuts, for example, may 
appear on the high risk list. Such products undergo control measures, 
such as health certificates and testing, similar to those required for 
food products of animal origin. For example, all consignments of 
pistachios from Iran are sampled and checked. The safeguard measures 
are lifted once the problem has been addressed. 

Food products of nonanimal origin--including fruits, vegetables, 
cereals, tubers, nondairy drinks, food of mineral origin (such as 
salt), spices, and condiments--represent less of a risk and as such, do 
not need to come from approved countries or establishments. These 
products can come into any EU port of entry. However, they are still 
subject to certain EU requirements in order to verify that that they 
comply with EU food standards. Among other things, food business 
operators in non-EU countries must monitor the safety of products and 
processes under their responsibility, follow general hygiene provisions 
for primary production, develop HACCP principles, and register 
establishments with the appropriate competent authorities. The EU 
member states' competent authorities are responsible for carrying out 
regular controls of goods imported into EU territory. 

The EU requires that member states ensure that adequate financial 
resources are available for organizing official controls on imports. 
Member states may therefore collect fees to cover costs occasioned by 
these controls. However, they must collect fees for certain activities, 
including controls for products of animal origin, such as meat 
inspection, and controls of dairy establishments. Fees are also levied 
for certain import controls on these commodities. EU officials stated 
that the fees may not be higher than the costs borne by the competent 
authorities. 

Japan takes a similarly risk-based approach to inspections. Each year, 
the Ministry of Heath, Labor, and Welfare produces an imported foods 
monitoring and guidance plan that, among other things, spells out the 
quantity and category of inspections to be conducted each year. In 
fiscal year 2007, for example, the goal was approximately 79,000 random 
inspections for 124 food groups. If an imported food belongs to a food 
group that is known to be at an increased risk for contamination from a 
pathogen, pesticide residue, or animal drug, the ministry issues an 
order requiring that products with a high violation probability are 
inspected every time they are imported (lot by lot). According to the 
imported foods monitoring and guidance plan, moreover, if the number of 
imported foods from a specific country, area, or business entity 
violating the law is above 5 percent of the overall number of foods 
inspected, and if it is likely that the importation of violating goods 
will continue, given conditions in the exporting country, the ministry 
may ban the importation of such goods altogether. 

While there is no cost to importers for random inspections at Japanese 
quarantine stations, if products are required to undergo more intensive 
inspections as a result of past problems, the importer pays for 
additional inspections. Japan also imposes financial penalties for 
importers found to be in noncompliance. According to an expert on the 
Japanese import system, many Japanese importers therefore require 
testing certificates from exporters to reduce the potential for 
violation. In situations where import violations are severe, the 
Ministry of Health, Labor, and Welfare lists the names of violators on 
its Web site, which is updated every few weeks. 

The Selected Countries Take Steps to Ensure Certain Food Imports Meet 
Equivalent Safety Standards: 

The selected countries take steps to ensure that certain food imports 
meet equivalent safety standards. In the EU, for example, food products 
of animal origin imported from non-EU countries must meet standards at 
least equivalent to those of the EU for food quality and hygiene. If 
such foods are found not to be as safe as those of the EU and do not 
meet the requirements of EU hygiene regulations, the overseas firm is 
not allowed to export to the EU. The EU maintains a list of non-EU 
countries for which it has recognized the capacity of the competent 
authorities, as well as its animal and public health system but does 
not maintain such a list for food of nonanimal origin. Among the 
requirements for approving the export of products of animal origin are 
the following: 

* a country's formal submission of a written application to export to 
the EU; 

* the EU's verification of the exporting country's animal and public 
health system, such as legislation, control systems, disease 
surveillance measures, and laboratory facilities; 

* the country's submission and approval of a monitoring plan for 
residues of banned or restricted substances in the EU, including 
veterinary medicines and growth-promoting hormones; and: 

* the country's provision of sanitary certification that the products 
to be exported to the EU meet import requirements. 

Inspectors from the EU's Food and Veterinary Office normally visit non- 
EU countries to verify compliance with these conditions. If compliance 
is satisfactory, the EU may approve countries and establishments for 
export to the EU. In addition, non-EU countries must certify and 
approve business establishments wishing to export to the EU, noting 
that they meet the relevant EU requirements. The EU maintains lists of 
these establishments online for all the major categories of animal 
products (e.g., beef, dairy, fish, or poultry), and compliance is 
verified during follow-up inspections. 

In Canada, the Canadian Food Inspection Agency requires importers of 
meat and seafood products to meet Canadian standards. Determination of 
a foreign country's equivalency is based on the approval of a country's 
system of meat inspection, approval of establishments operating within 
that system, and review and registration of individual meat products 
prepared in these establishments. To approve the exporting country's 
inspection and certification system, the Canadian Food Inspection 
Agency follows a process of equivalency evaluation, based upon 
provisions in the Agreement on the Application of Sanitary and 
Phytosanitary Measures of the World Trade Organization. The agreement 
requires each member to accept as equivalent sanitary and phytosanitary 
measures of another member if the exporting member objectively 
demonstrates to the importing member that its measures achieve the 
importing member's appropriate level of protection. 

Canada's Foreign Country Meat Inspection Systems Evaluation Program 
requires that imported meat products--unless specifically exempted by 
Canadian legislation--meet the same standards and requirements as if 
they were produced in registered establishments in Canada. It also 
requires that the exporting country's inspection and certification 
systems, along with the establishments operating under those systems, 
be approved by the Canadian Food Inspection Agency before meat products 
can be exported to Canada. The competent authority of the exporting 
country must issue an official meat inspection certificate for every 
shipment of meat products exported to Canada. The competent authority 
is also expected to take appropriate actions if the Canadian Food 
Inspection Agency notifies it about meat products found to violate 
Canadian requirements and is to communicate any actions to the agency. 
The Canadian Food Inspection Agency may require additional examination 
of subsequent shipments to Canada, with additional certification, for a 
predetermined number of shipments and/or weight of the certified 
shipment. The majority of the agency's inspectors are focused on meat 
products because of the higher risk relative to most other foods. 
Canada currently allows importation of meat products from 40 countries. 

In the case of seafood, Canada enters into agreements with other 
countries it believes have reliable inspection systems and uses these 
agreements in concentrating its inspection resources on products and 
countries representing increased risk. Under some agreements, the 
Canadian Food Inspection Agency agrees that products from specified 
processing facilities meet certain standards and therefore are subject 
to fewer inspections at the border. The agency normally assesses these 
plants before it adds them to a list. Other agreements represent 
recognition by the agency that the inspection system in another country 
is equivalent to the system in Canada. Under these agreements, the 
competent authority in the other country will inspect and maintain the 
list of establishments eligible for reduced inspection frequency upon 
export to Canada. 

Canada has an equivalency agreement in place with the EU for meat 
products and is working toward bringing an equivalency agreement for 
fishery products into force. The Canada-EU Veterinary Agreement allows 
equivalency determination according to criteria set out in the 
agreement that specify gradual levels of equivalency. These levels 
allow work toward equivalency in products to be tracked over time. The 
agreement is aimed at recognizing the equivalence of Canadian and EU 
inspection and certification requirements for trade between the EU and 
Canada in live animals and animal products. 

Japan also requires importers to meet its food safety standards. For 
example, officials from the Japanese Ministry of Health, Labor, and 
Welfare or the Ministry of Agriculture, Forestry, and Fisheries engage 
in bilateral talks with their counterparts in the exporting country to 
explain Japanese food safety regulations. If a country has no prior 
record of exporting food to Japan, ministry officials may conduct field 
surveys to determine whether a country's food safety system can comply 
with Japanese food sanitary regulations and whether the exporting 
country's food safety regulations are comparable with Japan's. If Japan 
has already approved an exporting country and a new facility in that 
country seeks to export, ministry officials may conduct a pre-export 
inspection of that facility; if the review is satisfactory, the 
ministry will issue a certificate to the exporter, copies of which must 
accompany every shipment of goods to Japan. 

Japan also has arrangements with some governments to certify exports of 
certain high-risk products. According to Japanese officials, under a 
Japanese-Chinese agreement, for example, the Chinese government 
certifies Chinese spinach processors, who in turn oversee the practices 
of local farmers and test the product at three stages of production. 
Chinese authorities then conduct preshipment tests on the spinach 
before exporting, confirming that the exporter has observed the proper 
procedures on pesticide management. The spinach may be inspected again 
once it arrives in a Japanese port. 

Selected Countries and the EU Cite Key Elements of Food Systems as 
Critical to Effectively Responding to Outbreaks of Foodborne Illness: 

The selected countries reported that three elements of their food 
safety systems are critical in helping them respond to outbreaks of 
foodborne illness. These elements include traceback procedures, 
cooperative arrangements between government veterinarians and public 
health officials, and mandatory recall authority. Officials in most of 
the selected countries told us that with respect to public health, 
their procedures for tracking the source of foodborne illness outbreaks 
are generally similar to U.S. procedures. 

In general, the selected countries follow the same key steps in 
addressing outbreaks of foodborne illnesses. These steps include the 
following; 

* Identification of the outbreak. In most of the selected countries, 
this is the responsibility of local medical practitioners, who, after 
treating victims, also notify the national authorities when there is a 
suspected outbreak of foodborne illness. The first tests are often 
conducted at local laboratories. In cases where more sophisticated 
testing is needed to identify the pathogen and its source, the local 
laboratories send samples to specialized laboratories--called reference 
laboratories--that can conduct more sophisticated tests.[Footnote 6] 
Usually, the national public health monitoring institutes also collect 
data and confirm the number of illnesses in the outbreak. 

* Coordinated action to manage the outbreak. In most of the selected 
countries, local public health authorities manage the outbreak as long 
as it is confined to a local region. However, if the outbreak crosses 
provincial or state borders or if the outbreak is very large, the 
national surveillance institute or health ministry may take over 
control activities. 

The most common foodborne illnesses in the selected countries, listed 
in alphabetical order, are Campylobacter, E. coli, Listeria, norovirus, 
and Salmonella. (Noroviruses are a highly contagious virus transmitted 
by consumption of contaminated food or water or by direct person-to- 
person contact). 

EU Requirement That All Foods Be Traceable May Accelerate the 
Identification of an Outbreak Source: 

All food must be traceable "one step forward and one step back" in EU 
member states, allowing industry and national governments to quickly 
track any questionable food products to minimize harm to public health 
and reduce the economic impact on industry. Food and feed business 
operators must be able to document where a particular food product came 
from and where it is going next. Specifically, they must be able to 
document the names and addresses of suppliers and customers, as well as 
the nature of the product and date of delivery. They are also 
encouraged to keep information on the volume and quantity of a product; 
the batch number, if one exists; and a more detailed description of the 
product, such as whether it is raw or processed. Food and feed business 
operators must also have systems and procedures that allow them to 
provide this information to the competent authorities on demand. (As 
described in EU guidance, exporters in trading partner countries are 
not legally required to fulfill the EU's traceability requirement, 
except in circumstances where there are special bilateral agreements 
for certain sensitive sectors or where there are specific EU 
requirements, such as in the veterinary sector. However, these 
traceability requirements pertain to EU importers, who should be able 
to identify their direct supplier in the non-EU country.) 

Canada, Japan, and the EU also have mandatory animal identification 
programs for certain livestock species. In the EU, for example, in 
addition to farm registration obligations, producers must tag livestock 
with details of their origin, and when the animals are taken for 
slaughter, stamp them with the traceability code of the slaughterhouse. 
The tools used (ear tags, "passports," or bar codes) may vary from 
country to country but must carry the same information. In addition, to 
ensure the traceability of animals across borders, the EU established 
the Trade Control and Expert System, a central database for tracking 
the movement of animals both within the EU and from non-EU countries. 
In the event of a disease outbreak, the database ensures that all 
potentially affected animals can be quickly identified and that 
authorities can take appropriate measures.[Footnote 7] 

Although Canada does not have mandatory traceability for food, it does 
have mandatory cattle identification, which it is expanding to include 
all livestock. Beginning on January 1, 2001, Canadian farmers were 
required to tag all cattle with a bar-coded ear tag before the cattle 
left their farm of origin. The Canadian Food Inspection Agency began to 
fully enforce the program in 2002, with monetary penalties for 
noncompliance. In 2006, Canada initiated the transition to Radio- 
Frequency Identification (also known as RFID) tags on all cattle 
leaving their herds of origin. This tagging system is designed to 
facilitate the tracing of movement and identification of animals at 
various stages of the animal production chain, thereby helping to 
contain and eradicate animal disease. 

Japan has a mandatory system in which all beef and dairy cattle must be 
identified using an ear tag. Information is maintained on an animal's 
identification number, breed, gender, and production history from the 
farm of origin through distribution to consumers. 

Tracing Dioxin in Milk in the EU: 

According to EU sources, the EU’s traceability system proved useful 
during an incident that took place in 2004. During standard random 
monitoring of dioxin levels in milk at a Dutch farm, the national 
competent authorities found a high level of dioxin. The EU sources 
noted that the competent authorities immediately barred the farm from 
trade and began tracing the product through the food chain. They found 
that the source of contamination was clay, used in food processing to 
separate higher-quality potatoes from lower-quality ones. The dioxin-
tainted clay had contaminated potato peels used for feeding animals. 
The EU’s electronic Rapid Alert System for Food and Feed was used to 
trigger an exchange of information among national authorities about the 
problem. EU sources stated that the authorities quickly established 
that the clay had also been supplied to several food-processing 
companies located in Belgium, France, Germany, and the Netherlands. The 
authorities rapidly identified these businesses and barred from trade 
over 200 farms that had received the potentially contaminated potato 
peels. According to the EU, because of the traceability system, the 
contaminated products never reached consumers. 

Government Veterinarians and Public Health Officials in Some Countries 
Cooperate Closely to Trace the Source of Animal-to-Human Diseases: 

In light of concerns about highly pathogenic avian influenza and BSE, 
and in recognition of the connection between animal and human diseases, 
cooperation between public health officials and veterinarians has been 
critical in tracking the source of zoonotic (animal-to-human) diseases 
in some countries. For example, according to UK officials, the 
Veterinary Laboratories Agency, a regional network of 16 laboratories 
under the Department for Environment, Food, and Rural Affairs is 
responsible for veterinary research, disease surveillance, and 
diagnostic service. It has several memorandums of understanding with 
the Health Protection Agency--the UK agency that monitors outbreaks of 
infectious diseases--to conduct research. According to Health 
Protection Agency officials, the staff of these two agencies meets 
approximately once a month. In addition, staff from these agencies and 
the Food Standards Agency meets regularly to review trends in human and 
animal health. In particular, the Veterinary Laboratories Agency can 
assist in cases where a direct or indirect animal source is suspected 
in outbreaks of zoonotic diseases and where veterinary investigation or 
intervention could help reduce risks to the public. The agency may (1) 
conduct animal sampling for laboratory cultures, (2) help in 
identifying management and animal care factors that may have a bearing 
on human health risks, and (3) provide veterinary epidemiological 
input, such as data reports of Salmonella strains from farm animal 
surveillance. Strains of animal origin can also be selected for further 
identification and comparison with human strains. 

According to UK officials, the UK's Health Protection Agency and the 
Veterinary Laboratories Agency work closely in the investigation of 
outbreaks of food poisoning related to food production animals and have 
in place standardized laboratory and epidemiological methods for 
disease strain characterization and outbreak investigation. In 
addition, the Health Protection Agency, the Veterinary Laboratories 
Agency, and another body, the Centre for Infections (a large research 
institute) support a joint position to further standardize laboratory 
methods and harmonize databases. 

Health Protection Agency officials told us that communication between 
public health and veterinary officials has been useful during various 
outbreaks in the UK. For example, during the investigation of a 2004 
outbreak of an antibiotic-resistant strain of Salmonella among cattle 
on an English farm, rapid communication of test results and 
epidemiological information between the Health Protection Agency and 
the Veterinary Laboratories Agency led to the containment of the 
outbreak before it could spread to humans. Officials from the Health 
Protection Agency likewise said that there are numerous examples of 
similar collaborative activities between the Health Protection Agency 
and the Veterinary Laboratories Agency involving both Salmonella and a 
form of E. coli known as Verocytotoxin-producing E. coli. They also 
said that the agencies exchange strain typing and epidemiological data 
on an almost daily basis. They stated that the centralized nature of 
the UK government facilitates this close cooperation. 

Similarly, in the Netherlands and Ireland, officials told us that 
public health officials and veterinarians cooperate closely. In the 
Netherlands, for example, the Dutch National Institute for Public 
Health, a government research institute that conducts research projects 
on public health issues, among other things, collaborates closely with 
the Dutch Central Veterinary Institute on issues related to zoonotic 
diseases and animal food products. In Ireland, veterinarians 
participate in a national zoonoses committee made up of medical 
experts, public health officials, regional veterinarians, and 
environmental officers that convenes in the event of a foodborne 
illness outbreak. Irish officials told us that during an outbreak of 
Salmonella Agona in Ireland in 2006, collaboration between the 
veterinary and medical doctors made it easier to trace the pathogen to 
its source, which was poultry. Moreover, the Irish Department of 
Agriculture, Fisheries, and Food operates the Central Veterinary 
Research Laboratory, which is the national reference laboratory for 
Salmonella. The laboratory also carries out typing (identification) of 
Salmonella samples. 

All of the Selected Countries Have Mandatory Recall Authority: 

All of the selected countries have mandatory recall authority--the 
legal authority to remove, or require another party to remove, a 
product from the market. This authority enables them to force food 
producers to take a product off the market if there is a problem with 
it, such as microbial contamination, or the presence of allergens or 
non-permitted ingredients.[Footnote 8] 

The EU distinguishes between withdrawals and recalls and has authority 
for both. Withdrawals occur when the product is still under the control 
of the producer, and measures are intended to prevent the distribution 
or display of a dangerous product. Recalls occur when the product is 
already available to consumers, and measures are intended to have the 
unsafe product returned. All member states must notify the EU when 
there is a serious risk to human health. 

According to Irish and UK sources, one of the largest mandatory food 
recalls in the EU took place in February 2005, when the UK's Food 
Standards Agency discovered that a UK company had used spice 
contaminated with Sudan Red 1 dye in a variety of processed foods. 
Sudan Red 1 is an industrial dye used for coloring solvents, oils, 
waxes, and shoe and floor polishes. It entered EU countries in ground 
or crushed chili imported from India. Responding to the UK's rapid 
alert system notifications, other EU countries also recalled products 
contaminated with the dye. 

The Canadian Food Inspection Agency also has mandatory recall authority 
for unsafe food products, but, according to an agency official, it has 
only used this authority a total of seven times. Although rarely used, 
this authority is effective "because it is there," according to a 
Canadian Food Inspection Agency official, who also said that recall 
authority has contributed to more effective industry cooperation. 
According to Canadian officials, one of the most significant outbreaks 
of foodborne illness in Canada occurred in December 2004, when 
Salmonella linked to mung bean sprouts from a single company sickened 
300 people in Ontario. The Canadian Food Inspection Agency made 
preparations for a mandatory order to be issued because the company was 
not conducting a "proper" recall on its own. In the end, however, the 
company agreed to conduct a "proper" voluntary recall. 

The Japanese government has mandatory recall authority, but according 
to Japanese officials, it has rarely used this authority. Typically, 
the local health centers run by the Ministry of Health, Labor, and 
Welfare that test food suspected to be the source of an outbreak will 
"suggest" to a company that it recall its tainted product. According to 
a Japanese official, if the government communicates in this way to a 
company, the company feels obliged to recall its products. 

The Selected Countries Have Not Evaluated Their Reorganized Food Safety 
Systems, but Proxy Measures Indicate Improvements: 

None of the countries we reviewed had comprehensively evaluated the 
effectiveness of its reorganized food safety system, but most of the 
selected countries track certain indicators, such as the number of 
inspections conducted, enforcement actions taken, and foodborne illness 
outbreaks. Most of these countries had also assessed specific aspects 
of the country's food safety system. Furthermore, most of these 
countries use proxy measures, such as public opinion surveys, to assess 
effectiveness. In addition, industry stakeholders we interviewed cited 
the benefits of the reorganized food safety system. 

None of the Selected Countries Has Comprehensively Evaluated the 
Effectiveness of Its Reorganized Food Safety System, but They Do Track 
Certain Indicators: 

None of the selected countries has comprehensively evaluated the 
effectiveness of its reorganized food safety systems. One food safety 
expert noted that it is difficult to determine the effectiveness of a 
food safety system because it involves proving that something did not 
happen, i.e., that exporters did not try to ship unsafe food to a 
country, a shipment of unsafe food did not get past inspectors, and 
consumers did not eat or drink unsafe food that entered the national 
food distribution system. An agency official also said that it is 
difficult to find quantitative data to measure change and performance. 
In addition, another official said that when the number of foodborne 
illnesses changes from year to year, it is difficult to know with 
certainty the cause of the change. 

The food safety agencies in the countries we visited track key 
indicators, such as the number of inspections they conducted and the 
number of enforcement actions taken. Activities tracked by the 
Netherlands, for example, include the number of inspections conducted, 
the number of samples inspected, the number of approvals issued in the 
livestock and meat sector, international notifications of potential 
risk, and the number of written warnings issued. The EU also tracks the 
number of notifications and recalls member states issue under the EU's 
rapid alert system. Canada likewise tracks recalls. The public health 
or surveillance institutes of the selected countries monitor the number 
of foodborne illness outbreaks each year. 

Most of the Selected Countries Formally Audit Certain Aspects of Their 
Food Safety Systems: 

Although none of the selected countries had comprehensively evaluated 
the effectiveness of its reorganized food safety system, some of the 
selected countries had assessed certain aspects of it. For example, 
Canada's Office of the Auditor General, GAO's Canadian counterpart, has 
conducted four reviews of certain Canadian Food Inspection Agency 
activities, including (1) a 2004 study on regulation of plants 
developed using biotechnology, (2) a 2000 report on the agency's Food 
Inspection Program, (3) a 1999 report on the agency's management of a 
particular foodborne illness outbreak, and (4) a 1998 report on the 
agency's creation. In March 2008, the Auditor General also reviewed 
selected Health Canada activities, including progress made by Health 
Canada's Pest Management Regulatory Agency in applying its procedures 
for evaluating and registering new pesticides and reevaluating older, 
registered pesticides; it also reviewed the amount of time it takes to 
get new, possibly safer pesticides to market. (This assessment also 
evaluated the Canadian Food Inspection Agency's progress in increasing 
the scope of its program that tests for residues in fresh fruits and 
vegetables.) The Auditor General found that since an audit conducted in 
2003, the national government had made satisfactory progress in 
selected aspects of managing the safety and accessibility of 
pesticides, and it had shortened the time it takes to evaluate new 
pesticides. The Auditor General also reviewed Health Canada's progress 
in conducting national health surveillance in 2002. It found that 
Health Canada had made some progress toward resolving some of the 
weaknesses the auditors identified in a 1999 audit. However, it also 
found that national surveillance was still weak; many systems still 
lacked timely, accurate, and complete disease information; and gaps in 
surveillance continued. 

Health Canada is responsible for assessing the Canadian Food Inspection 
Agency's activities and has completed 10 assessment reports, 9 of which 
have been published online. The most recent assessments found that the 
agency was fulfilling its mission, although minor improvements are 
needed. For example, in 2005, Health Canada reviewed the agency's Fish, 
Seafood and Production Program's Quality Management Program, a 
mandatory inspection program for federally registered fish and seafood 
establishments. The evaluation found that the program was generally 
effective in enhancing the safety of fish and seafood products. 
However, Health Canada recommended, among other things, that Canadian 
Food Inspection Agency managers responsible for the program should 
conduct trend analysis of complaints and incident data, an action that 
would enhance the management of emergencies and incidents. The agency 
agreed with the recommendation. 

In the UK, the National Audit Office (GAO's UK counterpart) conducted 
an audit of the Food Standards Agency in 2003 and found that the agency 
had made progress in its stated objective of improving public 
confidence in food safety and standards. For example, according to the 
audit office, in 2001 and 2002 the Food Standards Agency investigated 
about 500 incidents with the potential to affect food safety. The 
agency issued 47 food hazard warnings to local authorities, alerting 
them to potential health dangers or requiring them to recall food from 
sale. More recently, the National Audit Office reviewed the agency's 
interaction with business and rated it highly on adopting innovative 
alternatives to classic regulation and on having an evidence-based 
culture. The auditors found that the Food Standards Agency was 
undertaking many positive initiatives in its risk assessment system. 
Areas needing further attention included developing a more strategic 
partnership with local authorities and providing better advice and 
guidance to small businesses. Overall, the auditors found that the 
agency was continuing to improve its performance from an already strong 
base. 

Certain agencies within some countries have also conducted-self- 
assessments. For example, the Canadian Food Inspection Agency has 
assessed its own performance using criteria developed in collaboration 
with the Canadian Treasury Board and measuring progress on four 
strategic outcomes: (1) protecting Canadians from preventable health 
risks related to food safety or the transmission of animal diseases to 
humans; (2) protecting consumers through a fair and effective food, 
animal, and plant regulatory regime; (3) sustaining the plant and 
animal resource base; and (4) securing Canada's food supply and 
agricultural resource base from deliberate threats. For each strategic 
outcome, the agency identified a number of specific targets. According 
to the agency's 2007 annual performance plan, the agency met or 
exceeded 31 of its 40 targets. In the UK, the Food Standards Agency 
conducted an internal review of lessons learned from the 2005 Sudan 1 
incident, in which illegal dye was found in food, and the agency's 
board subsequently conducted a separate review of the incident. The 
board noted that the agency should take a central role in ensuring more 
coordinated attention to intelligence gathering and implementing early 
warning systems, as well as proactively sharing this information with 
the food industry. 

In the EU, the Food and Veterinary Office develops an annual audit plan 
every year that identifies priority areas and countries it will audit 
that year. For example, in 2008, the office stated that it intended to 
conduct 256 audits and inspections, including 65 general audits in six 
member states. (General audits verify the extent to which countries 
comply with the multiyear control plans they have prepared.) As part of 
their audits, the Food and Veterinary Office inspectors may visit 
producers or processing plants to establish that enforcement mechanisms 
are effective in practice. If necessary, the Food and Veterinary Office 
can send out inspectors in response to disease outbreaks both within 
and outside the EU. 

During an audit, the Food and Veterinary Office assesses a member 
state's compliance with EU requirements for certain aspects of the 
member state's food safety system. For example, in its June 2005 
assessment of Germany's import control system and four operating border 
inspection posts, the office found that import controls were generally 
applied correctly in the posts visited, with only minor shortcomings. 
However, the office also found that (1) supervision of imports that do 
not comply with EU regulations was inadequate, (2) traceability was not 
reliable, (3) exit of these noncompliant products from the EU was not 
ensured, and (4) some of the border inspection facilities had 
significant deficiencies. If the Food and Veterinary Office finds any 
shortcomings during its inspection, it makes recommendations to, and 
requires an action plan from, the member's competent authority for 
addressing the shortcomings. Together with other EU bodies, the Food 
and Veterinary Office evaluates this action plan and monitors its 
implementation and could take legal action to ensure that member states 
meet their obligations. In response to the Food and Veterinary Office 
audit of its border inspection posts, for example, Germany said that it 
had already taken some steps to address the shortcomings identified and 
would work to address the others. 

Most of the Selected Countries Use Proxy Measures to Assess Their 
Systems, and Stakeholders Generally See Benefits of Reorganization: 

Among the proxy measures in the selected countries were consumer 
surveys. Several of the countries, including Canada, Japan, the 
Netherlands, and the UK, have surveyed their consumers on their views 
of the food safety system. This emphasis on public confidence in the 
food safety system comes in the wake of concerns about food agencies' 
ability to respond to outbreaks of BSE and other potential food 
contamination problems. For example, in 2003, the UK's Food Standards 
Agency noted that its effectiveness depended in part on the extent to 
which the public trusts it to provide reliable and impartial advice-- 
trust that it earns principally by identifying and responding to food 
safety concerns. Indeed, public confidence in the UK's system for food 
safety and standards was the agency's first aim, followed by reducing 
foodborne illness and protecting consumers through improved food safety 
standards. In 2007, the public's confidence in the agency's ability to 
protect against foodborne illnesses was an estimated 60 percent, 
compared with about 44 percent in 2001. 

Similarly, in 2005, the EU surveyed consumers to understand how they 
view risk, particularly food safety risks, in order to inform policy 
and communicate with the public on risk issues.[Footnote 9] It found 
that the public in all 25 EU member states was divided on whether food 
safety had improved in the past 10 years, with an estimated 38 percent 
believing it had, 29 percent believing it had stayed about the same, 
and 28 percent believing it had gotten worse. In some countries, 
however, views were more favorable. For example, the EU reported that 
an estimated 67 percent of people in Ireland believed that, overall, 
food safety had improved over the past 10 years. 

Surveys can also be used to understand where the food safety system 
needs to be improved. For example, according to an official with 
Japan's Food Safety Commission, part of the commission's risk 
communication strategy is to survey consumers in order to find out how 
effectively the government communicates risk--how clearly, accurately, 
and convincingly. From these surveys, the commission learned that the 
public generally does not understand the concept of assessing risk. 
Consequently, one of the commission's current goals is to better 
communicate its role to the public and in general improve the clarity 
of its risk communications. 

Germany has taken another approach to gauging public opinion. According 
to officials with the Federal Office of Consumer Protection and Food 
Safety, this agency convened stakeholders in November 2007 to discuss 
the effectiveness the Federal Office of Consumer Protection and Food 
Safety and the German food safety system in general. About 80 people 
from federal and state governments and trade associations attended. 
Comments on the agency's performance were generally positive. In 
particular, participants approved of the efforts of the national 
contact point for the EU's rapid alert system. However, they suggested 
some improvements in the system, and also suggested that the agency 
provide training to help prepare for Food and Veterinary Office audits. 
Participants also liked the Journal of Consumer Protection and Food 
Safety that the agency launched in 2006 to provide information, in both 
German and English, on basic and applied research and on official 
oversight of current developments in the areas of food and feed, 
veterinary medicine, and genetic technology. Participants suggested 
that the agency establish a greater presence at conferences, fairs, and 
schools and that it be more visible to consumers as a partner. 

The views of stakeholders, such as industry organizations and consumer 
advocacy groups, can also provide insight, albeit anecdotal, on the 
success of a country's food safety system. We spoke with 
representatives of stakeholder groups in each of the countries we 
visited and were told that, in most of the selected countries, the 
reorganization of the food safety system has been beneficial. In 
particular, stakeholders said reorganization has improved transparency. 
For example, one industry stakeholder in Canada said that consolidation 
greatly sped up the government's decision-making process and provided 
increased transparency, clarity, and accountability. In Japan, 
representatives of two consumer groups told us that the creation of the 
Food Safety Commission as an independent body responsible for risk 
assessments was a positive step, especially for increasing government 
transparency. A representative of an industry group in the UK also said 
that consolidation improved the functioning of the Food Standards 
Agency. This person believes the agency is now more transparent to 
industry, and it is easier to consult with agency staff on issues of 
concern. 

Industry stakeholders told us that another benefit of reorganization 
was having a single point of contact. In the UK, for example, according 
to a representative of an industry group, the group provides its views 
to the Food Standards Agency through one-on-one or committee meetings, 
and has seen changes as a result of these contacts. Because of industry 
concerns about the way the Food Standards Agency managed a product 
recall, the agency agreed to notify industry before publishing a 
mandatory recall and changed preparation instructions for this product. 
Similarly, Canadian industry representatives told us that the 
reorganized and consolidated food safety system has had benefits. For 
example, representatives from two industry groups generally agreed 
that, with the consolidation, the Canadian Food Inspection Agency now 
has staff dedicated to food safety issues, a fact that has allowed a 
working relationship between industry and government to evolve. In 
addition, a representative from a third Canadian industry group told us 
that consolidation also helped strengthen the Canadian Food Inspection 
Agency's expertise and capability by combining staff from different 
agencies, although this representative was concerned about how the 
agency managed recalls. 

Food Safety Officials in Other Countries Identified Issues of Future 
Concern: 

Experts in the six countries and the EU identified a number of 
challenges related to food safety that they expect to face over the 
next decade, with climate change the most frequently identified 
challenge. Table 3 summarizes the challenges identified. 

Table 3: Emerging Food Safety Challenges Identified by Various Foreign 
Food Safety Officials: 

Challenges: Climate change; 
Description: Climate change may result in new pathogens, such as 
foodborne viruses, mycotoxins (molds), zoonoses, and changes in 
biodiversity that can lead to threats to the food chain. 

Challenges: Climate change; 
Description: Climate change may enable pathogens to thrive and spread 
under new climatic conditions. For example, Listeriosis, especially in 
older people, seems to be increasing, perhaps because the climate is 
getting warmer, enabling Listeria to thrive. 

Challenges: Climate change; 
Description: Climate change (warmer sea temperatures) may lead to 
outbreaks of the Vibrio bacterium in oysters. Climate change might also 
bring about changes in new pathogens as the temperature changes, along 
with crops and associated pests. 

Challenges: Demographic change; 
Description: Countries are seeing increases in elderly populations, 
which tend to be more vulnerable than others to foodborne illness. 

Challenges: Demographic change; 
Description: Countries are seeing an increase in immigration; many 
immigrants bring home-prepared foods from overseas. If improperly 
prepared or preserved, these foods may cause illness. 

Challenges: Foodborne illness and zoonotic diseases; 
Description: Foodborne illness from Campylobacter has increased 
significantly in the last several years, and it is one of the most 
frequent sources of food contamination. Scientists' understanding of 
Campylobacter is still limited because it generally occurs in isolated 
incidents and it is therefore more difficult to study. 

Challenges: Foodborne illness and zoonotic diseases; 
Description: Incomplete knowledge of the nature and transmission of 
emerging zoonotic diseases (e.g., avian influenza and West Nile virus) 
is a growing concern, and inadequate veterinary care and public health 
infrastructure in some countries add to the complexity of managing 
these diseases. In addition, human and animal interactions are 
changing, with the potential for disease transmission, including E. 
coli and prions (which are involved in BSE). 

Challenges: Foodborne illness and zoonotic diseases; 
Description: New fungi, pathogens, and diseases will continue to emerge 
and evolve. 

Challenges: New types of food and preparation; 
Description: Popular new types of foods (e.g., ready-to-eat bagged 
salads) pose new risks. For example, a small amount of contaminated 
produce that is chopped and placed in multiple bags can affect a large 
number of people in disparate locations. 

Challenges: New types of food and preparation; 
Description: More people are consuming foods that are raw or that do 
not involve a terminal kill step, such as cooking. 

Challenges: New types of food and preparation; 
Description: Countries are seeing changes in production and processing 
based on new technologies, such as nanotechnology, genetic 
modification, and decontamination technologies (e.g., radiation). 

Challenges: Industry and trade development; 
Description: The consolidation of the food industry, with fewer and 
fewer major corporations dominating entire food sectors, means that the 
potential impact of outbreaks and/or recalls is greater. 

Challenges: Industry and trade development; 
Description: The food supply is becoming increasingly global and the 
volume of international food trade is growing, which means it is 
increasingly difficult to control all elements of the food chain. 

Challenges: Regulatory and management issues; 
Description: Assessing the risks of chemical and food additives, which 
are often imported as nonfood items, is a priority, and the number of 
contaminants is increasing. 

Challenges: Regulatory and management issues; 
Description: To focus more on risk, countries need to develop more 
data, which takes time and money. 

Challenges: Regulatory and management issues; 
Description: In spite of recent improvements in regulatory regimes, 
there is still potential for fraud in the system; it is difficult to 
develop a perfect system. 

Challenges: Regulatory and management issues; 
Description: Resources are sometimes mismatched with problems. 

Challenges: Regulatory and management issues; 
Description: The current regulatory system is not well suited at 
present to address certain new innovations, such as genetically 
modified organisms and nanotechnology. 

Challenges: Regulatory and management issues; 
Description: There are some differences between EU member countries in 
how they report information (e.g., zoonoses are reported by some 
countries as foodborne pathogens and by others as animal illnesses), 
which makes it difficult compare national statistics. 

Challenges: Regulatory and management issues; 
Description: Conducting risk assessments is getting more difficult. 

Sources: Food safety officials in Canada, the EU, Germany, Ireland, 
Japan, the Netherlands, and the UK, and documents from these countries' 
food safety agencies. 

[End of table] 

As agreed with your offices, unless you publicly announce the contents 
earlier, we plan no further distribution until 30 days from the report 
date. At that time, we will send copies to the appropriate 
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Commissioner of the Food and Drug Administration, the Office of the 
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make copies available to others upon request. In addition, the report 
will be available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. Key contributors to this report are 
listed in appendix II. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Country and EU Profiles: 

Canada's Food Safety System: 

Population and per capita gross domestic product (GDP). In 2007, Canada 
had an estimated population of 33.4 million, and in 2006 its estimated 
per capita GDP was US $35,700. 

Organization. The Canadian Food Inspection Agency (CFIA), created in 
1997, is an independent agency that reports to the Minister of 
Agriculture and Agri-Food. It is responsible for inspection and 
quarantine programs for foods, plants, and animals. According to agency 
officials, Canada consolidated the food safety function in order to 
reduce overlap and duplication, improve effectiveness and efficiency, 
save money, and separate risk management from risk assessment. 

Canada takes a "gate-to-plate" approach to food safety to safeguard not 
just the food supply but also the plants and animals upon which safe 
food depends. Products subject to CFIA's inspection range from 
agricultural inputs, such as seeds, feeds, and fertilizers; to fresh 
foods, including meat, fish, eggs, grains, dairy products, fruit and 
vegetables; and prepared and packaged foods. The government also works 
with commodity sectors to develop and review food safety plans. CFIA is 
responsible for all food safety inspections, including inspections of 
imported and domestic products, export certifications, laboratory and 
diagnostic support, crisis management, and product recalls. It also 
inspects foods for quality assurance and is responsible for animal 
health and plant disease control. At the consumer end of the spectrum, 
CFIA educates Canadians about safe food-handling practices and various 
food safety risks through its Web site, food safety fact sheets, and 
the Canadian Partnership for Consumer Food Safety Education, a group of 
industry, consumer, and government organizations that jointly develop 
and implement a national program to educate consumers on how to safely 
handle food. CFIA employs over 6,000 people, including approximately 
3,000 inspectors across all business lines. Approximately 10 percent of 
CFIA's budget comes from user fees. 

While CFIA is responsible for risk management, another government 
organization, Health Canada, under the Minister of Health, is 
responsible for risk assessment. Health Canada sets the policies and 
standards that govern the safety and nutritional quality of all food 
sold in Canada, and CFIA enforces these policies. Health Canada is also 
responsible for evaluating CFIA's food program effectiveness. Another 
organization, the Public Health Agency of Canada, a separate body under 
the Minister of Health, also conducts national food-and waterborne 
disease surveillance activities and helps respond to infectious disease 
outbreaks. 

CFIA verifies industry compliance with federal acts and regulations by 
registering and inspecting slaughterhouses and food-processing plants 
and testing products. If a food safety emergency occurs, CFIA works 
with Health Canada, the Public Health Agency of Canada, provincial 
agencies, and the food industry in implementing an emergency response 
system. 

In 2005, CFIA's border inspection function was shifted to the Canadian 
Border Services Agency. This agency is responsible for initial 
inspections of food and agriculture products arriving in Canada. It 
refers any questionable shipments to CFIA for follow-up action. 
According to CFIA officials, border guards open and inspect about 2 
percent of imports. A CFIA veterinarian inspects most imports of live 
animals upon entry. 

According to Canadian officials, in December 2007, Canada's Prime 
Minister announced the new Food and Consumer Product Safety Action 
Plan, which aims to strengthen and modernize Canada's safety system for 
health, consumer, and food products and to protect the health of 
Canadians. The Action Plan responds to changes in trade, industry 
supply chains, and consumer buying patterns, which require a different 
approach to food safety assurance. Programs focused on prevention, 
targeting highest risks, rapid response, and regulatory and legislative 
modernization will be implemented with the (Canadian) $113 million 
announced in Budget 2008. According to Canadian officials, proposed 
legislative amendments to Canada's Food and Drugs Act, along with a 
(Canadian) $62.2 million investment from Budget 2008, will enable CFIA 
to undertake a series of food safety initiatives, including the 
following: 

* working with industries, provinces, and territories to implement 
preventive food safety control measures along the food chain; 

* putting in place tools to better identify importers, track imports, 
and work with foreign authorities to verify the safety of foods at 
their country of origin; and: 

* increasing authority to monitor risks to Canadians and prevent unsafe 
products from entering the Canadian marketplace. 

Oversight of Imported Food: 

Certification programs and equivalency agreements. CFIA requires 
importers of meat and seafood products to meet Canadian standards. 
Determination of a foreign country's equivalency is based on the 
approval of a country's system of meat inspection, approval of 
establishments operating within that system, and review and 
registration of individual meat products prepared in these 
establishments. To approve the exporting country's inspection and 
certification system, CFIA follows a process of equivalency evaluation, 
based upon provisions in the Agreement on the Application of Sanitary 
and Phytosanitary Measures of the World Trade Organization. The 
agreement requires each member to accept as equivalent sanitary and 
phytosanitary measures of another member if the exporting member 
objectively demonstrates to the importing member that its measures 
achieve the importing member's appropriate level of protection. 

Canada's Foreign Country Meat Inspection Systems Evaluation Program 
requires that imported meat products--unless specifically exempted by 
Canadian legislation--meet the same standards and requirements as if 
they were produced in registered establishments in Canada. It also 
requires that the exporting country's inspection and certification 
systems, along with the establishments operating under that system, be 
approved by CFIA before meat products can be exported to Canada. The 
competent authority of the exporting country must issue an official 
meat inspection certificate for every shipment of meat products 
exported to Canada. The competent authority is also expected to take 
appropriate actions if CFIA notifies it about meat products found to 
violate Canadian requirements and is to communicate any actions taken 
to CFIA. CFIA may require additional examination of subsequent 
shipments to Canada, with additional certification, for a predetermined 
number of shipments and/or weight of the certified shipment. The 
majority of CFIA's inspectors are focused on meat products because of 
the higher risk relative to most other foods. Canada currently allows 
importation of meat products from 40 countries. 

In the case of seafood, Canada enters into agreements with other 
countries it believes have reliable inspection systems and uses these 
agreements in concentrating its inspection resources on products and 
countries representing increased risk. Under some agreements, CFIA 
agrees that products from specified processing facilities meet certain 
standards and therefore are subject to fewer inspections at the border. 
CFIA normally assesses these plants before it adds them to a list. 
Other agreements represent recognition by CFIA that the inspection 
system in another country is equivalent to the system in Canada. Under 
these agreements, the competent authority in the other country will 
inspect and maintain the list of establishments eligible for reduced 
inspection frequency upon import to Canada. 

Canada has an equivalency agreement in place with the European Union 
(EU) for meat products and is working toward bringing an equivalency 
agreement for fishery products into force. The Canada-EU Veterinary 
Agreement allows equivalency determination according to criteria set 
out in the agreement that specify gradual levels of equivalency. These 
levels allow work toward equivalency in products to be tracked over 
time. The agreement is aimed at recognizing the equivalence of Canadian 
and EU inspection and certification requirements for trade between the 
EU and Canada in live animals and animal products. 

Because of recent problems with Chinese and Vietnamese seafood imports, 
Canada has established more rigorous testing for specific seafood 
products from these countries. For example, from 2003 to 2005, Canada 
imposed a countrywide alert and instituted 100 percent testing of 
aquacultured fish products from Vietnam after repeatedly finding 
seafood products tainted with the antibiotic chloramphenicol, according 
to CFIA officials. The competent authority in Vietnam subsequently 
agreed to inspect and certify these products for the presence of 
certain antibiotics. 

Foodborne Illness Outbreaks: 

According to data from the Public Health Agency of Canada, the most 
prevalent intestinal pathogen in Canada is Campylobacter, followed by 
Salmonella and parasitic infections (Cryptosporidium, Cyclospora, 
Giardia, and Entamoeba). E. coli ranks fourth in prevalence. 

Response. If a foodborne illness outbreak occurs, CFIA, in partnership 
with Health Canada, provincial agencies, and the food industry, 
operates an emergency response system. This response system can be 
triggered by a consumer complaint, information from industry or trading 
partners, or the results of inspection and monitoring activities of 
CFIA or provincial food inspection agencies. In the event of an 
outbreak, CFIA investigates to pinpoint the source of the 
contamination. Health Canada gets involved in food safety emergencies 
when health risk assessments on food products are required, from either 
CFIA or the provinces or territories. The Public Health Agency of 
Canada gets involved in outbreak investigations when outbreaks involve 
more than one province or have international implications; if an 
outbreak involves only one province, the agency does not get involved 
unless its help is requested by the province. 

Once a food is identified as a source, CFIA conducts the food safety 
investigation. On the basis of the results of the outbreak 
investigation and the food safety investigation, Health Canada (HC) 
conducts a health risk assessment for the implicated food and CFIA 
coordinates the risk management actions, one option of which might be 
to issue a recall. (For provincial outbreaks, the same process applies, 
except that the provincial health ministries have the lead in the 
outbreak investigation.) The Public Health Agency serves as an adviser 
to CFIA and Health Canada in these situations. Health Canada provides 
risk assessments for all provincial emergency situations except for the 
province of Quebec. (For products produced and sold only in Quebec, the 
provincial authorities may conduct their own outbreak investigation and 
risk assessment and decide on recalls.) 

Canadian officials told us that in many ways, their procedures for 
addressing the public health aspects of foodborne illness outbreaks are 
similar to those followed by the U.S. Centers for Disease Control and 
Prevention (CDC). 

In 2006 and 2007, according to CFIA data, CFIA conducted 2,915 food 
safety investigations, of which 246 resulted in voluntary recalls. CFIA 
has mandatory recall authority for food, which it has used a total of 
seven times. Though infrequently used, according to a CFIA official, 
this authority has contributed to more effective industry cooperation. 
This official also said that mandatory recall is rarely used precisely 
"because it is there." According to a Canadian industry representative, 
the mandatory food recall process is an important part of the food 
safety system because it is the last stop in the supply chain. 

International coordination. CFIA has a memorandum of understanding with 
the U.S. Food and Drug Administration to cooperate on food recalls and 
exchange information. In addition, Canada participates in the CDC's 
PulseNet, a network of public health and food regulatory agency 
laboratories. 

Recent incidents. According to food safety officials, one of the most 
significant outbreaks of foodborne illness to occur in Canada was a 
2004 outbreak of Salmonella in mung bean sprouts from a single company. 
Health Canada conducted the health risk assessment for this incident, 
and the Public Health Agency got involved at the request of the Ontario 
government. The outbreak affected 300 people in the province of 
Ontario. CFIA made preparations for a mandatory order to be issued 
because the company was not conducting a "proper" recall on its own. In 
the end, however, the company agreed to conduct a "proper" voluntary 
recall. CFIA put a hold on other products by the same company. 

In 2006, moreover, Canada was affected by the same E. coli in spinach 
incident that occurred in the United States. One person in Canada was 
sickened by the tainted product. CFIA and Health Canada collaborated 
with the U.S. Food and Drub Administration (FDA) and the state of 
California to assess and reduce the risk to Canadian consumers, and 
Health Canada assisted with tracing the product back to the source of 
contamination. U.S. spinach was recalled from Canadian store shelves, 
and Canada subsequently required U.S. spinach producers exporting to 
Canada to participate in an on-farm quality assurance program. 

Although Canada does not have mandatory traceability for food, it does 
have mandatory cattle identification, which it is expanding to include 
all livestock. Beginning on January 1, 2001, Canadian cattle producers 
were required to tag all cattle with a bar-coded ear tag before the 
cattle left their farm of origin. The Canadian Food Inspection Agency 
began to fully enforce the program in 2002, with monetary penalties for 
noncompliance. In 2006, Canada began the transition to Radio-Frequency 
Identification (also known as RFID) tags on all cattle leaving their 
herds of origin. This tagging system is designed to facilitate the 
tracing of movement and identification of animals at various stages of 
the animal production chain, thereby helping to contain and eradicate 
animal disease. 

Efforts to Measure Effectiveness of the Food Safety System: 

Performance measures. The Canadian government has not comprehensively 
evaluated the results of its 1997 reorganization. A CFIA official told 
us that it is difficult to find quantitative data to measure systemwide 
change and performance. 

Evaluations and audits. Although there have been no comprehensive 
assessments of the Canadian food safety system, certain aspects have 
been formally reviewed. For example, Canada's Office of the Auditor 
General, GAO's Canadian counterpart, has conducted four reviews of 
certain CFIA activities, including (1) a 2004 study on regulation of 
plants developed using biotechnology, (2) a 2000 report on CFIA's Food 
Inspection Program, (3) a 1999 report on CFIA's management of a 
particular foodborne illness outbreak, and (4) a 1998 report on CFIA's 
creation. The Auditor General has also reviewed selected Health Canada 
activities, including progress made by Health Canada's Pest Management 
Regulatory Agency in applying its procedures for evaluating and 
registering new pesticides and reevaluating older registered pesticides 
and the amount of time it takes to get new, possibly safer, pesticides 
to market. (This assessment also evaluated CFIA's progress in 
increasing the scope of its program testing for residues in fresh 
fruits and vegetables.) The Auditor General found that since an audit 
conducted in 2003, the federal government had made satisfactory 
progress in selected aspects of managing the safety and accessibility 
of pesticides, and it had shortened the time it takes to evaluate new 
pesticides. The Auditor General also reviewed Health Canada's progress 
in conducting national health surveillance in 2002. It found that 
Health Canada had made some progress toward resolving some of the 
weaknesses the auditors identified in a 1999 audit. However, it also 
found that national surveillance was still weak; many systems still 
lacked timely, accurate, and complete disease information; and gaps in 
surveillance continued. 

Health Canada is responsible for assessing CFIA's activities and has 
completed 10 assessment reports, 9 of which have been published online. 
The most recent assessments found that CFIA was fulfilling its mission, 
although minor improvements were needed. For example, in 2005, Health 
Canada reviewed CFIA's Fish, Seafood, and Production Program's Quality 
Management Program, a mandatory inspection program for federally 
registered fish and seafood establishments. The evaluation found that 
the program was generally effective in enhancing the safety of fish and 
seafood products. However, Health Canada recommended, among other 
things, that CFIA managers responsible for the program should conduct 
trend analysis of complaints and incident data, which would enhance the 
management of emergencies and incidents. CFIA agreed with the 
recommendation. 

CFIA has also assessed its own performance using criteria developed in 
collaboration with the Canadian Treasury Board and measuring progress 
on four strategic outcomes: (1) protecting Canadians from preventable 
health risks related to food safety or the transmission of animal 
diseases to humans; (2) protecting consumers through a fair and 
effective food, animal, and plant regulatory regime; (3) sustaining the 
plant and animal resource base; and (4) securing Canada's food supply 
and agricultural resource base from deliberate threats. For each 
strategic outcome, CFIA identified a number of specific targets. 
According to CFIA's 2007 annual performance plan, the agency met or 
exceeded 31 of its 40 targets. 

Public opinion surveys. According to a CFIA report, public opinion 
research conducted in October 2006 and March 2007 suggested that CFIA 
was meeting its objective of ensuring that the public is aware of food 
safety risks. In the survey, 82 percent of Canadians said that they had 
heard about a food recall in the last year. According to CFIA, the 
research also indicated a positive link between Canadians' awareness of 
food recalls and their confidence in the food supply. In addition, in a 
September 2007 survey conducted by a third party on 29 federal 
departments using 11 indicators, CFIA and Health Canada were among 
those departments with the most public confidence. 

Stakeholder perspectives. The views of industry stakeholders who 
interact frequently with CFIA can also provide insight, albeit 
anecdotal, on the effectiveness of a country's food safety 
system.Industry representatives we spoke to in Canada generally 
believed that CFIA was effective and that consolidation of the food 
safety system had been beneficial. For example, one industry 
stakeholder stated that his organization was glad there was a single 
government body responsible for enforcing food safety policy and 
regulations. This individual further told us that as a result of 
consolidation, there were now CFIA staff dedicated to food safety 
issues, a fact that has allowed a working relationship between industry 
and government to evolve, a point echoed by a second industry group. 
His group also supported CFIA's focus on risk-based inspections. A 
third industry group representative said that consolidation also helped 
strengthen agency expertise and capability by combining staff from 
different agencies. However, this person also expressed concern about 
CFIA's management of recalls. 

Other Relevant Issues: 

Emerging trends and challenges. Officials identified the following 
concerns: 

* The consolidation of the food industry, with fewer and fewer major 
corporations dominating entire food sectors, means that the potential 
impact of outbreaks and/or recalls is greater. 

* The popularity of new types of foods (e.g., ready-to-eat bagged 
salads) poses new risks. 

* Imported foods and processes are a concern, especially those, such as 
produce, that do not involve cooking to kill pathogens. 

* Climate change, and the warmer sea temperatures that result, may lead 
to outbreaks of the Vibrio bacterium in oysters. Climate change might 
also result in new pathogens, new crops, and associated pests. 

* Incomplete knowledge of the nature and transmission of emerging 
zoonotic diseases (e.g., bovine spongiform encephalopathy (BSE, 
otherwise known as mad cow disease), avian influenza, West Nile virus, 
new strains of rabies), is a growing concern, and inadequate veterinary 
care and public health infrastructure in some countries add to the 
complexity of managing these diseases. 

The EU's Food Safety System: 

Population and per capita GDP. The European Union (EU) consists of the 
following 27 member countries: Austria, Belgium, Bulgaria, Cyprus, 
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, 
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the 
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, 
Sweden, and the United Kingdom. Together, the countries have a 
population of about 490 million people. The EU's 2007 estimated average 
per capita gross GDP was US $32,900. 

Organization. Since January 2006, the EU food safety system has been 
fully integrated and is regulated by EU legislation that applies to all 
EU member countries and importers. However, food safety in Europe was 
historically part of agriculture policy under the EU's Directorate 
General for Agriculture. Two events in the late 1990s--the crisis with 
BSE and the discovery of dioxin in chicken products--drove the EU to 
comprehensively reform its food safety legislation. The EU created a 
separate body, the Directorate General for Public Health and Consumer 
Protection (referred to as DG-SANCO), focused on food safety and 
consumer protection. DG-SANCO, headquartered in Brussels, Belgium, is 
independent of the EU's agricultural policy. 

DG-SANCO oversees three key areas: food safety, public health, and 
consumer affairs. The food safety mandate is broad, covering, among 
other things, animal health and welfare, veterinary inspections, plant 
health, food labeling, contaminants, and pesticide residues. DG-SANCO 
is divided into six directorates spread over three locations: Brussels; 
Luxembourg; and Grange, County Meath, Ireland. The Brussels office is 
involved in risk management. This includes the development of the EU 
policy on food safety, animal health and welfare, and plant health, and 
the daily management of food safety legislation. Luxembourg is home to 
a DG-SANCO group on public health and risk assessment. The Grange 
office houses the Food and Veterinary Office (FVO), which, through 
audits, inspections, and related activities, oversees member states' 
compliance with EU requirements for food safety and quality, animal 
health and welfare, plant health legislation, and imports from non-EU 
countries exporting to the EU. FVO also contributes to the development 
of EU policy on food safety, animal health and welfare, and plant 
health, and the development of effective control systems for food 
safety, animal health and welfare, and plant health. 

Other entities playing important roles in the EU's food safety system 
include the following: 

* The European Centre for Disease Prevention and Control (ECDC), based 
in Stockholm, Sweden, was established in 2005 and is the EU agency 
responsible for strengthening Europe's defenses against infectious 
diseases. Its mission is to identify, assess, and communicate current 
and emerging threats to human health posed by infectious diseases. The 
Center works with national health protection bodies across Europe to 
strengthen and develop continentwide disease surveillance and early 
warning systems. Its mission is centered on transmissible diseases to 
humans, and it collaborates with the European Food Safety Authority 
(EFSA), in particular in the field of zoonoses (ECDC transmits to EFSA 
the data it collects on foodborne diseases; EFSA includes these data in 
its annual report on zoonoses). ECDC also cooperates with the U.S. 
Centers for Disease Control. 

* EFSA is the main scientific agency for food and feed safety. Based in 
Parma, Italy, EFSA provides independent scientific advice on all 
matters with a direct or indirect impact on food safety--including 
animal health and welfare, plant protection, genetically modified 
organisms, and nutrition. Its work falls into two major areas: risk 
assessments and risk communication, but its tasks also include data 
collection (for example, the annual zoonoses report). At the request of 
the European Commission as well as member states and the European 
Parliament, EFSA assesses the risks associated with the food chain, 
including, for example, risk assessment related to food or feed 
additives submitted for premarket approvals, microbiological risk, 
contaminants, animal health and welfare, and plant health. These risk 
assessments inform the policies and decisions of EU risk managers, who 
establish limits on these substances. EFSA also communicates to the 
public the results of its scientific work. Because its mission is 
independent risk assessment, EFSA is separate from the DG-SANCO 
structure. EFSA cooperates closely with the scientific bodies 
responsible for risk assessment in the various member states and with 
the U.S. Food and Drug Administration. The EFSA Advisory Forum is 
composed of a representative from each of the member states' national 
bodies responsible for risk assessment. The forum facilitates the 
sharing of scientific information between the national authorities and 
EFSA and ensures close cooperation with the national scientific bodies 
to avoid duplication and to promote common scientific views on risk 
assessment and risk communication. 

At the national level, each EU member state has one or more agencies 
charged with implementing EU regulations, referred to as the "central 
competent authority" or "competent authority." For example, in the UK, 
the Food Standards Agency is the competent authority for food and feed 
safety, while the Department of Environment, Food, and Rural Affairs is 
the competent authority for animal health and welfare and plant health 
issues. Each member state is expected to prepare a multiyear control 
plan that contains general information on the structure and 
organization of the systems for feed and food control. This plan 
includes the designation of competent authorities and their tasks at 
the central, regional, and local level. The member states are required 
to provide the European Commission, the executive branch, or governing 
body, of the EU, with an up-to-date copy of their multiyear control 
plans on request. 

Regulatory Framework: 

The EU has adopted an integrated farm-to-fork approach to food safety 
that aims to protect human life and health while also taking into 
account the protection of animal health and welfare, plant health, and 
the environment. Under this framework, food law and feed law cover all 
stages of production, processing and distribution.[Footnote 10] Food 
and feed operators have primary responsibility for food safety; member 
states ensure surveillance and control of these operators, and the EC 
tests the performance of member states' control capacities and 
capabilities through audits and inspections. 

In the EU, food and feed business operators have primary responsibility 
for food safety, while member states provide oversight over these 
operators at all stages of production. Business operators are 
responsible for the food and feed (such as cattle fodder or pet food) 
that they produce, transport, store, or sell. They must (1) be able to 
rapidly identify any supplier or consignee, (2) immediately inform the 
competent authorities if they have reason to believe their food or feed 
is not safe, (3) immediately withdraw a product from the market if they 
have reason to believe the product is not safe, (4) apply HACCP 
principles[Footnote 11] in their processes and ensure that controls are 
applied at critical points,[Footnote 12] and (5) cooperate with the 
competent authorities in actions taken to reduce risk. The competent 
authority in each member state is responsible for monitoring producers 
to ensure that they are meeting these obligations. The EU's FVO then 
assesses the performance of the member states' competent authorities, 
countries aspiring to join the EU (referred to as candidate countries), 
and non-EU countries intending to export to the EU (referred to as 
third countries), to verify the effectiveness of national control 
systems for meeting EU standards in the areas of food safety, animal 
health and welfare, and plant health. Feed suppliers, for example, must 
apply HACCP principles, register with their national competent 
authorities to help ensure traceability, and comply with specific 
microbiological criteria, such as for levels of Salmonella, molds, and 
yeast. The competent authorities in each country approve certain feed 
operators (i.e., those manufacturing and/or selling certain feed 
additives) by visiting the facility before they start up any activity 
to ensure that the operators meet EU standards, and once the operator 
is approved, the competent authority provides oversight and imposes 
penalties for noncompliance. In turn, FVO inspects the competent 
authorities' oversight and provides recommendations when there are 
shortcomings. It also inspects countries aspiring to join the EU, and 
non-EU countries intending to export to the EU, to verify the 
effectiveness of national control systems to implement EU standards in 
the areas of food safety, animal health and welfare, and plant health. 
As for imported feed, importers must ensure that the feed meets EU 
standards. 

According to EU sources, the primary law laying out the regulatory 
framework for food safety in the EU is the General Food Law of 2002. 
Subsequent legislation merged, harmonized, and simplified detailed and 
complex hygiene requirements previously contained in 17 directives 
covering the hygiene of foodstuffs and the production and marketing of 
products of animal origin. According to these sources, the EU's food 
legislation framework includes the major regulations and directives 
described in table 4. 

Table 4: Major EU Laws, Regulations, and Directives: 

Regulation: General Food Law (Regulation [EC] 178/2002); 
Major provisions: Covers the general principles and requirements of 
food law and procedures in matters of food safety and includes the 
following key provisions: (1) Safety: Business operators shall not 
place on the market unsafe food or feed; (2) Responsibility: Business 
operators at all stages of production shall ensure that food or feed 
satisfy the food law; (3) Traceability: Business operators shall be 
able to identify anyone from whom they have been supplied a food or 
food component; and (4) Emergency: Business operators shall immediately 
initiate withdrawals of food or feed from the market if they have a 
reason to believe that it is not in compliance with food safety 
requirements. 

Regulation: Hygiene I (Regulation [EC] 852/2004); 
Major provisions: Covers the general rules for food business operators 
on the hygiene of all foodstuffs, noting that primary responsibility 
lies with business operators, food safety starts with primary 
production, and implementation of HACCP should reinforce business 
operator responsibility. 

Regulation: Hygiene II (Regulation [EC] 853/2004); 
Major provisions: Covers specific rules for food business operators for 
foods of animal origin, including processed and unprocessed foods, and 
covers rules for importers of foods of animal origin. 

Regulation: Hygiene III (Regulation [EC] 854/2004); 
Major provisions: Covers specific rules for the organization of 
specific controls for products of animal origin intended for human 
consumption, in particular for businesses producing meat, raw milk, 
eggs, or fishery products, and includes detailed inspection tasks. 

Regulation: Hygiene IV Directive [EC] 2002/99; 
Major provisions: Covers the general animal health rules governing all 
stages of production, processing, and distribution within the European 
Community and the introduction from non-EU countries of products of 
animal origin intended for human consumption. The stated aim is to 
prevent the spread of animal diseases as a result of placing animal 
produce on the market. 

Regulation: Council Directive [EC] 97/78; 
Major provisions: Covers the principles governing the organization of 
veterinary checks on products of animal origin entering the EU from 
third countries. 

Regulation: Regulation [EC] 882/2004; 
Major provisions: Covers official controls performed to ensure the 
verification of compliance with feed and food laws, animal health, and 
animal welfare rules. 

Source: EU documents. 

[End of table] 

DG-SANCO provides training to member states to harmonize their food 
safety regimes and to ensure uniform application. The implementation of 
EU legislation in member states is reviewed by other EU members and by 
FVO. EU legislation is mostly in the form of regulations or decisions 
that are directly applicable in the member states. In other cases, the 
EU legislation takes the form of directives, which the member states 
must translate into national law. Directives establish the target 
objective(s) and allow member states to decide on the most appropriate 
measures and adapt them to their situations in order to reach the 
defined objective(s). 

EU member states may also institute their own country-specific food 
safety regulations, as appropriate for their particular situations, 
provided that the level of protection defined at the EU level is not 
jeopardized and that the additional measures proposed do not impede the 
free circulation of goods among the member states. 

The EU also emphasizes the importance of being able to trace food "one 
step forward and one step back" to quickly track any questionable food 
products. Each food and feed business operator must be able to identify 
its suppliers and which businesses it supplied. Specifically, the 
operator must be able to document the names and addresses of the 
suppliers and customers, as well as the nature of the product and date 
of delivery. The operators are also encouraged to keep information on 
the volume and quantity of a product; the batch number, if there is 
one; and a more detailed description of the product, such as whether it 
is raw or processed. Food and feed business operators must also have 
systems and procedures that allow them to provide this information to 
the competent authorities on demand. (Exporters in trading partner 
countries are not required to fulfill the EU's traceability 
requirement, except in circumstances where there are special bilateral 
agreements for certain sensitive sectors or where there are specific EU 
requirements, such as in the veterinary sector. However, these 
traceability requirements pertain to EU importers, who should be able 
to identify their direct supplier in the non-EU country.) 

According to EU sources, the EU's traceability system proved useful 
during an incident that took place in 2004. During standard random 
monitoring of dioxin levels in milk at a Dutch farm, the national 
competent authorities found a high level of dioxin. EU sources noted 
that the competent authorities immediately barred the farm from trade 
and began tracing the product through the food chain. They found that 
the source of contamination was clay, used in food processing to 
separate higher-quality potatoes from lower-quality ones. The dioxin- 
tainted clay had contaminated potato peels used for feeding dairy 
animals. The EU's electronic Rapid Alert System for Food and Feed was 
used to trigger an exchange of information among national authorities 
about the problem. According to EU sources, the authorities quickly 
established that the clay had also been supplied to several food- 
processing companies located in Belgium, France, Germany, and the 
Netherlands. The authorities rapidly identified these businesses and 
barred from trade over 200 farms that had received the potentially 
contaminated potato peels. EU sources noted that because of the 
traceability system, the contaminated products never reached consumers. 

EU producers must also tag livestock with details of their origin, and 
when the animals are taken for slaughter, stamp them with the 
traceability code of the slaughterhouse. The tools used (ear tags, 
"passports," or bar codes) may vary from country to country but must 
carry the same information. In addition, to ensure the traceability of 
animals across the EU, the EU established the Trade Control and Expert 
System (TRACES), a central database for tracking the movement of 
animals both within the EU and from third countries. In the event of a 
disease outbreak, TRACES ensures that all potentially affected animals 
can be quickly identified and that authorities can take appropriate 
measures. 

Oversight of Imported Food: 

Import controls. The EU's guiding principle is that all food products 
in the EU should be safe, regardless of origin. However, imported 
products require specific controls, owing to different animal, public, 
and plant health situations in countries of origin. Animal products 
such as meat, milk, fish, and honey, as well as live animals, present 
the highest level of risks because they can transmit serious human and 
animal diseases. Certain plant products, such as cereals and nuts, also 
present higher levels of risks because they may be contaminated by 
aflatoxins. "Shelf-stable" products, such as canned, processed, and 
dried foods present lesser risks; control requirements are thus 
tailored accordingly. 

Equivalency agreement/certification programs. One of the key features 
of EU regulations is that products of animal origin imported from non- 
EU countries (referred to as third countries) must meet safety 
standards at least equivalent to those of the EU. If such food is found 
not to be as safe as that of the EU, the overseas firm is not allowed 
to export to the EU. For example, the EU maintains a list of third 
countries in which the capacity of the competent authority has been 
recognized, along with the country's animal and public health system 
and status, but the EU does not maintain such a list for food of 
nonanimal origin. On the basis of this recognition, third countries' 
competent authorities propose establishments to be approved for export 
of products of animal origin to the EU. Among the requirements for 
approving the export of products of animal origin are the following: 

* formal submission of a written application to export to the EU; 

* verification of the exporting country's animal and public health 
system, such as legislation, control systems, disease surveillance 
measures, and laboratory facilities; 

* submission and approval of a monitoring plan for residues of banned 
or restricted substances in the EU, including veterinary medicines and 
growth-promoting hormones; and: 

* provision of sanitary certification that the products to be exported 
to the EU meet import requirements. 

FVO normally visits countries to verify compliance with these 
conditions. If compliance is satisfactory, the EC may formally decide 
to approve countries and establishments for export to the EU. In 
addition, third countries must certify and approve business 
establishments wishing to export products of animal origin to the EU, 
noting that they meet the relevant EU standards. Lists of these 
establishments are maintained online by the European Community for all 
the main categories of animal products (e.g., beef, poultry, fish, or 
dairy), and compliance is verified during follow-up FVO missions. To 
help reduce problematic imports, DG-SANCO provides technical assistance 
to developing countries. In particular, DG-SANCO trains people overseas 
on hygiene and HACCP. 

Inspections. The EU bases its inspections of imports on the degree of 
risk presented by particular food types. According to the EU, it has 
shifted its focus from regular, but random, sampling to paying 
attention to the sources of greatest risk. Risk may be high because a 
particular product is traded in large quantities, or because a product 
or the area it comes from is known to be susceptible to a particular 
plant or animal disease. If the risk of a given food product is not 
known or quantified, the EU applies what it refers to as the 
"precautionary principle:" If there are reasonable grounds for 
suspecting a problem, the commission acts to limit the risk. The EU 
asserts it does not necessarily need to wait for proof that there 
really is a risk. 

Because of countries' differing risk profiles, the EU has different 
inspection methods for food products of (1) animal origin, (2) 
nonanimal origin, and (3) high-risk foods of nonanimal origin. 

First, all imports of live animals and animal products must enter the 
EU through its roughly 300 approved border inspection posts, which 
include airports, rail stations, and deepwater ports. The posts are 
under the authority of each member state's official veterinary 
services. A member state's customs service cannot release consignments 
unless they have passed through veterinary controls. The system thus 
requires the cooperation of veterinary authorities and customs 
officials. The border inspection posts must be notified in advance of 
the presentation of such consignments, which must undergo an official 
veterinary check at the inspection post. When a consignment arrives at 
a post, three types of checks are carried out: 

* Documentary: A documentary check is carried out on all consignments. 

* Identity: An identity check is carried out on all consignments to 
verify that the identity of the goods corresponds fully with the 
veterinary documents supplied. 

* Physical: A physical check is carried out on a percentage of 
consignments on the basis of the type of animal or animal product and 
the country of origin to ensure it does not pose a threat to public and 
animal health. According to EU officials, EU legislation also specifies 
a minimum number of physical checks to be carried out for each product 
group (e.g., meat, fish, or dairy) by each member state. A physical 
inspection may also involve taking samples for laboratory tests. 

When all tests and checks are satisfactory, the consignment is issued a 
Common Veterinary Entry Document and is placed on the EU market. 

In cases where testing is carried out because of unfavorable results of 
previous tests on the animal product or when a problem is suspected, 
the consignment will not be cleared or allowed to leave the border 
inspection post until the border authorities receive the results of the 
new tests. 

If a consignment does not comply with EU requirements, it may be 
rejected. In these cases, EU officials negotiate with the owner of the 
consignment and the country of dispatch, where appropriate, about 
whether to destroy the product, to retreat it for uses other than the 
human food chain, or to redispatch it. Food or feed business operators 
or their representatives are responsible for the consignment and are 
liable for any costs incurred by the competent authorities to destroy 
or redispatch it. In addition, if consignments are not in compliance, 
all other border inspection posts are notified through the Rapid Alert 
System for Food and Feed. This electronic notification system, managed 
by DG-SANCO, alerts all EU member countries to a potential food 
problem, including either a direct or an indirect risk to human health 
from food or feed. The rapid alert system involves all member states, 
the EC, and EFSA, as well as Iceland, Liechtenstein, and Norway (non-EU 
countries). Each participating country has a rapid alert contact point 
to collect information on national notifications and enter them into 
the database. The exchange of information allows participating states 
to immediately ascertain whether they are also affected by a problem 
and take appropriate measures. Since all EU border posts are connected 
electronically, problems at any one border can quickly be announced via 
the rapid alert system to all other border posts. Future imports from 
the same exporting country are then scrutinized more closely. 

Second, food products of nonanimal origin--including fruits, 
vegetables, cereals, tubers, nondairy drinks, food of mineral origin 
(such as salt), spices, and condiments--do not need to come from 
approved countries or establishments and can come into any EU port of 
entry. However, they are still subject to certain EU control 
requirements in order to verify that they comply with EU food safety 
standards. Among other things, food business operators in third 
countries must monitor the safety of products and processes under their 
responsibility, follow general hygiene provisions for primary 
production, develop HACCP principles, and register establishments with 
the appropriate competent authorities. In the EU, the competent 
authorities of the member states are responsible for carrying out 
regular controls of the goods imported into EU territory. Controls are 
determined based on potential risks. 

Finally, the EU maintains a list of food products of nonanimal origin 
that may represent a health risk to humans. As noted above, cereals and 
nuts, for example, may appear on the high-risk list. Such products 
undergo control measures, such as health certificates and testing, 
similar to those required for food products of animal origin. For 
example, all consignments of pistachios from Iran are sampled and 
checked. The safeguard measures are lifted once the problem has been 
addressed. 

Problems with imports are normally brought to light by inspections 
carried out by the FVO, checks at border inspection posts, checks 
carried out during the course of "market surveillance" by member 
states,[Footnote 13] business or consumer groups, or media reports. The 
following actions are available to address these problems: 

* circulate information through the rapid alert system to all member 
states, especially their border inspection posts, to enable a higher 
level of surveillance; 

* request that the exporting country take corrective action, such as 
deleting the exporting establishment from the authorized list for 
export to the EU; 

* introduce additional requirements, such as a higher level of testing 
at border inspection posts, retention of consignments awaiting 
laboratory confirmation of noncontamination, and additional 
certification requirements through "safeguard decisions"; and: 

* ban exports to the EU outright. 

These measures are normally introduced in full consultation with the 
member states. In recent years, safeguard decisions have been taken in 
relation to products from a wide range of third countries, including 
China (all animal products banned in 2002) and Brazil (100 percent 
testing of poultry and meat products for veterinary residues). In 
urgent cases, the EU can also take safeguard measures on its own 
initiative, pending confirmation by the member states. 

With respect to actions that can be taken domestically in response to 
an import problem, the EU distinguishes between withdrawals and recalls 
under the rapid alert system and has authority for both. Withdrawals 
occur when the product is still under the control of the producer and 
consist of measures aimed at preventing the distribution or display of 
a product that is dangerous to the consumer. Recalls occur when the 
product is already available to consumers and consist of measures aimed 
at achieving the return of an unsafe product. All member states must 
notify the EU when there is a serious risk to human health. 

The EU requires that member states ensure that adequate financial 
resources are available for organizing official controls on imports. 
For that purpose, member states may collect fees or charges to cover 
the costs of these controls. However, they must collect fees for 
certain activities, including controls of products of animal origin, 
such as meat inspection, and controls of dairy establishments. Fees are 
also levied for certain import controls on these commodities. EU 
officials said that fees may not be higher than the costs borne by the 
competent authorities. 

Foodborne Illness Outbreaks: 

According to EFSA, in 2005 the most frequently reported zoonotic 
pathogen in humans within the EU was Campylobacter, followed by: 

Salmonella. Other common zoonotic pathogens include Verotoxigenic E. 
coli, [Footnote 14] Yersinia,[Footnote 15] Listeria, and Brucella. 
[Footnote 16] Salmonella, Campylobacter, and foodborne viruses--
especially calicivirus--were the most prevalent causes of foodborne 
outbreaks in the EU in 2005. 

Response. Responsibility for investigating and controlling outbreaks of 
foodborne illness rests with local or regional authorities in most of 
the EU member states. National epidemiologists collect and analyze 
outbreak data and cooperate with other responsible bodies, such as the 
environmental health office or the regional veterinarian, to implement 
control measures. For larger outbreaks, or for those that cover more 
than one region, the member state's national surveillance institute, 
which monitors and investigates public health issues, often assists. 
The ECDC is not involved in outbreaks confined to one member state, 
except for providing training, guidelines, and possible expertise when 
requested. However, the country investigating an outbreak informs the 
ECDC if it finds that the contamination may affect other EU citizens 
because, for example, the food product is distributed in EU countries, 
or if the outbreak is likely to spread to other EU countries. The 
investigating country informs the ECDC through the Early Warning 
Response System--a computer database that deals with communicable 
diseases. ECDC assesses risk at the EU level to confirm a threat and 
then (1) works with other entities to ensure a coordinated approach to 
investigation and control; (2) cooperates closely with other EU 
agencies, particularly EFSA; (3) ensures proper communication with the 
EU and the public; and (4) assists the member states involved. 

Data from all foodborne illness outbreaks are reported to EFSA and 
published annually. Cross-border outbreaks are not reported separately. 
In case of a foodborne illness outbreak, the member states must carry 
out epidemiological investigations. EFSA also provides guidance on what 
information should be reported in case of a foodborne illness outbreak. 

ECDC manages a computerized database--Enter-net--an international 
surveillance network for human gastrointestinal infections. It involves 
all 27 EU countries, as well as Australia, Canada, Japan, South Africa, 
Switzerland, and Norway. Network participants include the 
microbiologists in charge of each country's national reference 
laboratory for Salmonella and E. coli infections, and each country's 
epidemiologist is responsible for the national surveillance of these 
diseases. The network conducts international surveillance of 
salmonellosis and E. coli, including antimicrobial resistance. Limited 
data on each laboratory-confirmed case of Salmonella or E. coli 
infection identified by the national reference laboratories are 
transferred to the central databases at the Enter-net hub. These 
records include microbiological and epidemiological data, which are 
analyzed on a regular basis and reported to all participants. The 
central database allows Enter-net to monitor trends in infection and 
recognize unusual events that can be seen only when the data are pooled 
internationally. The Enter-net database has led to a number of recalls, 
including, for example, peanuts from China. 

When more than one EU member state is involved in an outbreak, human 
data are communicated to other member states through the Early Warning 
and Response System, a database managed by the European Commission with 
the support of the ECDC and used by public health authorities in member 
states and in European Economic Area (EEA) countries.[Footnote 17] The 
system is a forum for exchanging information on the details of specific 
events caused by communicable diseases and the public health measures 
planned or undertaken at national level to respond to those events. The 
database is confidential and can be accessed only by the officially 
nominated public health authority in member states, the commission, and 
the ECDC. 

Information on any food involved in an illness outbreak is immediately 
communicated through the rapid alert system. There are also networks of 
EU reference laboratories linking national reference laboratories for 
each of the major foodborne pathogens. These networks provide support 
to member states' competent authorities in analyzing suspect food and 
exchanging information on the molecular typing of isolates (samples). 
The epidemiological investigation of foodborne outbreaks is an 
important tool for identifying the major causes of foodborne infections 
in humans. It is a major source of information used when deciding on 
priorities for the control of foodborne infections in the EU. 

Recent incidents. According to EU officials, the EU has had some recent 
problems with dye and chemical contamination of food, but there have 
not been any EU-wide incidents of foodborne illness outbreaks to date. 

Efforts to Measure the Effectiveness of Food Safety Systems: 

Performance measures. According to EU officials, performance measures 
for the EU include annual reports from EFSA on trends in foodborne 
illness, reports by individual member states on their effectiveness, 
and an EU health indicators database. 

Evaluations and audits. FVO audits are the key EU instruments to ensure 
that member states and non-EU countries are complying with regulations. 
Under the EU's farm-to-fork approach, FVO must examine the entire 
chain. Each year FVO develops an inspection program that identifies 
priority areas and countries it will audit that year. During the audit, 
it assesses a member state's competent authorities and compliance with 
EU requirements. Competent authorities must have their own audit 
authorities, which FVO also audits. As part of their reviews, the FVO 
inspectors may visit producers or processing plants to establish that 
enforcement mechanisms are effective in practice. If necessary, FVO can 
send out inspectors in response to disease outbreaks both within and 
outside the EU. FVO makes recommendations to the country's competent 
authority to address any shortcomings found during the inspections. The 
competent authority in each member state is then asked to present an 
action plan to the FVO on how it intends to deal with any identified 
shortcomings. Together with other EU bodies, the FVO evaluates this 
action plan and monitors its implementation. According to FVO staff, if 
an audit turns up deficiencies, the commission could put in place 
safeguard measures that, for example, block trade from a particular 
country if the audit finds there is immediate harm to public, animal, 
or plant health. The commission can also issue an alert to all member 
states through the rapid alert system. As a last resort, the commission 
could take legal action to ensure that member states meet their 
obligations. 

In 2006, FVO carried out 255 inspections, of which 68 percent were 
related to food safety, 14 percent to animal health, 13 percent to 
animal welfare, and 5 percent to plant health. Sixty-three percent of 
the audits were in EU member countries, 26 percent were in non-EU 
countries, and 11 percent were in EU candidate countries. 

Public opinion surveys. The EU periodically surveys citizens in its 
member countries on a variety of issues as part of the Eurobarometer 
series.[Footnote 18] According to a 2005 Eurobarometer survey published 
in 2006, an estimated 38 percent of people in the EU stated that, 
overall, food safety had improved, 29 percent that it had stayed about 
the same, 28 percent that it had worsened, and 5 percent did not know. 
In addition, 47 percent of those surveyed stated that public 
authorities' actions in the EU with regard to food safety risks are 
usually appropriate, 33 percent that the actions are insufficient, 8 
percent that the actions go beyond what is needed, and 12 percent did 
not know. Finally, according to the Eurobarometer survey, an estimated 
59 percent of people in the EU agreed that food produced in the EU is 
safer than food imported from elsewhere, 27 percent disagreed, and 13 
percent did not know. 

Other Relevant Issues: 

Officials we spoke with at the DG-SANCO and FVO identified the 
following ongoing and future challenges to the EU's food safety system: 

* The EU is looking to develop a more risk-based veterinary imports 
control program to identify the greatest risks associated with imported 
food, so that it can focus more on problem areas. Officials believe 
that it is possible to have a more flexible approach to veterinary 
controls in some areas without diminishing the overall approach. 
However, in order to focus more on risk, the EU needs to develop more 
data, and EU officials currently are looking to improve data 
availability. The development of data takes time and money. 

* Despite regulatory improvements, there is still potential for fraud 
in the system. 

* Resources are sometimes mismatched with problems. 

* The food supply is becoming increasingly global, which means it is 
more difficult to control all elements of the food chain. 

* The current regulatory system is also not well suited to address 
certain innovations, such as genetically modified organisms, certain 
agricultural crops, and nanotechnology. 

* Some items, such as dyes, which are chemicals, are imported as 
nonfood items but can be used as additives in certain processed foods. 

* There are also differences between the EU member countries in how 
they report information. For example, zoonoses are reported by some 
countries as foodborne pathogens and by others as animal illnesses. 

* The number of contaminants, such as mycotoxins, as well as 
unauthorized additives, is increasing. 

* Conducting risk assessments is also getting more difficult. New 
legislation has moved to risk-based approaches. Member states have more 
leeway on how they define risk. 

Germany's Food Safety System: 

Population and per capita GDP. In 2007, Germany had a population of 
approximately 82.4 million, and in 2006 it had an estimated per capita 
GDP of US $31,900. 

Organization. In 2002, the Federal Office of Consumer Protection and 
Food Safety (BVL) and the Federal Institute for Risk Assessment were 
established within the portfolio of the Federal Ministry of Consumer 
Protection, Food, and Agriculture. The German government took this 
action in response to numerous crises, including dioxin-contaminated 
chicken feed, misuse of antibiotics in pig feed, and the emergence of 
BSE in Germany in the late 1990s. The reorganization separated risk 
assessment from risk management. Prior to the reorganization, three 
federal ministries--for public health, agriculture, and environmental 
protection, overseeing a total of 18 agencies--were responsible for 
food safety. 

Germany's 16 federal states are responsible for overseeing compliance 
with laws, and as such, they are in charge of food and feed safety, 
animal health and welfare, and plant health. Local authorities in each 
state are in charge of control and enforcement, and the federal states 
oversee inspections performed by local governments. To harmonize food 
safety activities among the states, the German government and federal 
states have established a set of standard operating procedures for the 
control of food establishments and the sampling of food products, among 
other things. As a result of this decentralized structure, BVL 
coordinates--but does not oversee--the activities of the federal states 
in these areas. BVL conducts surveillance (not audits) to ensure the 
states adhere to the EU regulations for food safety. 

BVL's main focus is risk management. Other responsibilities include 
cooperating with the Federal Ministry of Consumer Protection, Food, and 
Agriculture in the areas of food safety, veterinary affairs, and 
consumer protection by providing data and support. BVL also provides 
logistical and organizational support to the states on food safety- 
related matters and houses the national and EU reference laboratories 
for residues, including veterinary medicines, for contaminants, and the 
National Reference Laboratory for Genetically Modified Organisms. The 
agency is also Germany's central contact point for the EU's Rapid Alert 
System for Food and Feed and for the EU's Food and Veterinary Office. 
BVL has approximately 430 employees. 

The Federal Institute for Risk Assessment is in charge of risk 
assessment and risk communication. It provides scientific opinions on 
food and feed safety and animal health, as well as assessments of the 
health effects of chemicals, and risk assessments on genetically 
modified animals, plants, and feedstuffs. Its research results and 
recommendations are an important decision-making aid for a number of 
public agencies, including the Federal Ministry of Consumer Protection, 
Food, and Agriculture and BVL. The Federal Institute for Risk 
Assessment is also the primary German point of contact for the European 
Food Safety Authority. The institute houses 14 national reference 
laboratories related to food safety and hygiene. 

The Robert Koch Institute is responsible for disease prevention and 
control. It is also responsible for scientific investigation, 
epidemiological and medical investigation, and analysis of dangerous 
diseases. It also collects, maintains, and reports epidemiological data 
at the federal level. 

Each German state also has a ministry that oversees the control, 
planning, and coordination in all areas of food, feed, and veterinary 
matters in the state. Each state also has one or more authorities that 
oversee food safety and/or veterinary matters at the district or 
municipal level. In addition, five German states have provincial 
governments that supervise food-related matters at the provincial 
level--between the state and local level--and provide oversight over 
local authorities. 

Although the Federal Ministry of Consumer Protection, Food, and 
Agriculture is the national-level competent authority for import 
controls on animals and food of animal origin, the individual states 
implement the veterinary import controls, and local authorities oversee 
Germany's 22 border inspection posts. 

Oversight of Imported Food: 

According to BVL, Germany imports about 47 million tons of food per 
year, 19 percent of which comes from developing countries. 

Import controls. Germany's regulations are fully harmonized with the 
EU's. For a more detailed summary of the EU food safety requirements, 
see the EU profile. 

Inspections. See the EU profile for more detail. 

Equivalency agreements/certification programs. See the EU profile for 
more detail. 

According to German officials, Germany has some of its own laws 
overseeing food safety matters, including the Law on Food and Feed and 
certain other legislative acts pertaining to foods of animal origin and 
certain other specific products. According to these officials, some of 
Germany's most important food safety regulations include the following: 

* a regulation for the execution of provisions of community food 
hygiene laws as a national executive order requiring implementation of 
EU regulations on food safety and other directives on adapting and 
consolidating national provisions concerning food import and market 
regulations, labeling and sanitary rules, and distribution; 

* an import regulation for foodstuff of animal origin; 

* product-specific regulations, such as those for wine, honey, and 
milk; and: 

* general administrative procedures. 

The 16 federal states do not have their own food safety laws, but their 
regulations and administrative rules apply to their responsibility for 
enforcing food safety legislation. 

The federal states also do not impose fees for regular controls--only 
for controls detecting infringements. 

Foodborne Illness Outbreaks: 

According to data from the Robert Koch Institute, the most commonly 
reported intestinal pathogen in Germany in 2006 was norovirus, with 
75,766 reported cases, followed by Salmonella, with 52,267 reported 
cases. Campylobacter was the next most common pathogen in Germany, with 
52,035 reported cases. In addition, there were 6,470 cases of E. coli 
and 508 cases of Listeria infection. 

Response. Multiple agencies in Germany are involved in managing an 
outbreak of foodborne illness. Local health agencies are the primary 
points of contact when an outbreak occurs. These agencies identify, 
treat, and report the illness to the Robert Koch Institute. The 
institute's epidemiological department collects data and identifies and 
confirms the number of illnesses. The institute is also the primary 
conduit for communication to the public throughout an outbreak. If the 
outbreak does not spread to a neighboring county or federal state, the 
local county health official retains responsibility for managing it. 
However, if the outbreak does spread, the Robert Koch Institute manages 
it, in collaboration with the local authority. The Federal Institute 
for Risk Assessment collaborates with the Robert Koch Institute to 
determine what the illness is, including the strain of the pathogen and 
the source of the outbreak. Local laboratories send any samples to the 
Federal Institute for Risk Assessment's reference laboratories for more 
sophisticated testing. The institute also has food and veterinary 
experts who assist in the investigation. (In the context of foodborne 
illness outbreaks, most of the food scientists are veterinarians 
specializing in food microbiology.) BVL helps track the source of the 
outbreak, provides information to other national agencies and the 
states, coordinates activities at the federal level, conducts tracking 
and tracing, and coordinates a recall if necessary. However, in 
Germany, it is the federal states that have the recall authority; BVL 
does not issue recalls. German officials told us that their procedures 
for addressing the public health aspects of foodborne illness 
outbreaks--in terms of identifying pathogens and tracking diseases--are 
generally similar to those followed in the United States by the Centers 
for Disease Control and Prevention. 

International coordination. During an investigation of an outbreak of 
foodborne illness, BVL is responsible for notifying the EU's rapid 
alert system and for sending information received from other EU member 
states via the rapid alert system to competent authorities in the 
states. In 2006, Germany issued 425 rapid alert notifications, 
including 2 related to microbial contamination and 20 related to 
potentially pathogenic organisms. The Robert Koch Institute is the 
competent German body providing scientific advice to European Centre 
for Disease Control. A scientific officer from the Robert Koch 
Institute is member of the Center's Advisory Forum, where information 
on health threats is exchanged. 

Recent incidents. According to a report by the Robert Koch Institute, 
on August 15, 2007, the institute detected an outbreak of Salmonella 
Panama in several German states during its routine computerized 
analysis of state-reported monitoring data. In all, 10 states reported 
Salmonella Panama cases. On the same day that they identified the 
outbreak, Robert Koch Institute officials asked the states to 
investigate the issue at the local level, including having the local 
health officials ask the victims' parents to participate in a telephone 
interview so the institute could learn more about the child's illness 
and the food the family had eaten. Laboratories were asked to send 
Salmonella Panama samples to the national Salmonella reference 
laboratory in the state of Saxony-Anhalt. 

A month earlier, the Robert Koch Institute had learned that during the 
course of semi-annual monitoring, a worker at a meat-processing plant 
had been diagnosed with asymptomatic Salmonella Panama. The plant 
produced, among other things, minisalami sticks, a snack popular with 
children. The institute then included consumption of minisalami sticks 
in questions about what had been eaten by the children who became ill. 
In several instances, parents separately told interviewers that their 
children had eaten minisalami sticks. To confirm the connection between 
the minisalami and the Salmonella Panama infection, institute staff 
conducted a case-control study, using 22 victims of the July outbreak 
as the "cases" and people from 20 affected communities as the controls. 
To identify the control cases, the institute asked certain local 
offices in the affected regions to select from their databases up to 30 
families with children in three different age groups. Local officials 
used a statistical procedure called frequency matching to select 62 
control cases. As part of a telephone survey, officials asked the 
parents of both the "case" (i.e., victim) and control subjects about 
their shopping and eating activities in the week prior to the outbreak. 
The institute then included consumption of minisalami sticks in 
questions about what the sick children had eaten. The experts found 
that in the 7 days before the outbreak, there was a high statistical 
correlation in the cases between consumption of minisalami and 
Salmonella Panama infection. 

While the Robert Koch Institute was conducting the surveys, the 
reference laboratory identified the specific strain of Salmonella 
involved in the outbreak and confirmed that all 11 samples from the 
cases belonged to the same strain, as did the sample from the 
asymptomatic worker at the salami plant and a coworker's 10-month-old 
grandchild, who had become ill. BVL also queried the EU's rapid alert 
system to see if there had been any case of Salmonella Panama between 
January 1, 2006 and August 2007, and found none. The local competent 
authorities also examined minisalami samples from the processing plant 
thought responsible for the outbreak for Salmonella but found none and 
did not find any in minisalami products taken from shops in two states 
where the firm's products were sold. 

In early September, staff from the local food safety authority and the 
Federal Institute for Risk Assessment again inspected the salami 
manufacturer. The competent authorities also conducted a thorough 
review of the firm's records. No shortcomings were found in hygiene 
procedures. Officials nonetheless concluded that the minisalami sticks 
were the most likely cause of the outbreak, even though the pathogen 
was not found in tests of the product. 

In summarizing the incident, the Robert Koch Institute pointed out that 
this outbreak was discovered only through the nationwide aggregation of 
institute-collected data and computerized analysis, because the number 
of victims in any one state was too low to signal an outbreak. 
Furthermore, the case-control telephone survey enabled officials to 
conduct an almost real-time epidemiological analysis. In addition, 
according to the institute, close cooperation among the Federal 
Institute for Risk Assessment, BVL, the Robert Koch Institute, the 
national reference laboratory, and local authorities contributed to 
rapid investigation and management of the outbreak. 

Efforts to Measure the Effectiveness of Food Safety Systems: 

Although Germany had not conducted a formal review of its reorganized 
food safety system at the time of our review, BVL met with relevant 
stakeholders in November 2007 to discuss how the German food safety 
system and BVL are working. Participants included consumers, 
politicians, administrators, nonprofit organizations, industries, 
scientists, and representatives from the EU, who discussed how BVL had 
performed over the 5 years since it was created. Among the themes 
discussed were data management and analysis, cooperation between the 
federal government and the states, international cooperation, and 
research and scientific work. Overall, participants believed that BVL 
had been meeting its objectives, and views were generally positive. In 
particular, participants approved of the efforts of the national 
contact point for the EU's rapid alert system. However, they suggested 
some improvements in the system, and also suggested that BVL provide 
training to help prepare for FVO audits. Participants also had positive 
things to say about the BVL press office, and suggested that BVL allow 
its home page to be reviewed by users and by external media experts. 
Participants furthermore spoke highly of BVL's Journal of Consumer 
Protection and Food Safety, which was launched in 2006 to provide 
information, in both German and English, on basic and applied research 
and on official oversight of current developments in the areas of food 
and feed, veterinary medicine, and genetic technology. Finally, 
participants suggested that BVL establish a greater presence at 
conferences, fairs, and schools and that it be more visible to 
consumers as a partner for information and questions. 

Performance measures. According to BVL officials, measures used to 
evaluate performance include quality management systems within 
competent authorities, targets set through control and monitoring 
plans, data found in annual reports on food safety, and evaluation of 
rapid alert system notifications. BVL's performance is evaluated by the 
German Federal Court of Auditors, GAO's German counterpart. 

Evaluations and audits. BVL cannot audit or evaluate the state-level 
food safety systems. However, some states audit other states' local and 
regional food safety systems upon request. 

Moreover, between 2001 and 2007, FVO conducted 53 performance audits of 
certain aspects of Germany's food safety system and most made 
recommendations to German officials. In June 2005, for example, the 
office assessed the import control system and four operating border 
inspection posts in Germany. It found that import controls were 
generally applied correctly in the border inspection posts visited, 
with only minor shortcomings. However, it also found that supervision 
of imports that do not comply with EU regulations was inadequate, 
traceability was not reliable, and the exit of these noncompliant 
products from the EU was not ensured. Furthermore, it found significant 
deficiencies at some of the border inspection post facilities. FVO 
audits have been conducted on such topics as BSE, food hygiene, and 
animal welfare. The office discusses any problems it detects at the 
state level with BVL and the states. 

Public opinion surveys. Officials from BVL stated that the agency is in 
constant dialogue with stakeholders and evaluates daily consumer mails 
and queries related to food safety and consumer protection (including 
on economic issues). 

According to a 2005 Eurobarometer survey published in 2006, an 
estimated 37 percent of people in Germany stated that overall, food 
safety had improved over the past decade, 37 percent that it had stayed 
about the same, 21 percent that it had worsened, and 5 percent did not 
have an opinion. In addition, an estimated 56 percent of the Germans 
surveyed stated that usually public authorities' actions in the EU with 
regard to food safety risks were appropriate, 28 percent that actions 
were insufficient, 8 percent that the actions went beyond what is 
needed, and 8 percent did not have an opinion. Finally, an estimated 60 
percent of the Germans surveyed agreed that food produced in the EU was 
safer than food imported from elsewhere, 30 percent disagreed, and 10 
percent did not know. 

Stakeholder perspectives. The views of stakeholders who interact 
frequently with BVL can also provide insight, albeit anecdotal, on the 
effectiveness of a country's food safety system.In Germany, a 
representative of an industry group told us that overall the 
consolidated food safety system represented an improvement over the 
previous system. This person also said that the EU's rapid warning 
system was working well, although there was room for improvement in 
some areas. Furthermore, one of the positive outcomes of the 
consolidation, in this person's view, was the establishment of a 
working group of representatives from the 16 states who meet to discuss 
problems of food law interpretation. According to this person, one of 
the challenges of the German food safety system was the different 
interpretations of law at the state and local levels. For example, 
public warnings and information can vary among the state governments 
during food crises, and some states took different views on whether a 
product should be recalled. Finally, this industry representative noted 
that the EU's traceability requirements made firms more proactive in 
protecting their brand names. 

Other Relevant Issues: 

Emerging trends and challenges. Officials we spoke with identified the 
following areas of concern with regard to ongoing and future challenges 
to the country's food safety system: 

* Climate change may affect foodborne illness, in that illness can 
spread under new climatic conditions. 

* New fungi, pathogens, and diseases will continue to emerge. 

* Genetically modified organisms will continue to be developed, but 
there is zero tolerance for them in Germany. 

Ireland's Food Safety System: 

Population and per capita GDP. In 2007, Ireland had a population of 
approximately 4.1 million, and in 2006 its estimated per capita GDP was 
US $44,500. 

Organization. Before Ireland reorganized its food safety system, about 
50 different public agencies were in charge of food control, with 
little coordination among their activities. Responsibilities were 
shared between the Department of Agriculture and Food (now known as the 
Department of Agriculture, Fisheries, and Food--DAFF), the Department 
of Health and Children, 33 local authorities, 8 health boards, the 
Department for the Marine and the Department of Trade. With no central 
system of coordinating food safety control activities, there were 
overlaps and gaps in the functions of the different agencies. Some of 
the government departments had dual roles of promoting the industry and 
overseeing food controls, raising conflict-of-interest concerns. 

The Food Safety Authority of Ireland (FSAI) was created in 1998 to 
oversee the enforcement of food safety regulations. An independent, 
science-based body under the jurisdiction of the Minister for Health 
and Children, FSAI coordinates the enforcement of food regulations 
among various state agencies; sets food standards that are based on 
science and risk assessment; manages risk in association with other 
agencies and the Irish food sector; and communicates risks to 
consumers, public health professionals, and the food industry. It is 
the central competent authority for Ireland under EU legislation. FSAI 
has 87 employees who oversee a total of about 2,500 people working in 
39 other government agencies as part of the integrated national system. 
(About 1,200 members of this workforce focus exclusively on food safety 
issues, while others, such as veterinarians, work only a few days per 
week on food safety matters.) Twenty-five staff work at the three Irish 
border inspection posts. In all, FSAI and its partner agencies oversee 
food safety in nearly 45,000 food establishments. 

FSAI has service contracts with the 39 entities--such as DAFF, the Sea 
Fishery Protection Agency, the Health Service Executive, the National 
Standards Authority--to oversee specific elements of the system. For 
example, DAFF enforces food safety legislation for meat, milk, and egg 
products, and inspects live animals and products of animal origin 
coming through Ireland's three border inspection posts from non-EU 
countries, while the Health Service Executive inspect imports of food 
of nonanimal origin. Only specific products of nonanimal origin known 
to present a risk are restricted to specific points of entry. FSAI does 
not provide money to these government agencies for their work but 
instead establishes the terms of work, such as conducting a set number 
of inspections annually on the basis of the risk level of the food 
product. Each agency is audited to make sure it is carrying out its 
contractual obligations. FSAI's authority extends from the farm gate to 
the final consumer; its jurisdiction is only food safety, not on-farm 
hygiene or feed control. (The latter is overseen by DAFF, separately 
from the FSAI contract.) 

FSAI is charged with investigating and managing food-related incidents 
in Ireland and is the country's point of contact for the EU's rapid 
alert system. In 2006, FSAI conducted 76 investigations related to food 
safety, 16 percent of which were related to microbial contamination. 

One of the largest food recalls in Irish history took place in 2005, 
when FSAI oversaw the recall of 67 products contaminated with a chili 
powder containing carcinogenic industrial dye called Sudan Red 1 that 
was used as an ingredient in a variety of processed foods. The dye 
entered EU countries in ground or crushed chili imported from India; 
Ireland was notified by its counterpart in the UK, the Food Standards 
Agency, about the discovery in a primary ingredient used in the 
manufacture of other foods. FSAI then worked with official agencies and 
the food industry to ensure that all contaminated products were traced 
and removed from Irish retail stores. It advised consumers to either 
dispose of the product or return it to the store where it was 
purchased. FSAI also posted a list of the affected food products on its 
Web site. 

Two other entities are of particular importance to the food safety 
system: 

* The Health Service Executive, created in 2005, runs the health 
services in Ireland. It is also responsible for import controls on 
foods of nonanimal origin. Within the executive is the Health 
Protection Surveillance Centre (HPSC), which was established in 1998 to 
collect, interpret, and disseminate data on infectious disease and to 
provide data on foodborne illness to the relevant authorities. 

* A Scientific Committee was established in 2000 to assist FSAI in 
assessing risk. The committee is made up of scientists from a variety 
of disciplines whose work for FSAI is voluntary. Among other things, 
the committee clarifies scientific and technical issues relating to 
food safety and hygiene. FSAI then manages risk on the basis of the 
committee's assessments. 

Regulatory Framework: 

According to Irish officials, most of Ireland's food safety legislation 
comes from EU legislation, but some flexibility is allowed on how 
member states apply the food safety requirements within their national 
territory (in particular, for producers supplying small quantities of 
foods within their local areas). Ireland is examining the areas for 
which "national rules" can be applied to determine what national 
legislation should be introduced. Under consideration is the 
reintroduction of a national ban on the sale of raw milk in Ireland. In 
the area of labeling, Ireland has introduced national legislation that, 
according to Irish officials, requires all beef sold in Irish 
restaurants and catering outlets to include information on the country 
of origin. This would apply in addition to the EU beef labeling 
regulations. 

Oversight of Imported Food: 

Import controls. Ireland's regulations are fully coordinated with the 
EU's. For a more detailed summary of the EU food safety requirements, 
see the EU profile. 

Inspections. Ireland's regulations are fully coordinated with the EU's. 
See the EU profile. 

Equivalency agreements/certification programs. Ireland's regulations 
are fully coordinated with the EU's. See the EU profile. 

Ireland applies veterinary inspection fees to importers. Fees currently 
charged contribute a small proportion of the total import control 
budget. According to an Irish official, as of April 2008, the fee 
structure was being reviewed to ensure that it aligns with the EU Food 
Hygiene legislation. 

Foodborne Illness Outbreaks: 

According to Irish sources, the most common gastroenteric pathogen in 
Ireland is Campylobacter, of which there were 1,815 cases in 2006--more 
than four times the number of Salmonella infections (422). Other 
sources of foodborne illness in Ireland in 2006 were E. coli (158 
cases), Listeria (7 cases), and norovirus (1,639 cases). 

Response. Outbreaks in Ireland are generally managed at the local 
level, but HPSC gets involved if there is a large national outbreak or 
an international outbreak affecting Ireland. If someone becomes ill 
with 1 of 67 diseases that must be reported to public health officials, 
the local public health authority is immediately notified, and a local 
environmental or public health officer interviews the patient about 
where he or she had been and what was eaten and forwards the 
information to HPSC. 

To determine the cause of an outbreak, HPSC examines a sample of the 
pathogen to ascertain whether it is normally associated with food 
(microbiological evidence); determines whether other people have been 
afflicted by the same strain (epidemiological evidence); and looks at 
the hygiene of the food institution that produced the food 
(environmental evidence) if the source is thought to be food. If the 
foodborne illness appears to be an isolated case, no additional work is 
conducted. However, if a similar case occurs, samples of the bacteria 
are sent to reference laboratories for more precise typing. 

HPSC uses a surveillance database, called the Computerized Infectious 
Diseases Reporting System, to combine and link epidemiological data 
from laboratories and hospitals so that all notifiable diseases can be 
tracked. The Health Service Executive (HPSC's parent organization) 
notifies FSAI in the case of an outbreak and provides FSAI with 
information on the outcome of any investigations. It also shares these 
data with the European Centre for Disease Control in Stockholm. Irish 
officials told us the procedures they follow are generally similar to 
those followed by the U.S. Centers for Disease Control and Prevention 
for monitoring foodborne illness. 

DAFF's Veterinary Research Laboratory Service also provides a range of 
services in relation to identifying and addressing zoonotic diseases. 
As part of this, the DAFF Central Veterinary Research Laboratory is the 
national reference laboratory for Salmonella and carries out typing of 
Salmonella samples from official control samples and from samples taken 
by food business operators of their own products. 

International coordination. In the case of an outbreak, FSAI, as 
Ireland's competent authority, sends out the necessary data alerts to 
the public and follows up after the outbreak. 

Recent incidents. Detailed information on recent outbreaks was not 
provided. 

Efforts to Measure the Effectiveness of Food Safety Systems: 

An FSAI official told us that FSAI was working on a consolidated report 
on overall performance of the food safety system, but as of April 2008, 
the report was not available. 

Performance measures. According to an Irish official, FSAI's service 
contracts require that inspection frequencies be risk-based, so FSAI 
can measure performance against these requirements. 

Evaluations and audits. FSAI's audit and compliance unit periodically 
audits the work of all the contracted agencies to make sure they are 
meeting the terms of their contracts in such areas as the number of 
inspections and tests conducted, number of staff, and corrective 
actions to address previous audit findings (e.g., of food businesses or 
by the EU Food and Veterinary Office). Together, FSAI and the audited 
agency work to resolve any identified problems. If FSAI uncovers a 
problem with how an agency fulfills the terms of its contract, the two 
agencies meet to discuss it to prevent future occurrences. FSAI also 
monitors the contracts through regular reporting on inspection 
frequencies and outcomes and through food sampling and analysis. 

If noncompliance with a service contract is found to be particularly 
egregious, FSAI could also report it to the head of an agency, but this 
has not yet happened. In addition to FSAI audits, all of the agencies 
with service contracts to FSAI either have established--or will be 
establishing--internal audit systems, according to an Irish official. 

If FSAI finds breaches in food businesses' implementation of the EU and 
Irish food law, FSAI and the official agencies can take legal action 
against the food business, which may result in fines, and in extreme 
cases, prison sentences, but issuing enforcement orders and 
subsequently "naming and shaming" on the FSAI Web site is FSAI's main 
compliance tool. 

The EU's Food and Veterinary Office has also conducted a number of 
audits of various aspects of the Irish food safety system. Between 2001 
and 2006, the office conducted 31 audits in Ireland on such topics as 
on-farm animal welfare, import controls and border inspection posts, 
and traceability of beef and beef products, among others. As part of 
its evaluations, the Food and Veterinary Office provided some 
recommendations for improvement in areas where it identified gaps. In 
2005, for example, the office audited Irish import controls and border 
inspection posts. Auditors found that the import control system was 
well defined and generally applied in a uniform way in all the Irish 
border inspection posts, but on two occasions, implementation of 
certain EU legislation had been delayed. Major deficiencies identified 
in a 2003 audit had been for the most part corrected, with a few 
exceptions, according to the Food and Veterinary Office report. 
However, the office noted that Irish border inspection posts used a 
simplified customs clearance procedure for all consignments handled by 
customs agents that did not flag the need for veterinary checks 
required for products of animal origin. The Irish central competent 
authority for food safety follows up on any recommendations in Food and 
Veterinary Office reports to make sure that the corrective actions are 
taken. 

Public opinion surveys. According to a 2005 Eurobarometer survey 
published in 2006, an estimated 67 percent of people in Ireland stated 
that overall, food safety had improved over the past decade, 14 percent 
that it had stayed about the same, 11 percent that it had worsened, and 
8 percent did not know. In addition, an estimated 52 percent stated 
that usually public authorities' actions in the EU with regard to food 
safety risks are appropriate; 23 percent, that the actions are 
insufficient; 7 percent, that the actions go beyond what is needed; and 
18 percent did not know. Finally, an estimated 65 percent agreed that 
food produced in the EU is safer than food imported from elsewhere, 13 
percent disagreed, and 22 percent did not know. 

Stakeholder perspectives. The views of stakeholders who interact 
frequently with FSAI and the agencies it oversees can also provide 
insight, albeit anecdotal, on the food safety system's effectiveness.In 
Ireland, we spoke with representatives of one industry and one consumer 
group. Representatives of the industry group said that the 
reorganization that created FSAI had a positive impact and that its new 
umbrella structure is working well. In particular, they believed that 
this structure opened lines of communication between government and 
industry. They also approved of the approach FSAI took a few years ago 
concerning a major recall of a chocolate product. Nonetheless, they 
expressed concern that FSAI has little authority over local inspectors 
and needs more control over the service contracts with the agencies it 
oversees. A representative of the consumer group stated that, overall, 
consumers have great respect for FSAI and that the hygiene of food 
production had improved with consolidation of the system a few years 
ago. However, this representative believes the government could do more 
to educate the public on food safety issues. 

Other Relevant Issues: 

Emerging trends and challenges. Irish officials identified the 
following issues as areas of concern: 

* Resources for the number of inspections required were limited, and 
inspectors were concerned that they must rely to a certain extent on 
statements by importers, which means there is potential for fraud in 
the system. 

* The possible increased risk of botulism among migrant workers from 
Eastern Europe, who may import home-produced foods that are not 
transported under refrigerated conditions, is a concern. 

Japan's Food Safety System: 

Population and per capita GDP. In 2007, Japan had an estimated 
population of 127.4 million, and in 2006 its per capita GDP was 
estimated to be US $33,100. 

Organization. Several food safety-related crises in the past decade, 
including outbreaks of E. coli and concern over the BSE crisis, drove 
Japan to comprehensively reform its food safety system. In 2003, Japan 
established the Food Safety Commission (FSC) as a cabinet-level agency 
responsible for conducting objective, neutral, scientific risk 
assessments related to food safety, including the use of food 
additives, pesticide residues, the presence of illness-causing 
bacteria, and other issues. FSC became a fully functioning, independent 
agency in 2005. Previously, the two ministries primarily responsible 
for managing food safety--the Ministry of Agriculture, Forestry and 
Fisheries (MAFF) and the Ministry of Health, Labor and Welfare (MHLW)-
-conducted their own scientific risk assessments. FSC, MAFF, and MHLW 
are the three agencies responsible for food safety at the national 
level. 

While FSC assesses risks, MHLW and MAFF are responsible for managing 
these risks. MHLW is responsible for setting standards for food 
processing and manufacturing and monitoring imported and domestic food 
throughout the supply chain. It also operates quarantine stations 
throughout Japan, which are responsible for ensuring the safety of food 
entering the country, as well as regional health centers, which are 
responsible for dealing with cases of foodborne illness. In 2007, MHLW 
employed 334 inspectors, up from 314 the previous year. MAFF is the 
ministry primarily responsible for setting regulations for food 
labeling, setting nutritional standards for food produced in Japan, 
establishing nutritional guidelines for the Japanese public, and 
ensuring Japanese agricultural products comply with the World Trade 
Organization's (WTO) Sanitary and Phytosanitary (SPS) Measures. 

The National Institute of Infectious Diseases conducts research on 
contagious diseases. It serves as Japan's reference laboratory for 
infectious diseases and is responsible for collecting information on 
such diseases from the local public health centers. It also monitors 
incidents of infectious diseases around the country. In the event of an 
outbreak, the institute performs epidemiological investigations. 

Oversight of Imported Food: 

Import controls. Japan imports about 60 percent of its food. It uses a 
risk-based approach in inspecting imported food entering the country 
and also emphasizes the role of the exporting country in ensuring the 
safety of the food it exports. MHLW produces an Annual Imported Foods 
Monitoring and Guidance Plan intended to promote intensive, effective, 
and efficient inspections of imported foods at the border and also 
provides guidance to importers. The plan also spells out the quantity 
and category of inspections to be conducted each year. In fiscal year 
2007, for example, the goal was approximately 79,000 random inspections 
for 124 food groups. According to the plan, food safety should be 
secured by appropriate measures in every stage of the domestic and 
overseas food supply chain. On the basis of this principle, the plan 
lays out measures for ensuring the sanitation of food imports in three 
stages: (1) in the exporting countries, (2) at entry into Japan, and 
(3) through internal distribution. 

Inspections. Thirty-one quarantine stations at ports of entry 
throughout Japan are responsible for inspecting food imports. They are 
primarily responsible for reviewing import notifications and 
certificates. Some quarantine stations house Imported Food Inspection 
Offices, which are responsible for conducting more advanced technical 
tests, such as microbiological sampling. In addition, two specialized 
stations are responsible for conducting the most technically 
complicated tests. Quarantine stations randomly select shipments for 
monitoring on a daily basis; such tests are paid for by the Japanese 
government. In fiscal year 2006, MHLW conducted nearly 80,000 random 
inspections and found 360 violations. 

Port of entry inspections beyond routine document checks depend on a 
variety of factors: companies' past violations; whether Japan has 
certified the exporting companies; and information on exporting 
countries, including the types of agreements they have with Japan, 
resource materials, and manufacturing methods. Japan maintains this 
information in a national database. Additionally, Japan has specific 
concerns related to certain contaminants, such as aflatoxin and agro- 
chemicals. If an imported food belongs to a food group that is known to 
be at a higher risk for contamination (e.g., from a pathogen, pesticide 
residue, or animal drug), MHLW issues a Ministerial Inspection Order, 
which, according to Japanese sources, requires that products with a 
high violation probability be inspected at every time of importation 
(lot by lot). Japan prohibits the importation and distribution of 
products that fail to pass inspection; importers bear the cost of that 
inspection, and future inspections from that country are strengthened. 
In 2006, for example, Japan required compulsory testing of 100 percent 
of Vietnamese shrimp imports after inspectors repeatedly found 
chloramphenicol, a banned antibiotic, in shipments of Vietnamese 
shrimp. Moreover, according to the Imported Foods Monitoring and 
Guidance Plan for fiscal year 2007, if the number of imported foods 
from a specific country, area, or business entity violating the law is 
above 5 percent of the overall number of those inspected, and if it is 
likely that the importation of violating goods will continue, given 
conditions in the exporting country, MHLW may ban the importation of 
such goods altogether. 

Testing under the Ministerial Inspection Order includes laboratory 
testing for pathogens, which the importing company pays for. Violation 
information is entered into the database the quarantine stations use in 
making future inspection decisions. If a violation is found under a 
Ministerial Inspection Order, the shipment may be recalled, disposed 
of, or shipped back to the exporter (at the expense of the importer in 
Japan). The importing company is asked to investigate the cause of the 
violation, and before resuming importation must test a sample of the 
product. Companies with repeat violations will not be allowed to export 
to Japan, and the Japanese government publishes violations on its Web 
site. In fiscal year 2006, there were over 100,000 inspections 
conducted under the MHLW Ministerial Inspection Order, uncovering 681 
violations. Overall, in 2006, Japan inspected 11 percent of declared 
products coming into its ports. (This figure includes both random 
inspections and Ministerial Inspection Order examinations.) 

If MHLW believes that certain foods represent a particularly 
significant hazard, it can issue a comprehensive prohibition on the 
importation of those foods, which means that these high-risk items can 
be barred from Japan without even undergoing an inspection. According 
to an MHLW official, this type of prohibition has never been issued. 

Japan also provides the option for first-time exporters to submit their 
products to voluntary inspections, giving these exporters an 
opportunity to demonstrate that their products pose a low health risk. 
Before sending the first shipment to Japan, these exporters send 
samples of their products to private Japanese companies approved by 
MHLW for testing and analysis. On the basis of the outcome of these 
preliminary tests, the exporter is either rejected or approved to 
proceed with the first shipment. If an exporter is approved and 
subsequently exports to Japan, the first shipment will be subject to 
routine random monitoring; if the exporter did not go through with 
voluntary inspection, the first shipment would be subject to a 
Ministerial Inspection Order. 

Japan has also created a "Positive List" of substances that must be 
controlled in all imported foods stuffs.[Footnote 19] If an importer 
violates the positive list, MHLW will subsequently test 30 percent of 
all products coming to Japan from the violating country for 1 year. For 
a second violation, Japan imposes 100 percent "hold-and-test," meaning 
that all goods from the violating country will be held and tested for 2 
years and a minimum of 300 imports. 

In addition to government programs, there are Japanese private sector 
initiatives to help ensure food safety. For example, according to an 
official from the umbrella organization for the many private food 
cooperatives in Japan, all growers that supply products to co-ops are 
required to prove that they adhere to "Good Agricultural Practices," as 
well as specific regulations of the co-op, such as those for pesticide 
usage. Co-ops have their own specifications--separate from the 
government--for acceptable materials, additives, and labeling 
requirements, including detailed nutritional information. Some growers 
also provide the co-ops with information about their products (e.g., 
location of farm, names of the farmers, types of pesticides used, dates 
of planting, dates of cultivation, dates of packaging and shipping). 
Consumers can then access this information using a cell phone to scan 
the barcode on the product packaging. The Japanese Consumers 
Cooperative Union also has its own programs to ensure the safety of 
imported foods that are independent of the government. For example, it 
conducts its own inspections of overseas firms from which it imports 
foods and tests incoming products twice a year. 

As a result of a food safety scare in early 2008, when frozen dumplings 
imported from China were found to be contaminated with a dangerous 
level of pesticides, the Japanese government announced its plans to 
implement various new food safety measures in several areas, including 
(1) establishing a new consumer agency to oversee work currently being 
handled by multiple ministries, and (2) establishing a director-general 
position in the MHLW, MAFF, and other government bodies to oversee the 
distribution of information related to foodborne illness. In addition, 
public health centers will be required to be open 24 hours a day, and 
prefectural governments will be required to notify the health minister 
when there is a case of poisoning,[Footnote 20] (3) increasing testing 
for all imported foods, with special attention to agriculture residues 
in processed foods, and (4) requiring stricter labeling requirements. 
At the time of our review, these measures had not yet become law. 

Bilateral agreements/certification programs. According to Japanese 
sources, Japanese officials from MAFF and/or MHLW engage in bilateral 
talks with their counterparts in the exporting country to explain 
Japanese food sanitary regulations. If a country has no prior record of 
exporting food to Japan, MHLW officials may conduct field surveys to 
determine whether a country's food safety system can meet Japanese food 
sanitary regulations and whether the exporting country's food safety 
regulations are comparable to Japan's. If Japan has found an exporting 
country's food safety system and food safety regulations satisfactory, 
and a new facility in that country seeks to export to Japan, MHLW 
officials may conduct a pre-export inspection of that facility. If the 
review is satisfactory, MHLW will issue a certificate to the exporter, 
copies of which must accompany every shipment of goods to Japan. 

According to Japanese officials, under Japan's bilateral agreement with 
China to screen spinach imports, the Chinese government certifies 
Chinese spinach processors (exporters), who in turn oversee the 
practices of local farmers (including requiring them to, among other 
things, keep records on pesticide purchase and usage) and test the 
product at three stages of production. Chinese government authorities 
then conduct preshipment tests on the spinach before exporting, 
confirming that the exporter has observed the proper procedures on 
pesticide management. The spinach may be randomly inspected again once 
it arrives in Japanese ports. Chinese exporters of 19 other products, 
including tea leaves and frozen vegetables, are likewise required to 
register with the Chinese government, and blowfish and meat from China 
also require certification of processing. Japan has certification 
programs in place with other countries as well. For example, after 
concerns about high levels of antibiotics in Thai shrimp came to light, 
MHLW worked with the Thai government to identify shrimp exporters that 
were subsequently included on a "safe list" as being reliably able to 
comply with Japanese requirements for antibiotic levels. 

Foodborne Illness Outbreaks: 

Response. MHLW operates a network of regional health centers in 
partnership with local governments, which are responsible for the day- 
to-day operation of the centers. In cases of foodborne illness, these 
centers work with hospitals to identify the cause and the source of 
contamination. They will notify MHLW only if the number of patients 
with the same symptoms exceeds 50. According to MHLW officials, the 
most recent outbreaks over the past 2 years have been confined to 
single prefectures. In these cases, MHLW coordinates the work of the 
participating groups (e.g., hospitals, health centers, and food 
manufacturers), oversees data collection, and communicates with the 
public. The Japanese government has mandatory recall authority for 
unsafe food products, but according to a Japanese official, it has 
rarely exercised this authority. Typically, the government 
(specifically, MHLW-run local health centers responsible for testing 
food that is suspected to be the source of an outbreak) will "suggest" 
to companies that they recall their product. According to this 
official, if the government communicates in this way to a company, the 
company feels obliged to recall its products. 

With regard to animal tracking, Japan has a mandatory system in which 
all beef and dairy cattle must be identified using an ear tag. 
Information is maintained on an animal's ID number, breed, gender, and 
production history from the farm of origin through distribution to 
consumers. 

Recent incidents. Japanese officials did not identify any major 
outbreaks of foodborne illness. 

Efforts to Measure the Effectiveness of the Food Safety System: 

Performance measures. Japan does not have a systematic assessment 
mechanism in place to measure the effectiveness of its food safety 
system, and officials we contacted from the Board of Audit of Japan, 
GAO's counterpart organization, told us that they had not referred to 
the Japanese food safety system in the annual audit report or other 
reports. (Each year the Board of Audit prepares an audit report showing 
the results of all audits conducted that year and sends it to the 
Cabinet with the audited final accounts of revenues and expenditures of 
the state. The Cabinet then submits both of them to the Diet. The Audit 
Report is used in the Diet (legislative) session for deliberation on 
the state's final accounts and for future administration by the 
financial authorities.) However, Japanese officials indicated that some 
components of the system are subject to review under certain 
conditions. 

Evaluations and audits. The FSC conducts investigations to ascertain 
whether its assessment results have been appropriately reflected in the 
food safety policies implemented by the risk management agencies (MHLW 
and MAFF). Also, according to FSC and MHLW officials, if there is a 
food safety-related emergency, such as a natural disaster that affects 
the food supply, bioterrorism, or an outbreak of foodborne illness, FSC 
is responsible for monitoring and reporting on how effectively MHLW 
handles the crisis. However, Japanese officials noted that such a 
scenario has not occurred, so no assessments had been conducted to 
date. 

Public opinion survey. MAFF and FSC conduct public opinion surveys. A 
staff member from a Japanese nongovernmental organization told us that 
the August 2007 and February and March 2006 surveys conducted by MAFF 
indicate that consumers perceive imported foods in general to be 
unreliable and untrustworthy. A private organization, the Japanese 
Consumers Cooperative Union, also conducted some consumer surveys and 
noted that surveys from 2005 to the present have shown that the most 
important consumer concerns are country of origin (for imported foods), 
the trustworthiness of all suppliers (domestic and foreign), and the 
overall quality of the product. Food additives are a major concern for 
consumers, as is pesticide residue on food. The surveys generally 
indicate that Japanese consumers are more concerned about food 
additives and chemicals than about microorganisms. 

Stakeholder views. The perspectives of stakeholders can be useful in 
providing some insight into the effectiveness of a country's food 
safety system. In Japan, we spoke to representatives of two consumer 
organizations about their perceptions of the Japanese food safety 
system. Both individuals told us that the creation of the FSC has been 
a positive step, increasing transparency between government and 
stakeholders. One of these people told us that, previously, expert 
committee meetings within ministries were closed, but now they are open 
to the public, a change that is viewed as positive. A representative of 
the other consumer group stated that the government needs to improve 
its risk communication to the public; for example, many Japanese 
consumers are still highly suspicious of imported beef and do not fully 
understand the safety measures in place for beef. 

Other Relevant Issues: 

Officials in Japan identified the following areas of concern with 
regard to ongoing and future challenges to the country's food safety 
system: 

* Assessing the risks of chemical and food additives is a priority. At 
the time of our review, FSC was reviewing the potential public health 
risks of approximately 800 chemicals. 

* Foodborne illness from Campylobacter has increased significantly in 
the last several years and is one of the most frequent sources of food 
contamination. In response to this, FSC has initiated risk assessments 
relating to microorganism contamination of food, starting with 
Campylobacter. 

* The volume of international food trade is growing, and imported food 
is increasingly harder to track. 

* Human/animal interactions are changing, with potential for disease 
transmission, including E. coli and prions (which are involved in BSE). 

The Netherlands Food Safety System: 

Population and per capita GDP. In 2007, the Netherlands had a 
population of approximately 16.6 million, and in 2006 its estimated per 
capita GDP was US $32,100. 

Organization. In response to public concern about food safety stemming 
from the dioxin contamination of animal feed, the BSE crisis, and other 
animal diseases, as well as the EU's proposed food safety legislation, 
the Netherlands created the Food and Consumer Product Safety Authority 
(VWA) in July 2002. Consumers, parliament, and interest groups had 
demanded a single powerful organization to investigate and monitor food 
and product safety. Two organizations, the Inspectorate for Health 
Protection and Veterinary Public Health and the National Inspection 
Service for Livestock and Meat were combined into one agency under VWA 
as of January 1, 2006. 

VWA, an independent agency in the Ministry of Agriculture, Nature, and 
Food Quality, is responsible for assessing and communicating risk and 
managing food safety incidents. It monitors food and consumer products 
to safeguard public health and animal health and welfare. It also 
enforces food-related legislation, coordinates inspection activities 
throughout the country, and conducts research; each of VWA's five 
regional divisions has its own laboratory to carry out routine 
microbiological and chemical analyses for food safety controls. One of 
VWA's regional departments (southwest) is in charge of managing the 
Netherlands' seven border inspection posts and overseeing imports of 
foods of animal origin. VWA inspectors work with Dutch customs agents, 
who carry out documentary checks on imports. VWA is also the contact 
point for the EU's Rapid Alert System for Food and Feed and for the EU 
Food and Veterinary Office. In 2006, VWA had a total of 1,750 
employees. (The previous year, it had transferred its meat inspectors 
to private bodies.) 

The National Institute for Public Health and the Environment (RIVM) is 
a government research institute that conducts research on public health 
(infectious diseases, care, prevention, and food safety), medicines, 
nutrition, and the environment for VWA, as well as for a number of 
other inspection services and Dutch ministries. RIVM assists VWA and 
the Dutch government in developing food safety policy and conducts 
formal risk assessments for VWA. The formal risk assessments are 
commissioned through VWA's Office of Risk Assessment, to which the 
results are reported. VWA then advises the inspectorate and/or the 
ministries. RIVM houses several of the Dutch national reference 
laboratories as well as both the Dutch and EU community reference 
laboratories (on Salmonella and on residues). The institute also 
collaborates closely with the Dutch Central Veterinary Institute (part 
of Wageningen University and Research Centre) on issues related to 
zoonotic diseases and animal food products. RIVM's Centre for 
Infectious Disease Control, established in 2005, conducts surveillance 
on infectious diseases; collects data on health, illness, and disease; 
and provides early warnings on threats to public health. 

The RIKILT Institute for Food Safety (RIKILT), part of Wageningen 
University and Research Center, is a private research organization that 
also performs research for the Dutch government on food and feed. It is 
a reference laboratory for pesticide and veterinary residues, 
feedstuffs, and genetically modified organism analyses. RIVM is 
responsible for conducting risk analysis for food (fork), while RIKILT 
is responsible for assessing feed and food quality (farm). RIVM, 
RIKILT, and the Central Veterinary Institute are "house institutes" of 
VWA. They all assist VWA and the Dutch government in developing food 
safety policy and conduct formal risk assessments commissioned by VWA's 
Office of Risk Assessment. 

Meat inspection in the Netherlands is conducted by official 
veterinarians, who are employed by VWA either as permanent staff or as 
staff hired on a temporary basis. In the past, their assistants were 
employed by VWA as well, but these posts were privatized a few years 
ago. However, because these assistants work under the oversight of 
official veterinarians, meat inspection in the Netherlands is still in 
public hands. 

Oversight of Imported Food: 

Import controls. The Netherlands' regulations are fully harmonized with 
the EU's. For a more detailed summary of the EU food safety 
requirements, see the EU profile. 

Inspections. See the EU profile. 

VWA's annual budget is about 165 million euros, with 40 million to 43 
million euros paid by producing companies and 5 to 6 million euros from 
import control fees based on usage. The port of Rotterdam is the 
largest port in Europe and one of the largest in the world. The money 
Dutch customs officials receive from the EU's import tax is sent to the 
EU treasurer in Brussels after the Netherlands deducts 10 percent, 
which is the fee for administering the Dutch ports. (EU member states 
are required to give a certain percentage of their GDP to the EU, so 
any additional costs on import controls not covered by fees can be 
deducted from their annual payment to the EU). 

Equivalency agreements/certification programs. See the EU profile. 

In addition to government initiatives, a Dutch official told us that 
some private companies have programs in place to promote food safety. 
KLM airlines, for example, has a program called "OK to Forward" to 
conduct document checks before a company ships certain live animal 
products and before KLM accepts these products on its airplanes. This 
is an additional quality control and assurance procedure put in place 
to prevent problems at the port of entry. 

Foodborne Illness Outbreaks: 

Campylobacter is the most frequent cause of gastroenteritis in the 
Netherlands. In 2006, there were 3,401 confirmed cases. In 2006, there 
1,667 confirmed cases of Salmonella. (Dutch epidemiological studies 
indicate that if unconfirmed cases were included, the number would 
likely be much higher). There were 69 reported cases of Listeria. 
According to Dutch sources, E. coli has been comparatively rare in the 
Netherlands, with 78 cases reported in 2004. 

Response. Any instance of foodborne illness is first reported to VWA 
through local public health services, which are responsible for 
controlling the illness. If more than one local public health service 
is involved, RIVM's Preparedness and Response Unit, a branch of the 
Centre for Infectious Disease Control, takes charge of control 
activities. VWA and the regional public health laboratories may become 
involved in investigating samples. Moreover, at VWA's request, RIVM 
provides epidemiological resources to assist in tracing the illness. A 
committee for managing the crisis, called the outbreak management team, 
is also set up to bring all knowledge together to get the best possible 
advice. The Ministry of Agriculture takes the lead during a crisis 
related to contaminated food or animal products, but if a person is 
infected with a pathogen, the Dutch Ministry of Public Health takes 
over because it is then considered a public health issue. (Two persons 
infected with the same strain of a pathogen is considered an outbreak 
in the Netherlands). However, if there is a large and widespread 
epidemic, the Ministry of Internal Affairs will take over. 

Dutch officials told us that on the public health side, their 
procedures for addressing foodborne illness outbreaks are similar to 
those followed in the United States by the Centers for Disease Control 
and Prevention for identifying pathogens and tracking diseases. 
However, they noted that there is greater integration of veterinary and 
public health in the Netherlands. 

VWA has mandatory recall authority under EU legislation, but it has not 
used this authority very often. According to Dutch officials, when a 
recall is needed, VWA will first ask the affected company to recall the 
product by putting information in the newspaper, and the company is 
subsequently held accountable if there are any further issues with its 
product. 

International coordination. In the event of an outbreak, VWA would send 
out notifications to other EU member states using the Rapid Alert 
System for Food and Feed. In 2006, the Netherlands issued 55 rapid 
alert notifications, including 1 related to microbial contamination and 
3 related to potentially pathogenic microorganisms. RIVM is very 
involved in the networks of the European Food Safety Authority and the 
European Centre for Disease Control. In addition, RIVM reports results 
of the Dutch human laboratory surveillance for Salmonella, 
Campylobacter, and E. coli on a monthly basis to the EU network, Enter- 
net. 

Recent incidents. No information on recent outbreaks was provided. 

Efforts to Measure the Effectiveness of Food Safety System: 

At the time of our review, the Dutch government had not formally 
evaluated its reorganized food safety system. 

Performance measures. Indicators tracked by VWA include the number of 
inspections conducted, samples inspected, EU approvals in the livestock 
and meat sector, international notifications of potential risk, and 
written warnings issued. Of the approximately 145,000 inspections 
conducted in 2005, the greatest number were in the area of meat and 
fish. 

Evaluations and audits. Although there had been no formal evaluations 
of the impact of consolidation on the Dutch food safety system at the 
time of our review, the EU Food and Veterinary Office had conducted 45 
audits of certain aspects of the Dutch food safety system between 2001 
and 2007. For example, in March 2006, the office audited the 
Netherlands' import control system for products of animal origin and 
live animals and the application of import requirements in two border 
inspection posts. It found that overall the Netherlands has a well- 
organized system that complies with EU requirements, as well as good 
cooperation between veterinary services and customs. However, the Food 
and Veterinary Office also found that the EU requirement that the 
border inspection post and its inspection centers be in the same 
customs-designated area was not applied at the Rotterdam post, and that 
even though the movement of consignments to the inspection centers is 
controlled using a customs transit procedure, this procedure was not in 
conformance with EU legislation or consistent with practices at other 
large EU border inspection posts. Furthermore, the Food and Veterinary 
Office noted some shortcomings with respect to supervising the 
destruction of confiscated illegal imports of certain products of 
animal origin. 

Public opinion surveys. According to VWA, public confidence in food 
safety is the highest in Europe, at 80 percent. Moreover, according to 
a 2005 Eurobarometer survey published in 2006, an estimated 52 percent 
of people in the Netherlands stated that overall, food safety had 
improved over the past decade, 33 percent that it had stayed about the 
same, and 12 percent that it had worsened; 4 percent did not know. In 
addition, an estimated 53 percent stated that usually public 
authorities' actions in the EU with regard to food safety risks were 
appropriate, 22 percent that the actions were insufficient, and 17 
percent that the actions went beyond what is needed; 7 percent did not 
know. Finally, an estimated 57 percent agreed that food produced in the 
EU was safer than food imported from elsewhere, 34 percent disagreed, 
and 10 percent did not know. 

Stakeholder perspectives. The views of stakeholders who interact 
frequently with government food safety bodies can also provide 
qualitative insight, albeit anecdotal, on the effectiveness of a 
country's food safety system. In the Netherlands, we spoke to 
representatives of one consumer organization and one product board, 
which is a government-authorized trade association. A representative of 
the consumer organization stated that VWA and RIVM responded well in 
2005 to the Sudan Red 1 incident, in which an industrial dye was found 
in certain imported food products. During the outbreak, communication 
to the public, facilitated by VWA, was quite good. However, this person 
also said that it is sometimes difficult to know who takes the lead for 
communicating with the public during a food safety crisis--it can be 
VWA, RIVM, the Ministry of Agriculture, or the Ministry of Public 
Health. In this person's view, government communication during a crisis 
could be improved, and there should be a designated point of contact 
for providing information during a crisis. The industry representative 
told us that a 2006 reorganization of VWA that moved meat inspectors 
out of VWA and into private, accredited inspection firms that VWA 
audits has been successful, in that "people with the right 
qualifications are doing their job well." 

Other Relevant Issues: 

According to VWA documents, the agency is concerned with the following 
ongoing and future challenges to the country's food safety system: 

* climate change, including the potential for new foodborne viruses, 
mycotoxins (molds), new pathogens, and new plants and insects that can 
lead to threats to the food chain; 

* demographic change, such as immigration, and the impact of age on 
risks (children and the elderly tend to be more susceptible to illness 
than others); 

* sociocultural trends, including changes in lifestyle and behavior and 
the segmentation of society; 

* globalization (large-scale movements of humans, animals, and goods 
increase the risk of the introduction and rapid spread of pathogens); 
and: 

* changes in production and processing based on new technologies, such 
as nanotechnology, genetically modified organisms, and decontamination 
technologies. 

The UK's Food Safety System: 

Population and per capita GDP. In 2007, the United Kingdom (UK), 
consisting of England, Northern Ireland, Scotland, and Wales, had an 
estimated population of about 61 million, and its estimated per capita 
GDP in 2006 was US $31,800. 

Organization. The Food Standards Agency (FSA) was created in 1999 as 
the lead food safety body. Prior to this, food safety responsibilities 
were divided among several central government departments, such as the 
Ministry of Agriculture, Fisheries, and Food and the Ministry of 
Health, as well as local authorities. FSA was founded in response to 
(1) the loss of public confidence in the government's handling of food 
safety issues, such as BSE and Salmonella in egg products; and (2) 
perceived conflict of interest in the Ministry of Agriculture, 
Fisheries, and Food, which also promoted UK agriculture. FSA is 
responsible for developing and implementing food laws in the UK and is 
the UK's competent authority for EU food and feed legislation. FSA also 
conducts scientific research to guide the implementation of its key 
responsibilities and conducts surveys on nutrition and diet to document 
changes in eating habits. It is the main UK body in charge of assessing 
the risk of food. The agency employs about 2,350 staff, including 1,600 
inspectors in the Meat Hygiene Service, an executive agency within FSA 
that inspects premises where fresh meat is processed. According to FSA 
officials, the focus of the agency's inspections is on processes. For 
example, farmers are to employ HACCP measures to ensure food safety. 

Another independent government agency, the Health Protection Agency 
(HPA) was established in 2005 following reorganization of the UK's 
public health laboratory system. HPA is an "arm's length body," 
independent of government. It is responsible for managing infectious 
diseases, disease outbreaks, radiological health, and emergency 
planning. If a foodborne illness outbreak covers a wide area, HPA 
initiates investigations to determine the contaminant and identify the 
source and provides information to FSA to manage risk. HPA has a 
network of approximately 3,000 staff at three major centers and smaller 
regional and local centers throughout England and works with locally 
based colleagues in Northern Ireland, Scotland, and Wales. It also has 
a central office based in London. The infectious disease side of HPA is 
divided into three areas of responsibility: the Centre for Infections, 
based at Colindale, in north London, the laboratory and epidemiological 
center for characterizing disease strains and for coordinating national 
epidemiological investigations; Local and Regional Services, which 
coordinates outbreak investigations at the local level; and the 
Regional Microbiology Network, which is the laboratory equivalent of 
Local and Regional Service and is the frontline service for identifying 
the causes of disease. 

Other key agencies in the UK's food safety system include the 
following: 

* Department for Environment, Food, and Rural Affairs, which manages 
animal health and welfare and plant issues, including imports from non- 
EU countries for products of animal origin. 

* Veterinary Laboratories Agency, a regional network of 16 laboratories 
under the Department of Environment, Food, and Rural Affairs that are 
responsible for veterinary research, disease surveillance, and 
diagnostic services. 

* Animal Health, which is responsible for operating the UK's 23 border 
inspection posts for products of animal origin and live animals. Animal 
Health is responsible for ensuring that these posts meet the required 
standards and that veterinary checks are correctly and consistently 
implemented across the UK. 

* Her Majesty's Revenue and Customs oversees customs procedures to 
import goods and releases consignments after Animal Health and other 
requirements have been met. 

* Local authorities (district and county authorities) that enforce 
legislation on imported food. There are a total of 468 local 
authorities in the UK. 

Some private sector industry organizations in the UK also participate 
in voluntary food safety efforts. For example, according to a UK 
industry representative, the Assured Food Standards Association sets 
voluntary standards for industry on agricultural products. That is, it 
provides guidance for primary producers growing vegetables or raising 
animals for meat. The British Retail Consortium, a trade association, 
offers HACCP-based certification for processed foods. In addition, an 
association for smaller producers, called SALSA (Safe Food for Local 
Suppliers Association), is a membership organization made up of the 
National Farmers Union and other agriculture-related nongovernmental 
organizations that tries to improve small-scale production processes. 

Oversight of Imported Food: 

Import controls. The UK's regulations are fully coordinated with the 
EU's. For a more detailed summary of the EU food safety requirements, 
see the EU profile. 

Inspections. The UK's procedures for inspections are fully coordinated 
with the EU's. See the EU profile for more detail. 

Equivalency agreements/certification programs. See the EU profile for 
more detail. 

According to a UK official, EU legislation is implemented through the 
UK's food safety laws, for example, by implementing additional EU 
import control measures where there is a serious risk to public or 
animal health. 

Foodborne Illness Outbreaks: 

According to HPA data, Campylobacter is the most commonly reported 
bacterial cause of infectious intestinal disease in England and Wales. 
In 2006, there were 46,603 reports of Campylobacter, 12,633 reports of 
Salmonella, and 1,003 reports of E. coli O157.[Footnote 21] 

Response. An outbreak of foodborne illness is defined in the UK as 
either two or more linked cases of the same disease or when the 
observed number of cases unaccountably exceeds the expected number. 
General medical practitioners are required to notify the local 
authority--usually the Consultant in Communicable Disease Control, who 
is now a member of the Local and Regional Services Directorate of the 
HPA--of cases or suspected cases of food poisoning. These consultants 
are asked to report outbreaks through HPA's central reporting system. 
In cases of an outbreak extending beyond a local area, or in the event 
of serious localized outbreaks, the environmental health officers of 
the local authority are required to inform the FSA. 

Routine surveillance can help detect outbreaks, and the HPA has 
established a baseline for the expected number of cases of infection 
that generally occur at any given time. (All reports for a current week 
are compared with reports from the past 5 years to see if there are any 
exceedances of the baseline.) If HPA's reference laboratories determine 
that the total numbers of laboratory-confirmed cases have exceeded this 
baseline, they notify FSA. The Veterinary Laboratories Agency may 
provide assistance to outbreak control teams if a direct or indirect 
animal source is implicated in outbreaks of intestinal (or other 
zoonotic) diseases and where veterinary investigation or intervention 
could help reduce risks to the public. The agency may (1) conduct 
animal sampling for laboratory cultures, (2) help in identifying 
management and animal care factors that may have a bearing on human 
health risks, and (3) provide veterinary epidemiological input, such as 
data reports of Salmonella strains from farm animal surveillance. 
Strains of animal origin can also be selected for further 
identification and comparison with human strains. The HPA and the 
Veterinary Laboratories Agency work very closely in the investigation 
of outbreaks of food poisoning related to food production animals and 
have in place standardized laboratory and epidemiological methods for 
strain characterization and outbreak investigation. In addition, the 
HPA's Centre for Infections and the Veterinary Laboratories Agency 
support a joint post targeted at the further standardization of 
laboratory methods and the harmonization of databases. 

UK officials told us that in many ways, their procedures for addressing 
the public health aspects of foodborne illness outbreaks are similar to 
those followed by the U.S. Centers for Disease Control and Prevention, 
except that the UK reference and veterinary laboratory systems are more 
centralized than in the U.S. system. The UK officials also believed 
that the particularly close working relationship between the HPA and 
the Veterinary Laboratories Agency is different from the U.S. system 
and has proven useful in addressing foodborne illness outbreaks. 
Moreover, the close working relationship between the HPA's 
gastroenteric and epidemiological teams has also been beneficial during 
outbreaks. 

When an outbreak occurs in the UK, an outbreak control team 
investigates the incident. The team consists of a consultant on 
communicable disease control, an environmental health officer, and a 
consulting microbiologist. Depending on the size and nature of the 
incident, other individuals, such as representatives of the FSA, the 
Meat Hygiene Service, the Veterinary Laboratories Agency, a consultant 
in infectious diseases, a toxicologist, a food examiner/microbiologist, 
and others, may also become involved. The team follows an outbreak 
control plan that describes, among other things, the roles and 
responsibilities of each team member and information on arrangements 
for care of patients and for media liaison. 

During an outbreak, FSA works with the local authority in charge of the 
affected food producers, industry, and other government agencies and 
departments to determine an appropriate risk management strategy. FSA 
can also issue a food alert to local authorities who enforce the law, 
and it publishes these alerts on its Web site. It can force the 
producer to recall the product, although FSA officials said they have 
rarely used their recall authority, because it is the food business 
operator's responsibility to ensure the safety of the food the operator 
places on the market, and it is usually the operator who takes action 
to recall unsafe food. In 2006, FSA dealt with a total of 1,342 food 
safety-related incidents, including 146 related to microbial 
contamination. Ten (about 1 percent) of the incidents addressed in 2006 
were classified as high risk, that is, they had the potential to cause 
death or serious illness; they were complex (affecting a large number 
of products or required a high level of resources to manage); and/or 
they were widespread and likely to generate a high level of public 
concern. 

International coordination. As the designated UK point of contact for 
the EU's rapid alert system, FSA notifies other EU member nations about 
food problems it has identified. HPA coordinates with its European 
counterparts using an EU database called Enter-net; this database makes 
it possible for scientists to track pathogen strains throughout Europe. 

Recent incidents. In 2006, there was a major outbreak of Salmonella in 
chocolate products produced by Cadbury Schweppes, a large British candy 
manufacturer. Although no one died from the outbreak, over 130 people-
-mainly children--became ill. According to HPA officials, the incident 
came to light when, during routine surveillance, HPA discovered an 
increase in exceedances of the baseline level of Salmonella and 
determined that it was witnessing a major outbreak of Salmonella 
Montevideo, a rare strain of the Salmonella bacterium. A private food 
laboratory sent the HPA some Salmonella samples for identification. 
According to HPA sources, HPA scientists used a range of analytical 
techniques to trace the bacteria to Cadbury's chocolate products. They 
then notified FSA, and an outbreak control team was assembled, 
consisting of representatives from HPA, FSA, other government 
departments, and local authorities. To determine whether the outbreak 
had extended beyond the UK, HPA electronically transmitted a molecular 
profile of the outbreak strain to over 50 countries 2 days after 
recognition of the outbreak. (This electronic transmission was done 
through the EU-funded Enter-net network for the surveillance of 
Salmonella, Verocytotoxin-producing E. coli,[Footnote 22] and 
Campylobacter.[Footnote 23]) For its part, FSA used the EU's rapid 
alert system to communicate the distribution information of affected 
products outside the UK. HPA scientists also communicated with their 
Veterinary Laboratories Agency counterparts, who found the same 
Salmonella strains in poultry. Local authorities determined that a 
leaking pipe had dripped Salmonella-contaminated water into the candy 
manufacturer's products. No direct connection to poultry was found, but 
the laboratory findings strongly suggested that the animal source of 
the contaminating strain was poultry. Following identification of the 
outbreak in children, the time between the initiation of laboratory 
studies and withdrawal of the product was 8 or 9 days. In all, the 
bacteria had contaminated 30 different Cadbury products; over 1 million 
chocolate bars were removed from the market at a cost of over £30 
million (about $60 million). 

According to HPA officials, the established interactions between the 
HPA and the Veterinary Laboratories Agency, including standardized 
methods of strain typing and rapid communication of epidemiological 
findings (such as those described above) facilitated investigations to 
determine the animal source of the contaminating strain. HPA officials 
told us that such communications have been useful in several other 
outbreaks, including, for example, the investigation and containment of 
a 2004 outbreak of multiple antibiotic-resistant Salmonella Paratyphi B 
variant Java among cattle on an English farm. Rapid communication of 
typing results and epidemiological information between the HPA and the 
Veterinary Laboratories Agency resulted in containment of the outbreak 
before it could spread to humans. According to HPA, there are numerous 
examples of similar collaborative activities between the HPA and the 
Veterinary Laboratories Agency involving both Salmonella and 
Verocytotoxin-producing E. coli, with typing and epidemiological data 
being exchanged on an almost daily basis. The reporting of outbreaks to 
the HPA is done on a voluntary basis. There is no lower size limit on 
the number of cases affected for a report to be generated; HPA would 
follow up on single cases of severe diseases, such as botulism or 
listeriosis. 

Efforts to Measure the Effectiveness of the Food Safety System: 

At the time of our review, the UK had not conducted a review of its 
reorganized food safety system. However, FSA, the UK's National Audit 
Office (the UK equivalent of GAO), and the EU's Food and Veterinary 
Office have reviewed individual aspects of the system. 

Performance measures. Performance measures for FSA include the number 
of illness reported and consumer surveys on food safety issues. For 
example, FSA reported in 2006 that incidents of foodborne illness 
declined by 19.2 percent between 2001 and 2006. According to FSA 
statistics, this reduction equates to 1.5 million fewer people 
suffering from foodborne illness, 10,000 fewer in the hospital as a 
result of this illness, and an estimated total cost savings of more 
than £750 million (nearly U.S. $1.5 billion). FSA staff attributed this 
decline to, among other things, (1) an ongoing decline in Salmonella 
incidences as a result of efforts in the farming industry to reduce 
contamination of eggs, including improved biosecurity measures and 
vaccination of laying hens, and (2) measures undertaken to keep 
slaughterhouses clean and reduce cross-contamination. For example, 
HACCP measures were introduced in slaughterhouses, and new, clean 
henhouses were being used on many farms; and (3) FSA made efforts to 
educate the public on preventing Campylobacter contamination. 

Evaluations and audits. The UK's National Audit Office, GAO's 
counterpart in the UK, conducted an audit of FSA in 2003 and found that 
the agency had made progress in its stated objective of improving 
public confidence in food safety and standards. For example, according 
to the office, in 2001 and 2002 the FSA investigated about 500 
incidents with the potential to affect food safety. FSA issued 47 Food 
Hazard Warnings to local authorities, alerting them to potential health 
dangers or requiring them to recall food from sale. The audit office 
also made some recommendations for further progress. 

More recently, the National Audit Office assessed the extent to which 
FSA implemented a set of principles, referred to as the Hampton 
principles, that include the following: 

* Regulators, and the regulatory system as a whole, should use 
comprehensive risk assessment to concentrate resources on the areas 
that need them most. 

* No inspection should take place without a reason. 

* Regulators should provide authoritative, accessible advice easily and 
cheaply. 

* All regulations should be written so that they are easily understood, 
easily implemented, and easily enforced, and all interested parties 
should be consulted when they are being drafted. 

The National Audit Office review team concluded that, in many respects, 
FSA regulated in accordance with the Hampton principles. The office 
rated FSA highly on adopting innovative alternatives to classic 
regulation and on having an evidence-based culture. Many positive 
initiatives were being undertaken by FSA in its risk assessment system. 
Areas to develop further included developing more of a strategic 
partnership with local authorities and providing better advice and 
guidance to small businesses. Overall, the National Audit Office found 
that FSA was continuing to improve its performance from an already 
strong base. 

After the 2005 Sudan Red 1 incident in which illegal dye was found in 
food, FSA conducted an internal review of the lessons learned. In 
January 2007 the FSA Board established an independent panel to review 
the lessons learned following the incident, what changes had been 
introduced as a result, and how well different parts of the food chain, 
including manufacturers, retailers, enforcement authorities, and FSA, 
are able to identify emerging issues and prevent them from developing 
into food incidents in future. The board made recommendations to both 
FSA and industry. Among other things, it recommended that FSA take a 
central role in ensuring more coordinated attention to intelligence 
gathering and implementing early warning systems, as well as 
proactively sharing this information with the food industry. 

In addition to reviews conducted by UK agencies, the EU's Food and 
Veterinary Office conducted 71 audits in the UK between 2001 and 2007 
and provided recommendations for corrective measures in certain areas. 
For example, a 2006 report on import controls and border inspections 
found a largely functioning import control system in place, but also 
found that there were some weaknesses, such as in implementing a 
training program for contract/part-time officials. In addition, it 
found some general shortcomings related to implementation of the border 
control system, such as not all live animals arriving at the border 
inspection posts were checked as required, and veterinary checks on 
some species were being carried out by technical staff instead of by 
official veterinarians. Other Food and Veterinary Office audits have 
included reviews of import controls on food of animal origin, animal 
welfare on farms, and foot-and-mouth disease. 

Public opinion surveys. FSA annual consumer surveys between 2001 and 
2007 show a marked decline in the public's concerns about foodborne 
illness, from 71 percent to 57 percent. FSA surveys also indicated that 
public trust in FSA was an estimated 60 percent in 2007, compared with 
44 percent in 2001. The survey likewise found that FSA was seen as a 
reliable source of information for both food safety and healthy eating 
by the majority of those who use it, although it was used and 
considered reliable more for food safety than for healthy eating. 

According to a 2005 Eurobarometer survey published in 2006, an 
estimated 47 percent of people in the UK stated that overall, food 
safety had improved over the past decade, 30 percent that it had stayed 
about the same, 17 percent that it had worsened, and 6 percent did not 
know. In addition, an estimated 50 percent stated that usually public 
authorities' actions in the EU with regard to food safety risks were 
appropriate, 24 percent stated that the actions were insufficient, 12 
percent stated that the actions went beyond what is needed, and 13 
percent did not know. Finally, an estimated 47 percent agreed that food 
produced in the EU is safer than food imported from elsewhere, 32 
percent disagreed, and 21 percent did not know. 

Stakeholder perspectives. The views of industry and consumer groups can 
serve as an informal indicator of the effectiveness of a country's food 
safety system. In the UK, we spoke to representatives of two industry 
organizations. A representative of one such organization stated that he 
thought consolidation of the UK's food safety system had resulted in 
improvements; a representative from another organization said that FSA 
listens more to industry concerns now. According to one representative, 
FSA is now more transparent to industry, and it is easier to consult 
with the agency on issues of concern. Nevertheless, this person 
believed that FSA could do a better job of sharing information. Another 
industry stakeholder noted that FSA acted "disproportionately" to a 
recent recall. 

Other Relevant Issues: 

Emerging trends and challenges. Officials we spoke with identified the 
following areas of concern with regard to ongoing and future challenges 
to the country's food safety system: 

* Pathogens continue to evolve. 

* People are changing the types of foods they eat and the ways they 
prepare them. 

* More people are eating out, and food preparation in small restaurants 
and by caterers carries more risk. 

* Demographic changes mean that there are and will continue to be more 
elderly people in the UK, and these people tend to be more vulnerable 
to foodborne illness than others. 

* There is an ever-increasing international market for foods, 
particularly produce. Although only a very small proportion of such 
foods is contaminated with an organism capable of causing disease, the 
scale of food importation, particularly from countries where standards 
are not as stringent as in the UK, has resulted in an increasing number 
of international outbreaks. Such outbreaks have been regularly 
identified by the Enter-net network, and international intervention 
measures have been introduced on numerous occasions. 

* Incidences of foodborne illness caused by E.coli or Campylobacter 
have continued to increase at a steady rate in 2006. Scientists' 
understanding of Campylobacter is still limited because it generally 
occurs in isolated incidents (i.e., it is not an "outbreak" bacterium) 
and is therefore more difficult to study. 

* Listeriosis, especially in older people, seems to be increasing, not 
just in the UK but around the world. The reason for this increase is 
unclear and is likely to reflect multiple factors, including perhaps 
the fact that a warmer climate enables Listeria to thrive. 

* Many immigrants, both from other EU member states and from non-EU 
countries, bring home-prepared foods into the UK from overseas. If 
improperly prepared or preserved, these foods may cause illness. 

[End of section] 

Appendix II: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, Director, (202) 512-3841 or ShamesL@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, José Alfredo Gómez, 
Assistant Director; Anne Johnson, Analyst-in-Charge; Bart Fischer; 
Jeremy Rothgerber; Carol Herrnstadt Shulman; and Rebecca Yurman made 
key contributions to this report. Important contributions were also 
made by Kevin Bray and Michele Fejfar. 

[End of section] 

Footnotes: 

[1] GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-07-310] (Washington, D.C.: 
January 2007). 

[2] GAO, Food Safety: Experiences of Seven Countries in Consolidating 
Their Food Safety Systems, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-05-212] (Washington, D.C.: Feb. 22, 2005). 

[3] Department of Health and Human Services, U.S. Food and Drug 
Administration, Food Protection Plan (Washington, D.C.: 2007). 

[4] Interagency Working Group on Import Safety, Action Plan for Import 
Safety (Washington, D.C.: 2007). 

[5] Primary producers, that is, farmers, hunters, and fishermen, are 
not required to apply HACCP principles. However, guides to good 
practice encourage the use of appropriate hygiene practices at farm 
level. 

[6] Reference laboratories are specialized laboratories that assist in 
surveillance for, and investigation of, foodborne illness outbreaks. 
They use standardized equipment and methods to analyze samples isolated 
from humans, animals, and suspected foods. These laboratories generally 
have expertise in specialized areas in which there is a need for 
precise analytical methods and definitive diagnostic results. For 
example, a reference laboratory may conduct DNA "fingerprinting" of a 
pathogen such as Salmonella or E. coli to identify the precise strain 
of the pathogen. Networks of reference laboratories allow public and 
animal health scientists to identify patterns and determine whether a 
foodborne outbreak is occurring even if the affected persons are 
geographically far apart. 

[7] For information on the U.S. animal identification system, see GAO, 
National Animal Identification System: USDA Needs to Resolve Several 
Key Implementation Issues to Achieve Rapid and Effective Disease 
Traceback, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-592] 
(Washington, D.C.: July 6, 2007). 

[8] For information on recall authority in the United States, see GAO, 
Federal Oversight of Food Safety: High-Risk Designation Can Bring 
Needed Attention to Limitations in the Government's Food Recall 
Programs, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-785T] 
(Washington, D.C.: Apr. 24, 2007) and GAO, Food Safety: USDA and FDA 
Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe 
Food, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-51[ 
(Washington, D.C.: Oct. 6, 2004). 

[9] This information comes from the EU's Eurobarometer--a series of 
surveys regularly performed on behalf of the European Commission since 
1973. Eurobarometer produces reports of public opinion across the 
member states on a variety of EU-related topics, including social 
conditions, health, culture, and environment. 

[10] Stages of production, processing, and distribution mean any stage, 
including import, from and including the primary production of a food 
through storage, transport, sale, or supply to the final consumer and, 
where relevant, the importation, production, manufacture, storage, 
transport, distribution, sale and supply of feed. 

[11] Hazard Analysis and Critical Control Point (HACCP) is a science- 
based safety system for certain food products designed to improve the 
safety of food by having industry identify and control biological, 
chemical, and physical hazards in products before they enter the 
market. 

[12] Primary producers, that is, farmers, hunters, and fishermen, are 
not required to apply HACCP principles. However, guides to good 
practice should encourage the use of appropriate hygiene practices at 
the farm level. 

[13] Market surveillance refers to the routine monitoring of the rapid 
alert system's Web site and other sources to see if any products are 
being recalled. 

[14] Some forms of E. coli bacteria can produce toxins capable of 
killing a special type of cell called a Vero cell. These E. coli have 
thus become known as verotoxin or verocytotoxin E. coli (VTEC). VTEC 
O157 is the type most frequently associated with human disease. 

[15] Yersinia is a bacterium that causes an infectious disease called 
Yersiniosis. Infection is most often acquired by eating contaminated 
food, especially raw or undercooked pork products. Drinking 
contaminated unpasteurized milk or untreated water can also transmit 
the infection. Occasionally, infection occurs after contact with 
infected animals. 

[16] Bacteria of the Brucella family can cause an infectious disease 
called Brucellosis. Various Brucella species affect sheep, goats, 
cattle, deer, elk, pigs, dogs, and several other animals. Humans are 
generally infected by eating or drinking something that is contaminated 
with Brucella, breathing in the organism, or having the bacteria enter 
the body through skin wounds. The most common way to be infected is by 
eating or drinking contaminated milk products. 

[17] The European Economic Area consists of the EU member states, the 
European Community, and Iceland, Liechtenstein, and Norway. Switzerland 
is not part of the EEA. 

[18] Eurobarometer is a series of surveys regularly performed on behalf 
of the European Commission since 1973. It produces reports of public 
opinion across the member states on a variety of EU-related topics, 
including social conditions, health, culture, and environment. 

[19] The allowable residue of any chemical in a food commodity entering 
or produced in a country is known as the Maximum Residue Level (MRL) 
and is expressed in parts per million (ppm); in Japan, these MRLs are 
compiled into a master list called the Positive List. This is the list 
of allowable substances eligible for marketing in Japan. Foods 
containing residues exceeding the MRL levels on the positive list are 
prohibited from being sold or used as food in Japan. 

[20] A prefecture in Japan is a subnational jurisdiction, a 
governmental body larger than a city, town, or village. Japan has 47 
prefectures. 

[21] This paragraph refers to reports rather than cases because, 
according to UK officials, for every case of Salmonella reported 
nationally, there are about three other cases in the community. For 
Campylobacter, the multiplier is about 10, and for E.coli O157, it is 
about 2. 

[22] Some forms of E. coli bacteria can produce toxins capable of 
killing a special type of cell called a Vero cell. These E. coli have 
thus become known as verotoxin or verocytotoxin-producing E. coli 
(VTEC). 

[23] At the time of the outbreak the epidemiological and laboratory hub 
of Enter-net was based in the Department of Gastrointestinal Infections 
of the HPA, at the Centre for Infections, Colindale. In September 2007, 
Enter-net was subsumed into the newly formed European Centre for 
Disease Control, based in Stockholm, Sweden. Although not a member of 
Enter-net, the United States is party to all Enter-net communications 
regarding outbreaks and strain typing. 

[End of section] 

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