Food Safety: Selected Countries' Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness
Published: 2008-06-10T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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.  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.  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.
subsections: section_title: Background
paragraphs: 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.
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. 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.  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.
section_title: Selected Countries Have a Comprehensive, Risk- Based Approach to Import Safety
paragraphs: 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.
subsections: section_title: The Selected Countries’ Food Safety Systems Are Based on Farm-To-Table Oversight
paragraphs: 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.
section_title: Producers in Most of the Selected Countries Are Responsible for Food Safety
paragraphs: 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, 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.
section_title: Some Countries Separate Risk Assessment from Risk Management
paragraphs: 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.
The Federal Office of Consumer Protection and  Food Safety (coordinating body)
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.
section_title: Inspections of Imports Are Based on Risk, and in the EU and Japan, Importers Bear Some Costs
paragraphs: 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.
section_title: The Selected Countries Take Steps to Ensure Certain Food Imports Meet Equivalent Safety Standards
paragraphs: 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.
section_title: Selected Countries and the EU Cite Key Elements of Food Systems as Critical to Effectively Responding to Outbreaks of Foodborne Illness
paragraphs: 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.  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).
subsections: section_title: EU Requirement That All Foods Be Traceable May Accelerate the Identification of an Outbreak Source
paragraphs: 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.
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.
section_title: Government Veterinarians and Public Health Officials in Some Countries Cooperate Closely to Trace the Source of Animal-to- Human Diseases
paragraphs: 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.
section_title: All of the Selected Countries Have Mandatory Recall Authority
paragraphs: 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.
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.
section_title: The Selected Countries Have Not Evaluated Their Reorganized Food Safety Systems, but Proxy Measures Indicate Improvements
paragraphs: 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.
subsections: section_title: None of the Selected Countries Has Comprehensively Evaluated the Effectiveness of Its Reorganized Food Safety System, but They Do Track Certain Indicators
paragraphs: 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.
section_title: Most of the Selected Countries Formally Audit Certain Aspects of Their Food Safety Systems
paragraphs: 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.
section_title: Most of the Selected Countries Use Proxy Measures to Assess Their Systems, and Stakeholders Generally See Benefits of Reorganization
paragraphs: 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.  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.
section_title: Food Safety Officials in Other Countries Identified Issues of Future Concern
paragraphs: 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.
As agreed with your offices, unless you publicly announce the contents  earlier, we plan no further distribution until 30 days from the report date.   At that time, we will send copies to the appropriate congressional  committees, the Secretaries of Agriculture and State, the Commissioner of  the Food and Drug Administration, the Office of the U.S. Trade  Representative, and other interested parties. We will also make copies  available to others upon request. In addition, the report will be available at  no charge on the GAO Web site at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-3841 or shamesl@gao.gov.  Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report.  Key contributors to this report are listed in appendix  II.
section_title: Appendix I: Country and EU Profiles
subsections: section_title: Canada’s Food Safety System
paragraphs: 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.
subsections: section_title: Oversight of Imported Food
paragraphs: 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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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.
section_title: Efforts to Measure Effectiveness of the Food Safety System
paragraphs: 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.
section_title: Other Relevant Issues
paragraphs: 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.
section_title: The EU’s Food Safety System
paragraphs: 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.
subsections: section_title: Regulatory Framework
paragraphs: 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.  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 in their processes and  ensure that controls are applied at critical points, 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.
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.
section_title: Oversight of Imported Food
paragraphs: 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, 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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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,  Yersinia, Listeria, and Brucella.  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.  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.
section_title: Efforts to Measure the Effectiveness of Food Safety Systems
paragraphs: 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.  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.
section_title: Other Relevant Issues
paragraphs: 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.
section_title: Germany’s Food Safety System
paragraphs: 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.
subsections: section_title: Oversight of Imported Food
paragraphs: 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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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.
section_title: Efforts to Measure the Effectiveness of Food Safety Systems
paragraphs: 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.
section_title: Other Relevant Issues
paragraphs: 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.
section_title: Ireland’s Food Safety System
paragraphs: 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.
subsections: section_title: Regulatory Framework
paragraphs: 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.
section_title: Oversight of Imported Food
paragraphs: 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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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.
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.
section_title: Efforts to Measure the Effectiveness of Food Safety Systems
paragraphs: 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.
section_title: Other Relevant Issues
paragraphs: 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.
section_title: Japan’s Food Safety System
paragraphs: 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.
subsections: section_title: Oversight of Imported Food
paragraphs: 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.  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, (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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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.
section_title: Efforts to Measure the Effectiveness of the Food Safety System
paragraphs: 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.
section_title: Other Relevant Issues
paragraphs: 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).
section_title: Safety System
paragraphs: 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.
subsections: section_title: Oversight of Imported Food
paragraphs: 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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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.
section_title: Efforts to Measure the Effectiveness of Food Safety System
paragraphs: 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.”
section_title: Other Relevant Issues
paragraphs: 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    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.
section_title: The UK’s Food Safety System
paragraphs: 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.
subsections: section_title: Oversight of Imported Food
paragraphs: 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.
section_title: Foodborne Illness Outbreaks
paragraphs: 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.
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, and Campylobacter.)  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.
section_title: Efforts to Measure the Effectiveness of the Food Safety System
paragraphs: 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.
section_title: Other Relevant Issues
paragraphs: 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.
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: Staff Acknowledgments
paragraphs: 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.