Evolving inspection regime in Japan

Naoki Takatori
Japan Fisheries Association, Tokyo, Japan

ABSTRACT

In the past decade, there have been many outbreaks of foodborne disease mainly due to pathogenic bacteria, such as Vibrio parahaemolyticus, Staphylococcus aureus and Salmonella enteritidis. The frequency of food scandals has also increased, such as false labelling of food additives, residues of illegal contaminants in domestic and foreign food items and the presence of objectionable foreign bodies in food.

Consumer anxiety to new health hazards, such as Escherichia coli O157, dioxin and novel biotech products has risen dramatically. And also, concerns over health risks from the long-term exposure to agricultural chemicals, such as pesticides and antibiotics, are ever present and unresolved.

As a result, both government and industry have lost consumer confidence in the safety of foods distributed in Japan. To retrieve this situation, a new regime for food safety was needed. In late 1990s, the mad cow disease crisis prompted the move from traditional food safety control systems to a more reliable and consumer-oriented approach. The introduction of internationally harmonized standards and control procedures is one of the most important issues for government and industry, especially when considering the growing globalization of food trade and the necessity for internationally accepted standards.

Thus the Japanese Government has established new food-safety related laws and made necessary revisions of existing laws. This is now leading to a higher level of food safety and consumer protection in Japan.

OUTLINE OF FOOD PROCESSING INDUSTRY

Profile of food processors

The population of Japan is currently 126 million. As a whole, there are more than 60 thousand food processing establishments in Japan employing approximately one million people. The total annual amount of domestic import is approximately US$200 billion. Every year, Japan imports around US$46 billion of food and food ingredients and exports products valued at US$2 billion.

In the seafood sector, recent annual domestic fishery production is approximately 6.1 million tonnes valued at around US$20 billion. The main fish species caught are jack mackerel, pacific saury, sardine, mackerel, squid, pollock, crab, tuna, skipjack and salmon. Almost all of these fish and shellfish are harvested at sea. However, over recent decades, the tonnage has been declining mainly because of resource depletion and over fishing. Aquaculture production is currently at 1.3 million tonnes, of which major fish species include yellow tail, sea bream, sea-eel, scallop, oyster and seaweeds. The difference between imported volumes and the domestic production has been decreasing.

Though Japan is consistently one of the largest fish producers in the world, it is also the world largest importer of seafood. It currently imports approximately 4.5 million tonnes of seafood, accounting for 16 percent (in volume) of the world imports. About 150 countries export fish and shellfish to Japan. Major exporting countries are USA, China, Chile, Norway and Russia. Imported fish species include shrimp/prawn, tuna, swordfish, salmon and pollock. In dollar terms, the import corresponds to almost 25 percent of worldwide trade. Imported seafood, especially partly or fully processed fish and shellfish, is increasing its market share because of the convenience for both consumers and processors.

There are more than 11 000 seafood processors producing hundreds of different products. Seafood processors range from large to very small with about 90 percent of processors being small enterprises with less than 40 workers and annual sales of less than US$5 million.

Recent food-borne diseases and food-related accidents

In Japan, every year, approximately two thousand outbreaks of food-borne disease occur, thirty thousand patients are hospitalized with around ten deaths. In recent years, the number of cases of food-borne disease has been increasing. This phenomenon is due to: 1) people eating out of their home more often than before in response to an increase in various food service facilities; 2) an increased diversity of imported food ingredients available, many of which are unfamiliar to traditional Japanese processors and consumers; 3) many people, especially young generations, lacking the basic knowledge of hygienic food preparation; 4) children and older persons with lower immunity; and 5) environmental pollution becoming more prevalent.

The main pathogens and other causes are Salmonella enteritidis, Vibrio parahaemolyticus, Staphylococcus aureus toxin, Clostridium perfringens, Campylobacter jejuni, pathogenic Escherichia coli, SRSV (Small Round Structured Virus, or Norwalk Virus), parasites, histamine and biotoxins (e.g. tetrodotoxin and mushroom toxin).

Seafood accounts for almost 20 percent of the incidents and is the largest single cause of food-borne diseases, though in many cases the causative food remains unidentified. In Japan, people prefer to eat seafood raw or after minimal cooking. For that reason, large-scale outbreaks occur very often during summer, mostly due to V. parahaemolyticus in raw seafood, such as sashimi and sushi. Also, illnesses from SRSV, associated with eating raw or partially cooked oyster, are often reported during winter.

However, the number of outbreaks and related incidents are relatively low when compared with the US, for instance, where almost one third of populations suffer food poisoning every year. This is due to two reasons. Firstly, the Japanese government and industry have both been increasing their efforts in food hygiene. Secondly, Japan has a different type of reporting system to record the incidence of food-borne illnesses that has a tendency to keep the outbreak statistics low, as only a medical doctor is able to report an incidence to the local food safety control office. On the other hand, in the US, the Center for Disease Control and Prevention uses a scientific estimation based on several factors relevant to food poisoning.

In order for the Japanese government and industry to establish a more appropriate strategy to food safety, it is absolutely imperative to know what is really happening in the country. To solve this problem, several years ago, the Japanese government amended its food poisoning reporting system, requiring doctors to report a single outbreak and giving the local food safety control office the authority to independently investigate food poisoning events. Through these measures, the data collected on food poisoning events will become more accurate.

Most recently, there has been a number of food related incidents, including the following: 1) large-scale recalls due to contamination by extraneous matters, such as metal fragments and insects; 2) massive recall of some foods that were suspected to contain genetically-modified corn and potatoes; 3) concern about animals infected with Bovine Spongiform Encephalopathy (BSE), or mad cow disease, and Foot-and-Mouth Disease; 4) widespread suspicion about raw and processed foods with false labelling; 5) concern about foods that contain domestically unauthorized but internationally approved food additives; and 6) increased fear of environmental contaminants, such as dioxin, cadmium and mercury, in vegetables and fish and shellfish.

ADMINISTRATIVE ACTIVITIES TOWARD NEW GENERATION FOOD SAFETY CONTROL

Legislation of the Food Safety Principles Law

In response to the demand for improved consumer protection with regard to food safety issues, the Food Safety Principles Law came into force in May 2003. The law clearly defines the responsibilities of all stakeholders, i.e., national government, local governments, industries and consumers, and establishes the Food Safety Commission that will independently conduct risk assessment for various food safety hazards and advise on risk management options. The Commission will also improve risk communication with all stakeholders and establish guidelines on risk analysis and crisis management.

This initiative is expected to ensure the safety of the food supply from farm-to-table, based on proper science and internationally harmonized methodologies and thereby providing improved protection for the health of Japanese citizens.

The Commission is administered by a minister, and consists of seven commissioners that are experts in toxicology, microbiology and public health. In terms of risk assessment activities, the Commission will organize assessment teams specific to chemical hazards, biological hazards and noble foods and feed.

Re-organization of government agencies in charge of food safety

As a result of the establishment of the Food Safety Commission, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Agriculture, Forest and Fisheries (MAFF), as risk managers, revised their organizations. The MHLW now controls the safety and hygiene of processing and distribution of all food commodities, while MAFF is in charge of primary production of vegetables, food animals and fish.

The MHLW changed the organization of existing food safety departments so as to further devote its mission to consumer protection. Next, the MAFF abolished an old agency for rice farming control and established a new department that will control the safety of agricultural materials and chemicals, including feed, pesticides and animal drugs. These efforts of re-organization are to make the two agencies change their administration policy for food safety to a completely consumer-oriented focus.

Revision of the Food Sanitation Law

The MHLW, as the principal risk manager for food safety, vastly revised the Food Sanitation Law. The law now requires a more pro-active administrative decision making process to encourage self-control by each food establishment and to reinforce residue control regulations for primary production of agricultural commodities. The following are the major revised sections.

More stringent residue control

There cannot be zero-tolerance for residue limits of chemical substances in food. Because of technological innovation in analytical instrumentation, such as gas chromatography, high performance liquid chromatography and gas chromatography-mass spectrometry, the sensitivity of analysis for various hazardous chemicals has greatly improved. As a result, trace amounts of these chemicals are now being found in foods. Taking this into consideration, the MHLW is going to define more appropriate residue limits for all chemicals, based on the latest analytical procedures.

As imports of food into Japan increase, many foods are arriving that contain threshold amounts of agricultural chemicals, including pesticides, animal drugs and feed additives. Currently, many of these chemicals do not yet have residue limits set. To address this situation, the MHLW is going to establish a so-called positive list system, in which chemicals are categorized into three groups. For each group, residue limits will be defined.

Group I - the residue limit will be specified specifically for each of the chemicals.

Group II - a single residue limit will be specified for the whole group of chemicals.

Group III - chemicals that are generally regarded as safe to use and as such will have no residue limits.

Review of food additives

In Japan, currently, approximately eight hundred food additives are allowed to be used for various food commodities. In the past, only chemically synthesized food additives were officially examined and approved. In 1995, about four hundred additives (mostly colouring agents) of natural origin that were widely regarded as safe were also included in the officially approved additives list on an interim basis. However, the safety of some natural additives, about one hundred of them, had not been officially examined. To solve the problem, the MHLW is now intending to start testing those natural additives. The work will be finalized in three years. The agency will then delete from the list those additives that proved to be doubtful as regards their safety or that are not in use anymore.

Control of newly developed foods

Recently, the import and distribution of food that contains high concentrations of so-called health promoting ingredients and of new types of raw materials that have not been generally used in foods is increasing. Many of those foods are health hazards, therefore appropriate protective measures need to be officially taken now.

Thus, in the revised law, the MHLW is invested with the power to prohibit the sale of the above-mentioned foods, unless there is enough proof that the food will not be a danger to human health. At the same time, false or exaggerated labelling in terms of health promotion is strictly restricted.

Advanced import inspection system

In order to secure a higher level of safety of imported food, the MHLW is improving its import inspection system. The improved system will be taking into consideration the growing number and diversity of imported foods and increasing complexity of the distribution chains after importation.

The MHLW now has the authority to inspect any type of food it deems necessary and to prohibit its import if necessary. Before, the MHLW was authorized only to test groups of imported food specifically assigned by the Minister. Furthermore, in order to increase capacity for analysis, the law was revised to allow a private laboratory to become an officially approved inspection body. Of course, the laboratories must be operating under an appropriate level of good laboratory practices and must demonstrate fairness and independency.

Administrative programs for the safety of agricultural commodities

In view of the necessity to take appropriate control measures in each step from the primary production to the point-of-sale for securing the safety of food under the jurisdiction, the Ministry of Agriculture, Forestry and Fisheries (MAFF) is going to start several administrative programs, working cooperatively with the MHLW.

To completely eradicate the spread of Bovine Spongiform Encephalopathy (BSE) infected cow meat into Japanese market and to recover once lost consumer confidence to the safety of meat, MAFF will soon introduce a comprehensive regulation system that, for example, mandate farmers to put ear-tags showing individual identification number for each cattle, and, at the same time, make records documenting birth place and date, name of the farmer, movement thereafter, and other pertinent information. Meat packers and distributors (retailers) are also required to retain the records.

For preventing production of chemically contaminated animals and fish that may consequently pose hazards to human or other animals, pertinent laws were revised to: 1) totally prohibit the use of unapproved animal drugs; 2) restrict manufacturing and importing unauthorized drugs; 3) establish guidelines on hygienic practices for cattle farming; 4) register feed manufactures that implement proper quality control; and 5) prohibit the manufacture, import, sale, and use of feeds that contain dangerous substances.

Administrative programs for seafood

In the wake of the recent, and frequent, food-borne diseases and labelling scandals attributed to seafood, the Fisheries Agency has started several administrative programs aimed at improving food safety control in primary production, including aquaculture, in residue control over environmental contaminants in seafood and in labelling of the origin of fish and shellfish.

In aquaculture, older regulations that set standards for the use of each animal drug for every commercially important fish species were abolished. Instead, new regulations were made that set standards for the use of each animal drug across all fish species and that clearly ban the use of unapproved drugs. Farmers are required to keep a record on the use of chemicals and feeds.

Aiming to ease consumers' anxiety over seafood safety, the agency is also going to support the development of traceability systems, especially in aquaculture. In addition, studies are now planned to examine the effect of genetically engineered fish on the environment and to develop analytical technologies to distinguish GM fish from non GM fish.

OTHER PROGRAMS FOR FOOD SAFETY

New requirements for the control of V. parahaemolyticus in seafood

In 2001, the MHLW announced a new regulation for the control of V. parahaemolyticus in seafood. This was in response to both the recent increased number of outbreaks due to V. parahaemolyticus in seafood and the traditional eating habits of Japanese people, who often eat fish and shellfish in raw or partially cooked forms. Product standards were specified that fresh fish and shellfish, eaten raw or without further cooking - such as sashimi and raw oyster - shall have bacterial counts of less than 100 MPN/g, and that processed seafood that was cooked during manufacturing and eaten without further cooking - such as boiled crab and boiled octopus - shall be free from the bacteria. Processing standards also require seafood processors to prevent cross-contamination, to use clean water and, when preparing cooked products, to cook the product completely. The MHLW further recommends that distributors of such seafood should keep the product temperature at 4 degree centigrade or lower and that consumers should avoid cross-contamination in the home and eat these products within two hours of removal from the refrigerator.

Residue control of imported foods

For many years, the MHLW has been testing imported foods for residues of various agricultural chemicals banned in Japan. There are increasing numbers of imported agricultural commodities in which illegal residues of pesticides and animal drugs, such as chloramphenicol and nitrofurans, are detected. The Ministry is now setting up systems to test more samples using improved analytical procedures.

Public disclosure of research data on environmental contaminants in foods

In Japan, seafood consumption per capita per year is some 70 kilograms, amongst the highest in the world. In response to increased concerns over mercury in seafood, the MHLW, in June 2003, finally announced a dietary instruction advising pregnant women to limit - not to refrain from - their consumption of certain fish species because of the possible toxicity of methyl mercury. Those include "kinmedai" (alfonsino), swordfish, shark meat and whale sperm.

Shortly after the announcement, sales of kinmedai fell dramatically and the price dropped by almost 40 percent - sales did recover soon after, almost to former levels. However, the Ministry and the Fisheries Agency both worked hard to convince people not to panic and both stressed the benefit of eating seafood because of its nutrional value, i.e., high concentration of protein and omega-3 fatty acids.

At the same time, the MHLW, in cooperation with the Ministry of Environmental Protection, started a comprehensive epidemiological research study on mercury poisoning throughout Japan. The detailed risk profile, including the adverse effect of mercury to foetus and the exposure data on susceptible sub-populations, will be available in a few years time. Then, the mercury advisory statement will be reviewed based on the report, and may be revised accordingly.

Fish contaminated by dioxin is also a growing concern for consumers in Japan. Due to rapid industrialization over the last thirty years, pollution in coastal waters and sediments from harmful industrial chemicals has increased and has become a very serious public concern. It is now recognised that more than 90 percent of toxic chemicals ingested by the Japanese population come from food products with 80 percent of that coming from seafood.

The Fishery Agency has long been testing environmental contaminants in fish and shellfish caught domestically. However, this data was not fully disclosed to the public. More recently, as the government policy for risk communication on food safety has changed, the agency decided to make all of its vast research data, old and new, public in December 2002. According to the data, the average intake of dioxin by Japanese people is currently 1.68 pg-TEQ/kg body weight/day. The intake has been decreasing yearly. As a result, the agency is repeatedly emphasizing that, so long as people eat a balanced diet, the daily intake of dioxin will remain within acceptable levels, posing no significant adverse effect to human health.

Labelling requirement for allergenic foods

The MHLW revised the Food Sanitation Law in 2001 and incorporated a new provision in the law that requires a manufacturer to label foods that contain any ingredients that can give rise to allergic reactions in sensitive people. Those foods listed as apparent allergens are wheat, buckwheat, egg, milk and peanuts. The Ministry also publicises that certain other foods may pose similar allergic reactions, though the reactions may not be so strong. In seafood, those are abalone, squid, salmon, salmon roe (ikura), shrimp, prawn, crab and mackerel.

To avoid contaminating non-allergenic foods with allergenic substances, food processors are strongly encouraged to be aware of possible cross-contamination during processing and to state whether any incoming raw material contains (or carries over) trace amounts of allergenic materials.

Labelling requirements for the place of origin

Recently, there were several large scale violations by food processors, e.g., meat packers, involving misidentification of country of origin or place of production in order to deceive consumers and realise a higher profit.

To make labelling of agricultural commodities clearer and more accurate, MAFF laid down a guideline on proper labelling for fresh commodities, including fruits and vegetables, rice, meat, eggs, fish and shellfish, processed foods, organic foods and genetically engineered foods. In the guideline, fresh fish and shellfish products are required to have labels that indicate (a) whether the fish was naturally caught or farm-raised, (b) the place of harvest or off-loading, and (c) whether it was kept fresh (without freezing) throughout the whole processes or frozen after harvest and thawed at the retail outlet.

Further, the place of primary production of raw material (fish) must be indicated in processed seafoods, such as broiled sea-eel, lightly salted and dried mackerel and horse mackerel, dried or salted seaweed, and dried skipjack (katsuo-bushi). For imported seafood, the country of origin needs to be shown in its label.

Traceability systems

More and more, and due to reasons already mentioned, consumers are demanding better information about the foods they are eating. As a result, the Japanese food industry has become obliged to offer product tracing/traceability information to consumers. At the same time, government agencies developed programs requiring industry to implement such systems.

In June 2003, the MHLW, as the major risk manager in the country, established a new provision in the Food Sanitation Law that instructs every entity in the food chain to develop a system that can track the origin of the product it handles. According to the provision, an entity is requested to keep records of all purchases and other necessary information to identify raw material and food products so that the company can quickly and completely recall product that may, or was proven to, pose a health hazard.

In parallel with the above MHLW program, MAFF has started a program to promote more sophisticated traceability systems, on a voluntary basis, that can trace a product continuously in from the farm-to-table continuum. The system allows consumers to have detailed information on the product and the conditions of production, processing and distribution, and allows interested parties to trace-back product flow from the retail to the primary production. Aiming to smooth introduction of MAFF's traceability system, the Ministry issued a guideline to instruct what kind of information should be disclosed to the consumers. For example, in case of agriculture and aquaculture commodities, data on production (such as the name of producer), use of pesticides or animal drugs, date of harvest and any fertilizer or feed used should be information available to consumers. Further, for all types of food, data on distribution (including product temperature), bacteriological test results and the date and time of product arrival are recommended information to disclose to consumers. In view of the necessity to transmit a large quantity of data pertaining to whole aspects of production, processing and distribution, the guideline also indicates how industry can realize such a traceability system. This includes advice on the use of computer-aided electronics, such as internet based information retrieval systems, tiny IC tips and two-dimensional bar-code systems. In this regard, in 2002, MAFF committed funds to experiment and demonstrate the system for various food items, including cattle, fruit juice, surimi products, oysters, vegetables, rice, and poultry.

OTHER QUALITY CONTROL ORIENTED PROGRAMS

ISO 9000 series and ISO 14001

As an internationally recognised quality assurance system, the ISO 9000 series has been prevailing in Japan since 1993. There are currently almost 40 ISO 9000 certifying bodies and more than 20 000 companies have so far been approved and registered, and among those, about 500 are food processors.

On the other hand, ISO 14001 started its certification activity from 1996 in Japan. Because of the recent increase globally of concerns over environmental problems, such as chemical pollutants, ozone-layer destruction and global warming, every company needs to reduce its burden on the environment. Currently about 6 000 ISO 14000 environmental management systems are in place in Japan. In the food industry, however, implementation is still scarce, maybe less than 200 cases.

The Product Liability Law

The Product Liability Law was enacted in 1994 to assist people who had been injured by a defective product. It detailed the liability of the manufacturer or any other food handler. Prior to the law, a person who sustained an injury had to certify that the manufacturer failed to ensure product safety, regardless of the fact that a consumer of the product would not have enough technical information on the product. After the law, however, a plaintiff only needed to certify that a product was defective and consequently caused an injury to the person.

This had an effect on industry, as the food industry now had to take out product liability insurance on their products and had to implement precautionary activities to improve the level of safety assurance during product design and processing, typically using HACCP and/or ISO 9000 based systems. Further, food processors became obliged to issue warning instructions and directions for the product, in order to give the consumers more precise information on the safe use of products.

Recently, under the Product Liability Law, a restaurant was fined after it prepared and served fish contaminated with ciguatera-toxin to a guest without confirming the safety of the fish before serving it. The guest suffered severe food poisoning.

HACCP system

In Japan, HACCP systems were adopted for seafood export businesses after the EU and US changed their regulations to require HACCP-based control systems for domestic or imported products. However, HACCP-based control is not yet mandatory in Japan. Rather, the system has been gradually put in place voluntarily, taking into consideration underlying constraints derived from an old-fashioned industry profile of many small businesses and using traditional processing methods.

Government controlled programs

The MHLW regulates food safety and hygiene to protect consumers in Japan. In May 1995, the MHLW revised relevant sections of the Food Sanitation Law and established a "Comprehensive Sanitation Controlled Manufacturing Process". This was developed for use on a voluntary basis. This is the first official Japanese system for sanitation control based on HACCP systems.

Under the system, the MHLW inspects, approves and registers a firm upon request. For this, the MHLW visits a firm and verifies whether sanitation and hygiene systems operated by the firm satisfy the requirements. The introduction of this new control system is to promote "own-control" efforts on food hygiene by each company, rather than relying on the more traditional official inspection of final products. Currently, some firms processing milk, dairy products, meat products, surimi products and fresh drink products are registered.

Export-oriented programs in seafood

For companies exporting to EU member countries, the MHLW has an official registration system in place that complies with EU legislation mandating foreign seafood processors to operate under EU hygiene standards and by using HACCP-based systems. To meet those requirements, the MHLW has concluded a specific agreement with the European Commission and registered the approved establishments (currently about 15 establishments).

In addition, in 1997, the US Food and Drug Administration (FDA) enforced a new rule for seafood with requirements similar to those for the EU. The rule requires all the seafood, produced domestically or imported, to be processed using HACCP-based systems. However, for an imported seafood lot, the importer has responsibility to ensure that the lot is in conformity, rather than the exporting country's competent authority. There are five verification procedures listed in the rule that can be selected by importers to demonstrate to FDA that the lot is safe. In this connection, competent third parties - local government, Japan Fisheries Association (JFA) and private consulting companies - can issue certificates to exporters that state the exporting seafood processors meet US regulations. These competent third parties are currently certifying about 150 processors.

Training of HACCP

The success of the HACCP system depends on education and training. In this regard, since 1994, the Japan Fisheries Association has been holding HACCP training courses for industry. After completing the course, the trainees are expected to become HACCP team leaders in each processing plant or become consultants for the seafood industry.

The Japan HACCP Alliance was established in 1998. The alliance is administered by the Japan Food Hygiene Association, which serves as the pivotal organization for food hygiene issues for manufacturers, restaurants and other food suppliers. The steering committee of the alliance consists of several industry organizations representing major food commodities, including the JFA.

The activities of the Alliance are to: 1) train for trainers for various food commodities; 2) establish a standard curriculum for HACCP training; 3) maintain nationally an organized and harmonized approach to HACCP; and 4) develop a database used for HACCP training.

The Alliance has run many training courses for HACCP and basic hygienic control procedures and has also issued periodicals and bulletins to communicate information relevant to HACCP introduction and implementation.

Detention and rejection of fish at borders of major importing countries

Lahsen Ababouch
FAO, Rome, Italy
Gabriele Gandini
Ministry of Health, Padova, Italy
Carlos Lima Dos Santos
Rio de Janeiro, Brazil
S. Subasinghe
Infofish, Kuala Lumpur, Malaysia
John Ryder
Cheltenham, UK

ABSTRACT

In the international trade of fish and fishery products, some of the most serious difficulties of compliance faced by exporters from developing countries are the differences between importing countries' regulations and standards and the organization and function of inspection services. All products entering an importing country need to go across a border to gain entry and thus border control procedures are a key process in international fish trade. It is at these points where product may be inspected and where suspect product may be detained, rejected, re-exported or destroyed. Inspection data from the European Union, North America and Japan show a significant variation in the relative frequency of detentions of fish imports and in the causes of detentions of fish products. Also, the transparency of the data is varied making analysis and recommendations more difficult than it need be. The paper concludes with initial thoughts on what could be changed to improve international trade in fish and fish products at borders and on the potential role of industry, governments and international bodies in this process.

INTRODUCTION

International trade in fishery commodities reached US$ 57.7 billion in 2002. In 2001, developing countries registered a net fishery trade surplus of US$ 17.7 billion and accounted for over half of world exports in fish and fish products in terms of value and quantity (FAO, 2004). Many developing countries export some fishery products with revenues often being a major source of foreign currency. This makes fish exporting very important to many developing countries.

In 2001, total worldwide imports of fish and fishery products were 26 million tonnes, a figure that has been steadily rising since 1998 when imports were 21 million tonnes. In 2001, and consistently over the last number of years, the European Union has been the largest importer of fishery products, accounting for some 31 percent of total imports in 2001 (Table 1). Individually in the EU, Spain, France and Germany are the main importers. Japan is still the largest single country for imports of fish and fishery products, importing nearly 3.5 million tonnes in 2001. The United States, despite being the world's fifth major exporting country, was also the world's third main importer. More than half of the world's imports by weight (and 77 percent of the total world imports by value) are concentrated in these three areas and they dominate the world markets both in terms of prices and quality requirements.

TABLE 1
Total imports for major importing nations/regions (tonnes)

* Includes intra EU imports (EU country to EU country) and extra EU imports (non-EU countries into the EU). The split is approximately 50:50.

In the international trade of fish and fishery products, one of the most serious difficulties faced by exporters from developing countries is that different standards and regimes are being imposed by importing countries on producing countries to ensure that products meet the requirements of the target market. Even after the ratification of the Sanitary and Phytosanitary Agreement (SPS) under the World Trade Organization (WTO), differences between various national standards and inspection systems may maintain or create new non-tariff trade barriers.

Globalization of food trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for governments. This is exacerbated by the series of food safety scares in the 1990s (e.g. bovine spongiform encephalopathy (BSE) and dioxins) and by concerns over technological innovations from biotechnology (genetically modified organisms). Consequently, many countries have tightened up food safety controls.

Developing countries have often complained that they are penalized by the complexity of sanitary and quality regulations of major importing countries. In the past, it has been suggested that these regulations have been used as non-tariff barriers. There is no doubt that the implementation of the regulations and the lack of consistent and harmonized criteria has inhibited trade. Recent rounds in world trade negotiations have emphasized this problem.

The differences between importing countries regulations, standards, organization and function of inspection services, and the "modus operandi" of such services are among the most important practical difficulties of compliance faced by developing countries. A key problem is the border control where failed products are rejected or put in detention awaiting resolution or destruction, thus causing an interruption of trade. Therefore this complex area needs to be understood to reduce the problems faced by exporters. More importantly, when understood, future technical assistance can be better targeted in this area.

This study of border controls builds upon previous FAO assistance in capacity building for developing country fish exports which includes technical assistance in HACCP and risk analysis. This paper examines the ease of data collection for border inspection cases and presents the analyses of detention data with regards to variations in importing country actions on imported fish and fish products. This paper is an initial output from a detailed study on detentions of fish and fish products into major importing regions which will culminate in the publication of an FAO technical paper on the subject in 2004.

MATERIALS AND METHODS

There are two main sets of data used in this paper - border case data and import data. Currently, border case data are not held centrally anywhere, and thus data has to be sourced from the countries themselves. Import data is held centrally by FAO, but 2001 data was the latest available. Import data is also held by the countries themselves, and this is generally more up to date. However, a single data set for imports is not always examinable from both a product basis (i.e. imports broken done by products) and a country basis (i.e. imports broken down by exporting country). In this case, recourse is made to FAO data, but thus limiting the years considered.

For the sake of comparison, a period was chosen - 1999 to 2002. Attempts were then made to get the border case and import data from the major importing regions - the European Union, North America (USA and Canada) and Japan..

Border case data

For the European Union and Canada, detailed records were available for the 4 year period. Line-by-line data for the border cases from 1999-2002 were compiled in spreadsheets with subsequent breakdown by risk category, products and exporting regions. The data collected for the USA covers a 2 year period from mid 2000 to mid 2002, but line-by-line data was not available. The data collected for Japan was restricted to one 12 month period in 2001/2. Again, the level of detail was much less than for the EU and Canada.

Import data

Import data is more readily available than border case data, and the appropriate import data was collected from the FAO data resources (which include data provided by individual countries).

Putting border cases into perspective

While it is relevant to talk about the absolute number of border cases, taken in isolation these figures can become misleading. Comparative studies of such data between exporting and importing regions, or between risk categories and products types, etc. require the use of a figure that allows, even if crudely, a relative comparison. Thus we have used the volumes of trade in tonnes to provide a comparative figure. This is a crude figure, as the border cases do not indicate how many kilograms were involved in each border case - so a "case" could be 10 kg or 10 tonnes. If the latter were known, a rough calculation would also be possible for the total value of border cases to trade disruption. However, the number of border cases per unit volume does give an indication of the relative importance of various factors in border cases.

RESULTS AND DISCUSSION

There are major differences between the importing regions studied, both in terms of numbers and nature of cases. It is important however to realize that, beyond shear numbers, the type of border case (safety, quality or economic fraud) and its direct macro and micro-economic impacts are different and need to be taken into consideration when comparing the different cases and strategies to reduce them. Unfortunately, the available data do not always enable this type of refined analysis. Recommendations are provided later as to how data collection and dissemination can be modified to improve the analysis.

Relative frequency of border cases into importing regions

Figure 1 shows a quite dramatic difference in the absolute numbers of border cases in the various importing countries/regions when shown relative to import quantities. These highlight some important differences, even though it is not possible to determine the quantities of border cases (by weight) per unit weight of imports.

At first glance, the USA has around 10 times as many border cases per 100 000 tonnes as the EU or Japan, and 3-4 times as many as Canada. This should not be taken to indicate necessarily that the USA have a higher performance in border controls or that products exported to the USA have more non conformity problems.

In fact, the data need to be adjusted and substantiated to enable comparisons of performance between the regions studied. Firstly, a high percentage of US cases end up with the product actually entering the USA after re-examination, sorting, re-packing, new documentation and information or new labelling. During 1999-2001, 78 percent of detained shipments were released for import into the United States^[1]. Therefore, only around 22% of the US cases can be used in comparing the different regions as the other 78 percent ended up being accepted.

Secondly, the other countries/regions, especially the EU, use a "prevention at source" approach using national competent authorities to examine the country's own establishments and products to assess their conformity to EU requirements prior to shipments. By so doing, several non conformity cases are detected and stopped in the exporting countries. This approach has proven more preventative and cost effective than relying only on controls at the border. But the system can also penalize well managed seafood companies that can't export to the EU because they are in a country which does not have the resources and the capacity to develop a competent authority that meets the EU requirements. Likewise, Canada and to some extent Japan, have adopted a "prevention at source" approach, although less vigorously than the EU. The former has developed MOUs with a limited number of countries (including Thailand, Indonesia and Viet Nam), whereas Japanese importing companies have a long tradition of fielding quality controllers to work at the exporting sites. In both cases, some non conformity cases are eliminated before consignments are shipped.

More and more countries, including the USA^[2], are being advised to adopt the "prevention at source" approach because of its higher performance and cost effectiveness. However, care must be exercised to ensure that exporting developing countries are assisted in their efforts to build national capacity in safety and quality.

This is a win-win situation both for the exporter and for the importer. With reducing safety and quality problems, the inherent costs and damages are reduced for exporters. At the same time, resources for control at borders are reduced significantly and can be targeted better at problem areas, increasing efficiency. At the same time, reducing losses due to rejections and detentions should result in greater supply of safe fish and less illnesses due to unsafe foods.

A third difference is the types and methods of control at border, though this is not discussed in this paper. Suffice it to say, border check procedures are different, analytical techniques can be different and the criteria (standards) to judge conformity or non conformity are different (e.g. histamine and Listeria monocytogenes). This is being investigated and will be presented in more detail in the FAO technical paper.

Border case patterns and trends

The break down for the 4 countries/regions are summarized in Figure 2. The differences in the profile of each country are quite obvious, with both the EU and Japanese border cases being predominately microbial or chemical in origin, while these causes only account for a quarter to a third of border cases in the USA and Canada. Given the well publicised increase in 2001/2 of chemical (veterinary drugs) risks from Asia (especially for cultured shrimps), it is interesting to note that this becomes evident in the EU data, where chemical contamination becomes a dominant category, while for other major importers, this trend is not noticeable. These other regions were importing large quantities of shrimp from Asia during this period, but were clearly handling the imported products differently, or recording the data differently.

However, the obvious differences highlighted again point to the significant variations in approaches to controls at the borders of the countries being studied. For an exporter, it would be helpful if these procedures were harmonized, and that if they export a product, it should be treated the same way irrespective of who the importing country is. The extra costs imposed on traders by these differences will be significant, but are difficult to quantify due to the absence of relevant data, most importantly the quantities and value of rejected products.

The main causes for detentions for importing regions

The following series of tables breaks down the main causes noted above for each region.

For the European Union, it becomes apparent that until 2002, the dominant cause of border cases was microbial in origin. Chemical risks though were becoming more important and by 2002, chemical risks dominated. It is worth noting that "other causes" only played a small role in the cause for border cases throughout the EU.

The microbial risks that caused most problems at EU borders were Vibrio spp. and Salmonella accounting for around 66% of cases between them (Table 2). There were no significant rises or drops, except, perhaps, in the appearance of parasites as a cause in 2001 and 2002. However, it is interesting to note the complete absence of Listeria spp. as a cause for border cases.

As regards the chemical cases, some notable trends appear (Table 3). Prior to 2001, the main risks were from heavy metals, with mercury and cadmium accounting for nearly 70% of border cases in 1999 and 2000. However, in 2001 and 2002, two new chemical agents appeared dramatically in border cases, chloramphenicol and nitrofuran. In 2001 and 2002, these two chemicals accounted for over 65% of the border cases, with the heavy metals now accounting for only 14% of cases.

This increase in these two veterinary drugs is due to the bans and/or rigorous testing regimes imposed in 2001 and 2002 on shrimp (and other food) imports from various Asian countries by the EU. The main country affected was China. Commission Decision 2002/69 suspended the import into the EU of Chinese products of animal origin intended for human consumption or for use in animal feed. The main products affected by the suspension in volume terms were honey, rabbit meat, poultry and crustaceans, such as shrimps and prawns. During this period, Vietnam, Thailand and Pakistan were also requested to submit each seafood shipment for analysis for chloramphenicol and nitrofurans.

TABLE 2
Border cases in the EU from 1999-2002 - microbial risks

Source: European Commission

TABLE 3
Border cases in the EU from 1999-2002 - chemical risks

Source: European Commission

TABLE 4
Causes of detentions of seafood imports (USA)

Source: US FDA Office of Regulatory Affairs (ORA)

Later in 2002, the European Union decided to lift the import restrictions due to guarantees by exporting authorities and the results of further tests. It is worth noting that similar stringent testing regimes were imposed by other importers, such as the USA, Canada and Japan.

For the US, a direct comparison between the 2 one-year periods is shown in Table 4. The main causes of border cases were from "other causes", accounting for around 70% of all cases. Microbial (approx 23%) and chemical (approx. 5%) agents were of less importance.

Of interest are the substantial increases in Salmonella incidents. Salmonella increases seem to be related to particular attention dedicated to some products from Asia during the months of October 2002 and April 2003.

The increase by almost five times that occurred in the poison category reflected the FDA decision to introduce additional controls, e.g. analyses for chemical (polycyclic aromatic hydrocarbons, sulphites) and veterinary drug (chloramphenicol and nitrofurans) residues. The main problem was shrimp from Asian countries, especially China, mirroring similar problems in the EU market.

The category "other" covers a large number of different reasons such as mislabelling and lack of description of the process. The US has over 170 descriptors for the classification of the cause for a border case for all foods. Many of them reflect possible microbial or chemical problems but are not specified as such. The dramatic inflation in numbers appears to be the result of inspection for compliance with requirements such as the HACCP legislation, the labelling of catfish and from "insanitary"^[3] products. Based on FDA official Seafood Import Refusals statistics "filthy" is the single most common reason for seafood import refusal in the USA - defined as "The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food." Previous FDA data indicates that "filthy" was mainly related to product contamination by insect and/or insect parts.

In Japan, the picture is closer to that of the EU, in that microbial and chemical causes dominate (Figure 3). All microbial incidents area accounted for by one of three categories during the year with coliforms accounting for over 50% of cases. It is apparent that all the microbial cases in Japan arise from tests for indicator organisms or high counts, also an indicative test. Specific pathogenic bacteria do not account for any border cases, for instance, Listeria spp., Staphylococcus, Vibrio spp. etc.

Chemical risks are also a significant factor in border cases. The variety of risks identified under this category of risk is numerous, however, the majority of border cases due to chemical risk result from contamination with antioxidants, antibiotics or biotoxins.

In Canada, as seen in Figure 2, the main causes of concern were chemical (22%) and "other causes" (73%). The main chemical causes were from contamination with mercury, sulphites and histamine, and these appeared consistently during 1999-2002.

Table 5 details the breakdown of reasons for border cases classified as other causes from 1999-2002. The main problem is classified as "sensory evaluation", accounting for 47% of cases. Under Canadian procedures, sensory evaluation is used to determine quality attributes, though if decomposition is suspected, then samples are analysed for histamine (A. Bungay, Canadian Food Inspection Agency, pers. comm., 2004).

Net weight problems are next in importance (28%). This problem, however, does not always imply a health hazard to consumers and is often an issue of economic fraud. However, the can integrity test (19%) is used to protect consumers from possible health hazards, specifically from the anaerobic bacteria, for instance, Clostridium botulinum. This test is well developed in Canada and can detect minor faults in cans and the seals. As the requirements for can integrity checks are stricter in Canada than in other countries, especially regarding wrinkle measurements, companies not aware of these differences do not set their seaming machines and seam control to the Canadian requirements and their products can be penalized at the Canadian border.

TABLE 5
Border cases in Canada for 1999-2002 - "other causes"

Source: Canadian Food Inspection Agency

Furthermore, the USA has a specific regulation for low acid canned food and acidified food (LACF/AF) which requires the exporting establishment to be registered and must operate with a Better Process Control School (BPCS) certified supervisor. BPCS certify supervisors of thermal processing systems, acidification, and container closure evaluation programs for low-acid and acidified canned foods. In the EU, can integrity is part of the HACCP system and any product testing is carried out by the Competent Authority of the exporting country which also verifies the can integrity control records of the exporting companies, as part of the HACCP system. Thus the USA and EU rely more on quality assurance to protect against can integrity problems rather than quality control at their borders only.

Getting data on detentions

The ease of data collection was varied. All countries held data to varying degrees on a website. Table 6 summarizes what is available, and whether it was possible to transfer the data to spreadsheets for more detailed analysis.

The Canadian data was easiest manipulate and analyse, with direct cut and paste into spreadsheets possible. EU and US data could not be transferred simply to spreadsheets. However, the electronic EU data were obtained through personal contacts, thus allowing similar manipulation and analysis to that of the Canadian data. Japanese data was restricted to annual summary tables at a macro level i.e. there was no data for individual border actions.

TABLE 6
How border case data is held on the world wide web

PDF - Adobe Portable Document Format. Readable with free Adobe Acrobat software (www.adobe.com). HTML - Hyper Text Markup Language. The method used to layout web pages.

CONCLUSIONS

The results show that the major importing countries of fish and fish products handle fish imports in significantly different ways. Variations in the number of detentions are significant, the procedures for controlling imports are different, the causes of detentions are different, and all this for products of a broadly similar profile. This is unhelpful in terms of efficient trade systems.

The ultimate goal must surely be to have fish and fish products freely crossing borders with no impediments to trade unless the product will have a negative impact on consumers. Negative impact includes safety risks, quality defects or economic fraud.

Focusing on the food safety issue, it is now recognized that the risk analysis approach is currently the most effective method to ensure safe food. This must surely extrapolate therefore to being the best approach to ensuring unsafe food does not reach the final consumer. As with the advent of HACCP and the move away from end product testing towards quality assurance techniques, it would seem that the same arguments about the failure of sampling to find failed products should apply to border control. Also, the HACCP/risk analysis approach is equally valid for use at borders - find what is critical to control in the whole trade system and then control those risks at the appropriate point. This may not necessarily be at the border. Where the control point is a border then put in systems to make sure the process never goes out of control. This requires measurement and limits.

For food safety issues, this would mean a move away from random sampling at borders. However, it would also necessitate a more complete understanding than we have at present of the main points in the food chain where a risk to consumer health is both high and likely to happen. This is where good science will provide answers, and why governments must put such science as a priority for funding to develop risk assessment based controls and standards. The limited number of risk assessments to date needs to be expanded rapidly to provide the framework to ensure that unsafe food is not produced, or if it is, it is removed from the food chain. However, the systems used must also strive to remove the possibility of interrupting trade flows unnecessarily through inappropriate border actions that are not founded on scientific grounds.

Irrespective of the system employed, border control and inspection takes place on a daily basis and will continue to do so for some time before fully fledged "prevention at source" approach is harmonized and traceability schemes are well implemented to provide transparency among trading partners. This data is clearly valuable to the industry, but is also valuable to the inspection agencies to improve their systems, and to policy making or advising bodies that can advise on best practice. Unfortunately, the data is not both readily available and easily analysed with the exception possibly of Canada, though even this data is not complete in an ideal world. This needs to be addressed by governments. The upcoming FAO technical paper will address this issue in more detail and will provide recommendations for governments on the issues raised in this paper.

Developments in food security in the US Seafood Program

Philip Spiller and Don Kraemer
Office of Seafood, United States Food and Drug Administration, College Park, United States of America

INTRODUCTION

On Monday, I had the opportunity to describe some work that is going on in the United States seafood safety program, or that we are at least starting to think about. I characterized these as "beginnings".

In many respects, the US seafood program is either considering or experiencing new ways of doing business. And I indicated that what intrigues me the most about them is that they seem to involve some new ways of thinking and looking at the world. One example I gave was how we are figuring the best ways to use risk assessment as we develop risk management strategies for traditional types of problems, such as Vibrio parahaemolyticus.

Today I would like to give a few examples of "beginnings" in the area of food security, including how we are using some novel forms of risk assessment to help us anticipate and prevent intentional harm to the food supply.

There is no question that the events of 9/11 profoundly affected our perception of risk. Before 9/11, seafood safety programs - ours, yours, everybody's - looked at risk almost exclusively in terms of risk of unintentional contamination of food. After 9/11, we knew that we had to think about contamination in new ways and on a new scale.

But how do we do that? The only thing that was clear was that we had crossed into a new era and that somehow things would no longer be the same. And as it has turned out, 9/11 has given rise to a whole range of novel thinking and novel activities at FDA: from threat assessment to research on exotic agents such as anthrax and ricin; from new regulations to strengthened ties to the intelligence and law enforcement communities.

The most immediate effect on my office - the Office of Seafood - and on the seafood program itself, was a reduction in some traditional functions and activities in order to accommodate the new activities. Some staff resources from the Office of Seafood were diverted to food security activities - a diversion that slowed us down in the traditional sense but could lead to new ways of doing business in the future. Also, the U.S. Congress appropriated substantial funds to hire 800 additional personnel, many of them new FDA field investigators and analysts to focus on assuring food safety and food security at border crossings. The huge hiring and training effort that followed caused a short-term reduction in FDA's normal inspection, sampling and related field activities directed toward seafood products but has resulted in a larger field force with the potential for new capabilities.

FOOD SECURITY REGULATIONS

Last year, as I am sure most of you are very much aware, the US Congress enacted bioterrorism legislation that essentially mandated a substantial new program of information acquisition and management at FDA, designed to strengthen food security. We were given a relatively short timeframe to develop this program and to issue regulations implementing it. The requirements in those regulations should affect almost everyone who exports food products to the United States.

Each regulation was first published as a proposal for public comment. Two of them were issued in final form shortly before this conference: Prior Notice and Registration.

Because the regulations involve food generally and not just seafood products, my office has not been heavily involved in developing them. So in terms of details, I know little more than what you can read for yourself on our website. That website is www.fda.gov. It contains each regulation, a summary of information about it, the public comments that were received (including yours if you sent one!) and any additional relevant information that may be available. I probably do not have to tell you that the requirements involve registration of processors, record-keeping requirements to facilitate product tracing and prior notice of the arrival of imports. There is a detention requirement as well, but I'm not sure whether it is as relevant to imports as the other three.

The information to be gathered is very basic:

• Who is in the business?

• What products do they make?

• Where are they shipping it to?

• When will the products arrive?

It is also - as I see it - information management on a large scale. Moreover, aspects of it appear to me to have a relentless quality to them because the data acquisition never stops, especially with regard to shipment notification and to product tracing information.

So, basic as it is, it provides us with a new set of challenges:

• For the industry that has to maintain that information and provide it when necessary; and

• For my agency, to process and use it effectively and efficiently for the purposes for which it was intended and not to be overwhelmed by it.

Nonetheless, if managed properly, it should enable:

1. A clearer picture of the food that is being offered into commerce in the United States at any given time and the origins of that food; and

2. A greater ability to trace products quickly should there be a need to do so.

So I would not be surprised to see the management of food security worldwide - not just in the United States - increasingly involve the gathering and utilization of this kind of information as part of international trade and on this kind of scale at least. In other words, this is probably just the beginning.

Because it represents a beginning and because a lot of people are interested in the effect that these regulations will have on their lives, I would like to make a comment based on my experiences. Several years ago, concerns were expressed that the new US seafood HACCP regulations were going to cause major problems at the border for those exporting seafood products into the US. As it turned out, these problems essentially did not materialize, I think largely because it was never our intent to cause unnecessary roadblocks and thus we tried to avoid them. Hopefully that experience will repeat itself. Things have a way of working out for the best, more often than not.

FOOD SECURITY GUIDANCE FOR PROCESSORS & IMPORTERS

These regulations reflect a program of data acquisition that will better enable us to see the "big picture". We are also working to narrow that focus, to help us identify specific security risks in the food processing environment. Seafood personnel from my office have been heavily involved and will continue to be.

In March 2003, FDA published guidance on food security for food processors and also for importers of food products. The guidance identifies the kinds of preventive measures that food processors may take to minimize the risk of food under their control being subject to intentional contamination. For instance;

• Assessing the firms' food security procedures and operations;

• Securing the physical facility;

• Screening key employees; and

• Training employees to be alert to signs of intentional contamination.

While it was written with our domestic industry in mind, the guideline is available to anyone with access to our web site. We encourage all industry to use it to assess and, where necessary, improve food security in their processing facilities. In the United States, we are encouraging all federal, regional and local regulators to discuss and promote the adoption of this guidance by the food industry. This guidance provides recommendations and is not binding on anyone.

If you are familiar with HACCP, you will immediately recognize some of the thought processes behind these guidelines, because they involve:

• Evaluating the movement of product through the food processing system and identifying areas that present potential for food contamination; and then

• Identifying control measures that can reduce risk.

But traditional hazard analysis associated with HACCP was not designed to anticipate what an attacker might choose to do, nor was HACCP designed to control that kind of risk.

To help us with that, we have begun to perform "threat" and "vulnerability" assessments and to incorporate the results into our guidance. They are not new. They have been used for some time by the military and others who need to think in terms of "threats" and "vulnerabilities." But applying them to the food supply is a new development. They essentially involve two techniques:

Operational Risk Management (ORM): This involves looking at:

• How much damage could be done at a given point in a processing system - which is another way of saying "severity;" and

• How easily that damage could be done - which is another way of saying "probability."

Operational Risk Management does not take into account who might be behind the threat or what their capabilities might be. It focuses exclusively on the processing system.

CARVER (Criticality, Accessibility, Recouperability, Vulnerability, Effect, Recognizability): This technique does look at who might be behind the threat. It then looks at what their capabilities are and what their intentions are, at least as reflected by their past actions. Finally, it focuses on what kind of damage would satisfy their needs. For example, some organizations are unlikely to take an action unless it has the potential to kill many people. By contrast, "white collar" criminals might prefer to steal money without anyone ever knowing that money has been stolen. So killing and destruction would not be what they would want to do. A CARVER analysis looks in from the outside and examines what looks vulnerable from an external perspective?

As you can see, Operational Risk Management and CARVER are complimentary techniques and should be used together, as I will demonstrate. I would like to describe Operational Risk Management in a little more detail and then say a few more words about CARVER.

OPERATIONAL RISK MANAGEMENT

A primary goal in the application of Operational Risk Management is to distinguish higher risk scenarios from lower risk scenarios so that we can focus our activities at the higher end. In that respect, Operational Risk Management is a "screening" tool.

We looked across the food supply at:

1. Foods;

2. The important points in the production of those foods; and

3. Various potential terrorist agents (chemical and microbiological) that could possibly be used to contaminate food at the important points.

This allowed us to identify the combinations of these three aspects that presented the highest risk.

Because these aspects - types of foods, important points in production, and potential microbiological and chemical agents - are collectively vast, we went through a process of reducing the ones we would look at in order to make the analysis manageable. This screening process occurs before we actually perform Operational Risk Management.

It involved three steps, as follows:

First, for the food supply, we developed a list of foods to focus on by interviewing major US food trade associations for their input on foods of concern. To that, we added foods identified within the Food and Drug Administration. This was a fairly subjective process, but it also erred on the side of inclusion.

Second, to identify the points of production (what we sometimes call "activities") that we wanted to focus on, we broke the production system down into units. These units tended to be larger units than those that would normally be used for HACCP - examples include farm, fishing vessel, bulk transportation, manufacturing, finished product transportation, warehousing and retail/food service.

Third, in identifying the agents to include in the analysis, we reduced the extensive list of potential pathogens and poisons by considering the ability of the agent to survive the rigours of foods - dryness, acidity and so forth - and the processes that the foods are likely to undergo - heating, freezing, washing. We also considered whether the agent would cause any noticeable change in the food, such as odour, colour or taste. This could warn the consumer that something was amiss. Priority was also given to agents that had the potential to cause serious adverse health consequences, likely a desire of any terrorist organization. We integrated information from the US intelligence community and information on the availability of the agents into this screening process as well.

After we had reduced the types of foods, points in the production system and chemical/biological agents down to manageable numbers, we then used Operational Risk Management to assess risk by first calculating the severity (how much damage could be done at a given point) and then the probability (how easily the damage could be done). This work enables us to separate the many food/agent/activity scenarios into "high," "medium" and "low" risk categories. Without that separation, deciding where to take our first steps would have been very difficult.

Let's try an example - anthrax in milk on a farm - just to see how this works.

Anthrax in milk on a farm

Looking first at severity, this is defined as the public health impact of the hazard if it were to occur because of a control weakness (in other words, how much damage could be done). We will want to consider the seriousness of the illness and the number of people affected - the exposure.

Anthrax causes serious illness, but because most of the agents that we have looked at are likely to cause death, exposure turns out to be the more significant factor. We do not consider chronic effects, because it is unlikely that these are a desired outcome for a terrorist organization. Anthrax poses an acute health threat, so it is not screened out by that consideration. Taking all these things into account, we assign "anthrax in milk on a farm" a "high severity" rating.

For probability, we look the likelihood that a control weakness could exist that would allow the contamination to occur. In this case, based on what we know about security on farms, we assign it a "medium probability". Taking these two together ("high severity" and "medium probability") and feeding this into our analysis gives anthrax in milk as a high risk.

Incidentally, we have discovered four factors that are consistently associated with foods that are assessed as being "high risk":

1. They typically have a large batch size. This is because the large batch size results in a large number of contaminated servings and thus having a very significant impact on exposure;

2. They typically have a short shelf-life which results in a rapid turnaround at retail and rapid consumption. Any illness outbreak is essentially a race between the outbreak and public health efforts to control it. When the shelf-life of the food is short, the outbreak is likely to win the race, especially if it is coupled with a long incubation period for the agent - in that case people keep eating because no one knows that some have already been exposed;

3. It is possible to achieve a uniform mixing of the contaminant in the food. The goal of the terrorist would be to spread the contaminant throughout the batch so that as many units as possible will contain a lethal dose.

4. And finally, the point of production must be accessible to the terrorist for the event to occur.

CARVER + SHOCK

Now back quickly to CARVER. Remember, CARVER analyses who the threat is, what their capabilities and intentions are and what harm they would need to cause in order to satisfy their needs. We apply CARVER to food/production point/agent combinations that have been identified with the highest risk by the Operational Risk Management process.

We actually do not use CARVER alone, but in combination with the potential shock effect of a terrorist act, which we simply refer to as " CARVER plus Shock."

"Shock" involves the potential economic and psychological impacts of terrorist actions, in addition to the public health impact. It includes things like public alarm, loss of confidence in the food supply or in the government, or interruption of the availability of food. "Shock" consequences could overshadow the public health consequences, as they did in the anthrax episode in the United States shortly after 9/11.

"CARVER plus Shock" has built upon the vulnerability assessments that we had previously performed using Operational Risk Management. It has helped identify production points that are the most likely targets for terrorist attack. It has also helped us to identify countermeasures that can be used to reduce the risk at those production points.

THE FUTURE

As a next step, we expect that a new version of these food security guidelines for industry will be developed that will be specific to seafood processing. I anticipate that the FDA will be working with industry to accomplish this in the near future.

Guidelines that are specific to the seafood industry should be able to better focus on the vulnerabilities that exist in that industry rather than could general food security guidelines for all processors. The best we could do with general guidelines was to provide processors with a "laundry list" of possibilities. The new food security risk assessment techniques will be fully utilized in the development of seafood specific guidelines.

As an additional matter, we also see a lot of laboratory-oriented work in our future, focusing on the development of analytical methods to detect agents that could be used to contaminate food and on the stock piling of laboratory reagents and equipment should a contamination event occur. The vulnerability assessments clearly link to the laboratory work because they help us determine our priorities for methods development.

Presumably, all of this is just the "beginning" for food security. How our food security activities will evolve, and how they will ultimately integrate into regular compliance activities as well as into protocols for handling unusual events cannot be fully answered at present. We just do not know. Possibilities include:

• visiting "high risk" processors to encourage activities and thinking based on our guidelines;

• taking more samples for food security reasons; and

• engaging in more physical examinations of products for counterfeiting and similar matters.

And how all of this will ultimately be integrated into international regulatory and industry operations by all countries remains to be seen, but it is reasonable to assume that food security as a day-to-day aspect of our food safety programs is here to stay.