FOOD EXPORT CONTROL AND CERTIFICATION

(Paper prepared by Ms Shashi Sareen, Director, Export Inspection Council, India)

1. INTRODUCTION

The establishment of the WTO gives opportunities to all countries to benefit from greater access to world markets. The global trade is expanding rapidly and significantly due to increase in consumer demands linked to growing education and awareness of consumers, internationalization of tastes and habits, developments in science and technology, and improvement in communications and transportation. Coupled with the breaking down of tariff barriers and quantitative restrictions, quality and safety have become very important in international trade. Not only have consumers all over the world become conscious of quality, but at the same time governments have realized their role in protecting the health and safety of their populations by imposing stringent regulations based on health, safety and environmental considerations.

The TBT and the SPS Agreements, while permitting countries to impose standards to protect their populations and ensure fair trade, require that certain rules and disciplines are maintained so that standards and regulations do not create unnecessary barriers to trade. Both the Agreements also encourage member countries to recognize each other's conformity assessment systems based on international standards so that products certified in one country are accepted without need for further inspection/testing by the other through 'equivalence' or 'Mutual recognition' Agreements.

The need for a strong import control mechanism is quite obvious. The need for an equally strong export control mechanism is a natural corollary of such import control systems of importing countries, which have to have a provision for recognition of export certification systems of their trading partners through equivalence agreements.

In recognizing that quality and safety can be assured through application of proper or well designed food control systems (exports and imports), the Codex Alimentarius Commission established the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) to develop principles and guidelines in this area.

Although food control should cover both export and import as is evident from the terms of reference of this Committee and most of the documents it developed, most governments have emphasized on development and strengthening of import control systems with a view to protecting their populations and to prevent dumping of inferior quality products into their country. However, the situation in India and some other exporting countries has been somewhat different, with export inspection and certification being compulsory in certain food items.

In this paper, the importance of food export control and certification, broad concepts to be followed, the experiences in the area of export control including the systems being implemented in India, observations regarding export control systems being developed in other countries and lessons to be learnt or issues of focus are highlighted.

2. IMPORTANCE OF FOOD EXPORT CONTROL AND CERTIFICATION

The SPS Agreement permits member countries to impose measures to protect human, animal and plant life or health. Furthermore, the Agreement, through its provision for adherence/adoption of Codex standards, which in turn provide for legislative framework for imports and the role for official/government inspection/certification agencies and recognition of such agencies at the exporting country's end through equivalence agreements, permits members to establish formal systems of import control to ensure the appropriate degree of protection for their populace.

Taking strength from these Agreements, developed and developing countries have installed strong import control systems in the food sector. Many of these countries also maintain export inspection systems, but these are very minimal and basically cater for providing sanitary, phytosanitary or health certificates when desired by the importing country.

The need to have a well-developed food quality control system for export is more important for countries that are major exporters. Some of the benefits of such export control systems are highlighted below:

3. BROAD COMPONENTS OF EXPORT CONTROL SYSTEMS

3.1 Export Food Control Policy and Strategy

Export food control activity is a multi-disciplinary activity covering a number of aspects such as food science, microbiology, analytical chemistry, plant pathology, veterinary science, etc. A number of agencies would normally be involved in any country including various departments of government, control organizations, promotional bodies, research institutions, agricultural institutions, farming community, trade associations, non-governmental organizations (NGOs), consumers etc. There needs to be a suitable documented export control food strategy with clear objectives, including the countries of focus, well designed plan of action with role clarity provided for different players and clear networking of the organizations within the country.

3.2 Legislative framework

Food legislation includes acts, regulations, and requirements or procedures prescribed by the government relating to export of foodstuffs to meet requirements of the importing country while ensuring conditions of fair trade. Food control needs to be simple, complete, covering various aspects of the food chain as needed and address requirements of importing country - both issues of safety and quality. It should provide authority to carry out controls at all stages of the food chain. Furthermore, it should be flexible to allow taking into account new technologies, developments and changing trade needs. It also needs to be WTO compatible and as far as possible based on Codex standards, guidelines and recommendations, but depending on importing country's requirements. Legislation may also include provisions for registration of establishments or listing of certified processing plants, establishment approval, licensing or registration of traders or agents, equipment design approval, penalties, coding requirements and charging of fees. Necessary provisions need to be included for ensuring integrity, impartiality and independence of the official and officially recognized inspection and certification systems.

3.3 Control programmes and operations

Inspection services should design control programmes based on precise objective and appropriate risk analysis. HACCP or a similar quality and safety assurance and management system based approach should be encouraged with responsibility for meeting the food quality and safety regulatory requirements of importing country resting with the food industry with all segments of the food chain having responsibility for establishing food safety and quality controls. The responsibility of food control regulators is to ensure, through a surveillance system of industry and other components of the food chain that they meet the requirements specified by the importing country.

Elements of a control programme should include the following:

- Inspection;
- Sampling and analysis;
- Checks on hygiene, including personal cleanliness and clothing;
- Examination of routine and other records;
- Examination of the results of any verification systems operated by the establishment;
- Audit of establishments by the national competent authority responsible for export control;
- National audit and verification of the control programme.

An administrative procedure should ensure that controls by the inspection systems are carried out regularly proportionate to the degree of risk, where non-compliance is suspected and in a coordinated manner between different authorities (if several exist).

Control should also cover, as appropriate, the establishment, installations, means of transport, equipment and material; raw materials and ingredients for preparation and production of food stuffs; semi-finished and finished products; cleaning and maintenance products; processes for manufacture or processing of foodstuffs; preservation methods; labelling integrity and claims etc. Formal documentation of the export control programmes is also necessary.

3.4 Decision criteria and action

Control programmes should target the appropriate stages of operation depending on specific objectives. The frequency and intensity of controls should be designed to take into account the risk as well as the reliability of controls already carried out by those handling the products at various other stages i.e. production, manufacturing, etc. In case of rejected products, information should be sought by the export food control authority from the importing country as per CAC/GL 25-1997 - Codex Guidelines for the Exchange of information between countries on rejections of imported foods. Such information on rejections should be provided at the earliest opportunity, by the export control authority, to the exporter, the manufacturer, producer and any related department depending on the situation.

3.5 Facilities, equipment, transportation and communication

Adequate facilities including equipment, transportation and communication facilities should be available to ensure delivery of export inspection and certification services.

3.6 Laboratories

Laboratories are the backbone of the inspection and certification activity. In order to test to requirements prescribed by the importing countries, the laboratories should have state-of-the-art equipment and manpower that is qualified and trained to operate such equipment. The laboratories used by the export inspection and certification services need to be accredited as per international standard ISO 17025 under officially recognized programmes to ensure that adequate quality controls are in place to provide for reliability of test results. Internationally accepted quality assurance techniques should be implemented to ensure reliability of analytical results.

3.7 Personnel

Official inspection and certification services should have access to a sufficient number of qualified personnel in food science, technology, chemistry, biochemistry, microbiology etc. The personnel should be trained in areas of inspection and certification systems, audit techniques, risk analysis techniques, testing, technological aspects etc. and have a status that ensures impartiality and no direct commercial interest in the products or establishments being inspected or certified.

3.8 Certification systems

Certification should provide assurance of conformity of a product to importing country requirements by checks on each product or a batch of products or by approval of the system being implemented by the processor with regular checks by the inspection and certification service on various aspects of the system being implemented. The competent authorities should take all necessary steps to ensure the integrity, impartiality and independence of official or officially recognized certification systems.

3.9 Official accreditation

Export inspection or certification bodies may be officially accredited to provide services on behalf of official agencies. These bodies shall comply with criteria laid down in international standards such as ISO/IEC 17020, ISO Guides 62 and 65, as well as Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems with specific reference to competence, independence and impartiality of personnel. The performance of such inspection and certification bodies should be regularly assessed by the competent authority.

3.10 Assessment and verification of inspection and certification systems

The export inspection and certification system should be subject to audit separate from routine inspection, may be self-evaluation or by third parties. Internationally recognized assessment and verification procedures should be used. Guidelines for conducting assessment and verification of an exporting country by an importing country have been given in the Annex to CAC/GL 26-1997 and an importing country may undertake a review of the exporting country's systems, if so agreed.

3.11 Transparency

For decisions relating to food export control systems, both developmental as well as implemental, there is a need to have information as well as data that is scientifically collected, shared with decision makers and implementers as well as processors. This would include information on regulatory requirements of importing countries; data on residues and other parameters which would help in framing regulatory requirements as well as being used for decision making on implementation actions to prevent food-borne hazards, plan food control activities etc. While ensuring transparency, any constraint of professional and commercial confidentiality should be respected.

4. EXPERIENCES IN THE AREA OF EXPORT CONTROL AND ISSUES ARISING OUT OF THESE

4.1 Export Control Systems in India

India has been operating export control systems since 1963 which have been well-defined and established under the Export (Quality Control and Inspection) Act, 1963. The Act empowers the Central Government to notify commodities for pre-shipment inspection and certification, specify the minimum standards (generally recognizing international, importing countries' standards and contractual specifications), and prescribe the manner of export inspection and certification, whether compulsory or voluntary.

The export control system is operated by the Export Inspection Council of India (EIC), India's official export certification body, through its field organizations, the Export Inspection Agencies, having head offices in Chennai, Delhi, Kochi, Kolkata and Mumbai with 41 sub-offices including laboratories around the country.

Over the years, under the provision of the Act, nearly 1000 commodities have been notified by the government for pre-shipment inspection and certification covering such sectors as chemicals, pesticides, rubber products, engineering products, food and agricultural products, textiles, footwear etc. However, presently only sensitive items such as marine products, egg products, dairy products, poultry products and honey are under compulsory export certification by the Export Inspection Council of India. In the case of other food products, although many of these are notified under the Act, there is no compulsory certification and in many cases, and in case required by an importing government, EIC certifies the products. An example is the case of black pepper exported to USA, or basmati rice to the EC for duty benefits, etc. However, if required by the buyer or government, these food items may be certified by private inspection agencies. Details of export control systems being operated by the Export Inspection Council of India are given in the Conference Room Document prepared by India.

4.2 Experiences in the Area of Export Controls

Implementation of export control systems strengthens a country's infrastructure of food control and, streamlines trade between countries. During the course of operation of export control systems, India has encountered varying experiences, some of which are highlighted so that these may be taken note of and consciously addressed for capacity building in the country as well as addressing problems and removing hurdles.

(i) Equivalence Agreement/MOUs

The concept of equivalence has been recognized in both the SPS and the TBT Agreements and is also being encouraged at the international level by the Codex Alimentarius Commission with a view to using pooled resources more effectively, avoiding duplication of inspection and testing, and ensuring that health and safety requirements are met effectively. These also serve as an important means of facilitating trade by recognition of the standards and certification systems of the exporting country to provide for an equivalent level of protection against health risks as those of the importing countries and also lead to reduced rejection rates and provide for reduced inspection of export products in overseas markets. Such Agreements are possible only if there is a strong export control system being maintained by the exporting country.

India has been seeking recognition of its export certification from the importing regulatory authorities of India's trading partners through MOUs/Mutual Recognition Agreements (MRAs). The EIC has been recognized by the European Commission, USFDA, AQIS (Australia) and Sri Lanka Standards Institution for various products.

With countries where Agreements have been signed or where the export certification system has been recognized, there is a smooth trade flow and any issues identified are sorted out through mutual discussions. However importing countries often avoid such Agreements, with varying arguments such as - this is not a priority for them, import controls are a means of income and by signing such Agreements they would lose financially, or the administrative burden of entering into these is not justified or they do not want to lose control over imports. At times it is seen that important components are not addressed in such Agreements as these are not in the interest of the importing country such as provision for retesting and appeal in case of rejections. Other countries have appointed private inspection agencies to carry out this task rather than recognizing the official certifying body. It may be mentioned that such an Agreement would benefit exporters in a 'developing' country as the financial burden as well as risk of rejection would be reduced.

(ii) Information on Requirements of Importing Country

Export certification has to cater to the level of protection specified by the importing country. Many countries specify levels more stringent than international ones. There are two issues here - a) certifying to different standards and b) need to have information on the SPS requirements of various importing countries in terms of their standard and legislation. The former cannot be questioned as the SPS Agreement permits members to fix their ALOP. However, scientific justification is not always forthcoming. With regard to the latter, there is often absence of information on the regulations and the procedural norms, such as methods of sampling, inspection and testing. New regulations are brought out and implemented without even giving the producers in the exporting country a chance to become familiar with these. Often standards are available only in the language of the importing country or are presented in a very complicated manner. The result is that neither the exporters nor the export certification authorities are clear about the specific requirements that they need to meet or certify against. This has, at times, led to rejection at the point of import.

(iii) Imposition of Infrastructure Requirements

In building up export certification systems, in addition to end product criteria, a food safety assurance and management systems approach to include GMP/GHP/GAP/HACCP is increasingly being implemented in the food sector especially for more risk prone products such as marine, meat, poultry, egg and dairy products, etc. Under this approach, the focus is on assessment of hazards and establishing control systems which address preventive measures instead of relying primarily on end product testing for certifying health and safety aspects.

Although under this system, flexibility of implementation has been provided for, some countries are insisting on installation of specific infrastructural requirements such as milking machines for milk production, a large number of change rooms, flake ice machines, etc. by the exporters. The exporting country is thereby forced to cover the needs of each importing country. This has resulted in the whole concept of equivalence getting lost. Implementation of such systems at the primary production level becomes difficult in a country such as India, which has a large number of small farms with their own inherent systems.

(iv) Traceability/Product Tracing

Traceability/Product tracing is an important concept. Codex has adopted a definition of Traceability/Product tracing and is working on this in its various committees. In a large country like India, where farms are of small size and raw materials are procured by processing units or exporters through traders, the concept of Traceability/Product tracing to the farm is sometimes not possible. Export certification therefore takes into account the concept of equivalence and alternatively requires a strong raw material control system at the point of entry into the factory. Such concepts addressing the area of equivalence are sometimes not accepted by importing countries and these need to be specifically addressed in documents being developed by Codex on principles for the application of Traceability/Product tracing.

(v) Rejection and Destruction of Consignments

One would expect that with an export certification system based on international established guidelines, rejections should not take place at all, or even if they do, these should be absolutely minimal based on chance factors. However, it has been observed that rejections normally continue. An assessment of these rejections shows that on a number of occasions, the importing country is adopting different methods for sampling and testing and also testing for parameters/contaminants, which are not notified; which can become reasons for rejections.

Another increasingly important issue is that of destruction of consignments. Certain health authorities have recently started destroying contaminated consignments (either because of biological or chemical contamination) instead of returning them to the exporting countries as requested by the exporters/importers or even the Official Certification Body on the grounds that if the contaminant is harmful to one country it would be harmful to another. With the implementation of official export certification, return of consignments to the exporting country needs to be formally accepted, if desired by the exporting country so that it can, under its responsibility, take a decision on the fate of the consignment. It is important that, the competent authority of the exporting country has an opportunity to retest the consignments and ascertain whether it is contaminated and if so, analyze the cause before any decision is taken on destruction of the consignment. There have been instances of consignments having tested positive in one laboratory of the importing country and negative in another laboratory, or negative in the laboratory of the exporting country. Therefore, unless there is uniformity in methods of testing being followed, such rejections and destructions would not be justified. Further, in cases, where contamination can be taken care of through reprocessing as in the case of Salmonella contamination, the exporting country may decide to proceed with the same.

(vi) Non-recognition of Health Certificates of Export Certification Body

An issue that has recently been faced is non-recognition of 'health certificate' of the official export certifying body by the import control authorities in the importing countries. An example can be cited where an importing country insisted on a health certificate for egg powder by the Ministry of Agriculture in India and would not accept the health certificate of the official certifying body, namely Export Inspection Council of India, as the same was under Ministry of Commerce. As mentioned, the export quality was under control of EIC so the option was to either get an endorsement on the certificate by Ministry of Agriculture in India, which in effect would have no meaning or convince the importing country of the situation in the country. The latter course was the more logical one and is currently under discussion.

(vii) Accreditation of certification bodies as per international standards

World over, the requirement today is that certification bodies implement international criteria such as 'Codex Guidelines on Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems' (GL 26-1999), ISO/IEC Guide 65 for product certification, ISO/IEC Guide 62 for system certification etc. It is further necessary that these certification bodies are accredited against these standards. Implementation of such systems helps in building transparency in inspection and certification activities, bringing about clarity in the procedures being followed and overall strengthening the inspection and certification activities. The need to implement such formal systems has recently been felt with the initiation of agreements for recognition of the export certification. As a result, India has recently started working towards implementing such systems by its official export certification body and aims to further seek accreditation against international standards.

(viii) Strengthening laboratories

Export control and certification have to be supported by test facilities meeting the requirements of the importing country. By carrying out export certification against the requirements of countries such as the EC, India has been able to build up its test capabilities to test against the most stringent requirements. For example, while certifying marine products, egg products etc for the EC markets, veterinary drug residues had to be tested at less than 1 ppb levels, for which testing had to be done with HPLC MS MS. The equipment was procured and around 11 laboratories were strengthened in the first instance. All the laboratories being used, specifically for export testing, are now gearing up for accreditation against ISO 17025. Export certification has thereby led to strengthening test facilities and bringing them at par with those in the most developed countries.

(ix) Identifying areas that need to be addressed

A well-defined export certification activity has helped in identifying areas to be addressed to strengthen the food control activities in the country. For example, an assessment of the export control system by the European Commission for residues showed that although veterinary drug residues were being controlled in the processing units, control at the farm level was not very effective. The reason was that the Official Certification Body, under the Ministry of Commerce, did not have the legislative authority to implement controls at farm level. The Ministry of Agriculture, has authority over farms and the Ministry of Health over drug stores. It was necessary to develop coordination between the three ministries for effective control over the final end product. New legislation to cover all areas was developed and the flow of information between the Ministries of Health and Agriculture and EIC was strengthened. This has now led to effective controls on the use of veterinary drugs at farm level and also controls on veterinary drug stores leading to fewer rejections.

(x) Strengthening sectors of industry

Compulsory export certification has been gradually introduced in marine, dairy, egg products, poultry products, etc. In all these sectors, a systematic approach is mandatory. Before introduction of compulsory certification for exports, most processing units had not been implementing GMP/GHP/HACCP. However, due to the mandatory need for such systems, they started implementing the systems and the benefits became obvious to management in terms of workers following better hygienic practices, strengthened raw material controls, effective record keeping, training of manpower etc which led to overall improvement of quality and supporting systems. Today, the areas in which compulsory export certification has been introduced, has processing units that can match the best in the world.

(xi) Data Availability

Export certification has led to streamlining activities and systematic testing of products and raw material in production units as well as by the export certification body. Further, residue monitoring plans have been developed and implemented, which has resulted in considerable data generation. With such supporting data, it has become possible to take up issues at international fora as well as with importing countries on issues of rejections, SPS limits fixed by them etc.

(xii) Empowering Personnel

As a result of export certification, the weaknesses in the capabilities of personnel both in conformity assessment activities (inspection, certification and testing) as well as in processing units and at farm level have been observed and based on this, training needs identified with focus on developing and upgrading skills of not only officials with regard to certification and testing, but also empowering industry to implement quality and safety as per international requirements. A Human Resource and Quality Development Centre was established in EIC to intensify training activities. A pool of eighty trainers was initially created through an FAO project on 'Manpower Development in Food Safety and Quality' which was further utilized for training. This has resulted in not only empowering personnel within the country for inspection and testing, but has generally helped in creating awareness and knowledge on health and safety issues even within the industry.

5. SOME OBSERVATIONS ON EXPORT CONTROL SYSTEMS BEING IMPLEMENTED IN OTHER DEVELOPING COUNTRIES

Although guidelines have been established for the design, operation, assessment and accreditation of food import and export inspection and certification systems, many countries are not effectively using the guidelines. Some observations on the export control systems implemented in different countries are given below.

6. LESSONS TO BE LEARNT/IMPORTANT ISSUES OF FOCUS

6.1 For export, a clear policy needs to be developed taking into account issues like - are all exports to be controlled or specific products, type of parameters (health and safety or quality also), the need to build in any voluntary requirements along with mandatory ones, who would be the authority, what are the systems of inspection and certification to be followed, is the country looking at signing MRAs or equivalence Agreements for recognition of its export certification or is the aim only to ensure that a safe and good quality product is exported.

6.2 Transparency - All specifications, inspection and testing methods and procedures need to be documented. In fact, the entire inspection and certification system for exports needs to be documented. The operative part of the legislation needs to be clearly laid down in the form of regulations or executive instructions, and given to each inspecting official so that they are available at the point of use. All specifications, inspection and testing methods should also be accessible to interested parties overseas to enable 'transparency' in line with Article 7 of the SPS Agreement.

6.3 Self-certification by industry needs to be encouraged. Exporting units should be approved based on their following a total quality management approach i.e. implementing GMP/GHP/HACCP as well as conformance to the requirement of international specifications and those of the importing country. Periodic surveillance of the unit should be done wherein the aspects that need to be specifically checked include sanitation and hygiene of the plant, process control, implementation of HACCP plan, records, observation of testing in the laboratory of the plant, drawing of samples from various stages in the plant for testing. The certification should also take into account the varying requirements of importing countries so that rejections at importing end are reduced. This is one of the issues which have been expressed as being of concern to the exporters.

6.4 Legislation needs to be simplified to have a single legislation for food quality control preferably to include both export and import. This should contain clear defined roles of various authorities with a view to avoiding overlap.

6.5 Inspection systems followed by different inspection and certification agencies need to be aligned with ISO 17020/Guide 65 and the Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems.

6.6 Equivalence agreements - The importing governments should enter into equivalence agreements with governments of other countries for recognition of each other's food export inspection and certification systems in line with Article 4 of the SPS Agreement. Such Agreements would provide an enhanced means of assuring that exported foods conform to importing country's requirements, avoid duplication of activities and use collective resources more effectively and efficiently, provide a mechanism for cooperative exchange of expertise, assistance and information to help assure and enhance conformity with requirements. Such Agreements should include in addition provisions for transparency of legislation relating to specifications, sampling, inspection and testing methods etc; retesting and appeal in case of rejections; return of rejected consignments; technical assistance etc. Such Agreements would facilitate exports and reduce inspections and rejections of products in overseas markets.

6.7 Accreditation - A system of accreditation needs to be developed in all countries for both inspection bodies (ISO 17020) and certification bodies (ISO Guides 62 and 65) as well as laboratories (ISO 17025) and all organizations performing such activities would need to become accredited. This would result in much-needed credibility to inspection and certification activities.

6.8 Training - Personnel need to be trained within the country as well as overseas on a regular and systematic basis to bring about awareness on the scenario for inspection and testing in the country as well as the latest testing techniques, methods of sampling, risk analysis, HACCP, document and record control, auditing techniques, etc.

6.9 Computerization - All organizations need to be networked so that information can be coordinated and accessed by all organizations. Websites need to be developed to contain information on standards as well as export inspection and certification systems and procedures to enable transparency for internal and outside personnel.

6.10 Promotion and market development - These activities need to be strengthened to create a market for the country's products. Export promotion needs to be given priority and some schemes developed to assist exporters. These could be in terms of financial/technical assistance to exporting units to set up in-house laboratories with basic test facilities, for implementing ISO 9000/14000 or HACCP. A logo may be developed and brand promotion campaigns launched in various countries. Participation in trade fairs may be intensified.

6.11 Guidelines for Exporters/Importers - A guideline document for exporters needs to be developed which gives an overview of the system of exports and imports as well as broadly the role of different organizations as also clearly laid down steps which an exporter would need to follow for exports.

6.12 Capacity Building - Clear areas need identifying for 'Capacity Building' of domestic, import and export inspection and certification systems to meet international requirements to include:

• Laboratory strengthening in terms of equipment and training;

• Implementation of ISO/IEC 17020 for inspection activity, ISO/IEC Guides 62 and 65 for certification and ISO/IEC 17025 for testing;

• Human resource empowerment especially inspectors in area of inspection and audits;

• Using a systems approach in export certification.

Advantage needs to be taken of Article 9 of the SPS Agreement and technical assistance sought on these areas from importing developed partners.

6.13 In case of rejections, an export control body should enter into dialogue with importing authorities to resolve problems that may arise due to rejection of a consignment in the importing country. Issues due to rejections have been differing standards/conformity assessment procedures, lack of transparency etc. This would be facilitated as due to export certification, the entire data and background is available with the export certification body.

7. CONCLUSION

Although the significance of export certification systems have not been fully recognized by many countries, these can play a very important role in the present day scenario of rapidly expanding global trade in food. These would be useful for both importing and exporting countries and would help to utilize pooled resources more effectively while ensuring that the food exported is safe and meets the sanitary requirements of the importing country as well as any voluntary requirements, which can also be built into the system. However care needs to be taken that such export control systems are established based on the Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems.

FOOD IMPORT/EXPORT CONTROL AND CERTIFICATION IMPORT SYSTEMS OF THE UNITED STATES OF AMERICA

(Prepared by the United States of America)

Introduction

With the proliferation of movement of people, food and agricultural products between countries, food produced in one country increasingly ends up on the dinner table in another. This process is accelerating and expanding, evidenced and hastened by the multitude of cooperative relationships being pursued and established among countries.

Within the United States of America (U.S.A.), two federal agencies have the primary responsibility for assuring the safety of imported foods. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) enforces laws and regulations relating to meat, poultry, and egg products. The U.S. Food and Drug Administration within the Department of Health and Human Services (HHS/FDA) enforces the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which provide jurisdiction over all other foods. Both agencies are charged with protecting the health of consumers and assuring truthful labelling for the foods under their authority.

All food products imported into the U.S.A. are required to meet the same standards as domestic goods. To enter the U.S.A., imported foods must be pure, wholesome, safe to eat, produced under sanitary conditions, and must meet all U.S. standards including having informative and truthful labelling in English.

Due to differences in the attributes of products falling under their respective jurisdictions, the differences in the historical development of the agencies and in their underlying legal authorities, USDA/FSIS and HHS/FDA take different approaches to the regulation of food, including imported food products.

Food Safety and Inspection Service

Countries that export meat, poultry and egg products to the U.S.A. must have an inspection system equivalent to the U.S. system. Foreign countries undergo a comprehensive review process before they may be considered eligible to export to the U.S.A. To ensure equivalency, FSIS works collaboratively with the inspection service of the exporting government. While the meat, poultry and egg product regulatory systems of other countries need not be identical to the FSIS system, they must employ equivalent measures considered to provide the same level of protection against food safety hazards. FSIS makes two types of equivalence determinations: (1) determinations of initial equivalence (termed "eligibility") for countries that are not yet trading partners, and (2) determinations of whether equivalence is being maintained by countries already eligible.

The evaluation of a country's inspection system to determine initial eligibility entails a document review and an on-site audit. Through the document review, an evaluation is conducted of the country's laws, regulations and other written information detailing its controls in five risk areas: sanitation, animal disease, slaughter and processing, residue and enforcement. If the document review process yields an affirmative equivalency determination, a technical team will visit the country to make an on-site evaluation of the five risk areas, in addition to other aspects of the inspection system. This initial equivalency audit includes plant facilities and equipment, laboratories, training programmes and in-plant inspection operations. Such on-site audits are intended to verify that countries have implemented inspection programmes properly and, if not, to resolve differences and clarify requirements.

Once equivalence has been established, the foreign country is eligible to ship products to the U.S.A. It is important to note that FSIS does not conduct food inspections in other countries, nor does it certify individual foreign establishments for export to the U.S.A. After it is determined that a country has an equivalent food regulatory system, FSIS will rely on that system to carry out daily inspection and to certify individual exporting establishments.

To verify on-going equivalence, FSIS regularly conducts on-site audits of the eligible foreign inspection systems and re-inspection of products upon arrival in U.S. ports. The term re-inspection is used because, due to the FSIS equivalence requirement, all entering products have been inspected and approved by the exporting country's equivalent inspection system.

As a general matter, all products enter the country under the authority of U.S. Customs and Border Protection (CBP), Department of Homeland Security. Importers of any merchandise into the U.S.A. must file an entry form with CBP within five working days following the arrival of the shipment at a U.S. port-of-entry. For meat and poultry shipments, FSIS requires two additional documents-the original certificate from the country of origin indicating that the product was inspected and passed by the country's inspection service and is eligible for export to the U.S.A., along with an import inspection application and report. The CBP also requires the importer to post a bond, usually of an amount to cover the value of the shipment plus duties and fees. As a result, meat and poultry shipments remain under bond and subject to recall by the CBP until FSIS re-inspection occurs and the product is cleared for release.

Once the necessary documentation is provided, every shipment is given a visual inspection for appearance and condition and is checked for certification and label compliance. In addition, a centralized system linking all inspection activities, the Automated Import Information System (AIIS), assigns to import inspectors other types of inspection. These include product examinations and laboratory analyses for microbiological contamination and chemical residues. These testing programmes are modelled after the microbial residue testing plans for domestic products in the U.S.A.

If the shipment fails the re-inspection, it is refused entry by FSIS; and the frequency of inspection is increased for shipments of similar product from the same foreign establishment until a record of compliance is re-established.

When a shipment is refused entry to the U.S.A., the importer has several options. The shipment can be re-exported from the country, destroyed, or, in some cases, converted to animal food. In addition, importers are permitted to re-label products to bring them into compliance with U.S. requirements.

Food and Drug Administration

HHS/FDA regulates all foods (e.g. seafood, fruits and vegetables, dairy products) except meat, poultry, and certain egg products. To ensure that HHS/FDA is notified of all regulated products imported into the U.S.A., the importer, or his/her representative, must file an entry notice and an entry bond with the CBP, pending a decision regarding the admissibility of the product. HHS/FDA inspection and enforcement procedures for imports are closely coordinated with CBP.

HHS/FDA receives notification of all HHS/FDA-regulated entries through CBP. If HHS/FDA does not wish to examine the entry, the product is allowed to proceed into U.S. commerce. Any time a sample of an article offered for import has been requested by the HHS/FDA for testing, the owner or consignee shall hold the shipment and not distribute it until further notice is received regarding the results of the examination of the sample.

Generally, if HHS/FDA decides to examine an entry, an HHS/FDA investigator or inspector will collect a sample from the shipment for laboratory evaluation. If the analysis indicates the product is in compliance, the shipment may be released into U.S. commerce.

If, after HHS/FDA examination, it appears that the product is in violation, HHS/FDA issues a Notice of Detention and Hearing to the owner or consignee of the article, specifying a place and period of time whereby the individual may introduce testimony either verbally or in writing. Depending upon the nature of the apparent violation of the FD&C Act, the importer may be provided an opportunity to submit a petition to recondition the product to bring it into compliance. The owner or consignee may submit an application to HHS/FDA to re-label or perform other actions to bring the article into compliance or render the article into something that is not a food, drug, device, or cosmetic. An application for authorization to re-label or perform other actions to bring the article into compliance shall contain a detailed proposal, specifying the time and place where such operations will be carried out and the approximate time for completion as specified by regulation. All petitions to recondition a product are subject to HHS/FDA review and approval.

The FD&C Act, Section 801(a) provides for refusal of admission of any article that appears to be in violation of the Act. If the product is not brought into compliance and is refused admission, the importer is required to either re-export or destroy the article under CBP or other approved supervision within 90 days of the date of the issuance of the refusal. If the refused product is not destroyed or re-exported as required, CBP issues a notice for redelivery to the importer of record. Failure to redeliver the refused product may result in CBP assessing liquidated damages against the importer's bond.

In some instances a Notice of Detention and Hearing is issued for a product as soon as it is offered for entry into the U.S.A. without physical examination, based on past history and/or other information indicating the product may be in violation. A product may be subject to a detention without physical examination (DWPE) recommendation until the shipper, manufacturer or importer demonstrates the product meets HHS/FDA guidelines or standards.

Occasionally, HHS/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 usually are initiated when there are no other avenues for resolving the problem.

In addition to required import entry forms, certain products should be accompanied by the submission of additional information to facilitate processing and to assure compliance with applicable HHS/FDA regulations. For example, foreign manufacturers of low-acid or acidified low-acid canned foods (LACF) must register and file processing information before shipping their product to the U.S.A.. Providing HHS/FDA with the Food Canning Establishment (FCE) number of the manufacturing site as well as the Scheduled Process Identification (SID) number at the time of entry is strongly recommended.

To assure the expeditious handling of imported products, HHS/FDA has automated its import operations. By combining HHS/FDA's Operational and Administrative System for Import Support (OASIS) and CBP's Automated Commercial System (ACS), a HHS/FDA reviewer is able to more efficiently evaluate and process each import entry. The import filer transmits the required shipment-specific HHS/FDA data into the ACS. Within several minutes, the filer is notified that either the shipment has been released or HHS/FDA wishes to review it. This system provides HHS/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, manufacturers and importers.

Prior Notice

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires that HHS/FDA receive prior notice of food imported into the U.S.A., beginning on 12 December 2003. HHS/FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Nearly all of the current imported food shipments can comply by using CBP's Automated Broker Interface (ABI) of the ACS, and the rest by using HHS/FDA's Prior Notice System Interface (PNSI). Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to CBP when foods arrive in the U.S.A. Now, the Bioterrorism Act requires that this information also be provided to HHS/FDA in advance of an imported food's arrival to the U.S.A. HHS/FDA uses this advance information to determine whether to inspect the imported food. Failure to comply with prior notice requirements may result in refusal of the food. If refused, food must be held and cannot be shipped to the importer, owner, or consignee until prior notice requirements have been met.

Requiring Certificates for Importation of Food

Unlike FSIS, HHS/FDA does not require that countries exporting food to the U.S.A. supply certificates attesting to compliance with U.S. food safety laws and regulations. The HHS/FDA operates with the expectation that U.S. and foreign food producers and manufacturers will comply with U.S. safety requirements for the product in question, whether imported or produced domestically. Products found to pose a safety hazard or appearing to pose such a hazard, based on reliable information (e.g., testing of previous shipments of the food) are subject to refusal. Similarly, products that are not in compliance with U.S. labelling requirements and are thus "misbranded" also are subject to refusal.

Food products under HHS/FDA's jurisdiction that are entering the U.S.A. need not be covered by an equivalence determination. Although a country may seek an equivalence determination from the U.S., generally such a determination would confer small, if any, advantage in providing greater access to the U.S. market. Nor do food products under HHS/FDA's jurisdiction need to be accompanied by a certificate from the exporting country attesting to the safety of the product or compliance with U.S. requirements. Although certificates are not required for entry of HHS/FDA-regulated food products, HHS/FDA examines and tests the foods being offered for entry into the U.S.A. for food-borne hazards, whether chemical, microbial, or physical. HHS/FDA does require, by regulation, that seafood and juice products be produced under Hazard Analysis Critical Control Point (HACCP) systems, but neither needs export certificates from the government of the exporting country attesting to this fact as a condition for importation.

Conclusions

In the U.S.A., two federal agencies have the primary responsibility for regulating the import of food products. All food products imported into the U.S.A. are required to meet the same standards as domestic goods, and the historical development of the two regulatory agencies and their underlying legal authorities has led them to take different approaches to the regulation of imported food products.

Meat and poultry imports, regulated by FSIS, must originate from countries and facilities judged to have equivalent inspection systems to the U.S.A. and, thus, eligible to export to the U.S.A. HHS/FDA, which regulates all other food products, operates with the expectation that the foreign food producers and manufacturers will comply with U.S. safety requirements. If foods are not in compliance with U.S. requirements and present a public health hazard, both agencies will take swift and firm regulatory action to assure that such foods do not reach the U.S. consumer.

Points of Discussion

The Forum may wish to consider the following points regarding food import/export control and certification systems.

• This paper presents two different approaches for food import/export inspection and certification. Are there other models that countries find effective?

• Apart from resource constraints, are there significant difficulties that countries are experiencing with respect to their food import/export control and certification systems?

• Is there additional international guidance (e.g., additional Codex guidance on food import/export control systems) that should be developed on food import/export control and certification?

• What should be the role of an exporting country government in assuring that its products meet the requirements of an importing country?

• Are there areas where cooperative regional programmes can operate with respect to food import/export certification that can assist those countries that have limited resources to make their existing programmes more effective?

EPIDEMIO-SURVEILLANCE OF FOOD-BORNE DISEASES AND FOOD SAFETY RAPID ALERT SYSTEMS

(Paper prepared by the FAO/WHO Secretariat)

1. Introduction

An adequate and safe food supply is critical for normal growth and development and to maintain health across the life span. Although the true global incidence of food-borne diseases is difficult to estimate, it is clear that many people fall ill and die as a result of eating unsafe food. Surveillance of food-borne disease is an important tool for maintaining the safety of the food supply. It is instrumental in estimating the burden of food-borne diseases, identifying public health priorities, evaluating disease prevention and control programmes and assessing the relative cost of control measures. It allows rapid detection and response to disease outbreaks and helps identify emerging food safety issues and research needs. In addition, it is a major source of information for conducting risk assessment as part of the new risk analysis framework. Within this framework surveillance data is of paramount importance for conducting a risk assessment and eventually for formulating risk management options and implementing risk communication (1).

Countries differ in their public health systems, giving rise to a wide variation in national surveillance systems including surveillance systems for food-borne diseases. Notably, in many countries the disease surveillance systems do not necessarily focus on food-borne diseases. This paper provides a description of the important aspects of a well-functioning food-borne disease surveillance system including its link to rapid alert systems in the food safety arena. For the purpose of this paper food-borne disease surveillance is defined as the ongoing systematic collection, collation, analysis, interpretation and use of information relevant to the assessment, prevention and control of food-borne disease. This includes epidemiological and microbiological information about pathogens and toxins in food animals and foods, sometimes referred to as monitoring (1).

2. National Surveillance Systems for Food-borne Diseases

There are various levels of intensity and coordination in national surveillance systems. Surveillance can be active or passive, general or sentinel, continuous or intermittent, disjointed or integrated. In general, the intensity of surveillance is a product of social (i.e. priority of disease, societal impact), practical (i.e. availability of epidemiological knowledge) and financial factors. The main objectives of food surveillance are detection of contamination, evaluating control interventions, and monitoring the progress towards a control objective and programme performance. However, surveillance is not merely a routine measure of the current situation (as opposed to monitoring), but a basis for giving qualified feedback to producers, tracing back contamination to its origin, pin-pointing critical (control) points during production and initializing response actions (2).

Many Member States maintain surveillance systems for communicable diseases, which are collaborative efforts based on passive or active surveillance systems and often include a requirement for mandatory reporting of specific diseases and the pathogens that cause them. Many of these existing surveillance systems have the capacity to detect clusters of food-borne disease, provided the cluster is large enough and the effects severe enough to cause people to seek medical attention. However, the focus of these systems is communicable diseases, and their capacity to detect and investigate food-borne illness rapidly may be limited (3).

A number of Member States already maintain surveillance systems to detect and investigate food-borne illnesses caused by food-borne pathogens. In many cases these systems are passive and rely on reporting by laboratories or physicians. Statistical analysis of information from such systems can reveal unusual clustering of illnesses by time or geographical area as compared with baseline values. Unfortunately, passive surveillance systems result in underreporting of disease, because only a small fraction of ill people seek medical care or submit samples for laboratory analysis. Furthermore, laboratories only test for a limited number of disease-causing agents and thus report only selected information to health officials (3). In most cases, hospital laboratories are not equipped to analyze for chemical contaminants present in food. This, in combination with the fact that most diseases caused by chemical contaminants result in nonspecific symptoms, leads to a situation where the burden of disease estimates obtained from most surveillance systems do not include estimates on the part of the disease burden that is related to chemical hazards in food.

Some countries maintain active food-borne disease surveillance systems to determine the burden of disease from food-borne pathogens more accurately. England, the Netherlands and the United States were among the first countries to conduct special studies to understand the disease burden attributable to food-borne pathogens. Following this 'first generation' of studies, a number of other countries, including Australia, Canada and Ireland, launched similar studies. Studies from all these countries fall into two general designs: (i) prospective cohort studies with community etiology components or (ii) cross sectional surveys with or without supporting targeted studies. Although the design determines specific outcomes, all of these studies share the same overarching goal of defining the magnitude of acute gastrointestinal illness by taking into account under ascertainment and determining the proportion of acute gastrointestinal illness attributable to food. Researchers from each of these countries continue to work together closely, sharing research tools, reviewing and analyzing data and discussing future research goals. These active surveillance systems increase the timeliness of information and provide information on the baseline incidence of food-borne illness, which is needed to measure the effectiveness of control measures (4).

Most national surveillance programmes aimed at ensuring that food does not contain unacceptable levels of contaminants are designed to measure selected chemical contaminants in a variety of raw agricultural commodities. Since the concern for chemical contamination is chronic disease and not acute illness, surveillance for chemical contaminants focuses on ensuring that the level of contaminants is below a predetermined maximum allowable limit rather than linking the contaminant level to an acute illness. When chemical contaminates are below the maximum allowable limit, consumers can be assured that the product has been produced according to good agricultural practices and their exposure to the chemical contaminant will be below the established acceptable daily intake level.

3. Globalization of the Food Supply: The Need for Global Surveillance

By virtue of the international nature of travel and trade, food safety has increasingly become a global issue. There have been many documented cases of contamination of food from one country causing significant health effects in other parts of the world (3). Couple the massive global trade of food and animal feeds with other factors affecting the global food supply and safety such as population growth, poverty, adverse climatic and social events; and the need for a globally coordinated strategy to control food illnesses becomes acutely apparent.

Concerns about the global spread of food-borne disease can best be addressed through strong surveillance systems, renewed commitment to public health, and strong international partnerships that strengthen national efforts of food-borne disease prevention and control. In view of the disparity among national surveillance systems, partnerships in global surveillance are a logical starting point.

4. The Role of the World Health Organization (WHO) in Food Safety Surveillance

4.1 Mandates and Regulations

To be effective, global surveillance must be free of political bias. Global surveillance requires a neutral reporting and response environment. WHO is the international health organization with a primary mandate to protect public health and to provide technical assistance and advice to Member States on all health issues. In 1969, WHO adopted International Health Regulations (IHR) after agreement by the international community. These regulations represent the only regulatory framework for global public health security. The IHR prevent the international spread of infectious diseases by requiring national public health measures that are applicable to travellers and products at the point of entry. While the current IHR require Member States to notify WHO only of all cases of cholera, plague and yellow fever; the IHR are undergoing revision to meet the increasingly complex risks of existing and emerging infectious diseases. The revisions proposed include a requirement to notify WHO of all public health emergencies of international concern. In view of the need to contain disease and public health risks at their origin and to minimize international control measures, Member States would be obliged to identify and control all events of international public health importance, including infectious and non-infectious diseases as well as unacceptable levels of microorganisms, toxins and chemicals in food (3).

The new proposed IHR will provide guidelines for implementing the required surveillance and response programmes for public health emergencies. Essential elements of the programme include rapid detection and reporting of public health emergencies, verification and preliminary control measures and response capacity, including notification to WHO of events or risks of international significance. This includes notification of a need for assistance to contain or control further spread of the contamination, and for travel and traffic restrictions on the movement of people, conveyances and goods including food, plants and animals. Information and recommendations developed by WHO will serve as a guide for responses appropriate to the actual health risk (3).

In 2000, the 53rd World Health Assembly (WHA) adopted a resolution to recognize food safety as an essential public health function and called for the development of a Global Strategy for reduction of the burden of food-borne diseases. The resolution WHA 53.15 encouraged Member States to implement and keep national, and when appropriate, regional mechanisms for food-borne diseases surveillance. In 2002, WHO published a Global Strategy for Food Safety (5). The overall objective of this strategy is to strengthen surveillance of food-borne disease to provide Member States with the data necessary to reduce the burden of food-borne disease.

4.2 Global Initiatives to Enhance Surveillance on Food-borne Illnesses

A recent WHO Expert Consultation defined four surveillance categories (No formal surveillance, Syndromic surveillance, Laboratory-based surveillance, Integrated food chain surveillance) and discussed the feasibility of establishing sentinel surveillance in regions lacking reliable food-borne disease estimates. The attributes of each of these four surveillance systems are summarized in Table 1. Following this Consultation, studies on the burden of food-borne disease in developing countries were initiated. Jordan has been selected as the first sentinel site for this project and the selection of additional sites is underway^[18](6).

Table 1. Surveillance systems in relation to the assessment of the burden of disease

Table adapted from (6).

4.3 Global Food Surveillance Programmes

In order to engender the political will required to initiate and sustain a strategy to reduce food-borne disease, the magnitude of the problem must be determined. Global surveillance information can also be used by countries to perform rapid risk assessments and prioritize food safety needs. WHO has implemented a number of sentinel site programmes to develop special studies in regions currently lacking good data on food-borne illnesses and has created a network connecting countries involved in these surveillance activities related to acute gastrointestinal illnesses. One of the global programmes designed to strengthen surveillance of food-borne disease is Global Salm-Surv. Global Salm-Surv is a laboratory based surveillance system that has been operational since January 2000. It consists of a network of institutions and individuals involved in Salmonella surveillance, serotyping and antimicrobial resistance testing. This programme, initiated by the WHO, the Danish Veterinary Laboratory (DVL) and the Centers for Disease Control and Prevention (CDC) and now also supported by the Institute Pasteur, United States Food and Drug Administration, Health Canada and Wageningen University; endeavours to reduce the global burden of food-borne disease by strengthening national and regional surveillance and response activities (7). The WHO Global Salm-Surv external quality assurance system (EQAS) is an important step toward improving the quality of Salmonella serotyping and antimicrobial susceptibility testing worldwide (7). The core elements of the Global Salm-Surv programme include regional training workshops, a moderated electronic discussion group, an external quality assurance system, a country databank of annual Salmonella surveillance summaries, a web site http://www.who.int/emc/diseases/zoo/SALM-SURV/index.html and reference testing services. Training workshops for microbiologists and epidemiologists have involved numerous representatives from almost 100 countries from all six WHO designated regions.

WHO also monitors and performs exposure assessments of chemical contaminants in food. The WHO Global Environmental Monitoring System/Food Contamination Monitoring and Assessment Programme (GEMS/Food) provides information on the concentration of chemical contaminants in food, their contribution to total human exposure and their significance for public health and trade. GEMS/Food provides baselines of chemical contaminants in food that may be used to assess contamination. The Programme is an important component of the global risk assessment of chemicals in food and provides exposure assessments that form part of the basis for setting national and international food safety standards. GEMS/Food maintains a network of WHO Collaborating Centres, national focal points and participating institutions located in over 70 countries. It maintains links with international organizations such as Food and Agriculture Organization of the United Nations (FAO), the International Atomic Energy Agency (IAEA), the United Nations Environment Programme (UNEP) and nongovernmental organizations such as the International Union of Food Science and Technology (IUFoST) and the International Union of Pure and Applied Chemistry (IUPAC)(3).

4.4 Global Outbreak Alert and Response Systems

Under the WHO Programme on Global Alert and Response, WHO has established a mechanism for providing accurate and timely information about important disease outbreaks. This information is delivered systematically and rapidly to key professionals in international public health through the international networks for specific disease surveillance including FluNet for influenza, RabNet for rabies, Global Salm-Surv for salmonellosis and DengueNet for dengue (3).

Outbreak verification is a new approach to global disease surveillance that aims to improve control of epidemics by active collection and verification of information on reported outbreaks. Verification of outbreaks is based on a broad range of sources of information, including the Global Public Health Information Network (GPHIN). GPHIN is a Web-based electronic system developed by Health Canada in collaboration with WHO, which scans the Web to identify suspected disease outbreaks. The suspected outbreaks are followed up with the affected countries to verify the existence of the epidemic, its cause and the control measures being taken. The information is then disseminated via the outbreak verification list to over 900 institutions and key decision-makers in international public health, such as WHO Collaborating Centres, national institutes of public health and the major non-governmental organizations. Since 1996, over 500 outbreak reports have been investigated and the information disseminated when it was found to be of international public health importance. WHO offers assistance in all cases (3).

The WHO Global Outbreak Alert and Response Network (GOARN) provides immediate public health assistance for the containment of disease outbreaks. The Network provides a coordinated mechanism for outbreak alert and response. It consists of a technical partnership between institutions and networks and complements existing systems. Its role is to combat the international spread of outbreaks by rapid identification, verification and communication of threats, leading to a coordinated response. It ensures that appropriate technical assistance reaches the affected Member State rapidly, minimizing the health impact of the outbreak and preventing further spread of disease. WHO responds to requests from Member States for assistance in outbreak management by fielding special teams of experts. Recent examples of outbreaks in which WHO participated directly in the field include: Rift Valley fever in Kenya and Somalia, monkey pox in the Democratic Republic of Congo, avian influenza (H5N1) in Hong Kong (China)(3).

4.5 Improving Global Food Safety through an International Food Safety Authorities Network (INFOSAN)

In addition to providing necessary information for monitoring outbreaks of food-borne diseases and evaluating control measures, global surveillance can serve as an early warning system for food outbreaks and provide the rationale for public health intervention including the cessation, and resumption, of trade. Early detection of food-borne diseases and immediate public health intervention can not only limit the number of illnesses and deaths, but also lessen the negative effects on international travel and trade. Global food-borne disease surveillance and response is a decisive element in maintaining public health and facilitating trade of food, plants, animals, and animal products (8).

WHO, together with FAO, is now enhancing its ability to respond to food-borne disease emergencies by establishing an International Food Safety Authorities Network (INFOSAN), an information network for the dissemination of important information about global food safety issues. In January 2003, WHO identified the need for a food safety network to complement and support the existing WHO information and response programmes. INFOSAN is designed to enhance the ability of the GOARN Network to combat the international spread of food-borne disease by rapid identification, verification and communication. Embedded in INFOSAN is INFOSAN EMERGENCY, this food safety emergency network will help to minimize the health impact of food-borne disease outbreaks and prevent further disease spread by an implicated food (8).

Each participating country will have one or several INFOSAN Focal Points. The INFOSAN Focal Points are expected to receive INFOSAN information and disseminate it. Several INFOSAN Focal Points may be identified in countries where responsibilities are divided among several food safety authorities, including those involved in food legislation, food control and management, food inspection services, laboratory services for monitoring and surveillance, and information, education and communications, across the so-called farm-to-fork continuum (8).

Each country will have one dedicated INFOSAN EMERGENCY contact point that, in addition to receiving the general information, will be activated to deal with major international incidents involving an imminent risk of serious injury or death to consumers. INFOSAN EMERGENCY will be used to alert food safety authorities to food-borne disease outbreaks or food contamination events of international significance. The INFOSAN EMERGENCY Contact Point will be expected to accept some notification and response responsibility and to facilitate the communication of urgent messages during food safety emergencies. INFOSAN EMERGENCY will be closely linked to the GOARN Network (http://www.who.int/csr/sars/goarn/en/index.html) at both the national and international levels. INFOSAN and INFOSAN EMERGENCY are limited to government entities or entities appointed by government (8).

5. The Role of Surveillance in Assessing New Technologies and Emerging Risks

Many countries have well developed, established surveillance systems for monitoring food and the environment for chemical contaminants such as dioxins, PCBs, heavy metals and residues of pesticides and veterinary drugs. Surveillance systems directed at food-borne pathogens are more recent as are microbiological risk assessments and pathogen reduction programmes. The development of a comprehensive food safety surveillance framework not only enables the continued assurance of food safety regarding known chemicals and pathogens, but provides a mechanism to protect against emerging hazards.

The application of modern biotechnology to food production presents new opportunities and challenges for human health. The potential benefits to consumers include enhancing the nutrient content of foods, decreasing their allergenic potential, and improving the efficiency of food production. On the other hand, the potential effects on human health of the consumption of food produced through genetic modification must be carefully examined. Modern biotechnology must be thoroughly evaluated if it is to bring about a true improvement in our way of producing food. Having a fully functioning, global food safety surveillance network will provide an added measure of confidence to consumers across the world that the safety of food produced by genetic engineering is being monitored.

Antimicrobial agents are essential medicines for human and animal health and welfare. The development of antimicrobial resistance is a global public and animal health concern that is impacted by both human and non-human antimicrobial usage. A comprehensive food safety surveillance framework will not only be capable of the monitoring food-borne pathogens but will be capable of determining the development of antimicrobial resistance in these pathogens when it is associated with the use of antimicrobials in agriculture and veterinary medicine. This information is critical for determining risks associated with the development antimicrobial resistance for specific microorganism-antimicrobial combinations and for developing risk management options aimed at reducing the risk associated with the use of antimicrobials in agriculture and veterinary medicine.

6. Food Surveillance to Detect the Malicious Intentional Contamination of Food

The intentional malicious contamination of food is not a new threat. However, the centralization of food production and the widespread distribution of food enhances the potential public health impact of intentional food contamination. The potential impact on human health of deliberate sabotage of food can be estimated by extrapolation from the many documented examples of unintentional outbreaks of food-borne disease. The largest, best-documented incidents include an outbreak of S. typhimurium infection in 1985, affecting 170 000 people, caused by contamination of pasteurized milk from a dairy plant in the United States of America. An outbreak of hepatitis A associated with consumption of clams in Shanghai, China, in 1991 affected nearly 300 000 people and may be the largest food-borne disease incident in history. The number of people impacted by an intentional contamination incident is likely to be considerably higher.

In 2002, WHO published a report on "Terrorist Threats to Food: Guidance for Establishing and Strengthening Prevention and Response Systems" (3). This report identified two major strategies for countering the threat of food sabotage, i.e., prevention and response, including preparedness. According to the report, the key measures needed to prevent food terrorism include the establishment and enhancement of existing food safety management programmes and the implementation of reasonable security measures. Detection of the food contamination is needed to activate a response.

The main requirement for rapid detection of covert or overt acts of food terrorism is a surveillance system with the sensitivity to rapidly identify small clusters of food-borne illness. Such systems permit identification of disease outbreaks, whether intentional or unintentional, but do not necessarily permit the identification of the disease or its mode of transmission. Strong national surveillance systems provide information on the expected frequency and size of various disease outbreaks, thus providing a baseline for identifying unusual clusters that might herald a terrorist incident. Early detection of disease resulting from food terrorism will depend upon sensitive general surveillance systems for communicable disease at local and national levels, with close cooperation and communication among clinicians, laboratories and public health professional. Once food terrorism is detected, there is a need to activate response systems including verification of the threat, management of the consequences by aiding the affected population, identification and removal of the food from sale and management of the social, political and economic consequences of the act (3).

The report concluded that effective preparedness for food terrorism requires both strengthening of the general public health surveillance and improving coordination and communication among the sectors responsible for an emergency response. The lack of integrated surveillance, epidemiological and laboratory activities and lack of preparedness planning for emergency response in many developing countries are still significant obstacles to effective detection and response to threats posed by the deliberate as well as unintentional introduction of hazardous agents into food (3). The assistance of WHO and FAO can help prevent, quickly detect and mitigate the effects of food terrorism, as well as the effects of unintentional food-borne outbreaks and contamination events. The new INFOSAN network is intended to support this work.

7. Concluding remarks

Both industrialized and developing countries can best address concerns about food-borne disease including those from new technologies and intentional acts of terrorism through strong surveillance systems, renewed commitment to public health and strong international partnerships. There is a need for a common high standard of food safety to protect consumers worldwide. Surveillance programmes serve as a tool for monitoring and continuous improvement of food quality through detection of food-borne illnesses or contamination in food production and initiation of appropriate responses. Since the challenge is to produce safe food at affordable prices, surveillance programmes need to be sensitive, sensible and cost efficient. Currently, the infrastructure and capacity needed to efficiently coordinate and operate national food-borne contaminant and food-borne disease surveillance programmes varies among countries worldwide. International organizations have a major role to play in promoting integration of food safety surveillance at the national and international level.

The WHO and FAO have a critically important roles to play in food safety at the international level. The WHO, in many cases in direct collaboration with FAO, functions to implement the International Health Regulations (IHR); coordinate worldwide disease surveillance networks; and coordinate international responses to communicable diseases. FAO and WHO work to assess the health risks associated with chemical and biological agents and radio nuclear materials and the potential to mitigate such risk as well as support the development of food safety infrastructure in Member States. These functions place these organizations in a unique position to play a key role in: 1) the coordination of global surveillance for food safety emergencies; and 2) the facilitation of responses to food emergencies of international significance to human health; and 3) the provision of technical assistance for national preparedness and response. The development of INFOSAN and INFOSAN Emergency will enhance the efforts of WHO and FAO in providing the world with a safe food supply.

8. References