APPENDIX IX - Working papers of the Second Global Forum of Food Safety Regulators

STRENGTHENING OFFICIAL FOOD SAFETY CONTROL SERVICES

(Paper prepared by the FAO/WHO Secretariat)

Introduction

Food safety is a major element of public health and an important determinant of food trade. It involves a number of stakeholders, including primary producers, food handlers, processors and traders along the food chain, official food control services, and consumers. The official food control services play a key role in ensuring that food is safe and suitable for human consumption. They also have an impact on the organization and activities of other stakeholders.

The role of official food control services must be analysed within the framework of a national food control system, the elements of which are presented in the first part of this paper. Different types of existing organizational structures of official food control services are described and discussed. Next, the paper explores ways to improve the management and effectiveness of official food control services. Finally, the paper discusses some specific issues related to food control services in developing countries.

Some important issues which have been selected as subjects of specific topic papers will be only briefly mentioned in this paper.

1. ELEMENTS OF A NATIONAL FOOD CONTROL SYSTEM

While the components and priorities of a food control system will vary from country to country, most systems will typically comprise the following components.

1.1 Food law and regulations

The development of relevant and enforceable food law and regulations is an essential component of a modern food control system. To the extent possible, modern food laws not only contain the necessary legal powers and prescriptions to ensure food safety, but also allow the competent authorities to build preventive approaches all along the food chain.

In addition to food laws and regulations, governments need updated food standards. They should take full advantage of existing Codex standards, guidelines and recommendations and of food safety lessons learned in other countries. They must tailor available information, concepts and requirements to the national context, so as to develop a regulatory framework that will both satisfy national needs and meet international obligations and trading partners' demands.

The efficiency of food safety official and non-official control depends on the pertinence of the food law and regulations. This subject will be discussed under Agenda Item 4.2 - Topic paper 1.2 presented by South Africa (GF 02/5a).

1.2 Food control management

Effective food control systems require policy and operational co-ordination at the national level. They would include the establishment of a leadership function and administrative structures with clearly defined accountability for issues such as:

• the development and implementation of an integrated national food control strategy;

• operation of a national food control programme;

• securing funds and allocating resources;

• setting standards and regulations;

• participation in international food control related activities;

• developing emergency response procedures;

• carrying out risk analysis, etc.

Core responsibilities include:

• establishing regulatory measures;

• facilitating continuous improvement; and

• providing overall policy guidance.

1.3 Official control services (inspection services)

While the responsibility for the supply of safe food is shared by all involved in the production, processing and trade along the entire food chain, the official control services are responsible for the enforcement of food safety legislation. By inspecting food, premises and processes, they prevent the trade of unsafe food.

The food inspector is the key person who has day-to-day contact with the food industry, trade and often the public. He must be qualified, trained, efficient and honest. The training of staff of official food safety control services will be discussed under Agenda Item 4.3 - Topic paper 1.3 presented by France (GF 02/6).

As modern food control systems have shifted from removing unsafe food and punishing responsible parties after a problem has occurred, towards a preventive approach, industry and trade should develop and implement in-plants control based on HACCP to the extent that capacity, experience and resources permit. This leads food inspectors to foster the implementation of HACCP and to conduct risk based audits. This subject will be discussed under Agenda Item 4.4 - Topic paper 1.4 presented by Thailand (GF 02/7).

The responsibilities of the official food control services also include inspection, sampling and certification of food for import/export control. This matter will be discussed in detail under Agenda Item 4.5 - Topic paper 1.5 presented by India and the USA (GF 02/8a and 8b).

1.4 Laboratory services: Food monitoring and epidemiological data

Laboratories underpin decisions of food control services. Besides, their analytical results are often used as evidence in court law or in dispute between exporting and importing countries. Therefore, they must ensure that their analyses are performed in an effective and efficient way. This depends in particular on the equipment available, the qualification and skills of the analyst and the reliability of the method used.

Furthermore, it is essential that effective linkage be established between food control laboratories and the public system. In this way, information on food-borne diseases may be linked to food monitoring data, and lead to appropriate risk-based food control policies.

1.5 Information, education, communication and training

An increasingly important role for food control systems is the delivery of information and advice to stakeholders across the farm-to-table continuum. These activities include:

• the provision of balanced factual information to consumers;

• the provision of information packages and educational programmes for key officials and workers in the food industry;

• development of train-the-trainer programmes;

• provision of reference literature to extension workers in the agricultural and health sectors.

2. ORGANIZATIONAL STRUCTURE FOR NATIONAL FOOD CONTROL SYSTEMS

Given the wide scope of food control systems, there are at least three types of organizational arrangements that may be appropriate at the national level. The system may be based on:

• multiple agencies responsible for food control;

• a single and unified agency for food control;

• a national integrated approach.

2.1 Multiple agency system

In this case, sectoral initiatives have resulted in the establishment of separate food control activities by different agencies responsible for the various sectors, such as meat and meat products, fisheries, fruits and vegetables. In the same country, they may come under different government ministries, such as health, agriculture, commerce, environment, trade and industry, tourism, and the roles of each of these agencies are specified but quite different.

(a) Drawbacks of multiple agency system

A system in which several agencies are involved in food safety control usually leads to a duplication of regulatory activities, affecting negatively the efficiency of the system. In addition, it may also result in:

• lack of consistency of regulations between different sectors, such as level of hygienic provisions not directly related to the level of risk;

• frequent confusion over jurisdiction and resultant inefficiency in performance;

• gaps in the coverage of food safety control activities.

In general there is a lack of co-ordination at national level and subsequently at the level of the different bodies involved in food policy monitoring and control of food safety. Thus, in one food-producing establishment, food safety aspects may be controlled repeatedly by different agencies, while another establishment remains unknown by control services.

Furthermore, even if food safety is a predominant objective of each agency, most of the agencies have other responsibilities which may compete in terms of resources and priorities with food safety programmes. Examples of such additional responsibilities include:

• protection of the consumer against fraudulent practices; control of weights and measures, etc.

• control of all consumer goods, in addition to food;

• control over pharmaceutical products, in addition to food;

• responsibility for the development of the food sector;

• prevention of food losses and conservation of natural resources;

• promotion of export trade.

Achieving the necessary balance between food safety control and other responsibilities can be difficult, but not impossible.

(b) Strengthening multiple agency systems

Despite the above drawbacks and for various historical or political reasons, many countries have maintained these multiple agency systems and introduced important improvements to increase their efficiency.

· Sharing responsibilities

The first step towards improvement is the development of a national food safety strategy. Within this framework, the responsibilities and tasks of different agencies must be defined. This matter will be discussed in detail under Agenda Item 4.1 - Topic paper 1.1 presented by Ireland (GF 02/4).

It is essential to determine which aspect of food safety control each agency is in charge of, keeping in mind the need to cover all stages of the food chain and within each stage, different aspects of food safety control.

The food chain includes production of food of plant and animal origin, post-harvest treatment, processing and handling of food at wholesale, retail and household levels. All these elements must be covered, although the activity of the agencies at the household level is limited to consumer information and education. Control of each of these stages implies control of important related fields. For example, control of food of animal origin implies control of animal health, in particular zoonoses, of feed and of veterinary medicine.

If all controls at the level of an establishment cannot be carried out by a single agency, it is important to clearly determine which control is done by which agency; for example, at a meat processing plant, which agency will be responsible for the control of:

• prior approval of the establishment, if needed;

• hygiene of premises, equipment, staff and handling;

• health of worker;

• water suitability;

• finished goods, etc.

While overlapping is sometimes inevitable, it is essential to ensure that such overlapping is minimal and, more importantly, that there are no gaps in the coverage of the control system.

Once determined in the food safety strategy, the responsibilities of the various agencies must be clearly defined in the legislation, as well as in the administrative and penal competence of their respective inspectors.

· Intra-agency co-ordination

Agencies that are also entrusted with missions other than food safety control, must clearly determine their objectives in each field as well as the means they allocate to each mission. People in charge of food safety in the agency need to know the resources available to them in order to organize their activities.

Where there may be conflict of interest between food safety control and another responsibility of the agency, these two activities have to be well identified and separate in the organizational chart. Procedures are drawn up in order to avoid that any decisions on food safety are altered by considerations that may be legitimate, but that challenge the human health objective.

The consequences of conflict of interest also have to be addressed in a longer-term. Staff working in food safety control should not run the risk of endangering their chances of promotion due to the negative effect of their decision on another objective of the agency, such as promotion of a food sector or export trade.

· Inter-agency co-ordination

All agencies involved in food safety control in a country should co-ordinate their activities. Even outside an integrated system there can and must be some co-ordination among agencies at least in fields where there is a sharing of responsibilities. Some agencies may decide to co-ordinate their activities on a particular part of the food chain. This should be formalized by a document that the staff of the concerned agencies are informed of.

It is vital that agencies in charge of public health and food safety monitoring programmes exchange their data. Food monitoring data are necessary for the understanding of the epidemio-surveillance of food-borne diseases, and results of the epidemio-surveillance have to be taken into account in setting up food monitoring programmes.

Where the food control system is fragmented among state and local bodies, the concerned agencies should exchange information on approaches and experiences to harmonize their intervention so that consumers receive the same level of protection throughout the country.

2.2 Single agency system

(a) Advantages

The consolidation of all responsibilities for protecting public health and food safety into a single food safety agency, with clearly defined terms of reference, has considerable merits. The benefits include:

• harmonization of food standards, and uniform application of protection measures at all the links of the food chain;

• ability to act quickly and consistently at all the concerned links of the food chain in order to efficiently protect consumers, respond to emerging challenges and the demands of the domestic and international marketplace;

• improved cost efficiency and more effective use of resources and expertise;

• provision of more streamlined and efficient services, benefiting industry and promoting trade.

(b) Competence scope

Whereas the idea of a single agency system is quite appealing, it is unrealistic to recommend a single organizational structure that will universally meet the requirements and resources of every country's socio-economic and political environment. The decision has to be country specific and all stakeholders should have the opportunity to provide inputs into the development process.

A single unified agency for food control is firstly a risk management body. Nevertheless, it may be interesting to also entrust it with risk assessment and/or risk communication functions. Risk assessment (especially in a proactive manner) and risk communication can be more mutually supportive. Indeed, this may:

• facilitate communication between risk assessors and risk managers - they both will share the same perception of actual and potential risks, risk assessors could acquire an immediate knowledge of the signals originating from the inspectors in the field;

• improve the consistency of activities in risk assessment, management and communication.

On the other hand, a single agency system pools staff and resources which permits a more efficient and less costly management.

However, it is important to keep in mind that risk assessment must be carried out by independent experts in a functional framework where risk assessor and risk manager tasks are clearly separate. Therefore, within the single unified agency, risk assessment must remain distinct from risk management in terms of functionality and responsibility.

Food safety risk management includes different activities from defining standards to enforcing them. While enforcing standards is typically the task of a food control agency, the level at which this agency is involved in the setting of standards requires careful consideration.

Food safety control is often related to several other fields of control; one of the main issues is to determine the limits of the food safety control agency's competence. As food quality is closely related to food safety, the agency is also obviously responsible for food quality control. However, food quality includes a number of aspects, such as ingredients, nutritional value, additives, labelling, organic food, marks of quality, protected geographical indication, etc. and it is important to clearly determine the role that the agency may have in food quality control.

Depending on the country situation and priorities, food safety and quality control may benefit from synergies with control of plant protection, animal health (beyond zoonoses) and welfare, feedstuffs, veterinary medicine, and other non-food products. In this case, the inclusion of some of these fields in the agency competence should be considered.

2.3 Integrated system

An integrated food control system is a halfway mark which warrants consideration where there is desire and determination to achieve a consistent and co-ordinated approach across the-farm-to-table continuum without merging all the agencies concerned. Typically, the organization of an integrated food control system would have several levels of operation:

• Level 1: Formulation of policy, development of standards and regulations;

• Level 2: Co-ordination of food control activity, monitoring and auditing;

• Level 3: Inspection and enforcement;

• Level 4: Communication, education and training.

In reviewing and revising their food control system, governments may wish to consider a model which calls for the establishment of an autonomous national food control agency which is responsible for activities at Levels 1 and 2, with existing multisectoral agencies retaining responsibilities for Levels 3 and 4. The advantages of such a system include:

• coherence in the national food control system with uniform application of control measures across the whole food chain throughout the country;

• politically more acceptable as it does not disturb the day-to-day inspection and enforcement role of other agencies;

• better equipped to deal with international dimensions of food control such as participation in work of Codex, follow-up on SPS/TBT Agreements, etc.;

• encourages transparency in decision-making processes, and accountability in implementation; and

• is more cost-effective in the long term.

The role of such food control agency is to establish national food control goals, and put into effect the strategic and operational activities to achieve these goals. Other functions may include:

• commissioning of food safety risk assessment;

• revising and updating the national food control strategy;

• advising relevant ministerial officials on policy matters, including determination of priorities and use of resources;

• supporting research and development;

• developing consumer education.

3. MANAGEMENT OF FOOD SAFETY CONTROL SERVICES

The efficiency of food control services depends very much on the way in which they are managed. This, in turn, is a reflection of the professionalism of the staff involved, the legal framework in which they operate and the means available to them to perform their duties. This paper will deal only with the management side; the other aspects will be covered in the following topic papers.

The basic function of food control services consists of inspection and control. This represents a huge number of punctual checks of many kinds of items by many different people, and in different part of the country. The management team has to organize these scattered activities to improve their consistency and efficiency. Management of inspection and control implies:

• harmonization of tasks;

• planning and programming;

• preparation of administrative documents;

• monitoring of activities and situation; and

• crisis management.

3.1 Task definition and harmonization

The results of an inspection depends much on the way it is carried out. In order to ensure the same level of consumer protection all over the country and to avoid distortion among establishments in the impact of regulatory disposition, it is necessary to harmonize the conducting of the inspection and control.

(a) Harmonized procedure of inspection and control

In the absence of a well-defined procedure, the inspector will carry out inspection and control in the way they think most appropriate, but in fact this is done in various ways. The inspectors must follow a defined procedure that covers all aspects of the requirement in an appropriate and balanced way, using means proportionate to the objective. The procedure should include preparation of the inspection, documentary check, visit of the establishment, debriefing of the establishment manager or his representative, a written report, and subsequent follow-up.

The advice issue is important. Control officers are often the only available persons the establishment manager can ask for advice and officers should be willing to provide it. However, advice and control are distinct missions that are often incompatible, insofar as one of the requirements of control is its independence.

Concerning monitoring plans, the results of food analysis and their interpretation are very dependent on the way in which the controller carries out the sampling, with regard to the technical condition, as well as the choice of samples so that they give a representative image of the inspected product. Therefore, all sampling programmes must be accompanied by detailed instructions for the official in charge of taking the sample and for those in charge of analysing them.

(b) Harmonized appraisal and follow-up

Food hygiene regulations contain expressions such as in "hygienic way", "adequate", "in good repair", "detailed documentation", "regular examination" etc. Checking compliance with requirements put into these words, may be quite subjective. Moreover, experience shows that, in practice, even where regulation uses precise terms, there are often differences in their interpretation by inspectors. This may be related to the inspector's former experience or concomitant activities, or the local context. For example, an inspector in charge of the control of different kinds of establishments will not judge a poultry slaughterhouse in the same way as an inspector specialized in this kind of abattoir; and a food processing plant may be judged leniently because it is situated in an area where the hygienic level of the establishments is generally low. Therefore, it is important to provide inspectors with clear instructions as to what is required and how it can be appraised.

Inspection of a food establishment results in a decision of the food control services, which usually addresses the shortcomings. It determines the corrective measure(s) that must be taken and its/their timeframe. It may sometimes involve legal proceedings. Harmonizing follow-up is essential to ensure fair treatment of all stakeholders.

(c) How to harmonize

Traditional means of harmonizing the working habits of staff includes circulation of instructions on the way to apply and enforce various regulations or vade mecum, which clarify or justify requirements. These guidelines should not be considered as added new requirements, but merely as means to explain how to apply and enforce requirements already in force.

Professional training, both initial and continuing, is also a decisive element of an adequate and harmonized enforcement of regulation by official services.

In addition, more participative means can be used to further enhance harmonization, such as identification of suitable experts, meetings and working visits to the field.

In general, there are among the inspectors of any agency some who are specialised in inspecting specific types of establishments or to carry out well defined tasks, and have become very competent in their fields of work, i.e. experts with very valuable practical experience. Other inspectors in the agency should take advantage of this expertise. The management must identify these "practical" experts and entrust them with harmonizing control practice by preparation of guidelines and participation in training.

Another interesting means of harmonization consists of enabling controllers from different units to share their field experience within the framework of meetings dedicated to the harmonization of practice in a specific field. Such meetings may result in drafting guidelines or vade mecum.

Sharing experience can also take place in the field when inspectors from different units pay a working visit to an inspection team in an establishment it is in charge of. This may be an opportunity for reviewing and revising local control practice.

It is important to note that each of these means of harmonization can be applied at local and national level as well as at regional level in the framework of international co-ordination.

3.2 Programming

Food control agencies/authorities have many regular controls to carry out, often with a limited number of staff. Whereas the problem of lack of resources is often put forward, the question of using existing resources more efficiently is always a challenge. One of the main problems is how to allocate available staff time and work means to the different tasks entrusted to the agency/authority, on the understanding that it should be done based on risk analysis.

(a) Determining priorities

These tasks stem from the legal obligation of control, as well as priorities determined by the competent authorities, which must take into account:

• public health objectives and results of the epidemio-surveillance of food-borne diseases - control will stress food and types of establishments blamed for outbreaks;

• outcome of the previous control - control will stress food and type of establishment on which numerous and important shortcomings have already been reported;

• origin of imported products - products likely to cause contamination because of the sanitary situation or deficiencies of control authorities in the country of origin will be checked more systematically and thoroughly;

• main export products - their control has to give trust to importing countries.

The determination of priorities should involve all stakeholders, both public and private, in order to match the actual needs of the country. Agency management must make field staff aware of the priorities, particularly prior to periodic planning of their activities.

(b) Inventory of tasks

The control agency should draw up an inventory of the tasks and evaluate the work time each task requires, taking into account that some tasks can be undertaken together.

Inspection of establishments and food contamination monitoring underpin food control activities, but as food contamination monitoring is discussed under Sub-theme 2, the rest of this paper focuses on establishments. Each inspection unit should have an exhaustive list of the establishments and sites that it is likely to control, and headquarters should have statistics on the different kinds of establishments the different units are in charge of.

(c) Risk classification of establishments

Establishments and sites should be inspected regularly and where shortcomings are suspected. In the framework of risk management, the frequency of inspections for a given establishment should match the risk it represents. The different kinds of establishments can be divided into a limited number of risk groups, based on handling undergone by food. It is mainly related to microbiological risk.

Although it seems possible to consider a priori that some products are riskier than others and set a classification on this basis, this classification should rather be adapted by countries according to the information given by epidemio-surveillance of food-borne diseases and the local context. For example, in many countries appertized canned food is deemed very safe, while in other countries some establishments do not perfectly control this technology.

In addition, competent authorities can estimate the average time required by inspection of the various types of establishment on the basis of the different checks included in the inspection and of the country's experience.

Knowing the number of establishments of various kinds each unit is in charge of, and the time their inspection requires, the manager of the agency is in a position to determine on an objective basis how staff should be divided between the different units according to their workload.

Subsequently, the director of local services should refine the risk level of each establishment, taking into account the number and skill of staff in the establishment, the production volume, involvement in quality assurance, as well as the outcome of former inspection and possible blame for a food intoxication outbreak. Accordingly, he will adapt the control rate to risk level of establishments.

Control programming does not set a deadlocked situation; it is a dynamic process that takes into account development of the context and incoming requests from authorities.

3.3 Administrative documents

It is important that the necessary instructions and report accompany all control activities. Beyond the actual transmission of a message, the written form should ensure that:

• the responsible person is identified insofar as it signed;

• all the addressees receive the same information and can make reference to it;

• information is recorded and classified; it can be traced and used in subsequent studies or investigation.

Control instructions should always indicate at least the order sender, the officer that has to carry out the control, the legal basis, the exact tasks to be carried out, the timeframe in which they have to be accomplished, as well as the way of giving an account of the control.

All inspections should result in a report of the findings since without a report it is not possible to follow-up and monitor the results.

Furthermore, such documents are essential for the agency, as they are the basic elements by which it can demonstrate the effectiveness and the efficiency of its activities. Traditionally, the control agency is requested to give an account of its activities to the government. Nowadays, in order to match transparency requirements, it should also provide all stakeholders with objective information on the performed control and its result.

3.4 Monitoring

Monitoring is a necessary task at each hierarchical level which consists of verifying that instructions have been clearly understood and carried out, and comparing performed to planned control. Whereas analysis of reports is the basis of monitoring, the competent authorities should consider further means.

At the field level it is sometimes useful to have officers accompanied by an expert or a superior, who may identify difficulties in the implementation of instructions.

The agency management also has to monitor the way its decentralized units run their missions in order to ensure that its instructions are correctly carried out and there are neither drifts nor differences among units. Besides periodic reports, some agencies use senior officers whose mission is to audit on-the-spot the activities of local units, whether it is on the implementation of technical instructions or the staff and financial management.

3.5 Crisis management

Food control services must be able to react rapidly and efficiently, if a major problem arises. Firstly, it means that they must be informed as early as possible of the problem before it spreads. Rapid alert systems will be discussed under Sub-theme 2. Then when informed, they have to very quickly take appropriate measures. This implies that these measures have be planned as far as possible within the framework of an emergency plan, with standing orders and various scenarios indicating the means allocated to each task.

These measures affect a number of stakeholders, who will respond effectively as they are confident of the efficiency of control services and have been involved in the preparation of the plan. It means that a good risk communication with all stakeholders well before the crisis will facilitate its management.

4. SPECIFIC ISSUES OF DEVELOPING COUNTRIES

4.1 Basic infrastructure

In many developing countries inadequate facilities and infrastructure undermine food safety systems. Control services should identify and draw competent authorities' attention on the necessary improvement of basic infrastructure relevant to food safety, such as safe water supply, electricity, storage facilities including cold storage, transport facilities and network.

4.2 Food processing industry

Food production, processing, and marketing is often highly fragmented among a large number of small producers and handlers who lack appropriate knowledge and expertise in the application of modern agricultural practices and food hygiene that match agricultural intensification and increasing urbanization. Control services should encourage these stakeholders to get organized, and participate in the determination of their training needs.

Besides multiple small producers and shopkeepers, food-processing industries often include large facilities, some of which are sophisticated. Therefore, control services have to be able to deal efficiently with a large range of very heterogeneous establishments and have to adapt their way of working to technical and financial capacity of each category, taking into account the risk related to their market and without neglecting any fragment of the food industry.

Food export is vital for many developing countries; in general it concerns a limited number of products. In the long run, "dual safety standards" for exported and domestically consumed products, respectively, are not desirable, but they are likely to persist for some time. Therefore, it is appealing to concentrate control means on the export field while neglecting control of the national market, which penalizes national consumers. On the contrary, control services should use experience gained in export plants and at the contact with importing country control services, in order to improve the efficiency of the national food control system. For example, they can see how establishments closely related to foreign customers implement good hygienic practice and HACCP, or the procedure followed by importing country control services for inspection. Insofar as this seems relevant, they can consider the extent to which it could be used in establishments limited to the local market. From this perspective, if inspectors in charge of export control are specialized in this task, it is important that they remain in touch with inspectors in charge of local market control.

4.3 Street food

Due to rapid urbanization, a large proportion of the urban population depends partly or entirely on street food, which include ready-to-eat foods and beverages in streets or public places such as around the workplace, schools, hospitals, railway stations, and bus terminals. These foods are generally prepared and sold in unhygienic conditions, with limited access to safe water, sanitary services, or garbage disposal facilities.

Control services should draw local authority's attention to the necessity to provide street food sectors with adequate basic infrastructure. Furthermore, they should encourage the development of specific and adapted guides of good hygienic practices, and where needed, HACCP, and enforce their actual implementation.

4.4 Food control infrastructure and resources

Food control services often suffer from shortage of funds; this may be particularly visible in laboratory equipment and working means, but also shows its effects in recruitment and training of qualified staff. These limited resources call for an emphasis in the organization and management in order to streamline and optimize the use of available means. Sections 2 and 3 of this paper have presented different ways of improving the food control service and to demonstrate the good use of funds to decision-makers.

The controlling authority should be adequately resourced, and be independent of the management of the establishment and other industry interests, as the Codex Alimentarius states. Food safety control concerns human health and safety, and therefore falls under the responsibility of the government. Nevertheless, delivering safe food comes firstly under corporate responsibility, and food control allows food industry to take its responsibility. That is why in developed countries establishments producing or handling food are asked for covering control cost, in a way that does not undermine controller's independence. Cost recovery options include fees for licensing, inspection activity, and food analysis. In developing countries, this should be managed carefully as any costs passed directly onto the food industry will ultimately be passed onto consumers as an indirect tax on food, and this falls disproportionately on poorer sectors of society. This qualification applies only to food put on the local or national market, while the export field is supposed to cover control costs.

4.5 Technical assistance

The need for technical assistance in strengthening food control systems in developing countries is well recognized. FAO and WHO are the two main specialized agencies of the United Nations involved in food quality and safety technical co-operation programmes with developing countries.

Both the SPS Agreement (Article 9) and the TBT Agreement (Article 11) specifically refer to the need to provide technical assistance to developing countries. In particular, developed countries which import food from developing nations are required, upon request, to provide technical assistance to the developing exporting countries to enable them to meet their SPS and TBT obligations in international food trade. As this new opportunity to access technical assistance under the WTO Agreements has not yet been fully utilized by developing countries, it should be discussed among other vehicles at the Workshop on Partnership.

Conclusion

1. Strengthening official services for food safety control is part of a strategy that affects all elements of the national food control system; which includes food law and regulations, food control management, laboratories, information, education, communication and training.

2. The national food control system may be based on multiple agencies, a single agency or an integrated approach; cultural, economic, and political conditions of the country will determine the appropriate model to be followed. Whatever the considered model, a thorough review must be carried out to determine how control activities can be coordinated, to prevent gaps or conflicts, and to explore possible synergies with other related controls (plant protection, animal health, biosafety). In any case, food safety control systems must cover efficiently and consistently all components of the food chain.

3. The management of food control services should ensure that their staff carry out control with technical and legal competence, and independence, in a harmonized way all over the country. They should also ensure that the available means are judiciously allocated by programming, that the control activities are supported by relevant documents and monitored, and that the services are ready to face crisis.

4. In developing countries, food control services should be adequately resourced and strengthened to play a decisive role in protecting consumer's health and supporting the food export trade. They should participate in the organization and training of small producers and handlers, in particular for street food, and address the dualism between export and local market. FAO, WHO, other concerned agencies and donor countries are called upon to assist developing countries in strengthening their food control services.

DEFINING THE RESPONSIBILITIES AND TASKS OF DIFFERENT STAKEHOLDERS WITHIN THE FRAMEWORK OF A NATIONAL STRATEGY FOR FOOD CONTROL

(Paper prepared by Alan Reilly, Deputy Chief Executive, Food Safety Authority of Ireland)

Introduction

Over the past few decades the issue of food safety has been in the public eye as never before. A chronology of food scares has damaged consumer confidence in the safety of food, has raised doubts about industries' commitment to produce safe food and has raised questions regarding the ability of the regulatory agencies to police the food chain. In the past the emphasis of food control systems was placed on the stimulation of trade and commerce. More recently that balance has moved to ensuring foods are safe and consumers' interests are protected. The responsibility for food safety is shared among all stakeholders involved in the production and marketing of foods. To ensure consumers' health and consumers' interests are adequately protected, the co-operation of many organizations and individuals both in the regulatory agencies and in the food industry is required. Consumers also have their own part to play in choosing healthy diets and ensuring hygienic handling and proper cooking of food to protect their own and their family's health.

The concept of a national strategy for food safety control has gained prominence in recent years in many countries worldwide. It has become a realization that effective food control at national level can be undermined by the existence of fragmented legislation, multiple jurisdictions, and inconsistencies in enforcement and weaknesses in food surveillance and monitoring. Many possible options exist as to how food safety controls can be organized at national level. Guidelines have been produced by Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) that provide advice to national authorities on strategies to strengthen food control systems to protect public health, prevent fraud and deception, avoid food adulteration and facilitate trade (FAO, 2003). These guidelines can facilitate the development of national policies for choosing the most suitable options for their food control systems in terms of legislation, infrastructure and enforcement mechanisms. A national strategy enables a country to develop an integrated and effective food safety control system and to determine consumer protection priorities and promote economic development.

There are many stakeholders involved in ensuring the safety and quality of foods moving in both national and international trade. Responsibilities are shared by national governments, farmers, food processors and manufacturers, food retailers, caterers and consumers. A positive interaction is required between all of these players if the system is to be successful.

This paper attempts to describe the responsibilities and tasks of the different stakeholders within the framework of a national strategy for food safety control.

Integrated controls from farm-to-fork

The food chain has become more complex in recent years with increasing liberalization of trade and expanding global distribution of food and feed. Meeting the requirements of trade agreements such as the World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT) is essential for countries wishing to have access to international food markets. Countries are now obliged to demonstrate that food safety measures provide appropriate public health protection and are not unnecessarily restrictive to trade. The ability to demonstrate adequate national food controls are in place at all stages of production, processing and marketing is also necessary to remain competitive in the international market. There are many links in the chain which is only as strong as its weakest link. Integrated controls are required at all stages of production and in all sectors in line with the "farm to fork" principle. The introduction of the "farm-to-fork" principle to food control allows the creation of a systematic, comprehensive system covering all food in all sectors, replacing the current sector specific, patchwork of rules. Experience both at national and international level, has shown that in order to ensure consumer protection it is necessary to consider all aspects of the food production chain as a continuum, from and including primary production up to and including sale or supply of food to the consumer because each element may have a potential impact on food safety.

In recent years the concept of integrated controls across the food chain has expanded from national level to regional trading blocks, such as those of the European Union (EU 2004), Australia and New Zealand, North American Free Trade Agreement (NAFTA), Asian Free Trade Association (AFTA) and the Gulf Cooperation Council (GCC). The intent is to achieve sufficient uniformity such that food businesses do not have to comply with different consumer protection regulations and standards when trading across borders. The most effective method of demonstrating harmonized controls is to ensure that regulations are based on sound science and are consistent with the international standards developed by the Codex Alimentarius Commission.

Responsibilities for food control at government level

National governments have the overall responsibility for food safety policy and for ensuring that adequate resources are allocated for food safety control. For successful implementation, a national food control system must have support at the highest level of government. In reality the responsibility for food control in many countries is shared between different agencies or ministries. The roles and responsibilities of these agencies or ministries may be quite different and duplication of regulatory activity, fragmented surveillance and a lack of coordination are common. There may also be wide variations in expertise and resources between the different agencies or ministries, and the responsibility for protecting public health may conflict with obligations to facilitate trade or develop an industry or sector. Additionally responsibilities may be shared between central and local government, with central government having more of a policy role and local government enforcing regulations.

The key responsibilities at government level are for the development of food laws and regulations that will facilitate integrated controls across the food chain; ensuring the infrastructure exists for the effective management of official controls; ensuring officers in the food inspection service are qualified and adequately trained; and that an official laboratory network exists to monitor the food chain and to support the food surveillance and food-borne disease surveillance networks.

· Food laws and regulations

Food laws are the set of legal rules governing the growth, production, harvesting, processing and sale of food. An effective food control programme must be based on appropriate food law that prioritizes food safety and consumer protection. Such laws should be sufficiently flexible to meet the needs of a changing food sector, the introduction of modern technology and the development of new food products. While food laws have been traditionally concerned with the introduction of a control system to address problems of food quality and contamination and to protect the consumer against fraud, it is now widely recognized that there is a need to pay greater attention to the safety of consumers. As a consequence, there is a worldwide trend to move away from detailed, compositional, commodity-based (or "vertical") requirements and place more emphasis on risk analysis and on "horizontal" food safety standards that can apply to many or all foods. Where once the focus was on food hygiene, such as in slaughter houses or dairies or on adulteration of food with harmful substances, the focus has now extended to deal with a myriad of issues including natural contaminants, flavours, additives, labelling, food composition, nutrition, food supplements, genetic modification as well as the traditional food hygiene issues. Also in recent years there has been a growing trend for food law to take into account broader issues such as animal health, welfare, plant health and the environment. In addition to basic legislation, governments require up-to-date and internationally accepted food standards, such as those of the Codex. The FAO and WHO have published guidelines for the development of a national food law (FAO/WHO, 2003). Many examples of food laws exist, both at national and regional level (Table 1).

· Management of official food controls

A clear responsibility at national level is for coordination and collaboration between all government agencies to ensure the effective operation of a food control system. It is important that food legislation clearly identifies the role of each agency to avoid duplication of effort and to bring about a measure of coherence among them. Where the competence to carry out official controls has been delegated from central level to a regional or local level, effective and efficient coordination between all levels must be ensured. Within the context of integrated food controls from "farm-to-fork" many countries are re-evaluating how they manage their systems of food control. The current trend in developed countries is to establish food safety agencies with the view towards coordinating official controls. This practice has not been so widespread in developing countries.

It is often not possible to have a single unified structure or an integrated food control system at national level, due to various historical and political reasons. In such cases, it is necessary to develop a national food control strategy to clearly identify the role of each agency to avoid duplication of effort and to bring about a measure of coherence among them. There are at least three types of organizational arrangements at national level for the management of official food controls. These are where many agencies are responsible for food control (a multiple-agency system), where a single agency is responsible for a unified system (single agency system) or where a national integrated approach has been taken (an integrated system). The advantages and disadvantages of each type of system have been discussed (FAO/WHO, 2003). What is evident is that there is not a universal system in existence; the reality is that each country must adapt the management of their food controls to suit their national needs. Some examples of food safety agencies are provided in Table 2.

· Inspection services

The administration and implementation of food laws require a qualified, trained, efficient and honest food inspection service. The food inspector is the key functionary who has day-to-day contact with the food industry, trade and often the public. The reputation and integrity of the food control system depends, to a very large extent, on their integrity and skill. The food inspection services are responsible for enforcing food laws and verifying whether food business operators fulfill the relevant requirements of the law at all stages of production, processing, distribution and sale of food. For these purposes, food inspectors must be trained and have experience in enforcement and prosecution. Different qualifications are required by food inspectors at different stages of the food chain, for instance at primary production agricultural officers, veterinarians, meat inspectors and fisheries inspectors; in retail and catering environmental health officers or food inspectors; and public health specialists and medical doctors in the investigation of food-borne illness. There is a requirement for a multi-agency, multi-disciplinary approach to food inspection to ensure that there are no gaps in the enforcement of food law.

· Monitoring and surveillance

The surveillance and monitoring of food for chemical and microbiological contaminants is essential for the protection of public health. Collection and analysis of data on contaminants in the food supply is also essential for underpinning risk assessment work and for setting standards. The application of risk assessment in setting national food standards is a requirement under the Sanitary and Phytosanitary Agreement of the World Trade Organization. A food monitoring and surveillance programme is essential to ensure that consumers are not exposed to unacceptable levels of chemical contaminants or harmful microorganisms in the food supply. Such programmes also detect if controls at industry level are effective in reducing exposure to unacceptable levels of pesticides and veterinary drug residues, chemical contaminants or pathogens. It is the responsibility of national governments to ensure that an official laboratory network exists to monitor the food chain and to support the food surveillance and food-borne disease surveillance networks.

Laboratories involved in the analysis of official samples should work in accordance with internationally approved procedures or criteria based performance standards and use methods of analysis that have been validated. Data collected on pathogens isolated from food should be coupled with data from outbreaks, data on human disease and data on animal disease and used to provide a composite picture of the animal reservoirs, the food vehicles and the pathogens of public health importance. Information obtained from monitoring and surveillance programmes form the basis of risk management decisions and underpin control and prevention programmes.

In line with good management practice national agencies performing official controls should meet a number of operational criteria so as to ensure their impartiality and effectiveness. They also should have a sufficient number of suitably qualified and experienced staff and possess adequate facilities and equipment to carry out their duties properly.

· Information and communication

In addition to the responsibilities of government for ensuring the effective management of food controls, an increasingly important role is the delivery of information, education and advice to stakeholders across the farm-to-table continuum. These activities include the provision of balanced factual information to consumers; the provision of information on food safety; ensuring that quality educational programmes are available for key officials and workers in the food industry; and the development of train-the-trainer programmes. Food control agencies should address the specific training needs of their food inspectors and laboratory analysts as a high priority. These activities provide an important means of building food control expertise and skills in all interested parties, and thereby serve an essential preventive function.

Responsibilities of the food industry

Food production, processing and marketing systems have grown more complex in recent years. Food production can range from very sophisticated state-of-the-art facilities to small artisan operations producing traditional foods for local communities. Modern food manufacturing and processing involves the use of highly technical and complex methods to facilitate product stability, extend shelf-life and preserve food quality. Rapid advancement in food technology provides new avenues for improving food manufacturing and processing and for the development and introduction of new products. Global sourcing of ingredients and expansion of international trade in foods all present new challenges and risks.

The primary responsibility for the production of safe food is that of the food sector. They must ensure that control systems are in place at all stages of the food production chain that will prevent, eliminate or reduce to acceptable levels risks to consumers. To complement and support the efforts of food businesses, there must be adequate and effective official controls organized and implemented by national governments. It is therefore essential that the food industry, at all levels, engages in proactive dialogue with regulatory bodies to agree food safety standards and ensure efficient and effective integration of industry and official food safety control systems.

Food industry organizations have a key role to play in working with their members in developing and promoting codes of best hygienic practice and food safety assurance programmes. Food industry organizations at national, regional and international levels have roles in advocating the use of the highest possible food safety standards in their respective sectors. Food legislation applies to all food sectors, both large and small, and sets down the objectives to be achieved by industry. How to achieve objectives set out in legislation is a matter for each food sector and industry organizations can develop agreed codes of practice, guidance documents and industry standards that are food sector specific. Such organizations also have a role to play in assisting in the development of international codes of practice, recommendations and guidelines, and in the provision of technical support and expert advice. An example of the role of industry organizations in working with international agencies in the development of food standards is the large number of such organizations that currently have observer status with the Codex Alimentarius.

· Primary production

With the increasing intensification of animal production in recent years, the farmer has been divorced from the consumer. In industrialized farming systems there has been a tendency for farmers to underestimate the potential health consequences of their actions and focus only on their direct customers rather than the ultimate consumer. In Europe, the BSE crisis redressed this balance and today there is a developing understanding amongst farmers that food safety issues on the farm directly affect consumers' health and hence their purchasing patterns and consequently the market dynamics. Quite simply, what happens on the farm will influence the safety and quality of foods throughout the remainder of the food chain.

Farmers must focus on the safety and quality of their raw materials and their production methods and understand the effects these may have on the safety and quality of the final product be it an animal or a crop. Contamination of animal feeding stuffs or the farm environment will lead to contamination of the final foodstuff and potentially affect consumers' health. Consequently, farmers must think beyond the farm and exert food safety controls on all the inputs into the farm. In this respect farmers should keep detailed records of their raw materials, husbandry practices, animal movements and customers to facilitate quality and food safety control as well as traceability to serve consumer information or food recall purposes. While exemptions may exist for small farmers in developing countries, these general principles should apply.

Risks exist regarding the inappropriate use of veterinary drugs resulting in residues in foods of animal origin. Similar risks exist regarding the inappropriate use of plant protection products such as pesticides and biocides and harmful residues in cereals, fruit and vegetables. Additionally poor hygiene on the farm may lead to contamination of fresh fruit and vegetables and milk or dairy products with increased risks for consumers.

Farmers are responsible for the application of the basic principles of good agricultural practices and good management practices when growing, harvesting, sorting and packing plant crops. Animal medicines, including vaccines, play an important role in the control and prevention of animal disease. Farmers and veterinarians have the responsibility for following strict controls governing the authorization, distribution and use of animal medicines. Ensuring product safety at all points in the chain is essential. This includes the supply, storage, use and disposal of animal medicines. A key requirement is that adequate records of animal remedy usage should be maintained. Farmers have similar responsibilities for the use and monitoring of farm chemicals such as pesticides and biocides. Products should comply with the International Code of Practice - General Principles of Food Hygiene and with other standards set by the Codex Alimentarius Commission on pesticides and veterinary drugs.

Many fresh fruits and vegetables are eaten with little or no cooking and can be a source of disease-causing bacteria, viruses or parasites. Food-borne disease outbreaks have been associated with a broad range of vegetables including raw tomatoes, carrots, sprouts, lettuce, cantaloupe and cabbage (FSAI, 2001; Hillborn, et al.1999; Solomon, et al 2002). It is essential that fruit and vegetables are free from contamination and are produced, handled and packaged under good standards of food hygiene. It is the responsibility of growers and packers to ensure that only safe produce is placed on the market. Guidelines have been published on good agricultural and management practices during growing, harvesting, washing, sorting, packing, and transporting of fruits and vegetables (see Codex texts and references under Primary Production).

Complying with animal health regulations is essential; only foods from healthy animals should go into the food chain. The World Organization for Animal Health (OIE) is working on scientific standard-setting activities for animal production food safety. In this area it is working with other organizations in reducing food-borne risks to human health due to hazards arising from animals, prior to primary processing of animal products (OIE, 2004). There is general recognition that zoonoses and diseases transmissible to humans through food, whether or not animals are affected by such diseases, may occur and such risks need to be identified and managed.

Farming is becoming more competitive and controls used to assure food safety can often reap rewards in enhanced product quality with subsequent access to markets and increased margins. However, full compliance with all relevant legislation is only a baseline. From there farmers may have to exert enhanced controls in response to consumers' demands as signalled by their direct customers. Hence the development of on farm quality assurance schemes that build on basic legal compliance. Because farmers are the first step in the food chain they are the foundation of food safety control systems and therefore they have a fundamental role in ensuring food safety.

· Food processing and manufacture

Food processors can be divided into primary processors and secondary processors. Primary food processing activities may be carried out on or off the farm. In either event the highest standards of food hygiene are required when animals are slaughtered at abattoirs; on harvesting and slaughtering of farmed fish; during milking and on-farm milk storage; during the milling of seed crops or washing of fruits and vegetables and during the handling of such products as eggs and honey. Secondary food processing is almost exclusively an off farm activity where the products of primary processing activities are further processed for the manufacture of complex consumer foods. Poor standards of hygiene may result in these foods serving as vectors in the transmission of disease.

Food processors must know who is supplying them with food materials and agree standards for the quality and safety of these products. They have an obligation to apply controls to assure the safety of their products and this is best achieved through a food safety management system consisting of a Hazard Analysis and Critical Control Point (HACCP) system (ref. CCFH documents) built upon a sound pre-requisite programme involving good hygienic practices, good manufacturing practices; and equipment and structures that are fit for the purpose. Sometimes in primary processing the emphasis of food safety control is more towards maintenance of hygiene. For example, the safety of milk and dairy products are reliant to a large extent on hygiene standards on the farm. Good dairy hygiene practices should include the integrity of farm buildings, pest control and cleanliness of milking equipment and storage facilities for milk. Similarly good hygienic practices should be followed in the primary processing of fish, meat and eggs. The Codex standards and codes of practice give excellent examples of the standards of hygiene required to assure consumer protection and food safety (WHO/FAO Codex 2004).

Where feasible, primary processors should also monitor the safety of the materials they are supplied with as well as the products they produce as a means of verifying the effectiveness of their food safety management systems. Processors must set specifications for their raw materials that take account of legal limits for chemical and microbiological contaminants and legal requirements for labelling and traceability as well as quality characteristics. This also requires them to maintain records for traceability purposes and develop efficient recall systems.

Full compliance with food safety regulations and co-operation with regulatory authorities is necessary to ensure the effectiveness of food safety control programmes. However, quality assurance schemes are also becoming prevalent in this sector resulting in the operation of independently audited, certified food safety and quality standards that are more stringent than legal requirements. Future developments will inevitably involve the recognition of independent certification to agreed standards by regulators attempting to design cost efficient and effective national control programmes.

· Food retailing

Food retailing involves the sale of food to the consumer and as such consists of both grocery and catering businesses. Today, the distinction between grocery and catering businesses is eroding as more and more grocery retailers extend their businesses into offering hot take-away food and delicatessen items. Similarly, some caterers now supply a more traditional grocery line on their premises, usually focusing on the artisan ingredients used in the preparation of their food.

It is essential that food retailers like processors adopt a food safety management system to control the safety of their food products. Even businesses whose activities only involve the distribution of pre-packaged food must adhere to good hygienic practices and use the HACCP approach to proactively identify and manage food safety hazards. In traditional grocery businesses where packaged and unpackaged food is sold to the consumer for home preparation or consumption, the control of the foods they receive and control of the foods they display on a first-in-first-out principle is a vital element of a food safety management system. This coupled with hygienic practices; traceability systems and an effective food recall system comprise the basis of effective food safety controls. In retail businesses where food is prepared for consumption by consumers on or off site, the preparation of the food can lead to food safety issues. Catering businesses must therefore implement HACCP systems and be especially diligent about staff personal hygiene, the hygiene of the equipment and premises as well as staff training. The transient nature of workers in the catering business can put a particularly heavy burden on the ability of the business to train its staff. However, unless staff are trained appropriately in food hygiene, the risks of food poisoning increase and many outbreaks of food-borne illness can be attributed to lack of adequate hygiene knowledge and consequential poor practices in catering establishments.

HACCP systems can be effective in the catering retail business but their application is more difficult than in manufacturing due to the diverse non-linear arrangement of the food preparation processes. A particular challenge for businesses and regulators in this area is to adapt the traditional HACCP approach to achieve proactive food safety control. Caterers have a role in dialogue with regulators to achieve successful adaptation and application of the HACCP system. Regulators have a role in simplifying the HACCP concept and facilitating ease of application in the catering environment.

There are important food safety concerns associated with "street foods" in developing countries where street food vendors are an important component of the food supply chain. These foods are generally prepared and sold under unhygienic conditions, with limited access to safe water, sanitary services, or garbage disposal facilities. Hence street foods pose a high risk of food poisoning due to microbial contamination, as well as improper use of food additives, adulteration and environmental contamination. Specific guidance on the responsibilities of street food vendors has been provided by WHO (WHO, 1996).

· Consumer food preparation

Consumers have a responsibility to protect themselves and their families from risks associated with the preparation and consumption of foods. Food-borne illness can occur as a result of foods being incorrectly stored, not fully cooked, or when cross-contamination between raw and cooked "ready-to-eat" food is allowed to happen. Consumers need to be aware of the practices and precautions that need to be taken to prevent the spread of disease. Consumer education in the basic principles of food hygiene and safety is a necessity. A good example of the basic information the consumer needs to protect themselves and their families is outlined in the WHO - Five Keys to food safety; cook, clean, separate raw and cooked foods, store at correct temperature and use safe water and materials (http://www.who.int/foodsafety/publications/consumer/5keys/en/).

Role of international agencies

International organizations play a major role in facilitating international dialogue, in building consensus towards a science-based risk analysis process and in harmonizing food safety standards. It is important that these activities engage both developing and developed countries and are both open and transparent. The need for technical assistance in strengthening food control systems in developing countries is well recognized. FAO and WHO are the two main specialized agencies of the United Nations involved in food quality and safety technical cooperation programmes with developing countries. In the area of food safety, the SPS Agreement formally recognizes the standards, guidelines and recommendations established by the Food and Agriculture Organization (FAO)/World Health Organization (WHO) Codex. The recognition of Codex standards eliminates the need for each country individually to do its own risk assessment for any given hazard for which a standard, recommendation or guideline exists. If countries adopt national food safety standards based on the Codex standards, and have mechanisms for monitoring compliance among food producers with these standards, then their food safety measures are presumed to be consistent with SPS provisions.

Both the SPS Agreement (Article 9) and TBT Agreement (Article 11) specifically refer to the need to provide technical assistance to developing countries. Such assistance may be in areas of processing technologies, research and infrastructure, establishment of national regulatory bodies, etc. In particular, developed countries which import food from developing nations are required, upon request, to provide technical assistance to the developing exporting countries to enable these countries to meet their SPS or TBT obligations in international food trade.

The specialist international agencies in the area of food safety and food quality technical assistance, such as FAO, OIE, UNESCO, UNIDO and WHO should collaborate to avoid overlaps and duplication and strengthen formal and informal relationships.

Conclusion

The responsibility for food safety is shared among all stakeholders involved in the production and marketing of foods. The way forward is for integrated food controls at all stages of production and in all sectors in line with the "farm to fork" principle which allows the creation of a systematic, comprehensive system covering all food in all sectors, replacing the current sector specific, patchwork of rules. Communication and consultation with stakeholders on all aspects of food safety at all stages of the decision-making process are key to a credible, open, transparent and accountable food safety system.

TABLES

Table 1 Examples of food laws

Table 2 Examples of food safety agencies

LEGAL BASIS FOR FOOD SAFETY OFFICIAL AND NON-OFFICIAL CONTROL: "STRENGTHENING OFFICIAL FOOD SAFETY CONTROL SERVICES"

(Paper prepared by South Africa)

1. INTRODUCTION

Various food inspection and certification systems have been implemented in a number of countries over a period of time as a response to the management of food-borne risks to human health. For some time in South Africa it has been recognized that the control over foodstuffs is fragmented between a number of authorities and components at national, provincial and local level, as well as between several other organizations. Foodstuffs are not always regulated as foodstuffs but also as animals, animal products, plants or plant products. The objectives of such control relate to human health concerns such as food safety and nutrition, as well as to quality and to animal and plant health. The same commodity is therefore often controlled by several different authorities in relation to different sets of legislation albeit from different view points and for different reasons.

2. OFFICIAL CONTROL

Legislation and mandates of role players

The South African legislation relating to food and related matters and the authorities that are involved in the administration and enforcement of such legislation include the following:

2.1 Department of Health

a) The Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). This Act governs the manufacture, sale and importation of all foodstuffs from a safety/public health point of view and is administered by the Directorate: Food Control of the Department of Health. General law enforcement is conducted by authorized local authorities in their areas of jurisdiction while import control is exercised by the provincial health authorities on behalf of the national Department.

b) The Health Act, 1977 (Act 63 of 1977). Regulations under this Act govern the hygiene aspects of food premises (including milking sheds) and the transport of food. These are also administered by the Directorate: Food Control of the Department of Health and enforced by local authorities in their areas of jurisdiction. Provincial health departments are however involved in enforcement in areas where there are no local authorities.

c) The International Health Regulations Act, 1974 (Act 28 of 1974) has certain provisions that relate to food. The Department of Health is responsible for the approval of the source of food for consumption on the premises of ports and airports as well as on vessels and aircraft. It also states that such food must be handled in a hygienic manner. Currently the provincial health authorities are conducting these approvals on behalf of the national Department. The Act requires local authorities to inspect the premises and take food samples for analysis.

d) The Medicines and Related Substances Act, 1965 (Act 101 of 1965) is administered and enforced by the Directorate: Medicines Administration of the Department of Health. The Act inter alia makes provision for the registration of veterinary drugs, as well as for the registration of foodstuffs and food supplements with medicinal effects or in respect of which medicinal claims are made.

According to the Constitution, there are concurrent health legislative competencies for the national as well as the provincial departments.

The National Health Plan determines that the National Health Authority (NHA) is responsible for the development and provision of all health care in South Africa. This includes the formulation of national policy and strategic planning, as well as the co-ordination of planning and the functioning of the overall health system in the country. The NHA must develop guidelines, norms and standards to apply throughout the health system and transform policy into relevant integrated programmes in health development. The central level will elaborate policy statements and health legislation. The NHA must ensure the implementation of national priorities, plans and strategies whilst co-coordinating the organizations providing national services. International liaison is another listed function.

The following are some of the functions of the National Department of Health as listed in the White Paper:

• provide leadership in the formulation of health policy and legislation, including the development of a health system;

• provide leadership in quality assurance, including the formulation of norms and standards;

• develop a coordinated information system and monitor the progress made in the achievement of national health goals;

• provide appropriate regulation of the public and private health sectors, and regulate health-related activities in other sectors;

• liaise with national health departments in other countries and international agencies.

The White Paper also states that the Directorate of Food Control is responsible for developing standards for food hygiene, additives, labelling and identification, and ensuring food safety through regulation and public education, as well as the ratification of, and participation in, international standards. Legislation relevant to nutrition must be reviewed, strengthened, implemented and enforced:

• to protect breast-feeding, and to control the marketing of infant foods;

• for the mandatory iodination of salt;

• for the mandatory fortification of appropriate staple foods;

• to ensure food safety and quality.

The Foodstuffs, Cosmetics and Disinfectants Act, 1972, provides the Minister and the Director-General of Health with a number of mandates, most of which have been delegated to a lower level within the National Department, mostly within the Directorate: Food Control:

• the authorization of inspectors;

• the authorization of analysts;

• the authorization of local authorities;

• approve extended health detention;

• acceptance of a guarantee in respect of extended health detention;

• issuing an order in respect of the disposal of an imported foodstuff;

• make regulations as set out in Section 15 of the Act;

• approval to make known the contents of an analyst's report;

• apply any provision of the Act to any foodstuff in transit to another country;

• approve the sale of irradiated food.

The Directorate: Food Control is the National Contact Point for the Joint FAO/WHO Codex Alimentarius Commission in South Africa. This is by agreement with the other most important role players in this regard, namely the Department of Agriculture and the Department of Trade and Industry, and with the approval of the remaining members of the National Codex Committee, namely the Department of Foreign Affairs and the National Consumer Forum.

The White Paper also states that the Directorate: Nutrition is responsible for developing policies, strategies and guidelines for a national integrated nutrition programme, while the National Forensic Chemistry Laboratories are responsible for an effective chemical laboratory service at the national level in support of forensic medicine and law enforcement, through regulatory control of chemical substances harmful to health.

The Department of Health is the co-coordinator of the Health sector of the Southern African Development Community and as such has the mandate to initiate the development of policy on food safety and related matters.

2.2 The Provincial Health Departments

According to the Constitution, provinces must supervise local government. The National Health Plan for South Africa states that the provinces must support, monitor and evaluate district health services.

According to the White Paper, the mission of a provincial health department is to promote and monitor the health of the people in the province, and to develop and support a caring and effective provincial health system, through the establishment of a province-wide district health system based on the principles of primary health care.

Provincial health authorities, into which the regional offices of the former Department of National Health and Population development were incorporated, are currently conducting food import control on behalf of the National Department.

2.3 District Health Authorities and other Local Government

The Constitution states that local government must ensure the provision of service to communities in a sustainable manner. They must promote a safe and healthy environment, render municipal health services and licenses and control the undertakings that sell food to the public.

According to the National Health Plan for South Africa, district health authorities are to promote primary health care/management and coordination of services, including environmental health, nutrition and control of communicable and non-communicable diseases. Services such as public utilities - including food handling premises - will be the responsibility of the local authorities.

The White Paper states that the health system will focus on the districts as the major focus of implementation, and emphasizes the primary health care approach. Health districts must provide for collaboration with other sectors of Government and NGOs in promoting health and ensuring the rendering of health services in the health district. They must also ensure primary environmental health services, the promotion and maintenance of environmental hygiene, the enforcement of environmental health legislation - including food hygiene - and identify and control local health hazards.

2.4 Various laboratories

The Pretoria and Cape Town Forensic Chemistry Laboratories of the Department of Health conduct chemical analyses of food submitted by provincial and local authorities. The laboratories of the South African Institute for Medical Research and the Pathology Laboratory of KwaZulu-Natal Province are contracted by the Department of Health to conduct microbiological analyses of food submitted by provincial and local authorities. Analysts at these laboratories, as well as at a number of other laboratories in the country, have been authorized under the terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972.

The National Health Plan for South Africa refers to the integration of laboratory services into the primary health care system.

2.5 Standards South Africa (STANSA)

The Standards Act, 1993 (Act 29 of 1993) which is administered and enforced by Standards South Africa (STANSA) - part of the South African Bureau of Standards - inter alia has regulations which address canned meat (more than 10% meat) and canned and frozen marine products. STANSA compiles its health-related mandatory specifications by agreement with the Department of Health and in terms of the Standards Act, 1993. The system of control inspections in terms of these compulsory standards are based on resident inspectors in and around factories during production periods. STANSA also operates a mark scheme by means of non-compulsory specifications.

STANSA protects the interests of South Africa in foreign markets by ensuring that locally manufactured products intended for export are of acceptable quality. It is the competent authority for the certification of various food items of marine origin and offers an export certification service to the fishing industry.

Section 10 of the Foodstuffs, Cosmetics and Disinfectants Act, 1972, also authorizes certain officers of STANSA as inspectors under the Act.

2.6 The Commissioner of Customs and Excise

The role of the Commissioner of Customs and Excise in the control over the importation of food is set out in Sections 10 and 14 of the Foodstuffs, Cosmetics and Disinfectants Act, 1972.

2.7 Department of Agriculture

2.8 Department of Trade and Industry

The Trade Metrology Act, 1973 (Act 77 of 1973), and the Trade Marks Act,1963 (Act 62 of 1963), both relate to food labelling.

2.9 By-laws of local authorities

Many local authorities have food hygiene by-laws which they enforce in addition to the national regulations.

3. NON-OFFICIAL CONTROL

3.1 EUREPGAP

The EUREPGAP system was established to specifically aim at controlling food safety related aspects at producer level. Eurep (Euro Retailer Produce Working Group) uses GAP (Good Agricultural Practice) as a production standard for the certification of good agricultural practice in the agricultural and horticultural industry. At this moment, the GAP standard is being applied in fresh fruits and vegetables. All kinds of agricultural products for human consumption can be certified with this standard. Special standards for flower, animal production, grain, coffee, and feed are under development. Eurepgap is based on the principles of risk prevention, risk analysis (among other through HACCP), sustainable agriculture by means of Integrated Pest Management (IPM) and Integrated Crop Management (ICM), using existing technologies for the continuous improvement of farming systems.

EUREPGAPAFRICA, a regional leg of EUREPGAP, was formed to specifically address issues pertaining to GAP aspects in the African region. As we all know, Africa has its own unique culture just like any other part of the world. Thus, there would be differences in the application and interpretation of protocols developed in Europe for this part of the world.

3.2 ISO

ISO standards contribute to making the development, manufacturing and supply of products and services more efficient, safer and cleaner. They make trade between countries easier and fairer. They provide governments with a technical base for health, safety and environmental legislation. They aid in transferring technology to developing countries. ISO standards also serve to safeguard consumers, and users in general, of products and services - as well as to make their lives simpler.

ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce their implementation. A certain percentage of ISO standards - mainly those concerned with health, safety or the environment - has been adopted in some countries as part of their regulatory framework, or is referred to in legislation for which it serves as the technical basis. Such adoptions are sovereign decisions by the regulatory authorities or governments of the countries concerned; ISO itself does not regulate or legislate. However, although ISO standards are voluntary, they may become a market requirement, as has happened in the case of ISO 9000 quality management systems.

Developing countries in particular, with their scarce resources, stand to gain from this wealth of knowledge. For them, ISO standards are an important means both of acquiring technological know-how that is backed by international consensus as the state of the art, and of raising their capability to export and compete on global markets.

The ISO standards are administered by STANSA in South Africa. PPECB achieves ISO 9001:2000, as well as, 62 and 65 certification from STANSA which is a member body of ISO.

3.3 Organic certification e.g. Ecocert

These organizations administer systems which are market driven. These systems contribute to international standards and thus promote the food safety chain nationally and internationally.

3.4 Internal control e.g. Production Operation systems

These systems are based on international standards to contribute to food safety globally.

3.5 British Retail Consortium (BRC)

The objective of the BRC Global Standard - Food is to specify food safety and quality criteria required to be in place within a manufacturer's organization to supply product to UK retailers. The format and content of the Standard is designed to allow an assessment of the supplier's premises and operational systems and procedures by a competent third party, thus standardizing food safety criteria and monitoring procedures.

The Standard requires:

- the adoption and implementation of HACCP;
- a documented and effective quality management system;
- control of factory environment standards, product, process and personnel.

An assignee of the Department of Agriculture, namely PPECB has been authorized by the British Retail Consortium (BRC) in London to certify organizations that package fresh produce according to the BRC Global Standard - Food.

Organizations complying with this standard will receive an internationally recognized certificate displaying the BRC quality mark. This certificate of compliance will give assurance to potential customers that the product they are buying is safe for their consumers.

European retailers not only require a quality product, but also a safe product. As a result, producers and pack houses that supply European markets are now being forced to implement various food safety related systems. Pressure is now also being exerted on pack houses to implement food safety systems.

The BRC Global Standard - Food is recognized by European retailers as the standard against which pack houses must be audited to verify that food safety control systems have been effectively implemented.

The advantage for South African producers and exporters of fresh fruit and vegetables being certified to the BRC Global Standard - Food is that their produce will automatically gain entry to EU markets.

3.6 Nature's Choice

This is a code of practice covering biodiversity, conservation and environmental management developed by Tesco and ADAS (Agricultural Development Advisory Service) for farms that supply Tesco with fresh fruit, vegetables, salad and horticultural products. Suppliers in South Africa must be accredited to this code. This code also includes production and produce handling practices which are sustainable and protect, and where possible enhance the well being and biodiversity of the environment. Nature's choice demonstrates Tesco's commitment to protecting and wherever possible enhancing the environment and to raising standards in the industry.

4. CONSEQUENCES OF MULTIPLE LEGISLATION

Multiple legislation governing food control in South Africa results in fragmentation, duplicate decision-making and government involvement. Some examples are the following:

4.1 The Foodstuffs, Cosmetics and Disinfectants Act, 1972 and the Agricultural Product Standards Act, 1990, both set standards for milk and dairy products, including the labelling thereof. The former are health related and are enforced by local authorities (locally) and provincial health authorities (import) while the latter are quality related and are enforced by the Directorate: Food Safety and Quality Assurance of the National Department of Agriculture. The Animal Diseases Act, 1984 however, also controls milk and dairy products (including imports) from an animal health point of view and regulates the Bovine TB and Brucellosis Eradication Schemes.

Milking shed regulations which have been elaborated under the terms of the Health Act, 1977, are enforced by provincial and local authorities but not always by the local authorities into whose areas the milk is distributed. Provincial animal health officers who visit farms regularly and who are involved in mastitis control, which includes milking shed hygiene, are not authorized to inspect milking sheds. Foreign importing countries however often require the veterinary authorities to certify milk and dairy product exports.

Local authorities have their own by-laws governing milk premises in their areas of jurisdiction.

At least four sets of legislation and six different authorities at all levels are therefore involved in the control of milk and dairy products. Import control is conducted by three different authorities. Each authority may only inspect and sample specific aspects in terms of its own legislation. Samples are submitted for analysis to a number of different laboratories.

4.2 The importation of foodstuffs is controlled by a variety of authorities. At the larger ports of entry officers of the Directorates of Veterinary Public Health, Animal Health, STANSA, as well as provincial health authorities are engaged in full-time import control and often inspect and sample the same product in terms of different legislation and then submit samples to a number of different laboratories. The Directorate: Food Safety and Quality Assurance does not inspect imported foodstuffs at the point of entry. This is only done when products are encountered in the trade.

In contrast, at many of the inland ports of entry no control is exercised by any of these components. Because of the fragmented responsibilities none of these authorities feels that its specific area of control justifies the attention of a full-time import control officer. Collectively however, one officer to carry out the responsibilities of all the authorities could be justified at many points of entry that are currently unmanned for food control purposes.

4.3 Many more examples where more than one official control mechanism is active for a food commodity can be named. On the positive side, the fragmented structural and legislative control however precludes an efficient multidisciplinary approach which is necessary for the proper control, by specialists in their fields, of many products and which would provide assurances for the consumer from production until the product is purchased and consumed. On the negative side, the fragmentation has been confusing to importers, exporters and producers and made it impossible to implement a national food monitoring programme or to compile a national data base in this regard.

5. INTERNATIONAL IMPLICATIONS

The necessity for an efficient national food control system arises not only from public health considerations but also from trade and economic implications. In this regard, South Africa's membership of the World Trade Organization (WTO), the Codex Alimentarius Commission (CAC) and the World Organization for Animal Health (OIE) are of prime importance.

The WTO is the legal and institutional foundation of the multilateral trading system. It provides the principal contractual obligations determining how governments frame and implement domestic trade legislation and regulations. It is the platform on which trade relations among countries evolve through collective debate, negotiation and adjudication.

The Marrakesh Agreement concluded in 1994 resulted in almost 30 multilateral trade agreements to which all members of the WTO are committed. Two of these agreements, namely the Agreement on Sanitary and Phytosanitary Standards (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement), have a direct impact on food safety issues.

In order to successfully conduct trade in food an importing country must be satisfied that imports meet its legitimate requirements, so that public health is appropriately protected, quality standards are maintained, and fraudulent practices are prevented.

5.1 The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) concerns the application of food safety and animal and plant health regulations. The main purpose is to ensure that countries do not undermine international trade by imposing non-tariff barriers. The basic provisions of the SPS Agreement are that any measures that may affect international trade must not be stricter than necessary for the protection of human, animal or plant health, must be based on scientific principles, and must not be maintained without sufficient scientific evidence.

The SPS Agreement defines "international standards, guidelines and recommendations", with reference to food safety as those established by the Codex Alimentarius Commission and with reference to zoonosis as those developed under the auspices of OIE.

Codex and OIE standards and guidelines therefore assumed a completely new dimension as the reference of national trade requirements. For this reason the World Health Organization in Circular C.L.8. 1994 dated 26 April 1994 stated: "Consequently it will be prudent for the health sector to participate even more actively in the work of the Codex Alimentarius Commission and its subsidiary bodies, both at national and international levels."

Article 3 (Harmonization) of the SPS Agreement includes the following paragraphs:

"1. To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist,..."

"4. Members shall play a full part,...., in the relevant international organizations and their subsidiary bodies,..... to promote within these organizations the development and periodic review of standards, guidelines and recommendations with respect to all aspects of sanitary and phytosanitary measures."

Article 5 deals with the Assessment of Risk and Determination of the Appropriate Level of Sanitary and Sanitary Protection. Paragraph 8 of this Article states:

"When a Member has reason to believe that a specific sanitary or phytosanitary measure introduced or maintained by another Member is constraining, or has the potential to constrain, its exports and the measure is not based on the relevant international standards, guidelines or recommendations, or such standards, guidelines or recommendations do not exist, an explanation of the reasons for such sanitary or phytosanitary measure may be requested and shall be provided by the Member maintaining the measure."

Article 4 dealing with equivalence, is also very important:

"1. Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shall be given, upon request, to the importing Member for testing and other relevant procedures.

2. Members shall, upon request, enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures."

5.2 The Agreement on Technical Barriers to Trade modifies the GATT Agreement which has existed since 1980. It seeks to ensure that technical regulations and standards, as well as testing and certification procedures, do not create unnecessary obstacles to trade. It applies to all commodities and covers all technical requirements and standards that are not covered by the SPS Agreement. Therefore the SPS and TBT Agreements can be seen as complementing each other. The TBT Agreement's application to food would cover issues such as labelling.

5.3 The implications of the above Agreements can be summarized as follows:

• South Africa's food safety regulations must be in line with the minimum Codex standards. Should they be stricter than Codex standards, without sound scientific justification, the country can become involved in a dispute. Weak control and less strict regulations or the absence of regulations governing specific matters can lead to the dumping of undesirable food as well as problems in terms of the application of equivalence. Failure to meet the demands can lead to losses of potential exports worth millions.

• All components involved in food control must therefore possess the human and other resources that will enable them to function in an optimal manner, determine policy and write and administer regulations that comply with global norms and standards.

• South Africa must participate in the activities of the CAC and its various general and commodity committees. Not only does South Africa have such an obligation in terms of Article 3.3 of the SPS Agreement; it also needs to make its inputs into those measures which will affect South Africa directly. Sessions of the CAC and its committees are in effect extensions of South Africa's regulatory activities. They have the added benefit of global expertise concentrating on specific issues, thereby saving months or even years of work in isolation. Major powers tend to favour their economic interests at such meetings making it imperative for developing countries to be present to protect and further their own interests.

• Article 4 (Equivalence) makes it imperative that South Africa's sanitary (food safety control) measures are at least at the same level as those of its major trading partners. According to the SPS Agreement such sanitary measures include:

"All relevant laws, decrees, regulations, requirements and procedures including inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments, provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety."

Article 4 applies to the food safety, animal and plant health activities of the Departments of Health and of Agriculture. The country as a whole must therefore ensure that its food control system, inclusive of animal and plant health control, is at least equal to that of its major trading partners, such as the USA and the European Union.

6. SUMMARY

Food safety legislation should give a sound basis to the national system for the delivery of food control and food inspection services that should satisfy at least the following minimum criteria:

6.1 Must be able to satisfy and adhere to national and international norms and standards.

6.2 Effective utilization of resources with clear policy on private vs. public goods. Those activities that are obligatory government functions (government financed) vs. those functions that can be outsourced/done by the private sector, must be clearly defined. In general the setting and auditing of norms and standards should be a government function while certain inspection and certification functions could be outsourced and/or delivered on a user-pay principle.

6.3 The system must be able to satisfy the food safety objectives of a country and must guarantee the required level of protection for human, animal and plant health.

6.4 The system must be able to render production support i.e. facilitate and promote trade. It must also be able to supply according to the needs of he country and not inhibit or discourage production and trade.

6.5 The decision-making process and policy formulation must abide with international criteria i.e. must be scientifically justified.

REFERENCES

Primary Production

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Safe Use of Livestock Medicines for Cattle and Sheep Farms, The Irish Agriculture and Food Development Authority (Teagasc), Dublin, Ireland
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Good Agricultural Practices, Agriculture Department, Crop and Grasslands Services, Food and Agriculture Organization of the United Nations (FAO).
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Good Agriculture Practice, Department of Agriculture and Rural Development, UK
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Good Agriculture Practice, The Joint Institute for Food Safety and Applied Nutrition (JIFSAN), United States Food and Drug Administration (FDA) and the University of Maryland, USA.
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Food Safety Authority of Ireland (2001). Code of Practice for food safety in the fresh produce supply chain in Ireland.
http://www.fsai.ie/publications/index.asp

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European Commission http://europa.eu.int/comm/food/fs/sc/indexen.html

EU (2004). Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
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National Dairy Farm Assured Scheme 2004 (NDFAS)
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OIE (2004). International Office for Animal Health - initiatives in food safety.
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Solomon, E. B., Yaron, S. & Matthews, K. R.(2002). Transmission of Escherichia coli O157:H7 from contaminated manure and irrigation water to lettuce plant tissue and its subsequent internalization. Applied and Environmental Microbiology <http://aem.asm.org/cgi/content/abstract/68/1/397>, 68, 397 - 400, (2002).

Hillborn, E. D. et al. (1999). A multistate outbreak of Escherichia coli O157:H7 infections associated with consumption of mesclun lettuce. Archives of Internal Medicine <http://archinte.ama-assn.org/issues/v159n15/abs/ioi80779.html>, 159, 1758 - 1764,

Guo, X., van Iersel, M. W., Chen, J., Brackett, R. E., & Beuchat, L. R. (2002). Evidence of association of Salmonellae with tomato plants grown hydroponically in inoculated nutrient solution. Applied and Environmental Microbiology, 68(7), 3639-3643

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