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| Agenda Item 4 | GF 02/3 |
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Paper prepared by the FAO/WHO Secretariat)
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.
While the components and priorities of a food control system will vary from country to country, most systems will typically comprise the following components.
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).
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:
Core responsibilities include:
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).
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.
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:
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:
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 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:
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:
Achieving the necessary balance between food safety control and other responsibilities can be difficult, but not impossible.
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.
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:
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.
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.
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.
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:
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:
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.
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:
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:
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:
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:
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.
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.
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.
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.
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.
These tasks stem from the legal obligation of control, as well as priorities determined by the competent authorities, which must take into account:
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.
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.
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 nspection 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.
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:
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.
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 no 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.
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.
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.
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.
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.
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.
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.
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.