(Paper prepared by the Ministry of Agriculture, Nature
and Food Quality and
the Food and Consumer Product Safety Authority of the Netherlands)
Agenda Item 4.2
Effective food control systems are essential to protect the health of consumers. They are also vital in enabling countries to assure safety and quality of food products for international trade and to verify that imported food products meet national requirements. The legal framework for food safety in the European Union Member States is currently in process. Serious food safety incidents during the nineties urged the European Union and other countries across the world to review their food safety systems and to look for better ways to protect consumers against unsafe food. In 2000 the European Union launched its White Paper on Food Safety as a start for a new legal basis for appropriate food and animal feed production and food safety control. The Codex Alimentarius Commission continues to develop international standards, guidelines and recommendations to reduce food safety risks. The Codex Alimentarius developed risk analysis, the integrated food chain approach and HACCP. The risk analysis paradigm, including risk assessment, risk management and risk communication have been incorporated as general principles in EU law and form the legal basis of the food safety systems in the Member States.
In the White Paper of the EU the entire food production chain (including animal feed) is held responsible for the safety of food. The Governments of the Member States verify that this responsibility is adequately met by the producers to protect the health and well-being of consumers. The document contains 84 action points that have to be processed into community law to strengthen the food safety systems of the Member States. Within this framework, the EU introduced the General Food Law in 2002, defining general food safety principles and food safety procedures. Once this Regulation was in place, the European Food Safety Authority was set up. This organization started its activities in 2003, by focusing on risk assessment and scientific advice in the field of food safety questions. The White Paper has helped to strengthen and synchronize hygienic conditions and practices throughout all the EU Member States. This year an integrated EU Hygiene Package was completed in which the existing rules on hygiene were incorporated.
The European Union has established a specific legislation to harmonize official control procedures in the Member States. It also regulates the provisions that countries outside the EU should fulfill for entering the EU markets with their food products. Although control procedures are largely harmonized, the structure and set-up of control organizations is quite different across the European Union. The variety in national political and economical conditions have led to differences in the way Community legislation was transposed in national law and in operational systems for food production and inspection. Therefore, there is a large variety of food safety control systems throughout the Member States. In certain countries the responsibility of food control is decentralized and mandated to regions or provinces, whereas in other countries food safety control is in the hands of just one central organization. In recent years many countries in the European Union have established a National Food Safety Authority. Again, the responsibilities and tasks of this organization may vary from one country to another. The main task is usually enforcement of food control regulations, but risk assessment and scientific advice, and risk communication are also often included.
Risk management remains basically a prime responsibility of governments to protect consumers against food safety hazards. Risk management is based on risk assessment and scientific evidence, but also other aspects of food production could be taken into consideration like environmental protection and animal welfare. An effective food safety management system may be a combination of direct governmental supervision based on food safety requirements prescribed by law and private food safety control systems. Certification of production processes by accredited organizations may help producers to reduce risk levels and to convince Governments and consumers of the safety and quality of their produce. The confidence of consumers strongly depends on the quality of the certification body. In many western countries the private sectors have established their own additional quality requirements and certification schemes for specific product groups. These non-official requirements may improve certain quality aspects of products, but such higher demands may also hinder the access of businesses to markets. All European Union legislation and other related information can be found at website: <http://europa.eu.int/eur-lex/>.
2. The EU White Paper on Food and Feed, principles of food control
White papers are documents containing proposals for Community action in a specific area. They sometimes follow a green paper published to launch a consultation process at European level. While green papers set out a range of ideas presented for public discussion and debate, white papers contain an official set of proposals in specific policy areas and are used as vehicles for their development.
Assuring that the EU has the highest standards of food safety is a key policy priority for the European Union. The White Paper on Food Safety reflects this priority. A radical new approach has been proposed. This process is driven by the need to guarantee a high level of food safety. Greater transparency at all levels of food safety policy is the thread running through the whole White Paper and will contribute fundamentally to enhancing consumer confidence in EU Food Safety policy.
The writing of a white paper on food safety was mainly driven by events and developments during the 1990s. The well-known dioxin and BSE crises have led to a whole new approach of risk management. The risks associated with the contamination of foods were brought into sharp focus by the dioxin crisis. Steps will be taken to address those areas where existing legislation needs to be improved to provide adequate protection. But also developments in the rulemaking process have led to new ways of dealing with food safety control. The experience of the Commission's own Food and Veterinary Office, which visits Member States on a regular basis, has shown that there are wide variations in the manner in which Community legislation is being implemented and enforced. This means that consumers cannot be sure of receiving the same level of protection across the Community, which makes it difficult to evaluate the effectiveness of national measures.
The White Paper proposes that, as a general principle, all parts of the food production chain must be subject to official controls. Responsibility for safe food production and control is shared between operators, national authorities and the European Commission. Operators are responsible for compliance with legislative provisions, and for minimizing risk on their own initiative. National authorities are responsible for ensuring that operators respect food safety standards. They need to establish control systems to make sure that Community rules are being respected and, if required, enforced. To ensure that these control systems are effective, the Commission, through the Food and Veterinary Office (FVO), carries out a programme of audits and inspections. These controls evaluate the performance of national authorities against their ability to deliver and operate effective control systems, and are supported by visits to individual premises to verify that acceptable standards are actually being met.
One of the action points in the White paper is to develop a regulation on official food and feed safety controls. Earlier this year Regulation 882/2004/EC (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) was published. This Regulation sets a Community framework of national control systems, which will improve the quality of controls at Community level, and consequently raise food safety levels across the European Union. The operation of such control systems remains a responsibility of the individual Member States.
3. The EU General Food Law, the legal basis of European Union food control
An important need mentioned in the White Paper was to create a coherent and transparent set of food safety rules. With the publication of the General Food Law (GFL), the European Union has made a new legal framework laying down the principles to ensure a coherent approach and to fix the principles, obligations and definitions that apply in the field of food safety. It defines the common principles underlying food legislation and the establishment of a food safety policy as a primary objective of EU food law. This Regulation also provides the general frame for those areas not covered by specific harmonized rules but where the functioning of the Internal Market is ensured by mutual recognition. Under this principle, in the absence of Community harmonization, Member States may only restrict the placing on the market of products lawfully marketed in another Member State when and to the extent that this can be justified by a legitimate interest such as the protection of public health and only when the measures taken are proportionate.
The General Food Law consists of three parts. The first part lays down the general principles and requirements of food legislation, the second part defines the establishment of the European Food Safety Authority and the last part lays down procedures in matters of food safety. Let us focus on the first part.
A general principle of food law is that operators in the feed and food business have the primary responsibility for food safety. Competent authorities monitor, enforce and verify this responsibility through the operation of national surveillance and control systems at all stages of production, processing and distribution. Member States are also obliged to lay down rules on measures and penalties applicable to infringements of food and feed law. They shall be effective, proportionate and dissuasive. The Commission concentrates on evaluating the ability of competent authorities to deliver these systems through audits and inspections at the national level.
A successful food policy demands the traceability of feed and food and their ingredients. This is an important requirement of the GFL. It includes the obligation for feed and food businesses to ensure that adequate procedures are in place to recall products that might pose a possible health risk. Operators should also keep adequate records of suppliers of raw materials and ingredients so that the source of a problem can be identified.
4. National implementation of the General Food Law
Regulations and directives in the framework of the General Food Law have to be transposed into national legislation of individual EU Member States regarding enforcement, sanctioning and the designation of the competent authority. Regulations are imposed directly on countries and need no further interpretation, while directives may be implemented according to national policies. For instance, in the national implementation of the General Food Law the penalties must be laid down to be applied if an operator does not have an adequate traceability system and the competent authorities for inspections and controls.
National implementation of EU law must fit into national structures, such as centralized and decentralized control structures. Therefore most EU food safety legislation focuses on criteria and procedures rather than on detailed regulations for control.
In addition to the legal implementation of EU legislation it is also necessary to put a national performance policy in place and to explain the meaning of this policy to the public. This process may give rise to questions that must be checked with other EU Member States and the European Commission.
In recent years many countries in the European Union have chosen to establish a National Food Safety Authority to contribute to higher food safety standards and more effective food safety control. These authorities comply with the requirements of the General Food Law but their establishment has never been obligatory. The responsibilities and tasks of these organizations may be quite different per Member State. In some countries their mandate is limited to risk assessment and scientific advice to the Government. In other cases their mandate includes risk communication and enforcement of food control regulations. Risk management tasks are usually kept in the hands of the responsible ministries.
5. Food safety control policies in the EU and its Member States
5a) General framework and coverage
Feed and food should be safe and wholesome. European Community legislation comprises a set of rules to ensure that this objective is attained. These rules on hygiene and safety extend to the production, processing and the introduction of food products on consumer markets.
The basic rules with regard to feed and food law are laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002, often referred to as the "General Food Law". This law lays down the general principles and requirements of food legislation, the establishment the European Food Safety Authority, and procedures in matters of food safety.
In addition to these basic rules, more specific feed and food laws cover different areas such as animal nutrition including medicated feeding stuffs, feed and food hygiene, zoonoses, animal by-products, residues and contaminants, control and eradication of animal diseases with a public health impact, feed and food labelling, pesticides, feed and food additives, vitamins, mineral salts, trace elements and other additives, materials in contact with food, quality and compositional requirements, drinking water, ionization, novel foods or genetically modified organisms (GMOs).
5b) Food safety responsibilities
Community feed and food law is based on the principle that feed and food business operators at all stages of production, processing and distribution within the businesses under their control are responsible for ensuring that products and manufacturing processes satisfy the requirements of feed and food law which are relevant to their activities.
This principle of placing the main responsibility on producers can only work adequately, when effective and efficient government controls are in place. As a consequence all relevant information on the application of process controls, essential for safe food production, should be fully available for government control purposes. The same applies to information that is of importance for proper traceability.
The EU-Members enforce feed and food law and monitor and verify that the relevant requirements of law are fulfilled by business operators at all stages of production, processing and distribution. Official controls should be organized for that purpose.
The organization of the official controls differs to a large extent throughout the European Union, as a result of different historical backgrounds and traditions. The differences vary from a completely centralized system (the Netherlands, Denmark, Belgium) to decentralized systems where the competent authorities are working according to a regional (Spain, Germany) or local system (United Kingdom, Ireland).
5c) Harmonization and coherence
To achieve equivalent official feed and food control systems across Member States, the European Commission has chosen to establish a harmonized framework of general rules at Community level for carrying out such controls. For this reason Regulation No. 882/2004/EC on the official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules and Regulation No. 854/2004/EC laying down specific rules for the organization of official controls on products of animal origin intended for human consumption have recently been adopted.
5d) National implementation and Community verification
In order to have a global and uniform approach with regard to official feed and food controls, EU Member States must establish and implement national control plans in accordance with broad guidelines elaborated at Community level. These guidelines should promote coherent national strategies, and identify risk-based priorities and the most effective control procedures. After developing these guidelines a Community strategy for a comprehensive, integrated approach to the operation of controls can be reached. Moreover, each EU-Member State has to present an annual report to the European Commission covering information on the implementation of the national control plans. This report is meant to provide:
the results of the official controls and audits carried out during the previous year and,
where necessary, an update of the initial control plan in response to these results.
The national control plans and the yearly reports will establish a solid basis for the European Commission Food and Veterinary Office to carry out controls in the EU Member States. The control plans will enable the Food and Veterinary Office to verify whether the official controls in the EU Member State are organized in conformity with the criteria laid down in these Regulations. If appropriate and in particular if the audit of a EU Member State against the national control plans shows weaknesses or non-compliances, detailed inspections and audits will be carried out.
Eventually Community controls in the EU-Member should allow the Food and Veterinary Office to verify whether feed and food law, and the legislation on animal health and animal welfare are implemented in a uniform and correct way throughout the European Union.
5e) Imported goods
Regulation 882/2004/EC gives rules for the official control on the import of products from third countries. For this reason, Community controls in third countries are required in order to verify compliance or equivalence with Community feed and food law. Third countries may also be requested to establish control plans similar to those intended for Member States, in respect of the feed and food exported by them. These plans, which must be established on the basis of Community guidelines, should form the basis for subsequent Commission controls, which should be carried out within a multidisciplinary framework covering the main sectors exporting to the Member States. This development should allow a simplification of the current control regime, enhancing effective control co-operation, and consequently facilitating trade flows.
To help developing countries in setting up official feed and food control systems equivalent to the control systems in the European Union, it is appropriate to identify and consider the special needs of those countries. The EU is committed under Regulation 882/2004 to support developing countries with regard to feed and food safety, which is an important element of human health and trade development.
Besides this Regulation, there is a specific Regulation No. 854/2004/EC for the organization of official controls on products of animal origin intended for human consumption. The purpose for a specific official control procedure for these products is that specific sanitary rules must be complied with here (Regulation No. 853/2004/EC).
The Member States are aware of the need to harmonize control procedures of imported goods across the European Union. There is a need for setting detection limits of certain residues in food products in order to facilitate uniformity of procedures and sanctioning at all European border posts.
6. Organization of official feed and food control according to European legislation
6a) General requirements
A EU Member State must designate competent authorities to carry out official controls. If a Member State has different competent authorities, it must ensure efficient and effective coordination between these authorities. To harmonize the verification of compliance with legislation, specific operational criteria are prescribed. Thus competent authorities must:
ensure their impartiality and effectiveness;
have a sufficient number of suitably qualified and experienced staff and possess adequate facilities and equipment to carry out their duties properly;
carry out the official controls using appropriate techniques developed for that purpose, including routine surveillance checks and more intensive controls such as inspections, verifications, audits, sampling and the testing of samples;
establish regular frequency of official controls proportionate to the risk, taking into account the results of the checks carried out by feed and food business operators under HACCP based control programmes or Quality Assurance Programmes, where these are designed to meet requirements of feed and food law;
carry out ad hoc controls where businesses are suspected of non-compliance with feed and food law;
carry out official controls on the basis of documented procedures so as to ensure that these controls are carried out uniformly and are of consistent high quality;
ensure that laboratories involved in the analysis of official samples work in accordance with internationally approved procedures or criteria-based performance standards and use methods of analysis that have as far as possible been validated;
ensure that adequate financial resources are available for organizing official controls. Where for that purpose fees are imposed on feed and food business operators, common principles should apply;
with regard to fees applicable for import controls, establish directly the rates for main import items with a view to ensuring their uniform application and to avoid trade distortions;
Breaches of feed and food law may constitute a threat to human health, animal health, and animal welfare. Such breaches should therefore be subject to effective, dissuasive and proportionate measures at national level throughout the Community and must include administrative action by the competent authorities in the Member States who should have procedures in place for that purpose;
Legal persons/corporations should also be subject to effective, dissuasive and proportionate penalties, because breaches of Community law to a large extent are committed in the interest of legal persons/corporations or for their benefit;
Feed and food business operators must have a right to appeal against the decisions taken by the competent authority as a result of the official controls, and be informed about such right.
6b) Specific requirements
With regard to the official controls on products of animal origin more specific requirements have to be met. These requirements concern:
the approval of production establishments;
the check of certain aspects and features;
the role of the official veterinarian and official auxiliaries;
the introduction of specific requirements for different types of products of animal origin.
The new legislation specific for products of animal origin is mainly based on pre-existing traditional "veterinary" rules, while at the same time new HACCP rules are coming into force. Whether these two quite distinct legislative approaches go well together has not yet been clearly documented. The traditional veterinary approach is labour intensive and relatively costly however, it does not seem to be scientifically based in all cases, nor focused on the most relevant human health risks.
7. The role of private food control systems
7a) General remarks
Private control systems have an important impact on the food safety systems as a whole. They can be divided into two different types:
Private control on official standards and procedures;
Private control on private criteria and quality schemes.
The first type may be helpful for governmental control bodies and for companies to meet standards. In this case the government verifies that the private controls and control bodies are reliable. Accreditation of certifying control bodies is a usual method for reliable verification. Internal control systems in production facilities, such as an (obligatory) HACCP system, may play an important role in the reduction of food safety risks.
The private sector may also require criteria and quality standards from their suppliers, not based on official standards. These non-official requirements are meant to further strengthen the confidence of consumers. In responding to the demands of consumers, retailers and their global suppliers have created and implemented a series of sector specific farm certification standards in the EUREPGAP quality schemes. The aim is to ensure integrity, transparency and harmonization of global agricultural standards. This includes the requirements for safe and high quality food, respect for workers' health, safety and welfare, and environmental and animal welfare issues.
7b) The International Standardization Organization (ISO)
Regulation 882/2004 states that the frequency of official controls should be regular and proportionate to the risk, taking into account the results of the checks carried out by feed and food business operators under HACCP based control programmes or Quality Assurance Programmes, where these are designed to meet requirements of feed and food law. At present ISO is working on a specific standard on food safety management system (ISO 22.000). This international standard specifies requirements for a food safety management system in the food chain where an organization needs to demonstrate its ability to control food safety hazards in order to consistently provide safe final products. These both meet agreed customer and applicable regulatory food safety requirements, and aim to enhance customer satisfaction through the effective control of food safety hazards, including processes for updating the system. This international standard specifies requirements to enable an organization to:
plan, design, implement, operate, maintain and update a food safety management system aimed at providing final products that, according to their intended use, will ensure that the food, when eaten, is safe for the consumer;
evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety;
demonstrate effective communication with customers and other interested parties across the food chain;
demonstrate conformity with applicable regulatory requirements as regards food safety;
assure that it complies with its stated food safety policy;
demonstrate such compliance to other interested parties;
seek certification or registration of its food safety management system by an external organization.
All requirements of this international standard are generic and intended to be applicable to all organizations wishing to design and implement an effective food safety management system, regardless of type, size and product provided. This includes organizations directly involved in one or more steps of the food chain (for example, but not limited to feed producers, farmers, producers of ingredients, food producers, retailers, food services, catering services, organizations providing cleaning, transportation, storage and distribution services) and other organizations indirectly involved with the food chain (such as suppliers of equipment, cleaning agents and packaging material and other food contact material). ISO 22000 follows the structure and approach of ISO 9001 on quality management and integrates this with food safety on the basis of HACCP, developed by the Codex Alimentarius Commission.
7c) Verification of delegated control activities
In premises where adequate and effective control systems exist, the frequency of official inspections may be diminished. Private control systems, like certification bodies, may help the competent authorities to perform their control tasks. However, it is important that the competent authorities actively verify the quality of those organizations and their activities. The Regulation gives the possibility that competent authorities delegate tasks to external control bodies under strict conditions. The main restrictions include:
external control bodies cannot impose sanctions, which means that in case a control body finds non-compliance they should warn the competent authority;
external control bodies should carry out their tasks in line with the description and conditions laid down;
external control bodies should have the expertise, equipment and infrastructure required to carry out the tasks delegated to them;
external control bodies should have sufficient numbers of suitably qualified and experienced staff;
external control bodies should be impartial and free from any conflict of interest as regards the exercise of the tasks delegated to them;
external control bodies should work and be accredited in accordance with European Standard EN 45004 "General criteria for the operation of various types of bodies performing inspection";
there should be efficient and effective co-ordination between the delegating competent authority and external control bodies.
Competent authorities that delegate tasks to external control bodies are obliged to organize audits. When repeated non-compliance is found and external control bodies fail to take appropriate and timely remedial action their tasks will be withdrawn without delay.
8. The European Food Safety Authority
Following a series of food safety crises in the 1990s (e.g. BSE, dioxins) which undermined consumer confidence, the European Union concluded that it needed to establish a new scientific body charged with providing independent and objective advice on food safety issues associated with the food chain. Its primary objective as set out in the White Paper on Food Safety would be to: "... contribute to a high level of consumer health protection in the area of food safety, through which consumer confidence can be restored and maintained". After the publication of the General Food Law this resulted in the establishment of the European Food Safety Authority (EFSA).
Set up provisionally in Brussels in 2002, EFSA provides independent scientific advice on all matters linked to food and feed safety - including animal health and welfare and plant protection - and provides scientific advice on nutrition in relation to Community legislation. The Authority communicates to the public in an open and transparent way on all matters within its remit. EFSAs risk assessments provide risk managers (consisting of EU institutions with political accountability, i.e. European Commission, European Parliament and Council) with a sound scientific basis for defining policy-driven legislative or regulatory measures required to ensure a high level of consumer protection with regards to food safety.
EFSA was born from Parliament and Council regulation (EC) No 178/2002 of 28 January 2002. The new Authority quickly found its feet, organizing its first Management Board meeting nine months later. Shortly afterwards it nominated its first Executive Director and created the Advisory Forum, made up of representatives from food safety bodies in the EU Member States. Momentum grew in 2003 as EFSA developed into a fully-fledged independent European Union agency. EFSA truly opened for business in May with the establishment of its Scientific Committee and Panels. World-class scientists from all over Europe were appointed to eight Panels, covering everything from food additives to animal health, and to a Scientific Committee with oversight of these panels.
In July 2003 a Chair of the Scientific Committee, a Deputy Director General, a Director of Science and a Director of Communications were appointed; the first scientific opinion related to GMOs was published. By December last year, the Authority employed around 70 people and already had over 120 registered scientific questions with confirmed deadlines to address in its working programme.
Staff numbers are expected to double during 2004, as EFSA continues to expand and prepares to establish itself permanently in Parma, Italy. Overall capacity building will continue, enabling the Authority to meet working programme commitments including the significant expansion of both its scientific and communications activities as well as the development of its institutional, stakeholder and international relations.
EFSA is now dealing principally with requests for risk assessments from the European Commission and plans to take on a wider brief from other European institutions in the near future. Notwithstanding the important needs of its key customers, EFSA is already undertaking its own work in order to look ahead and address broader issues of importance to its mandate. For example, through such "self-tasking", the Authority's Scientific Committee has initiated work in relation to the identification of emerging food safety issues. Website: http://efsa.eu.int/
9. Future developments
The European Union will review and further elaborate the legislation mentioned in the White Paper in the field of animal feed, animal health and zoonoses, animal by-products, contaminants and additives, labelling, pesticides, healthy food, plant reproduction materials and international relations.
International agreements, such as SPS and TBT, and standards and guidelines of international organizations, like Codex Alimentarius, the World Organization for Animal Health (OIE) and the International Plant Protection Convention, will continue to have impact on policy processes in the European Union.
The European Union will develop a more harmonized approach to verify the effectiveness of the official controls in the EU as well in third countries.
In special cases, direct controls and inspections of food performed by Governmental bodies, may evolve to Governmental supervision over accredited control bodies. In the further development of food chain control, process control systems will further improve and checks of final products will lose importance, although not entirely.
Food operators are entirely responsible for the quality and safety of the food they produce and provide to consumer markets. Food safety legislation and control are meant to impose this responsibility and to verify that all policy conditions are adequately met;
Food safety legislation in the European Union Member States is largely harmonized under Community law. A new policy approach has been introduced after food scares in the 1990s. It is based on risk analysis and complies with principles of the SPS Agreement of WTO. Therefore it is closely connected to the standards, guidelines and recommendations developed by the Codex Alimentarius Commission;
The harmonization process has strongly reduced the former policy differences between individual Member States and contributed to higher transparency of the European Union importation system and consumer markets. Control procedures and sanctions however, have not yet been fully harmonized;
Harmonization of food control in the EU is based on specific criteria and not on control structures. There should be one specific template for an official control structure, which takes into account a country's historical backgrounds and economic circumstances. Official controls should be fitted to the national food safety framework;
Imported goods have to comply with the internal EU standards. Exporting countries with well-organized official control structures will meet the EU requirements more easily than countries without it;
For developing countries and economies-in-transition technical assistance and capacity building in the field of food legislation and control are valuable tools to enhance the international trade of safe and wholesome food products.
(Prepared by the Ministry of Agriculture, Food, Fisheries and Rural Affairs - National School of Veterinary Services, France)
Agenda Item 4.3
Vocational training is not an objective per se but a tool for policy implementation in a given administrative and juridical framework. The context determines needs, constraints and solutions.
Any focus on the training of personnel in the food safety control services of different countries of the world requires an insight into their operational context and key developments. The organizational structures and areas of competence of these services are also decisive in determining training responses. We need to go beyond national particularities and discern elements of common interest in order to describe the existing situation and, above all, in order to fuel thought to the future.
The international standards of the Codex Alimentarius and OIE, which have served as the WTO framework of reference since 1995, have converging provisions on the quality of official control and inspection services and on the status, competence and training of personnel, especially regarding official certification. These texts are cited more in terms of objectives to be reached than means to be implemented.
For the purposes of this paper, official food safety control is defined as all the operations conducted by official services set up to verify and guarantee the conformity of food products with established standards in order to prevent risks to public health. It covers food produced and marketed domestically, as well food imported or intended for export (health certification). It covers all phases of production, processing, storage, transport, sale and final consumption. It comprises numerous operations, including inspection, verification of records, sampling, laboratory analysis, control of staff hygiene, audits and the checking of self-policing systems. Laboratories are not themselves covered because of the highly specific nature of issues relating to competence of laboratory staff.
A large number of structures are in some way involved in a field as complex as the control of food safety. For purposes of simplification, this paper will only deal with specialized food safety services, such as veterinary services, although a similar approach can be deduced by analogy for other services.
The tendency in food safety is to have measures covering the whole production and distribution chain: "from farm to fork" or from upstream (animal feed, veterinary drugs and phytosanitary products) to downstream (the consumer). This review only looks at services relating to food itself - from the time of harvest for crops and the moment of slaughter for animals, when food safety services are not organized holistically.
II. International And Societal Context: Basic Developments
Food safety concerns have intensified throughout the world in the past 15 years. The operational context of control services has undergone and is undergoing profound change in a framework of greater international connectivity. The following elements can impact strongly on training needs or policies:
(1) Increased media and consumer awareness, linked in particular to highly publicized cases of food contamination or crisis in developed countries and the emergence of new worrying phenomena (bovine spongiform encephalopathy, genetically modified organisms, dioxins...).
(2) The globalized impact of health issues because of increased trade, the complexity of production and distribution channels, the spread of non traditional consumption practices...
(3) The lowering of customs barriers and the resulting implications of safety obstacles to trade, especially with the opening of certain national markets to hitherto non-competitive imported products.
(4) The increasing harmonization of international requirements since the WTO SPS and TBT agreements came into effect. This principle of harmonization encourages countries to adopt national measures that mirror international standards, such as those of the Codex Alimentarius or the World Organization for Animal Health.
(5) The tightening of health standards in the North which raises international requirements:
- the refocusing of safety control methods and traditional examination of the finished product (with the discard of sub-quality products) towards preventive management through control of the production process (in particular the HACCP method);
- the blanket application of safety to the whole production chain, "from farm to table" (cf. BSE, mycotoxins, salmonella, residues and contaminants...);
- the transfer of primary responsibility for product safety to producers, with the State exercising second-level control.
(6) New interest in the role of end consumers, both as individuals and as a political force, through their associations and the media.
(7) The increasingly complex role of scientists because of the documented approach to risk analysis, the appropriation of scientific debate in trade disputes, media attention and more frequent application of the precautionary principle.
(8) The heavy impact of these developments on the developing and least developed countries, that for a long time, understandably, viewed food safety as a concern of the developed countries and of secondary importance to their economic and public health priorities (widespread epidemics, water). Concern for their food self-sufficiency had emphasized the importance of upstream production (animal and plant health) with the health control of foods of animal origin limited almost exclusively to post-slaughter inspection at the abattoir. These countries are now faced, internally, with (i) a change in production and consumption patterns (rural migration, rapid urbanization, food consumption outside the home...) representing a break from ancestral culinary traditions (cooking, drying...); (ii) the arrival on the market of imported products hitherto non-competitive because of tariff barriers...; (iii) poorly structured or indeed totally disjointed production and distribution channels, with poorly educated operators; (iv) and, at the same time, a number of highly qualified operators adopting modern techniques and employing personnel trained overseas (multinationals, export companies, the tourism sector, large retail outlets).
III. Administrative Organization: The framework of action
The competences that need to be developed among control staff are determined by the objectives, mandate and organization of the service concerned.
The way food safety control services are organized varies widely between countries and many different structures are in some manner involved. Different organizational possibilities and the combination of options will determine training needs.
(1) The degree of vertical integration:
- either the same service carries out integrated control of the whole food production chain (within a ministry or agency). In practice, such integration is often incomplete, not covering all stages or all products;
- or responsibilities are separated between upstream (primary production: animal health, crop protection) and downstream (processing), with the division at the slaughterhouse or harvest level.
Many countries have recently reorganized their administrations to have a single structure controlling the whole food chain.
(2) The administrative configuration:
- centralized States, whose field services are devolved from the central administration, have a single chain of command;
- in a majority of federal or decentralized States, control is exercised by administrative subdivisions, sometimes at different levels (states, regions, districts, municipalities...), with or without hierarchical link between the central State and the territorial echelons, with or without vertical and horizontal coordination; they can also have significant regulatory and/or budgetary autonomy;
- in contrast, some decentralized States maintain central or federal responsibility for food safety.
(3) Coordination is organized very differently, whether between ministries over the same territory or between different territorial levels. It might be non-existent, informal or institutionalized (cooperation protocols, institutional lead agency...).
(4) The delegation of selected control: control is seen as a prerogative of the central authority and is usually exercised as such by the administration (more rarely, by independent public agencies). Some countries, however, delegate selected control to private structures that are formally recognized by the administration.
(5) The distribution of responsibilities: under the traditional approach, responsibility for product safety is borne by the official services exercising first-level control over the finished product and, perhaps, production conditions. This continues to be the approach in many countries, at least for the domestic market.
At an intermediary level, operators are responsible for the quality of the products they market, with first-level control remaining in the hands of the official services.
Finally, the present trend is towards a division of responsibilities among: (i) operators responsible for the safety of their products and required to employ preventive measures, notably HACCP related; (ii) public authorities exercising second-level control and checking the measures taken by the operators; (iii) even consumers, given the importance of the post-purchase phases (conservation and preparation) for the maintenance of food safety.
All intermediary situations exist in reality and changes on the ground can only be introduced progressively.
(6) The above points to the following areas of frequent vulnerability:
- intervention at the limits of responsibility of different services (upstream/downstream);
- overlapping of service jurisdiction, all the more noticeable with a vague juridical framework;
- the absence of a culture of collaboration among services;
- the decentralization of control (except with highly organized collaboration) because of:
significant divergences between regions in terms of strategy, interpretation, density and quality of control, and in terms of training and culture of control agents;
the influence of local politics, especially where control agents and particularly supervisory staff are appointed by the local authorities;
divergences between local and national priorities;
difficulty in coordinating actions involving several adjacent subdivisions;
inadequate feedback to the central level.
IV. Control Staff
The control services employ different categories of staff. The terminology employed and the corresponding levels of training and responsibility vary enormously among countries.
For purposes of simplicity, there are two broad categories of staff or agent:
- officers, veterinary doctors (very widely represented, especially in the veterinary services), experts (in livestock production, fisheries, food processing, public health), microbiologists, chemists, jurists and, more rarely, doctors;
- support staff, technical agents and inspectors or other field agents with extremely diverse levels of education, sometimes very numerous, sometimes very few, depending on the country; some hold intermediary responsibilities.
Some of the characteristics of status of these agents impact on training policy.
Status and recruitment
Control agents are usually civil servants (or the equivalent with indefinite contracts), in application of the principle of independence of public service from political or economic pressure. However, in some countries supervisory staff are contracted privately, in which case their appointment and retention depends on the political authority. Recruitment in the decentralized States is often at regional or local level for the technical agents (civil servants), and sometimes also for the supervisory staff. Elsewhere, many countries employ part-time freelancers to make up control staff numbers, particularly for slaughterhouse inspection (veterinarians). But these do not represent the backbone of the system, even though there are countries where a majority of agents are employed on a part-time basis, with the attendant risks of conflict of interest.
Mobility and career development
Under certain systems, thematic and/or geographical mobility is possible, encouraged or even mandatory for promotion, especially for supervisory staff. This is facilitated under national recruitment systems and in services with broad responsibilities. It is a factor of motivation, fostering the harmonization of practices and coordination. In contrast, the possibilities of mobility are few or indeed nil in systems that are based on local recruitment and in services that have very narrow remits. Although these foster stability and capitalization of know-how, they nevertheless incur the risk of lethargy, demotivation and indeed collusion. Finally, the extensive random mobility that takes place in certain countries with the occurrence of political change is clearly a destabilizing element for control staff and services.
V. Forms of Training
V.1 Prior and post-recruitment initial training
Prior initial training designates the level required for recruitment. Post-recruitment or occupational initial training is training provided by the employer before taking up duties.
a) Supervisory staff
All countries require a certificate of higher education for entry at supervisory level (generally BAC + 5 or 6). Candidates have thus acquired a good general scientific base at university level. In most cases, this qualification is sufficient for recruitment, although some professional experience in the private sector is sometimes also required.
However, deficiencies are often noted, undermined effective performance in the official services.
For example, veterinarians trained as clinicians and pathologists have a very diverse understanding of food hygiene. Some universities provide advanced education in this area while others barely touch upon the subject. Disparity between countries is sometimes compounded by differences between universities within the same country, or between veterinarians trained abroad in different countries. To overcome this, some countries have made it mandatory that applicants should have attend selected veterinary university courses to be eligible for public service or to qualify for higher posts. Others resort to post-recruitment training.
This training, which is organized and paid for by the employer, is intended to supplement prior scientific training with the specific technical and administrative expertise that is required for public service in the food safety sector.
This form of training is unknown in many countries, where learning occurs on-the-job. Some services run short training sessions, lasting a few days to a few weeks, to present the central administrations and outline the legal dimension. The practice of setting a 6, 12 or 24 month probationary period before job confirmation is frequent, with or without associated short training, and sometimes with tutoring.
There appear to be very few countries that provide long-term post-recruitment training for their civil servants. In France, veterinary officials in the veterinary services have been trained in the specialized post-graduate National School of Veterinary Services (ENSV) since 1973. This training, open to foreigners, lasts one to two years and covers technical aspects (HACCP, environment, epidemiology, quality assurance), administrative matters (law, economics, international politics) and management. It prepares the ground for a range of appointments.
Such training meets the requirements of a new regulation adopted in 2004, governing the recruitment of official veterinarians. These have to pass an examination on a wide range of technical and administrative subjects (the actual training modalities are left for the Member States to decide) and have received 200 hours of tutored practical training.
b) Support staff
The differences in approach to supervisory staff also apply to support staff, depending on the administrative culture of each country.
This varies considerably: from recruitment with a university diploma (BAC+2), to a high-school diploma (BAC), to no initial qualification. Assigned responsibilities also vary. Some countries have job specifications for public posts which help determine the "appropriate training" for each individual post.
Post-recruitment occupational training
Post-recruitment training is far more common for this category of staff and generally focuses on a specific area of control (e.g. inspection at slaughterhouse). It rarely covers all potential fields of assignment.
The European Union's new regulation specifies that these agents should receive 600 hours of theoretical training (the programme is given) and 300 hours of practical training before sitting the qualifying examination. The duration of training will be increased to 1400 hours in 2010.
V.2 Staff development training
Staff development or intermittent training serves to keep agents abreast of technical or administrative developments or to enable their career advancement.
It does not exist in many countries, especially developing countries. At most, ad hoc training modules are included in bilateral or international cooperation programmes.
When such training is organized, the basic format is generally a session lasting a few days and focusing on a specific occupational theme.
The perception of staff development varies considerably. Some countries include it in a global policy of institutional training, with annual or even multi-annual programming organized by the employer ministry. The training sessions are either organized directly by the administration or commissioned from universities, specialist schools or vocational associations, following tailored specifications. This approach, which is easier to adopt in a centralized State, also exists in a number of decentralized States which view the training of staff in administrative subdivisions as an instrument of guidance and coherence.
This training often occurs in a less coordinated manner, especially when responding to market forces and the logic of supply. The sessions, paid by the employer or the staff themselves, are organized by universities or laboratories. However, they do not always convey the institutional line-of-thinking and might sometimes transmit divergent messages.
In the decentralized States, each administrative subdivision often designs its own actions based on its own policy, without vertical or horizontal harmonization.
Participation in training courses organized by other countries or in training at international level is an intrinsic ingredient of training policy of certain countries, especially in small countries that depend on the availability of training in their neighbouring countries.
Staff development training can be optional and free of charge to the agent, and might even represent a right rather than a duty. On the other hand, it is sometimes mandatory, even if only in principle, for certain courses, with a minimum number of days of training required each year and even a system of points to be accumulated over a given period. It might also be required for access to certain jobs.
The employer generally covers the cost, although some systems require the staff to pay for all or part of the mandatory training.
All the above points have a direct or indirect bearing on training policy: the general context, the organization of the different services, the status, mobility and conditions of recruitment.
Observation: The focus here is on the training of supervisory staff, unless specified otherwise, because their higher responsibilities and mobility make them a more complex group. The situation for other staff can be deduced by analogy.
The training of food safety controllers occurs in a determined political, economic, social, institutional, financial and juridical context. It cannot make up for inadequacies of infrastructure (slaughterhouses, laboratories), of personnel, of resources (vehicles and fuel, thermometers, computers...) or of funds, nor can it mitigate the constraints of a given political or territorial structure. Any consideration needs to take these limits into account, especially when setting the thematic and organizational priorities and planning the way forward.
Some prerequisites seem however essential, especially a demonstrated political will, a structured juridical framework (including the distribution of responsibilities among services, the powers given the controller, etc.), available and updated documentation and standards, and a clear institutional policy to be conveyed (training transmits, but does not generate, knowledge).
The primary objective of training is to enable staff to acquire the knowledge, tools and "soft skills" (self-management skills) needed to carry out their missions in their respective service of assignment.
The impact of training can however also be perceived on another level.
If properly directed, training is a service management tool. It is the prime vector for the transmittal of values and a shared culture and for the capitalization of know-how. It should aim to standardize practices and have these develop uniformly. By fostering mutual understanding and a common perception of inherent implications, training facilitates exchange between the central administration and its territorial services or subdivisions. It helps decompartmentalize the action of individual services. Key features include post-recruitment training, workshops for the exchange of practices, the mixing of staff development audiences (services, ministries...) and of training facilitators (speakers), etc.
Training is also an excellent tool for human resources management. The primary objective is to provide staff with the wherewithal for effective, appropriate and thus worthwhile action. Providing cost-free training or making training mandatory (especially for target courses) are fundamental decisions. Consultation and needs analysis will be arranged to secure staff input. Training can be taken into consideration for promotion, remuneration, mobility....
In summary terms, two types of knowledge need to be transmitted:
- the scientific and technical knowledge of a veterinarian or expert for example, which might need to be completed or strengthened;
- professional know-how relating to specific areas of public control (law, economics, international affairs, inspection procedures...).
These two types of knowledge can be acquired through three principal routes (section V): prior initial training, post-recruitment training and staff development training.
Scientific and technical knowledge
In theory, the employer can set the level required for recruitment. For example, the employer can insist that applicants have attended a specific veterinary university course, where such a course exist. There is also leverage on the content of university training in the form of international recognition of its diplomas.
In practice, recruitment is influenced by the university teaching available and by the attraction of government service to young graduates. In most countries, shortcomings noted at recruitment point to a need for supplementary training.
A number of solutions can then be envisaged, depending on the context. The first requisite is that staff should have the scientific background to thoroughly grasp the issue of food safety and sanitary production. Veterinarians can be relatively easily trained in the safety of animal-based foods because of their initial training in animal husbandry, anatomy, pathology, physiology, microbiology...
Post-recruitment training is the most common way of bringing staff up to the required level. Ideally, this should be sufficiently long to permit field training in consolidation of the theoretical instruction. The further training can focus on a specific field or type of food if the position to be filled is known.
Specialized training for public officials
Public officials need to have administrative and soft skills in addition to their technical training. These refer to civil, administrative and penal law, economics, finance, national and international public policy.
A period of training close to recruitment offers a number of advantages in terms of effectiveness and the moulding of professional identity. If sufficiently long, such training provides supplementary tools and indicators, instils a service-wide culture and facilitates subsequent mobility and refresher training. If short, it will target skills of immediate necessity. The limit is of course the cost to the administration, regardless of whether the new recruits are paid or not during their training.
Staff development training
Refresher training has become essential in an environment of constant scientific, technical, regulatory, international and other development.
The traditional concept of staff development is gradually adopting the notion of lifelong learning. Training acquired at the start of professional life will not be sufficient to perform effectively throughout a career because of knowledge and occupational developments. Training is thus conceived, from the very outset, as requiring further input during the course of a professional career.
In practice, this training is often along traditional lines, with short, target-specific sessions and rarely any diploma. When there is a need for, or emphasis on, more substantial staff development training, this will be based not only on new requirements, but also on the previous training of staff so that their basic competence can be brought up to date.
Adult training has special characteristics. Beyond conveying an academic or institutional message, the theory needs to be followed up with practice if there is to a long-term impact on performance. This means taking staff expectations into account as well as employer needs. The training can be entrusted to a specialized body which will be in a better position to accommodate the demands of both parties. The employer will define the benchmark competence (the skills needed) while the training body will translate these into an appropriate instruction programme (the learning needed to acquire the skills).
Formal recognition of acquired competence (diploma) can be envisaged if the training is sufficiently long.
Whether initial training or staff development, and whether organized by an administration, a university or a public administration school, it is very enriching to have a variety of course facilitators: lecturers in life sciences (veterinarians, technologists, hygienists, toxicologists, nutritionists, biochemists...), in law, economics, management, social sciences; representatives of administrations (the umbrella ministry, but also from the ministry of justice, trade, finance, the interior...); researchers; private operators...
Training trainers within the control service, who will be expected to give regular training, will help to spread the training sessions. The trainers will be selected for their specialist skill and their motivation and will receive instruction in face-to-face training. They will need to use standard materials so that the training message can be coherent (transparencies, slides, trainer manual, course book...).
Workshops on the exchange of practices on a given topic (e.g. crisis management) serve to build upon knowledge gained and enrich experience.
Training on the ground
In most cases, staff are only trained for their new post through actual on-the-job exposure. Such empirical training risks perpetuating bad habits, mistakes, compartmentalization and divergent approaches among services. It is worst in those small services, especially in developing countries, where a single poorly trained and inadequately equipped official is assigned to a remote region; he or she would have benefited from advanced training to deal with the host of tasks and responsibilities that go with the job...
Minimal acculturation can be acquired by spending time in a reference service, especially in the central administration.
Tutoring is another way of training new staff. Tutors should be volunteers and if possible selected from outside the service hierarchy (perhaps from another service) and need to be specially trained.
Where veterinary or other officers are responsible for providing initial or further training to their support staff (after having themselves been trained), it is important that this should be properly structured. The constraints lie in the absence of trainer training and in the inability of trainers to step back into the wider picture.
Materials - remote training
Training materials are clearly essential, whether for self-instruction or for in-person training. Many developments are expected from information and communication technologies (ICTs), although their actual content will have to be carefully designed. Remote training does not usually exempt in-person training. One current problem that developing countries face is the availability and fragility of computer equipment.
Nor should traditional printed materials be neglected, especially for officers used to self-instruction (normative texts, explanatory notes, books).
There will need to be complementarity between traditional techniques and new ICTs.
Sharing of training
Training is relatively costly, whether for a restricted audience or for broader dissemination. Hence the importance of rational decisions, the search for leverage, the dispersal of delivery... Several options have been considered above (trainer training, hierarchical training, tutoring, new ICTs, participation in training organized by other countries...).
The supranational organization of training is another possibility. This might be:
- the organization, by a national structure, of training for an international audience;
- the networking of national structures, with a distribution of disciplines, exchanges between facilitators, etc;
- the most successful approach, the joint organization of training for a group of countries or a region.
A regional approach to food security training has been considered by the countries of sub-Saharan Africa and donors. This approach, which is mirrors the creation of common regional markets, is sustainable in nature as removed from the influence of national political change. The eventual creation of a regional body of food safety veterinary inspectors in the WAEMU is a case in point. The Inter-State School of Veterinary Sciences and Medicine in Dakar (EISMV) already provides initial training for veterinarians of the region.
Observation: The developing countries sometimes have to cope with an alarming lack of resources, while most services exercise first-level control. Even though application of the academic HACCP approach does not correspond to traditional practices, using the rationale of the HACCP to identify priority problems and effective solutions can produce results - provided staff are properly trained and there is an appropriate regulatory framework. This would provide a methodology that applies to two major dimensions of food safety regulation, which are sometimes quite distinct in the developing countries: on the one hand, the economic impact, especially in the framework of international trade; and on the other, public health, especially at local or regional level. Such consideration and any resulting innovative training would no doubt be best handled at the supranational level.
The fields of expertise relating to food safety vary extensively. Training topics will need to be selected through multi-factor analysis, including, for initial post-recruitment training, the economic context, existing legislation (for example, first or second level controls), possible subsequent assignments, starting level, expected professional competence (occupational benchmark) and available training resources. A similar approach applies to staff development training, with the inclusion of possible multi-annual planning.
Targeted expertise will depend on individual situations:
- command, for tools and know-how needed for assigned missions;
- knowledge, for technical elements not used in everyday practice but where intelligible discourse is required with highly qualified operators or colleagues;
- awareness, for the more general elements.
For example, a field inspector will need to be able to draw up a report, whereas a worker at the central administration will only need a basic knowledge or even awareness. Similarly, an international negotiator will need to be well versed in the SPS agreement (i.e. have command) while a field inspector will only have to be aware of its existence.
Selected examples by way of indication:
Technical knowledge (perhaps focused on a specific line or phase of production):
- basic scientific training in life sciences, including general microbiology,
- agrifood technologies
- risks associated with foods, food microbiology, general food hygiene, physical and chemical contaminants
Depending on the situation and country or region:
- new technologies, new forms of production, conservation or consumption, new products (especially imported) and associated risks
- emerging risks and their management (mycotoxins, BSE, dairy production in hot countries, pesticides and leafy vegetables...)
- integrated approach to risk throughout the food chain
- HACCP and its inspection procedures
- risk analysis (in line with Codex Alimentarius)
- law applied to the public sector (administrative, civil, penal law)
- quality assurance in the control services
- inspection methodology - programming of controls...
- international (regional and world) context, existing agreements and implications for the country...
- economics of agrifood production, agricultural policy
- public finance
- the inspection function and relations with operators
- human resource management, management, foreign languages (non specific)
- communication, relations with the media, with consumers
- crisis prevention and management
- sociology of food - relationship between citizens and their food
Except in extreme cases, the value of a structure resides primarily in its staff. Investing in human resources and especially in initial training and staff development is the foundation of management of a control service.
Training is a means of achieving the objectives assigned a structure or control system. It is closely linked to the context and especially the financial constraints. Thus, while general guidelines can be traced in absolute terms (for example, lengthy post-recruitment training), these are often illusory as too costly, especially in developing countries. There is no universal answer, only lines of action and solutions tailored to each national or regional situation.
One prominent feature of food security is the global context which, since the rupture from the entry into effect of the WTO agreements, has tended to align approaches (professional accountability, HACCP, second-level controls, etc.) and thus to create common concerns. Shared training needs could encourage exchanges, even the introduction of innovative solutions at supranational level.
The developing and least developed countries are particularly vulnerable in the areas of public health and thus food safety: sanitary and climatic conditions combine with traditions and a lack of resources and qualified personnel. Such characteristics need to be taken into account in the context of globalization of trade. With regard to training, this is where there is even more call to start from concrete requirements on the ground and to respect cultural norms, if there is to be a lasting tangible impact.
Many countries rely on skills gained during initial training for their official controls, but these do not always seem commensurate with the task at hand. Knowledge-based training is easier to organize and therefore more frequently organized, while training in the hard and soft skills is more difficult to design. To be effective, such training needs to adopt a particular format and to be spread over an appropriate period of time. There would appear to be few experiences in this regard.
Reference material and bibliography available from the author.
(Prepared by Sirilak Suwanrangsi and Suwimon Keerativiriyaporn, Thailand)
Agenda Item 4.4
1. Introduction and Background on HACCP Implementation
HACCP is a systematic and preventive approach to achieve food safety standards. Originally developed in the United States to guarantee the safety of astronauts' food in space, HACCP is now being adopted worldwide as a scientific, systematic and effective approach to enhance food safety. Internationally, it is recognized that the application of the HACCP system to food production and preparation has clear benefits, including the potential of enhancing food safety and preventing many cases of food-borne diseases.
HACCP is becoming the international norm for food safety assurance. Regulatory food control authorities in many countries require HACCP implementation by food processing industries to ensure hygienic practices and safe products. This system has been adopted by many countries around the world and is mandatory in some countries. The requirements apply to various sectors in the food supply chain including domestic, exported and imported food products. The European Union and Japan require HACCP for specific products. In addition, many multinational food distribution chains now require a working HACCP programme as a prerequisite for becoming an accepted supplier.
Many Government agencies responsible for food safety control are shifting their agency's focus to prevention rather than inspection by encouraging the use of HACCP. Accordingly, HACCP based control programmes are increasingly adopted by food control agencies.
Government programmes to enhance the application of HACCP in small scale food processing establishments and in domestic and export markets have been the key to success of HACCP implementation by the food industry. In addition, in many countries, industry has taken the lead in developing in-house HACCP programmes and hiring and training personnel who are skilled in preventative quality control.
The HACCP approach can be used by all segments of the food production continuum and can be tailored to any individual product or process line. The advantage of using the HACCP system lies in the constant control it provides over food safety in the processing plant, from receiving raw materials to shipping the final products. HACCP is now applied to milk, fresh fruits, pasteurized juice and vegetables as well as meat, poultry and seafood.
In many cases, the move to introducing HACCP systems has been led by industry. The stimulus may have come from the firms themselves where, for enhancing food safety and/or quality or for market reasons, the decision was made to adopt HACCP. Food industries experienced in food safety management systems are more likely to appreciate the need to move to HACCP. Generally, they recognize the importance of HACCP in allowing them to gain access to domestic and foreign markets, to protect their reputation and to satisfy customer demand.
2. Government role in HACCP implementation
Governments in most countries play vital roles in promoting HACCP application through successful cooperation with all stakeholders in the food supply chain including industry associations, academia, individual processors and producers, suppliers of raw materials, exporters and importers.
Government agencies have both a strategic role in the implementation of HACCP, as well as an operative role in organizing the effective and ongoing assessment of HACCP systems of the food industry. A key role of government agencies is to demonstrate leadership by promoting and facilitating the implementation of HACCP. The type of activities that government agencies need to consider have been described in other FAO and WHO documents., In summary, these could include the following:
Government commitment is probably the single most important factor in the development and implementation of a successful HACCP initiative. In this respect, one of the most important tasks of governments is to raise the awareness of industry to the benefits of and need to introduce HACCP to produce safe food. To promote HACCP and secure the commitment of those involved, governments need to draw the attention of food enterprises to the following: the benefits achieved in rationalization of food safety management; risks inherent in certain foodstuffs or production processes; costs, including compensation costs resulting from production failure; and value of HACCP in safeguarding the enterprise's image from any associated outbreaks and/or product recalls.
2.2 Programme Requirements
To promote and facilitate HACCP initiatives, governments may need to consider implementing mandatory measures, as appropriate. Countries that have established mandatory HACCP schemes for specific products include: Australia, Canada, Japan, USA and the European Union. In some countries, control authorities have developed voluntary schemes and then sought participation by individual firms. For example, the Thai Department of Fisheries has used voluntary HACCP programmes to enhance the food safety practices, standards and the process for approval of fishery products for export. Whether the programme is mandatory or voluntary, clear guidelines should be provided for uniform application and scientific integrity.
Adequate training is important for overcoming barriers related to human resources in both government and industry. Governments need to take a leading role in training programmes. The support of academia and industry associations is vital. Training should include both industry employees and enforcement officials at different levels.
2.4 Technical Support
Industries, particularly those of small size, often lack the technical expertise required to implement HACCP and may therefore need external support. The capacity of governments and industry/trade associations and academia to provide adequate technical support is a critical factor in the successful implementation of HACCP. The type of technical support that could be offered by governments, academia or industry/trade associations may include:
Providing relevant, technical training with consideration given to the level of education, culture and language of managers and staff;
Facilitating the availability of appropriate, current, scientific support;
Facilitating access to low cost analytical services;
Providing accessible, sector-specific general guidance to businesses, such as industry guides, templates, and generic HACCP plans; and
Establishing and maintaining food-borne disease surveillance programmes and facilitating access to collected epidemiological data.
2.5 Infrastructure and Facilities
Implementation of HACCP may require improvements in the infrastructure and facilities, both within the community and in the business itself. In this regard, governments have a role and, in some instances, even an obligation to ensure that the appropriate infrastructure (electricity, roads, safe water supply, sewage facilities, etc) is in place and that environmental pollution is minimized. The major role of the government is to ensure sufficient infrastructure and the compliance of facilities with food hygiene requirements.
Inadequate communications between the government and businesses and between businesses can impede the introduction of HACCP. Government agencies have a duty to clearly communicate all health and safety standards, regulations, guidelines, and other requirements to the food industry. Communication strategies need to be part of any HACCP initiative. To ensure a common understanding, it is important to use consistent and accurate terminology, such as that contained in Codex documents. The use of appropriate and effective channels for communication is also important for effective communication.
Once established, the HACCP programme should be evaluated to assess cost-effectiveness, compliance with legislation (if appropriate), adherence to schedule and how improvements could be made. Governments play a crucial role in HACCP evaluation by ensuring that the programme meets food safety objectives and by seeking its further development and improvement. Governments also have a role in enhancing the programme evaluation for the industry (internal audits) and in advising on how improvements can be made.
The impact of HACCP initiatives on the enhancement of food safety can be measured directly (e.g. through data collected from programmes for surveillance of food-borne diseases or monitoring contamination of food) or indirectly (e.g. through data collected in industries on the results of auditing or inspection of design and implementation of HACCP).
3. Fostering success of HACCP implementation
Governments have multiple roles to play in food safety control systems. These include promoting, assisting and checking that manufacturers have appropriate control measures for potential hazards and properly maintaining their implementation. In some cases, industry may take the lead in HACCP application, especially in large companies and export oriented food businesses.
It is of utmost importance that government authorities have the capabilities to perform the necessary tasks, especially when industry relies solely on the judgment of the regulatory authorities. Thus, governments have to re-organize the activities and work force to support the industry, particularly in the following areas:
Organization management: To strengthen the workforce capabilities, personnel management should be addressed first. This may include increasing the number of staff and upgrading their competencies to carry out the jobs assigned. Assessors who have been familiar with traditional GMP inspections and are not able to shift to HACCP based assessment may have to limit their tasks to those related to GMPs. Many agencies have coped with the problem through recruitment and training of new employees. When recruitment is not possible, management of personnel should be given critical attention.
Knowledge and skills: Food control agencies should ensure that assessors have sufficient knowledge of HACCP and of the relevant processing technology. The potential food safety hazards that are likely to occur must be controlled. Assessors should have sufficient knowledge and experience to identify hazards relevant to raw materials and processing technologies. Ability to determine appropriateness of the established control measures, which are directly linked to the HACCP requirements, is also vital.
Training is therefore important to provide knowledge and experience to assessors. However, attention should be paid to the context and delivery technique of the courses, particularly for those who are new learners. Training should not only focus on obtaining theoretical understanding, but also practical skills and auditing skills, for example, the ability to seek evidence and evaluate findings. Proper training helps to maintain consistent performance of the assessors.
Minimum training for assessors should include the following subjects:
- Principles and application of HACCP;
- Food safety hazards and control measures;
- Prerequisites to HACCP;
- HACCP assessment;
- Relevant processing technology;
- National/international HACCP requirements.
While training their own workforces to enforce HACCP implementation, government agencies have been providing support to the industry in order to successfully implement the programme. Such support includes the following:
3.1 Technical support
Governments play a leading role in the provision of the following:
Information package: In addition to laying down laws, requirements or rules, guidance materials or application manuals have been developed to describe regulatory requirements and the government's role in the recognition and auditing of HACCP systems. General information is also given on HACCP and documentation requirements.
Application manual: The manual explaining HACCP principles, its application to specific processes and products and the principal programme components required by control agencies (i.e. prerequisite control, hygiene control programme, generic HACCP model) is vital for successful application of HACCP by industry. The manual is an aid to the official inspection workforce and to management and employees in industry. The manual is intended for use during the implementation phases of HACCP.
Industrial seminars: Communication to industry through meetings and seminars has become a useful tool for governments to explain HACCP requirements, initiatives, benefits, and programme objectives at the initial stages of the programme. Promotion materials (i.e. handbooks, leaflets, videos) are also helpful starters. Today, they are often replaced by web- based information, which is a readily- available source of information.
Hazard identification and control guides: A handbook describing hazards associated with specific raw materials, processes or products is necessary to provide science based information for hazard analysis and development of effective control measures. An example of such a document is the USFDA Hazard and Control Guides for Fish and Fishery Products, which provides a basic scientific foundation for industry application of HACCP. Specific hazard and control guides for raw materials and processes have been developed by many government agencies to meet particular needs in the countries.
Generic HACCP Models <http://www.inspection.gc.ca/english/fssa/polstrat/haccp/modele.shtml>: Generic HACCP models have been developed by technical staff of governments to be used as a basis for HACCP plan development. These have been developed as guides for the design of specific HACCP systems for food establishments.
Scientific information: Since the HACCP system is designed for food safety, control measures selected should be based on scientific information. Some control measures have already been set by regulatory authorities. Where specific data on the results of control measures and other important information is not available, appropriate studies should be undertaken. The studies may involve risk assessment to identify hazards and appropriate control measures. In addition, methods for validation and the need for validation of critical limits established for CCPs are necessary. However, it is not always possible for processors to carry out these activities, particularly small processors who do not have adequate personnel, knowledge, and skills. Governments should take the lead to conduct studies and provide necessary information to industries.
3.2 Training initiatives
Training programmes for industry/employees were initially a key role of government; however, this activity has since been taken over by academia, trade associations or private consultants. The aims of training initiated by governments are to enhance competency; enable uniform, science based application; ensure compliance; and to create confidence in one's ability, and thus confidence in the safety of the food supply.
Training in the initial stages of HACCP implementation is normally designed to provide processors with the kind of information necessary to develop and operate HACCP systems that would be in compliance with relevant regulations. During the implementation stage, on-going training should be conducted to strengthen weaknesses in certain areas, such as hazard analysis, internal auditing, validation, and how to maintain HACCP effectively.
Since the competence of the HACCP team is one of the driving forces affecting the success of HACCP implementation, the team members should receive adequate training to facilitate the implementation and maintenance of their company's HACCP system. In particular, the team leader may need advanced training. Training should not only focus on theoretical study, but also provide practical experience to facilitate a fuller understanding.
In some developed countries (i.e. Australia, Canada and the U.S.A.), training packages have been formulated for industry and regulatory officers by the government and by joint government/academia/industry teams, while developing countries have initially been assisted by international organizations in training their officials in the application of HACCP. Train-the-trainer courses funded by FAO and WHO have been the initial training efforts in many developing countries. Thailand has invested resources in training officials and industries to strengthen competencies in hazard analysis, programme application, programme assessment and audit and have worked with FAO and WHO in developing materials and training programmes for other countries in Asia.
Training programmes that conform to national standards, Codex requirements and importing country requirements have been developed and tailored to meet the needs of different sectors of industry, in particular small and less developed businesses (SLDBs). HACCP Curriculum Guidelines <http://www.inspection.gc.ca/english/fssa/polstrat/haccp/coure.shtml>, intended to assist providers who are considering the delivery of HACCP training courses, have been developed in various countries, through government initiatives and the support of academia and industry associations.
3.3 Hygiene improvements
As HACCP is not a stand alone system, it requires basic hygienic conditions and Good Manufacturing Practices (GMPs) to support the advancement of the programme. Prior to HACCP implementation, governments must provide the necessary assistance for hygiene improvements. Guidance for hygienic practices and GMPs for specific processes and products must be provided. The government must constantly review hygiene conditions with industry and develop a plan to encourage improvements and maintenance.
A programme to accelerate improvements of hygienic conditions and practices, such as good agriculture and aquaculture practices, a survey of hygienic conditions, training, on-site technical advice, and support of monitoring activities for primary and small scale processors has recently been initiated in Thailand.
3.4 Primary production controls
Even though HACCP is a tool for processors that is applied to manage food safety, some hazards existing in raw materials are environmental related problems, for instance, heavy metal contamination, pathogenic bacterial contamination and other types of pollution which are normally beyond the control of food processors alone. In this regard, a nationwide food safety programme should be conducted throughout the food chain. This includes control of the harvesting environment (whether in the wild or on farms), control of good handling practices prior to the processing establishments, etc. Government agencies should take the lead in these tasks.
3.5 Develop schemes that recognize HACCP systems
To accelerate effective HACCP implementation, development of schemes that recognize HACCP systems is necessary. This may include 1) the review of regulations and requirements to shift from end-point testing alone to a safety management system approach, and 2) applying reduced inspection rates where HACCP is effectively applied.
Regulatory audit: As the implementation of the HACCP system is making headway in food safety management systems of food industries, the traditional role of food control agencies, including that of food inspectors, is also changing, particularly in countries where the application of the HACCP system is mandatory. In addition to the inspection of food industries for compliance with GMPs and other regulatory requirements, government officials have to assume new responsibilities, including the assessment of industry designed and implemented HACCP systems.
Government authorities should define clear policy and procedures for audits to ensure uniformity and technical integrity. The role of government in HACCP audits is described internationally. A curriculum for audit training, including audit manuals, has been developed for government use. Assessment tools have been designed for assessing and ensuring competency and consistency. Government assessment includes the following:
Programme evaluation: Pre-approval of the HAACP programme by governments leads to the improvement of HACCP application by industry, as it ensures that the programme meets legal requirements and food safety objectives. Control authorities usually require processing establishments to have HACCP plans, but some do not require processors to have them pre-approved; thus there is no way of knowing whether a processing plant's HACCP plan is in accordance with the agency's requirements until it inspects the plant. Pre-approval also validates that the programme is sufficient to ensure food safety and guides the processors in their application.
On-site compliance audit: The on-site audit should assess the adequacy of implementation, i.e. whether the HACCP plan and the prerequisites for HACCP have actually been implemented in the food business, are being maintained and are functioning correctly.
List of recognized establishments: Government authorities usually set HACCP requirements or compliance standards. Once these conditions are met, which are verified through audit, processors are included in the approved list. These lists are exchanged between authorities having jurisdiction for control of import and export, thus providing market access to companies that have systems meeting agreed standards.
Certification: Certification is one of the tools used to provide assurance that industries have an effective HACCP system in place to ensure food safety and regulatory compliance. Many governments are not fond of the use of certificates, but it is still a common practice used to ensure compliance. Governments can establish a HACCP certification scheme to assure that food processors comply with HACCP requirements. The main purpose of these schemes is to facilitate trade.
Financial support: Governments may provide financial support to promote HACCP application through funding of hygiene improvements, infrastructure development, training and consultancy services.
4. Problems encountered in the application of HACCP
Although the HACCP system has been utilized for nearly 10 years, difficulties in HACCP implementation for both the industry and regulators are still obvious in many countries. One of the main reasons for this may be that the effective control of food safety hazards, such as through a HACCP system, require a scientific-based design and in- depth understanding of the management system. HACCP is not a one-dimensional management system, but requires a process of analytical thinking to ensure that proper control is established. Such a process needs to be reviewed either during the stages of HACCP development by processors or assessments by regulators. Some of the problems encountered in HACCP application are as follows:
4.1 Regulatory agency
4.1.1 Government support
Government commitment is a vital driving force of the success of a HACCP programme. A clear policy on food safety should be elaborated and turned into strategic plans for actual practices. In many instances, strong commitment from governments is still lacking, as reflected in the lack of real support at the operational level. Such support includes financial funding and manpower.
4.1.2 Legal requirements
In many countries, HACCP is widely applied only to exported products while domestic products are not dealt with, as there is no legal framework to enforce and assess HACCP systems in domestic products. Regulatory authorities face many time-consuming challenges in convincing processors to apply HACCP, especially small processors who already experience difficulties in complying with GMP requirements.
A limited number of technical officers to provide technical assistance to the industry and regulatory assessors are available in some agencies, especially where the inspection system has shifted towards the HACCP approach. As it is more appropriate if there is a functional separation between government adviser and regulator roles, personnel needs increase. Also, HACCP based assessment is more time consuming than traditional GMP assessment as HACCP assessment demands proper planning for audit, document and record reviews, as well as observing current practices during the process. Traditional GMP inspections mainly involve only evaluation of cleanliness and hygiene against set standards, which simply observe conditions and performance.
4.1.4 Assessor competency
Knowledge of HACCP: Government officers need to have sound knowledge of HACCP in order to assist industry in designing and implementing the programme, and to be able to address questions that may arise. Regulatory assessment of HACCP requires a consistent performance. Hence competency of auditors is an important key to achieve this. The competent HACCP officers and auditors must understand the 7 HACCP principles and how to correctly (scientifically) apply them. The ability to identify potential hazards that may occur during processing and to assess the appropriateness of their specific controls is essential. Knowledge required also includes (but is not limited to) hazards associated with different raw materials and processing technology, for example canning and freezing have different hazards and hence different controls should be applied.
Inadequate HACCP assessment influences the safety of foods produced if potential hazards and controls are missed. On the other hand, processors may also become discouraged to maintain HACCP if unnecessary hazards are too difficult to control. For example, if histamine is mistakenly determined as requiring control in non-histamine forming fish, the processor may be required to record fish temperature, have a certification of analysis from the fish supplier, or test for histamine in every incoming lot. Some processors have a tendency to think that more controls in a HACCP plan will promote safer food. However, too many controls may instead create a burden for the processor, especially when a deviation occurs and corrective action is necessary. Although nothing is wrong with these HACCP plans, processors may be unable to maintain the overall HACCP system, since more time is spent on unnecessary controls rather than significant hazards that are likely to occur.
Assessment technique: Apart from the basic assessment procedures, the greatest challenge to an assessor is the ability to collect sufficient evidence to support the judgment of HACCP compliance. Different processors may have different control approaches to the same hazards and may also provide different information for assessment. Therefore, assessors must utilize appropriate techniques to obtain the needed information in each situation. Some employers are very cooperative with the assessors, while others are not. Too much restriction with the assessment guides or generic HACCP models provided without flexibility to the situation may result in non-compliance to HACCP plans. On the other hand, inability to seek the right evidence may cause processors to lose control of potential hazards and risk the production of unsafe food.
4.2 Food industry
4.2.1 Technical difficulties
Hazard analysis (HA): Since the introduction of the HACCP system, applying hazard analysis has always been a hurdle, even for larger companies. The process requires specific expertise and knowledge of chemical and microbiological hazards and their attached risks, which is often not available. For this reason, proper HA application is always an important focus in good quality training programmes.
Validation of critical limits: Critical limits are borderlines to define acceptability and unacceptability of the product. Unfortunately, not all borderlines are defined by figures that are easy for industry to use. In this case, validation is vital. If the critical limits set for controlling hazards are not properly validated (for example, temperature and time used for pasteurization or cooking of the product), the HACCP plan will not be able to ensure safe food. Such processes need to prove their sufficiency to reduce the targeted bacteria to an acceptable level. In some cases, scientific support for all critical limits selected is not available and the support, if any, is not relevant to the processing conditions present in the facility. Large factories usually have their own equipment and experienced personnel to establish the process or can hire external experts to perform the studies. Validation is especially a problem for small processors who have limited financial resources and qualified staff. Difficulties still arise, even if the test is done by an external institute, if the processor does not fully understand how to utilize the study results.
Inconsistent implementation of HACCP: The implementation stage of HACCP involves monitoring, corrective action, and verification activities. At times, it is found that the documented HACCP plans have not actually been put into place or monitoring is not conducted as established. Corrective action is not always taken when the critical limit is deviated. Problems particularly arise with HACCP plans that are too restrictive to control, as many deviations can occur and corrective actions may be taken during daily operations. In the worst case, if processors are not very happy with this situation as it could cause an increase in production costs, they may choose to not follow the impractical HACCP plans. This is often the case when an external consultant prepares HACCP documents for a company without any involvement from the company's staff. Any further changes made, for any reason, to the first developed HACCP plan are often difficult for the processor to implement.
Improper conducting of internal verification is also another weakness of HACCP application. Much confusion arises during monitoring, verification, and validation methodology as some processors cannot differentiate the activities concerned with these three procedures. The overall system verification is sometimes misleading and may be limited to only a conduct of sanitation and GMP checks, rather than observing the overall HACCP related activities and reviewing documents as well as records. Verification is an important tool to check if the HACCP system is functioning properly. A lack of such activity may subsequently lead to the inconsistent implementation of HACCP.
Another technical issue concerning industry is the utilization of data obtained from monitoring and HACCP associated activities. HACCP application generates many important records which will be useful in providing the trend analysis, which contributes significantly to improving the HACCP system. However, to be able to carry out analysis also requires knowledgeable personnel who understand the process of trend analysis and know how to evaluate and utilize the results obtained afterwards, which is often lacking in small-scale processors.
4.2.2 Human resources
Limited qualified personnel is one of the constraints for the success of HACCP. Large plants, where personnel management is well handled, can minimize the problem. However, small processing plants, where the turnover of key staff is often high, have more difficulties in developing and maintaining a HACCP system.
In order to maintain the effectiveness of HACCP, it is necessary for the company to have at least one person who has knowledge of and experience with HACCP. In many instances, the processing personnel give much more attention to provide adequate personnel to meet the daily production demands, whereas the technical personnel are often not considered to implement its HACCP system. This also includes personnel associated with HACCP activities, for example, CCP monitors. Lack of personnel or limited time available for performing monitoring as frequently as designed may result in inconsistent control of hazards.
4.2.3 Financial capabilities
Financial concerns are a restriction particularly for the small establishments, where the majority of food in many countries is produced. As food hygiene standards are prerequisites to HACCP, basic environmental processing conditions must be achieved. For some processors this may be a large amount of capital as they have made considerable efforts to upgrade their premises prior to implementing HACCP. Besides the upgrading costs, HACCP also creates additional costs of recruiting new employees, increased paperwork, consultant fees, training, etc. Due to such reasons, many establishments are delaying HACCP implementation if it is a voluntary programme and its products are still marketable.
How can the present food safety systems be improved at all points along the food chain?
Application of HACCP principles in various sectors of the food supply chain, from production of raw materials to processing, is necessary to ensure safe food, but more is necessary. It is recognized that HACCP is one of the risk management tools available to the food industry. HAACP alone cannot resolve food safety problems, which is why it must be complemented by other control measures such as traceability, labelling and laboratory analysis. The latter should be directed towards monitoring programmes for agriculture chemicals, pollutants, contaminants and natural toxins, rather than end product inspection.
 World Organization for
Animal Health/International Office of Epizootics|
 World Trade Organization
 Cf. Codex Alimentarius, Guidelines CAC/GL No 26 (&24 et seq., &43, &47, Annex), CAC/GL No 34 (Annex) - OIE: Terrestrial animal health code (Chapter 1.3.3: Evaluation of veterinary services)
 Agreement on Sanitary and Phytosanitary Measures - Agreement on Technical Barriers to Trade
 Hazard Analysis Critical Control Point
 The control of sales outlets is often the responsibility of a different administration.
 Crops and fishery and aquaculture products might be the responsibility of a different structure.
 For example: Austria (2002), Belgium (2003), Bolivia (2000), Canada (1997), Spain, Netherlands.
 BAC: High-school diploma
 Without ignoring their importance, management and non-specific personal skills are not addressed
 WAEMU: West African Economic and Monetary Union
 Hazard Analysis and Critical Control Point
 Ms. Sirilak Suwanrangsi, Minister Counsellor (Agriculture), Office of Agricultural Affairs, Royal Thai Embassy Tokyo, Japan
 Ms. Suwimon Keerativiriyaporn, Director, Fish Inspection Center (Samutsakorn), Fish Inspection and Quality Control Division, Department of Fisheries, Thailand.
 WHO. HACCP: Introducing the Hazard Analysis and Critical Control Point System. WHO document WHO/FSF/FOS/97.2. Geneva, World Health Organization, 1997 (based on the Report of the WHO Consultation on Hazard Analysis Critical Control Point System: Concept and Application, with the participation of FAO, Geneva, 29-31 May 1995. WHO document WHO/FNU/FOS/95.7).
 FAO. The use of hazard analysis critical control point (HACCP) principles in food control. Report of an FAO Expert Technical Meeting, Vancouver, Canada, 12-16 December 1994. FAO Food and Nutrition Paper 58. Rome, Food and Agriculture Organization of the United Nations, 1995.
 Guidance on Regulatory Assessment of HACCP. Report of a Joint FAO/WHO Consultation on the Role of Government Agencies in Assessing HACCP. WHO document WHO/FSF/FOS/98.5, pp 25-28. World Health Organization, Geneva, 1998.