2. Rules and regulations governing fish and seafood safety and quality

2.1 International context

As early as 1980, there was an international drive towards reforming fish inspection systems to move away from end-product sampling and inspection into preventative Hazard Analysis Critical Control Point (HACCP)-based safety and quality systems. This preventative approach requires that:

• fish products are prepared/processed in certified plants and establishments. The certification process requires that the plant meets minimal requirements in terms of layout, design and construction, hygiene and sanitation;

• the industry takes responsibility in fish safety control and implements HACCP-based in-plant quality control programmes;

• a regulatory competent authority is in charge of certifying fish plants and establishments, approving and monitoring HACCP-based in-plant quality control programmes and certifying fish and fishery products before distribution;

• where necessary, national surveillance programmes of the harvesting areas should be in place to control the threats of biotoxins and other biological and chemical pollutants; and

• for export, an additional control can be exercised by the importing party and involves an audit of the national control system of the exporting country to ensure that it meets the requirements of the importing country. This should lead to the signing of mutual recognition agreements between trading countries.

While there is growing and strong evidence that the implementation of HACCP-based systems have contributed to improve fish safety and quality, there has been an increasing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. FAO defines the food chain approach as that where the responsibility for the supply of safe, healthy and nutritious food is shared along the entire food chain - by all involved with the production, processing, trade and consumption of food. (FAO, 2003a).

In fisheries, stakeholders include farmers, fishers, food processors, transport operators, distributors - and consumers, as well as governments obliged to protect public health. The holistic approach to food safety along the food chain differs from previous and present models in which responsibility for food safety is mainly concentrated on the food processing sector and government control services. The implementation of the food chain approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building.

In fisheries, there are five broadly-defined needs on which a strategy in support of a food chain approach to food safety should be based:

1. Fish safety and quality from a food chain perspective should incorporate the three fundamental components of risk analysis - assessment, management and communication - and, within this analysis process, there should be an institutional separation of science-based risk assessment from risk management, the latter being the regulation and control of risk.

2. Tracing techniques (traceability) from the primary producer (including animal feed and therapeutants used in aquaculture), through post-harvest treatment, processing and distribution to the consumer must be improved.

3. Harmonization of fish quality and safety standards is necessary, implying increased development and wider use of internationally agreed, scientifically-based standards.

4. Equivalence in food safety systems - achieving similar levels of protection against fishborne hazards and quality defects whatever means of control are used - must be further developed.

5. An increased emphasis is needed on "risk avoidance or prevention at source" within the whole food chain - from farm or sea to table. In the farmed sector, this includes development and dissemination of good aquaculture practices and safety and quality assurance systems (i.e. HACCP) to complement the traditional approach to fish safety and quality management based on regulation and control.

The principles of achieving harmonization of standards and equivalency in food control systems and the use of scientifically-based standards are embodied in two binding agreements of WTO - the SPS and TBT Agreements. The SPS agreement confirms the right of WTO member countries to apply measures necessary to protect human, animal and plant life and health.

The purpose of the SPS Agreement is to ensure that measures established by governments to protect human, animal and plant life and health in the agricultural sector, including fisheries, are consistent with obligations prohibiting arbitrary or unjustifiable discrimination on trade between countries where the same conditions prevail and are not disguised restrictions on international trade. It requires that, with regard to food safety measures, WTO members base their national measures on international standards, guidelines and other recommendations adopted by the Codex Alimentarius Commission (CAC), where they exist. This does not prevent a member country from adopting stricter measures if there is a scientific justification for doing so or if the level of protection afforded by the Codex standard is inconsistent with the level of protection generally applied and deemed appropriate by the country concerned. The SPS Agreement states that any measures taken that conform to international Codex standards, guidelines or recommendations are deemed to be appropriate, necessary and not discriminatory. Finally, the SPS Agreement requires that SPS measures are to be based on an assessment of the risks to humans, animal and plant life using internationally accepted risk assessment techniques.

The objective of the TBT Agreement is to prevent the use of national or regional technical requirements, or standards in general, as unjustified technical barriers to trade. The agreement covers standards relating to all types of products including industrial products and quality requirements for foods (except requirements related to SPS measures). It includes numerous measures designed to protect the consumer against deception and economic fraud. The TBT Agreement basically provides that all technical standards and regulations must have a legitimate purpose and that the impact or cost of implementing the standard must be proportional to the purpose of the standard. It also states that, if there are two or more ways of achieving the same objective, the least trade restrictive alternative should be followed. The agreement also places emphasis on international standards, WTO members being obliged to use international standards or parts of them except where the international standard would be ineffective or inappropriate in the national situation. The aspects of food standards that TBT requirements cover specifically are quality provisions, nutritional requirements, labelling, packaging and product content regulations, and methods of analysis. Unlike the SPS Agreement, the TBT Agreement does not specifically name the international standard setting bodies, whose standards are to be used as benchmarks for judging compliance with the provisions of the Agreement.

Risk analysis is widely recognized today as the fundamental methodology underlying the development of a food safety standard that provides adequate health protection and facilitates trade in food (WHO, 1995). There is a fundamental difference between a hazard and a risk. A hazard is a biological, chemical or physical agent in, or condition of food, with the potential to cause an adverse health effect. In contrast, risk is an estimate of the probability and severity in exposed populations of the adverse health effects resulting from hazard(s) in food. Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication. Risk assessment is the scientific evaluation of known or potential adverse health effects resulting from human exposure to food-borne hazards. Risk management is the process of weighing policy alternatives to accept, minimize or reduce assessed risks and to select and implement appropriate options. Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties.

The responsibility for the supply of fish that is safe, healthy and nutritious should be shared along the entire chain from primary production to consumption. Development and implementation of Good Aquaculture Practices (GAP), Good Manufacturing Practices (GMP), Good Hygienic Practices (GHP) and Hazard Analysis Critical Control Point (HACCP) are required in the food chain step(s). Government institutions should develop an enabling policy and a regulatory environment, organize the control services, train personnel, upgrade the control facilities and laboratories and develop national surveillance programmes for relevant hazards. The support institutions (academia, trade associations, private sector, etc.) should also train personnel involved in the food chain, conduct research on quality, safety and risk assessments and provide technical support to stakeholders. Finally, consumers and consumer advocacy groups have a counterbalancing role to ensure that safety and quality are not undermined by political considerations solely when drafting legislation or implementing safety and quality policies. They also have a major role in educating and informing the consumer about the major safety and quality issues.

The general principles of GHP/HACCP have been adopted by the Codex Alimentarius Commission (CAC) in 1997, 1999 and 2003 (FAO/WHO, 2003). They include requirements for the design and facilities, control of operations (including temperature, raw materials, water supply, documentation and recall procedures), maintenance and sanitation, personal hygiene and training of personnel. Similarly, the Codex Committee on Fish and Fishery products is working on a draft code of practice for fish and fishery products, including aquaculture products, which integrates these general principles and adapts them to the fish industry (FAO, 2003b). This Code is not intended to cover extensive fish farming systems or integrated livestock and fish culture systems that dominate production in many developing countries.

Control and prevention of chemical pollutants and biotoxins require the implementation of appropriate monitoring and surveillance programmes. This is particularly important for mollusc culture as filter feeders can concentrate pollutants, biological agents and biotoxins. The Codex Code of Practice describes the requirements for surveys and monitoring of growing areas to determine sources of domestic and industrial pollution, classification of growing areas as suitable for harvesting and relaying or non-suitable for growing or harvesting, and the frequency and methods of monitoring.

The following sections examine how this international framework for fish and seafood safety and quality is applied in international fish trade by the major importing countries/regions, with a particular focus on border controls.

2.2 The European Union

The principle behind assuring the safety of imported fish and seafood to the European Union is that of certifying Competent Control Authorities in the third countries exporting to the European Union. The European Union (EU) delegates the control of food safety to a Competent Authority in each country, who in turn ensures that exporting farms, vessels and processors are producing safe food under a system equivalent to that in the European Union - the principle of equivalence. National laws are "harmonized" with those in place within the European Union.

When the laws of any third country are harmonized and systems to monitor and control food (fish) processing establishments and vessels are deemed equivalent, the exporting country is approved for export to the European Union. Individual companies are checked by the Competent Authority and, if deemed appropriate, are listed as approved in a national register, with a certification number. This register is passed to the European Commission (EC) who make the information public via its website and other public documents^[3] These are the so-called List I countries. Other countries that are in the process of gaining approval but are deemed to be producing safe foods are shown in List II. Shipments from List II countries are, however, subject to 100 percent border checks (Table 2).

Unfortunately for processors, these are the only routes by which processors can export to the European Union. Even if a processing establishment is meeting international standards of safety and quality, it can only export if the country in which it operates is recognized and certified by the EC on List I or List II. This has caused problems for qualified processors in several countries who then have to wait for the government to complete the process of recognition by the European Union.

In addition to the certification requirements from exporting countries, the European Union operates a border inspection system to verify regularly that the European Union requirements are effectively implemented in the exporting country.

During recent years, the European Union has completed a recast of the legislation governing food hygiene and laying down specific hygiene rules for food of animal origin. EC Regulation 178/2002 is of very broad scope; it establishes the general principles and requirements of food law, lays down procedures on matters of food safety, and establishes the structure and role of European Food Safety Authority (EFSA). It also covers the basic concepts of equivalence and traceability.

The Regulation applies to all stages of production, processing and distribution of food and animal feed, setting the basic principle of "the farm to table" approach. It lays down the general principles of food law including risk analysis, the precautionary principle and protection of consumers' interests plus the general obligations of the different bodies in the food chain and their consequent liabilities. It also lays down the requirement for transparency rules (for public access to information), systems for data analysis, the rapid alert system and establishment of an organizational framework including the audit and control systems applicable to the EFSA.

EFSA's function is to provide the European Union (EU) with independent scientific and technical advice to underpin policymaking and legislation in the area of food safety and in related areas of plant health, animal health and environmental protection. The Regulation also states that third countries with which the European Union has concluded agreement might participate in EFSA.

One development has been regarding the concept of "equivalence" (Art 1123). The Regulation was revised as part of a review of Food Law and drawing on Art 11 of Directive 91/493 (on fish and fish products). Under this revision, in circumstances where a country may not have its own facilities, European Union authorities may accept as "equivalent" health certification issued by acceptable bodies in another country. The most quoted cases are Namibia, which can be certified by South Africa health certification bodies, and New Zealand, which can certify establishments in certain Pacific Islands.

TABLE 2
Lists of third countries from which import of fishery products is authorized for human consumption - EC*

List I. Countries and territories covered by a specific decision under Council Directive 91/493/EEC

* (as of 13/4/2004). Not including Kosovo as defined by the United Nations Security Council Resolution 1244 of 10 June 1999.

List II. Countries and territories meeting the terms of Article 2(2) of Council Decision 95/408/EC*

* COMMISSION DECISION 2004/359/EC of 13 April 2004 amending Decision 97/296/EC drawing up the list of third countries from which the import of fishery products is authorized for human consumption.
(1) Authorized only for imports of live crayfish (Astacus leptodactylus) intended for direct human consumption.
(2) Authorized only for imports of fresh fish.
(3) Authorized only for imports of caviar.
(4) Authorized only for imports of fishery products caught, frozen and packed in their final packaging at sea.
(5) Authorized only for import of live animals intended for direct human consumption.

A new regulation, EC/853/2004, lays down the food hygiene requirements for product of animal origin, including HACCP systems and procedures. New hygiene rules have been introduced that will adapt the concept of "farm to table" to hygiene policies and will, for the first time, create a single, transparent hygiene policy applying to all food operators including agreed steps to protect food safety. This new legislation will replace the patchwork of rules for specific sectors and types of product, which have gaps notably at the farm and primary production levels.

The new legislation gives food producers primary responsibility for the safety of food through self-checking and modern hazard control techniques. It integrates 16 existing product specific Directives and Directive 93/43 into a new "Food Hygiene Package" (Table 3).

The three regulations cover general hygiene of foodstuffs, hygiene of food of animal origin and official controls on products of animal origin (intended for human consumption). Part four of the package (animal health rules for products of animal origin) will apply no earlier than 1 January 2006 and will strengthen animal health requirements both within the Community and for imports. The last part of the package will remove a large number of previous regulations from the statute book.

TABLE 3
New European Union hygiene package of regulations and directives

2.2.1 Border control

Council Directive 97/78/EC of 18 December 1997 lays down the principles governing the organization of veterinary checks on products entering the European Union from third countries. Under the recent overhauls of controls by the EC^[4], these rules will remain in place since they are very specifically designed for the organization of the official controls on feed and food of animal origin. This Directive requires that all products of animal origin imported into the European Union from third countries must be checked at an approved Border Inspection Post (BIP) to verify their compliance with European Union legislation. Annex A.3 details the approved requirements for border inspection posts (taken from Annex II of Directive 97/78).

Within the expanded European Union there are 278 BIPs operated by national authorities (Table 4). These posts are at the point of first contact with the European Union. Most of these are ports and airports, others are road or rail links located in particular at the eastern borders of the Union.

The accession of the ten new Member States in May 2004 has extended the eastern frontier with the Russian Federation and moved the frontier eastwards to border with Belarus, Ukraine, the Republic of Moldova and Turkey. New BIPs equally have to be established along the borders with Croatia, Macedonia, Montenegro and with Serbia. Candidate countries proposed a total of 87 BIPs to be approved for checking imports into the Union. As of May 1 2004, 37 new BIPs were approved from the ten new Member States. At the same time, several BIPs in Italy, Germany and Austria disappeared, mostly road and rail BIPs. Table 4 shows the status of BIPs in the European Union.

2.2.2 Checks at border inspection posts

At these BIPs, there are three main types of veterinary check on all consignments; documentary, identity and physical.

Documentary

A documentary check is carried out on all consignments. This involves checking that the appropriate veterinary documentation (including the health certificate) exists and has been completed properly.

TABLE 4
Border inspection posts in the European Union (EU) - after May 2004

Source: Commission Decision 2003/831 (EU15) and Commission Decision 2004/273 (new EU10). * these are new figures from a draft Commission Decision which updates the numbers published in Commission Decision 2004/273 and are put into the table for completeness. Countries in italics are new entrants to the European Union.

TABLE 5
Consignment checks at European Union borders

Identity

Every consignment is subject to an identity check to verify that the consignment matches that described in the documentation (Table 5) and check the health mark, which typically identifies the country and company identity.

Physical

In principle, a physical check is required on all consignments. However for the majority of products where import rules are fully harmonized a physical check is carried out on a percentage of consignments. The percentage varies according to the product and country of origin (Table 6). A physical check involves an inspection of the contents of the consignment to ensure that it presents no animal or public health risk or quality defect. It may also involve the taking of samples for laboratory tests.

TABLE 6
Summary of physical checks at border inspection posts (Dec 94/360/EC)

Physical checks on products of animal origin are categorized by the animal product being imported and the level of sampling required. Some countries have special arrangements with the European Union. Table 6 summarizes the situation for fish and related products. The full table of animal products is shown in Annex A.2.

Some countries are exempt for instance, veterinary checks are not required for fishery products from Iceland and are not usually required for any animal products from Norway and the Faeroe Islands.

As a result of the above checks, consignments may be sent for further testing. The professional judgement of the inspectors will identify the tests to be carried out, for instance, histamine and heavy metals for tunas, various specific bacteria for a variety of at-risk products, or malachite green for farmed fish. Non-statutory tests for residues are also carried out periodically for chemicals such as veterinary drugs.

There is also a general rule of 1-5 percent random sampling. These tend to be sent for analysis for indicator organisms such as E. coli and faecal coliforms rather than the more specific tests already mentioned. Annex A.3 details an example of the documentary requirements for animal products (including fish) at a United Kingdom (UK) BIP. The UK procedures are based on European Community legislation.

Presently, samples are subjected to sensory, chemical (histamine, mercury, Total Volatile Bases TVB-N, etc.) or biological (total flora, indicator organisms, parasites, etc.). However, most microbiological testing standards and criteria are still not harmonized within European Union members, except for the following fish and fish products: Salmonella and E. coli in live bivalve molluscs, echinoderms, tunicates and gastropods; fRNA bacteriophages in live bivalve molluscs, and; Salmonella, S. aureus, E. coli and Vibrio parahaemolyticus in cooked crustaceans and molluscan shellfish (Decision 93/51/EEC and Directive 91/492). Consequently, several European Union members' countries use different microbiological criteria for the other seafoods, which creates confusion amongst exporters as to which standard or criteria to follow. Upcoming legislation, which is still debated and is currently in draft form is supposed to circumvent this problem. Annex A.4 details the existing and upcoming microbiological criteria for fish and fishery products.

Once a problem consignment has been identified at the border, the member state has an obligation to notify all other member states of the cause of the border case. This is now done via the Rapid Alert System of the European Union.

2.2.3 The rapid alert system

The Rapid Alert System for Food and Feed (RASFF) was established originally under Article 8 of Directive 92/59/EEC (superseded by Directive 2001/95), the directive on general product safety. Products in this case covers "any product, including in the context of providing a service, which is intended for consumers....", so the Directive is much broader than food and feed. This Directive provides for a procedure to inform the European Union Member States when a product presents a serious risk for the health and safety of consumers.

When Regulation 178/2002, which lays down general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, came into force, the food procedure covered by Article 8 of the General Product Safety Directive ceased to apply and was instead called the Rapid Alert System for Food and Feed (RASFF). The legal basis of the RASFF is to be found in Article 50 of Regulation 178/2002/EC. This new legal basis extends the rapid alert system for food to include animal feeds and includes the Border Inspection Posts network.

Basically, the purpose of the RASFF is to provide the European Union control authorities with an effective tool for exchange of timely information on measures taken to ensure food safety.

The RASFF is effectively a network of the relevant European Union member states authorities, but also includes other countries such as the EFTA/EEA states. Whenever a member of the network has any information relating to the existence of a serious direct or indirect risk to human health, this information is immediately notified to the Commission under the RASFF. The Commission immediately transmits this information to the members of the network. Article 50.3 of the Regulation gives further details on when a RASFF notification is required. (Annex A.5 details a flow chart for the process).

Basically, Member States shall immediately notify the Commission, under the rapid alert system, of:

(a) any measure they adopt which is aimed at restricting the placing on the market or forcing the withdrawal from the market or the recall of food or feed in order to protect human health and requiring rapid action;

(b) any recommendation or agreement with professional operators which is aimed, on a voluntary or obligatory basis, at preventing, limiting or imposing specific conditions on the placing on the market or the eventual use of food or feed on account of a serious risk to human health requiring rapid action;

(c) any rejection, related to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the European Union.

These latter notifications are called Information Notifications. Information notifications concern a food or feed for which a risk has been identified, but for which the other members of the network do not have to take immediate action, because the product has not reached their market. These notifications mostly concern food and feed consignments that have been tested and rejected at the external borders of the European Union. Products subject to an information notification have not reached the market or all necessary measures have already been taken.

The RASFF also issues Alert Notifications. These are sent when the food or feed presenting the risk is already on the market and when immediate action is required. Alerts are triggered by the Member State that detects the problem and that has initiated the relevant measures, such as withdrawal/recall. As of 26 May 2003 the European Union began posting a weekly internet report with information on all notifications from the Rapid Alert System^[5].

2.3 United States of America

The majority of United States Federal regulatory authority and activity for seafood regulation is vested with the Food and Drug Administration (FDA) within the Department of Health and Human Service. The FDA's mission is to enforce laws enacted by the United States of America Congress and regulations promulgated by the Agency to protect the consumer's health, safety, and pocketbook. Among the principal laws associated with seafood safety there is the Federal Food, Drug and Cosmetic Act (the Act) of 1938, as amended (21 USC.301-392).

A Federally Mandated Seafood Rule (FDA, 1995) promulgated in 1995 constitutes the basis for the sanitary procedures for processing and importing fish and fishery products into the United States of America, including Good Hygienic Practices and HACCP.

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC.381) authorizes FDA to examine food offered for entry into the United States of America through United States Customs, either prior to entry or after secured delivery to importers/ brokers. Importers, or their representatives, are required to file a notice with the United States Customs to gain entry of each shipment of goods. Importers are also requested to provide copies of Customs entry documents, together with an invoice of the items in each entry, to FDA. Recent electronic filing advancements are simplifying this procedure. Customs notifies FDA of notices received for all FDA regulated products. FDA decides which entries need to be examined and samples collected accordingly. All imported seafood is required to meet the same standards as domestic goods. Products which appear to be adulterated, misbranded, or manufactured, processed, or packed under insanitary conditions may be refused admission.

Section 702 of the Act (21 USC.372) authorizes FDA to take food samples for examination and investigation purposes. Each year, the Programme offices of FDA and the Office of Seafood at the Centre for Food Safety and Applied Nutrition (CFSAN) prepare Compliance Programme that direct the field inspection and surveillance activities. The Programme describe the product areas to emphasize, the types of product to target, the make-up of samples, the types of analyses to conduct on specific products, the analytical methods to be used, and the regulatory parameters to determine compliance. If, during the course of the year, concerns about specific products arise, assignments are written to address inspection and/or sampling to investigate the particular concerns.

Some of the areas of safety concern in seafood are:

• pathogens - Salmonella spp., Clostridium botulinum, Vibrio spp., Staphylococcus aureus, enterotoxigenic Escherichia coli;

• parasites - nematodes, cestodes, trematodes;

• marine toxins - paralytic shellfish poisoning, neurotoxic shellfish poisoning, diarrhetic shellfish poisoning, amnesic shellfish poisoning and ciguatera fish poisoning;

• decomposition - histamine, putrecine, cadaverine;

• environmental Contaminants and Pesticides - including methyl mercury and radionuclides;

• aquaculture drugs - unapproved drugs or unapproved applications;

• food and Colour Additives - unapproved or improperly declared; sulphites, borates, nitrate/nitrite, cyclamate, saffron, FD&C Yellow no. 5. FD&C Red Approaches No.4 and

• foreign objects - metal fragments.

The FDA also inspects seafood products for spoilage decomposition, filth, mould, proper labelling (including nutritional labelling), and economic deception such as short weights or specie substitution (the latter having the potential to cause serious allergenic effects in sensitive individuals or safety problems). Approved or unapproved applications of additives to mask decomposition have also recently become of great concern to the FDA. Annex A.5 details a flowchart for importing foods into the United States of America and Annex A.7 provides the FDA/Environment Protection Agency EPA guidance levels for contaminants in seafoods.

In the United States of America, the manufacturer or owner of the goods (including seafood) is responsible for the safety, wholesomeness, and truthful labelling of the products in his control. The FDA seeks to prevent entry or remove violative goods from commerce via advisory actions (warning letters and untitled letters), administrative actions (citations, detentions, and administrative meetings), judicial actions (seizure, injunction and prosecutions).

The Food, Drug and Cosmetic Act authorizes the FDA to detain a product that appears to be out of compliance with the Act. The FDA district office involved will issue a "Notice of Detention and Hearing" specifying the nature of the violation cited to the owner or consignee, who is entitled to an informal hearing to provide testimony and/or documentation on the suitability of the product for import to the United States. A "Notice of Detention and Hearing", although not providing information on the final disposition of the products, do show the type and nature of the violations cited by FDA and the products, countries and industry involved. If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue a "Notice of FDA Action" refusing admission to the product. The product then has to be exported or destroyed within 90 days.

Each month, an Import Refusal Report (IRR) (Annex A.8) is published based on data generated by the FDA's Operational and Administrative Import Support (OASIS). This report replaces the FDA Import Detention Report (IDR). The IDR gives an incomplete picture in that it only reflected the initial action by the Agency and not the ultimate determination of the compliance status of the product. Through the new IRR data are sorted by country and by product based on the industry code with a clear indication on products that have been found to appear in violation of the Act, the origin of the product and the reason to refuse admission of the product. The data are available (including on the Internet) by country and by product commodity (FDA, 1999).

2.3.1 Detention without physical examination

In some instances a product may be detained as soon as it is offered for entry into the United States. This procedure is the administrative act of detaining a product without physical examination and is based on past history and/or other information indicating the product may be violative. A product may be subject to a Detention Without Physical Examination (DWPE) recommendation until the shipper or importer proves that the product meets FDA guidelines or standards.

2.3.2 Automatic detention

Occasionally, the FDA identifies products from an entire country or geographic region for DWPE when the violative conditions appear to be geographically widespread. Detention recommendations of this breadth are rare and are initiated only after other avenues for resolving the problem have been exhausted (see vFDA Regulatory Procedures Manual, Chapter 9-25-00 for details on Detention Without Physical Examination - formerly known as Automatic Detention).

In 1979, the FDA was confronted by a serious and growing problem with Asian shrimp. The FDA's testing disclosed that a high percentage of shrimp entries from various Asian countries were contaminated by Salmonella, or decomposed, or contained filth or often a combination of the three.

Between March and August 1979, the FDA sampled and tested 835 entries of shrimp from six Asian countries. Of the total, 387, or 46 percent, were found violative and consequently denied entry. Decomposition accounted for 164 or 20 percent, and the remaining were detained for filth. The percentage of denied shrimp entries from each of the six countries ranged from 31-78 percent and a considerable number of violative samples for each country were found over a six-month period. The volume of incoming shrimp shipments and FDA's obligation to sample and test the shrimp created an overload in FDA's laboratories and shifted personnel from other health protection duties. FDA considered that it was fast becoming a "de facto" quality control agent for foreign shippers for these countries.

This deteriorating situation prompted FDA to consider carefully, and then implement countrywide blacklisting of the commodity. Two criteria must be reached before FDA will implement this action: 25 percent of the entries from a shipper or a country is violative for a single attribute and at least 10 violative samples have been found in a six-month period. Each of the six countries met the criteria and all shrimp shipments from all shippers in each of the six countries were blacklisted in October 1979.

The term "blacklisting" was soon changed to "automatic detention", which better reflects the nature of the action. Commodities or products automatically detained are not allowed to enter the United States commercial channels.

2.3.3 Import alerts

Import alerts have been developed to communicate guidance to FDA field offices. The purpose of an import alert is to identify and disseminate import information (problems, violative trends, etc.) to FDA personnel thus providing for more uniform and effective import coverage. Import alerts identify problem commodities and/or shippers and provide guidance for import coverage.

To assure the expeditious handling of imported products, FDA has automated its import operations. By combining FDA's Operational and Administrative System for Import Support (OASIS) and Customs' Automated Commercial System (ACS), an FDA reviewer will be able to more efficiently evaluate and process each import entry. The import filer transmits the required shipment-specific FDA data into the ACS. Within several minutes, the filer receives notification that either their shipment has been released or FDA wishes to review it. This system provides FDA with immediate data on imported products, provides information on potential problems, and maintains national historical data files to develop profiles on specific products, shippers, and manufacturers. Eventually all filers processing entries through Customs' ACS will provide FDA information electronically.

Of particular interest is the 2003 FDA Interim Final Regulation (21 CFR Parts 1 and 20) promulgated under the Public Health Security and Bio-terrorism Preparedness and Response Act. This regulation, which became mandatory in December 2003, requires that domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the United States of America register with FDA and submit, electronically, prior notice to FDA before the shipment is due to arrive into the United States of America. It is feared by several fish exporting countries that the implementation of these requirements may disrupt fish trade flows from exporting countries into the United States of America.

2.4 Japan

2.4.1 General principles for food imports

Much less information is available on Japanese safety and quality requirements for fish and fishery products, not least because of language constraints. However, information gathered by the authors during several international meetings and conferences indicate that application of HACCP-based food control regulations has been introduced for some years now, including sanitary and hygienic requirements for fish handling and processing establishments and conditions for storage and transport. Risk analysis principles are being incorporated along with spot checks at the border and with the quality control schemes that often control imports at the source.

The main laws controlling entry of food products are the Food Sanitation Law and Quarantine Law (Table 7).

Other laws are relevant to control of food imports and these include the Plant Protection Law, the Domestic Animal Infectious Diseases Control Law, Customs Law and for labelling, the Law Concerning Standardization and Proper labelling of Agricultural and Forest Products (JAS Law).

TABLE 7
Regulations applying to fishery products and prepared products - Japan

Notes:

1 Herring, codfish, sardine, horse mackerel, saury, scallop, adductors of shellfish, cuttlefish and squid are Import Quota items.

2 Fish (live) in 03-01 include those fish whose import is controlled by the Washington Convention (see Annex A.9).

3 Quarantine - No prohibited area is designated for the import of marine products. However, marine products from areas contaminated by cholera or from suspected areas shall be subject to inspection under the Quarantine Law.

Under the Food Sanitation law^[6] (AnnexA.10), all importers of food must submit an "import notification" to the Ministry of Health, Labour, and Welfare (MHLW) that a consignment is intended to be imported. Without such a notification, the imported food cannot be sold or used for business purposes.

The "Notification Form for Importation of Foods" is submitted to a quarantine station of the Ministry. All the entry points in Japan have such quarantine stations. There are some 31 quarantine stations at seaports and airports throughout the country.

A flow chart for the whole procedure of import notification of foods and related products is given in Annex A.11.

Postal cargoes from abroad are also subject to the Food Sanitation Law and an import notification must be submitted. Items that are imported for personal uses are exempted from import notification.

In recent years and in response to an increasing consumers' uneasiness concerning foods because of the problems of BSE, false labelling and pesticide residues, etc. the food sanitation law has been updated. As a result, sales and imports of food items may be prohibited without inspection when the Minister of Health, Labour and Welfare deems it necessary to protect consumers.

2.4.2 The process for fish and fish products on arrival in Japan

When a consignment arrives at a Japanese port, a "Notice of Customs Clearance (i.e., Arrival Notification)" is sent to the addressee from a customs office, and the customs clearance procedure is initiated. The import notification form must be submitted before the end of custom clearance procedures. In some cases a sanitary or health certificate from the exporting country must be attached to the import notification form (for instance puffer fish).

At the quarantine station, food sanitation inspectors carry out document examination and inspection to confirm that the foods comply with the Food Sanitation Law. This will include validation as to:

• whether the imported food, etc. complies with the manufacturing standards regulated under the Food Sanitation Law;

• whether the use of additives complies with the standards;

• whether poisonous or hazardous substances are present; and

• whether the manufacturer or the place of manufacturing has a record of sanitation problems in the past.

TABLE 8
Japanese “Import Notice” Item 1: Principal Import Quota Items

TABLE 9
Japanese "Import Notice" Item 2 - Goods originated in or shipped from certain specific area

There are clearly two possibilities at this stage.

(a) The consignment is deemed to comply with the law. In these cases, the consignment can complete customs clearance, be passed onto the importer and be moved into domestic distribution.

(b) The consignment needs to be further examined. This may happen to consignments with a record of non-compliance with the law in the past, or for imported puffer fish, for example. In such cases, an "inspection order" will be issued out in order to confirm compliance. (Annex A.12 provides further details of this and other inspection systems used in Japan). The importer is responsible for the cost of this inspection. Again, there are two possibilities:

(i) The consignment is judged to comply with the law and can thus complete customs clearance as in (a).

(ii) The consignment is judged to not comply with the law and cannot be imported into Japan. The MHLW quarantine station notifies the importer how the cargo violates the Food Sanitation Law, and the importer must take necessary measures by following the instructions from the quarantine station.

2.4.3 Consignments requiring prior approval

There are certain fish and fish products that require approval for import prior to customs clearance procedures. The Import Notices are either non-liberalized items governed by import quotas or items covered by international convention or agreement (Table 8) or designated goods originating in or shipped from certain specific areas and items controlled by international convention or agreement (Table 9).

2.4.4 Labelling requirements

Allergy Labelling under Food Sanitation Law

Requirements for labelling of foods containing allergenic substances were regulated in April 2002. Furthermore and specific to fish, it is recommended that foods that contain abalone, cuttlefish, salmon roe, shrimp, crab, salmon and mackerel as raw materials are labelled as such. Refer to Annex A.13 for further details on labelling of allergens.

JAS Standard System

(1) Quality Labelling

The names of foods and country of origin for fresh fish and the names of foods, raw materials, content quantity, manufacturer, open date, and preservation method for processed marine products shall be contained on the label.

(2) Affixation of JAS mark

(a) A JAS mark may be affixed by applying to the JAS standard grading organizations after the customs clearance for marine products including fish, meat, hams, sausages, etc. Using a JAS mark is at the discretion of the manufacturer (importer) and not mandatory. Processed marine products include specially packaged boiled fish pastes, processed sea urchin, flavour seasonings, mixed and dressed sea urchin, Kezuribushi (shavings of dried bonito), fish ham and sausage, kamaboko (flavoured boiled fish paste), dried small sardines, etc.

(b) JAS standard grading is available using inspection data from a "Designated Foreign Testing Organization", accepted by the Japanese Ministry of Agriculture, Forestry, and Fisheries.

2.5 Canada

The Canadian legislative framework for fish safety (including imported fish and foreign consumers of Canadian fish and fish products) addresses not only consumer safety but also product packaging and labelling requirements.

The main body is the Canadian Food Inspection Agency (CFIA), which was set up through the Canadian Food Inspection Agency Act in 1997. Under the CFIA Act, the CFIA is responsible for the administration and/or enforcement of all federal legislation related to food inspection, agricultural inputs and animal and plant health. The legislation covered includes the Fish Inspection Act, the Fish Inspection Regulations as well as the Consumer Packaging and Labelling Act as it relates to food and the Food and Drugs Act.

The main vehicle used by the CFIA to control the safety, quality and integrity of fish and fish products is the National Fish and Fish Products Inspection and Control System.

At the federal level, food safety is a shared responsibility between two ministries -the Ministry of Agriculture and Agri-Food and the Ministry of Health. The Ministry of Agriculture and Agri-Food, through the CFIA, conducts all federal food inspection activities. The Ministry of Health is responsible for establishing policies and standards relating to the safety and nutritional quality of food sold in Canada. The body responsible is Health Canada.

2.5.1 Import product control system^[7]

The Canadian Import Product Control System uses a variety of controls to ensure that all fish and fish products coming into Canada meet Canadian requirements.

To start with, all importers of fish and fish products must be licensed. This requires that the importer must maintain all records of recalls and complaints and must notify the CFIA if the results of an investigation indicate that the fish may be unsafe. In addition, importers of ready-to-eat and canned products must have further documentation that proves that processing conditions used have resulted in production of a safe product.

Importers must notify the CFIA within 48 hours of the importation of a product. The CFIA then decides whether the product should be inspected or not. The CFIA maintains a database of all fish imports - by processor and product description - and includes compliance data for any inspection undertaken.

In Canada, the importer can also take on this responsibility of inspection through a Quality Management Programme for importers (QMPI). The QMPI importer must develop a quality management system and provide details of that system to the CFIA. Once accepted by the CFIA, the importer must implement and comply with the written programme. The activities under the QMPI must meet or exceed the frequencies and type of analyses that would be performed on a lot by the CFIA. All microbiological and chemical analyses must be conducted by an accredited laboratory. The QMPI system targets larger importers as the system has significant costs associated with licensing and maintenance. However, the QMPI importer has total control over the imported fish and this can mean significant savings in time, often a critical aspect in the trade process. Currently there are 18 QMPI importers (out of a total of approximately 1 000 fish importers in Canada) who bring in around 40 percent of the fish imports into Canada. This system also allows the CFIA to target its inspection resources to areas of non-compliance.

In general, inspection rates will vary from 2 to 100 percent depending on the inherent risk of the product, additional controls placed on the product by the exporting country, the history of compliance of the product/processor and the quality management programme in place by the importer.

Less inspection effort is targeted at foreign exporters/processors with a history of good compliance. Consistent compliance (at least ten consecutive inspections) with Canadian regulations means that the foreign processors will be considered for the "A" List. The following criteria define an "A" List processor:

• a minimum of 30 lots imported in the last two years of the selected product category type (i.e. canned, ready-to-eat, fresh or other [frozen, raw, dried, etc.]);

• acceptable results for all analyses conducted, except minor label infractions in the last ten consecutive inspections, for products imported in the selected product category type, within the past two years.

Processors meeting the above criteria will be placed on the "A" List and selected for random inspection by processor, at the following frequencies for standard tests:

• canned product - 10 percent (instead of 15 percent);

• ready-to-eat-product - 10 percent (instead of 15 percent);

• other (not fresh) product - 10 percent (instead of 15 percent);

• fresh product - 1 percent (instead of 2 percent);

• raw molluscan shellfish - not applicable to the A List

Products from processors on the "A" List will be randomly sampled at a lower frequency than normal. The CFIA maintains the "A" List on its Web site^[8]. As of April 2004, this list contained 37 companies, 26 from United States of America, 5 from Thailand, 3 from China, 1 from India, 1 from Norway and 1 from Japan.

In addition, where the relevant authority in an exporting country places additional controls on its exporters and these controls are recognized by the CFIA through a Mutual Recognition Arrangement, the CFIA will then also reduce the inspection effort on imports from those countries. Such agreements (or Memoranda of Understanding MOU) exist with Australia, Ecuador, Iceland, Indonesia, Japan, New Zealand, Philippines and Thailand.

When an imported product fails to comply with the Fish Inspection Regulations, Food and Drug Regulations or the Consumer Packaging and Labelling Regulations, it is listed on the CFIA Import Alert List (IAL) which is searchable on the CFIA Web site. All subsequent importation of this product from the same producer will be subject to mandatory inspection until such time as four consecutive shipments pass import inspection requirements. Products that are failed by an importer operating under the QMPI also are listed on the IAL. Imported fish products that do not conform to Canadian requirements are not permitted entry into Canada. In such cases, the importer is notified on the refusal of entry and subject to the appeal process, the product must be destroyed, removed from Canada, or brought into compliance through culling, reworking or re-labelling.

2.5.2 Inspection testing

As indicated in the previous section, the system established for conducting inspections is dependent on a number of factors already discussed. However, when an inspection takes place, the imported products are subjected to microbiological, chemical, bioassay and/or sensory examinations depending on the product type, foreign country standards and Canadian standards. The products are assessed by the CFIA, by the importer under the QMPI programme or by a recognized foreign authority under an Arrangement. Whoever does the inspection, the procedures are the same.

The tests on random samples are divided into two categories:

• standard testing that is to be applied to all products; and

• specialized testing that normally depends on the safety risk implications of the product.

Standard tests include:

• labelling - which involves examination of the label, packaging and code markings to evaluate compliance to Canadian requirements;

• net content - examination to evaluate conformity to all weight declarations (e.g., net and/or drained weight, including fluid measure where applicable);

• sensory - examination to evaluate sensory and physical compliance to quality standards for taint (rancid or abnormal), decomposition, foreign matter, undesirable parts and parasites, and to evaluate conformity to all other content declarations such as style, count, composition, etc; and

• container integrity inspection to determine compliance of canned fish to Canadian standards for container integrity.

Specialized tests include:

• composition analyses to ensure that non-permitted or non-declared ingredients or additives are not present and to determine that declared ingredients/additives do not exceed regulatory guidelines;

• chemical analyses to determine that chemical contaminants do not exceed regulatory limits. This would include toxic elements, pesticides, industrial chemicals and drug residues;

• natural toxin analyses to determine that natural toxins do not exceed regulatory limits. Examples would include histamine, paralytic shellfish poison, domoic acid and other biotoxins such as ciguatoxin, okadaic acid and tetramine;

• bacteriological testing to ensure absence of pathogenic organisms. Examples would include analyses for organisms such as E. coli, Listeria monocytogenes, Salmonella sp., and Staphylococcus aureus; and

• safety parameter testing to determine that fish packed in containers sealed to exclude air and which do not depend solely on heat sterilization, freezing or refrigeration for safety have adequate pH and/or water activity and/or salt content to ensure product safety.

Other tests include tests done as part of an investigation or special project. Examples would involve monitoring of products from countries where commercially harvested fish may be exposed to chemical or microbiological contamination.

Annex A. 14 details the Canadian guidelines for microbial and chemical presence in fish and fish products.

2.5.3 Monitoring frequencies

Standard testing

Standard tests are conducted on products on the Import Alert List as required and products that have not been recommended for inspection in the past two years at a frequency of 100 percent. All other products will be monitored randomly at a frequency of 15 percent, with the exception of fresh fish, which will be inspected at a frequency of 2 percent (see Annex A. 15 for a more detailed breakdown of test frequencies).

Specialized testing

Microbiological and chemical analyses will be conducted on products on the Import Alert List and not inspected in the last two years, as required. Otherwise, products will be conducted randomly at a frequency of 5 to 15 percent, depending on the product history and the nature of the product.

Product from MOU/MRA processors

A lower random inspection frequency may apply to products from preferred status plants that are recognized under a Memorandum of Understanding (MOU) or a Mutual Recognition Agreement (MRA).

Product from "A " List processors

Products from "A" List processors are subject to random monitoring at a rate of 10 percent for all standard tests. Fresh fish will be monitored at a frequency of 1 percent.

2.6 Summary of border control systems for fish and seafood

In compiling the regulations for this study, it became apparent that these four importing countries/regions examined employ different systems to protect their marketplaces from unsafe and substandard fish and seafood. An attempt was made to summarize the main similarities and differences between them in Table 10.

The table shows that there are major differences between the border control systems used by different importing countries. These differences in procedures are further complicated by differences in the type of biological, chemical or physical tests to which samples are subjected, as well as the methods of analysis and standards applied as discussed further in Chapter 3. This can only have a negative impact on the free flow of trade between exporting and importing countries as exporters have to become knowledgeable about several (or more) systems, which are often not well substantiated, in order to get their products to market. This wastes time, adds cost and will lead to mistakes (incorrect or missing documents, most likely). Therefore it is less efficient than it could be.

Clearly then, it would be advantageous to harmonize not only the systems of border control, but also the standards, criteria and testing methods. This need has been recognized internationally, and the work of the Codex Alimentarius Commission is very important in this area.

Codex has published the combined texts for Food Import and Export Inspection and Certification Systems. This covers:

• Guidelines for the design, operation, assessment and accreditation of food import and export inspection and certification systems. CAC/GL 26 - 1997.

• Guidelines for the development of equivalence agreements regarding food import and export inspection and certification systems. CAC/GL 34 - 1999.

• Guidelines for the exchange of information in food control emergency situations. CAC/GL 19 - 1995;

• Guidelines for the exchange of information between countries on rejections of imported food. CAC/GL 25 - 1997.

TABLE 10
Comparison of fish import systems in the European Union, United States of America, Japan and Canada

The role of appropriate risk assessment in the development of food standards and control systems is a common theme throughout the texts. However, these basic safety principles still need to find their way into practical application for the promotion of harmonization and equivalency. The discrepancies between importing countries as regards the types of control, control procedures and standards are discussed in more details in chapter 3 under 3.6.7.