Food Safety
Selected Countries' Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness Gao ID: GAO-08-794 June 10, 2008Like 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 Canada, the EU, Germany, Ireland, Japan, the Netherlands, and the United Kingdom (UK) (1) ensure the safety of imported food, (2) respond to outbreaks of foodborne illness, and (3) measure the effectiveness of their reorganized food safety systems. 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.
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 illness. 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 had comprehensively evaluated its reorganized food safety system, although several track certain indicators, such as the number of inspections, enforcement actions, and foodborne illness. However, some countries' national audit offices (GAO's counterparts) have evaluated specific aspects of their countries' 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 in elderly people and immigration; and new types of foods, such as ready-to-eat salads, that may result in more incidents of foodborne illness.
GAO-08-794, Food Safety: Selected Countries' Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness
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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]
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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
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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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