58790 International Finance Corporation Study of Food Safety Inspections Author: Prof. GORDANA RISTIC, MD, PhD Study of Food Safety Inspections 2 International Finance Corporation Study of Food Safety Inspections Author: Prof. GORDANA RISTIC, MD, PhD Serbia 11000 Belgrade, Radoslava Grujica 7 phone/fax + 381 11 3087625, +381112456479 cell phone +38164 12 12 027 e-mail: delpasbelgrade@nadlanu.com 2009 3 IFC Ukraine Business Enabling Environment Project Contents: 1.0 Summary ..............................................................5 2.0 Glossary...............................................................8 3.0 Methodology ........................................................9 4.0 Findings ............................................................. 10 4.1. Results of the study ...................................... 11 5.0 Country reports ................................................. 21 5.1. Croatia .......................................................... 22 5.2. Denmark ....................................................... 27 5.3. New Zealand ................................................ 36 5.4. Poland .......................................................... 43 5.5. Serbia ........................................................... 47 5.6. Slovenia ........................................................ 52 5.7. Sweden ........................................................ 56 5.8. Uganda ......................................................... 61 5.9. USA .............................................................. 66 6.0 List of abreviations ........................................... 72 Study of Food Safety Inspections 4 Acknowledgments This report was prepared by Prof. Gordana Ristic Numerous individuals and organizations contri- for the Investment Climate Advisory Service (IC buted generously to the review of this report, in- AS) Business Line of the International Finance cluding IFC staff in the Central and Eastern Europe Corporation (IFC). The work was directed by Flo- region: Alberto Criscuolo, Kateryna Onul, Eugeniu rentin Blanc IFC AS ECA, as part of the know- Osmochescu and Denis Torkhov ­ all IFC AS ledge management work for the Business Entry and ECA, and Lars Grava, WBG IC AS. Operation product. 5 IFC Ukraine Business Enabling Environment Project 1.0 Summary nation. Also, food adulteration is additional prob- 1 lem in consumer protection where governments Foodborne diseases are globally spread public have an important role in prevention and control. health problems that reduce economic productivity Industrialization and increased mass production, and pose great burden to health systems. Hundreds urbanization, new food technologies and processing of millions of people suffer from communicable methods, changing lifestyles, increased worldwide and noncommunicable diseases caused by contami- tourism and international trade in foodstuffs, in- nated food and water both in developed and under- creased contamination of the environment and in- developed countries. The global incidence of food- creased consumer awareness pose significant chal- borne disease is difficult to estimate, but it has been lenges for food safety systems organization. reported that in 2007 alone 2.2 million people died from diarrhea diseases. 2 A great proportion of these Food safety is an important part of the national cases can be attributed to contamination of food health, agricultural, economic, environmental and and drinking water. Additionally, diarrhoea is a even defense policy. At the national level, food major cause of malnutrition in infants and young safety should be secured through proper legislation children. In industrialized countries, the percentage and enforcement of rules. Bodies responsible for of the population suffering from foodborne diseases enforcement are different inspections in charge of each year has been reported to be up to 30%. An control of plants, animals intended to be used as estimated 76 million cases of foodborne disease food, animal feed and final products to be used as occur each year in the United States. The great ma- food for humans. jority of these cases are mild and cause symptoms for only a day or two. Some cases are more serious, Since food is traded globally contaminants present and CDC estimates that there are 325,000 hospita- at one location could be disseminated easily. Pre- lizations and 5,000 deaths related to foodborne dis- vention of contaminants during primary production, eases each year. Costs of food borne diseases for processing and distribution of food proved to be the the US community are estimated to be 5 to 6 billion more effective than investigation of possible units dollars in direct medical expenses and lost produc- of contaminated final food products. The role of the tivity. 3 official inspection has changed from end ­ spot ­ check control to authorities which provide informa- The most severe cases are associated with old tion and consultation to all stakeholders in the con- people, babies and young children, persons with tact with food chain. Inspectors work with produc- chronic diseases which reduce their immune system ers in order to inform them on the legislative re- function, but also, in healthy people exposed to a quirements explaining to them how to apply such very high dose of a contaminant. Apart form those requirements, they provide information to exten- microbiological, chemical contaminants may also sion services and in the same time they serve as the emerge in food due to high level of exposure to information providers to consumers who demand pesticides, fertilizers, industrial or environmental wholesome information on food safety issues and contaminants. especially in case of food safety emergencies. In the same time a great deal of the traditional inspec- Food is the second most traded group of products tion work remained, and they still control weather globally (fuels and mining products being the first), food business operators act in accordance with leg- and export of food rises worldwide from 13% in islation requirements. In order to inform all stake- 2000 to 22% in 2008. In 2008, according to the holders rapidly and accurately on the status of the WTO statistics, food participated in the world ex- inspection control and findings, high level of trans- port with 1114.0 billion of dollars. It is important to parency of data on food safety should be enabled. notice that quantities of agricultural products are constantly rising and that need for export is grow- The modern approach to inspection is based on risk ing. 4 assessment, but modalities of such approach vary from one country to another. The best practices are Consumers worldwide are aware of possible con- recommended by the FAO, WHO, WTO and taminants associated with food and water, and it is should be included in national codes of practice. a government priority to secure consumer's health through measures that prevent food from contami- The scope of this report was to evaluate how food safety practices are applied in developed and transi- 1 Foodborne diseases, usually either infectious or toxic in nature, caused by tional countries and to highlight best practices in agents that enter the body through the ingestion of food. control, taking into consideration the level of de- http://www.who.int/foodsafety/foodborne_disease/en/ 2 Second Formal Meeting of the Foodborne Disease Burden Epidemiology velopment of countries, their historical background Reference Group (FERG). WHO, 2008 in terms of food regulation, specific characteristics 3 http://www.cdc.gov/ncidod/dbmd/diseaseinfo/foodborneinfections_g.htm#mo and the importance of food production for the na- stcommon tional economy. The report is targeted to policy- 4 WTO: International Trade Statistics 2009. Study of Food Safety Inspections 6 makers and government officials engaged in the al level (Codex Alimentarius, OIE, IPPC, EF- reform of the official food safety controls system in SA, governmental and non-governmental bo- transition and developing countries. IFC project dies) should be consulted, and risk assessment managers and advisory teams will also find it a use- undertaken only in cases when data do not ex- ful resource in designing food safety and agribusi- ist. It must be emphasized that country must ness interventions as part of the overall IFC strate- provide internationally recognizable data. gy on agribusiness. 7. Use of the regional database and knowledge in country's policy and specific activities should The nine countries we examined were chosen ac- be facilitated. Such database exist in the EU, cording to their: geographical position (countries New-Zealand/Australia. with or without land borders), historical and eco- 8. It is ideal to separate completely risk assess- nomical background (highly developed EU coun- ment from the risk management and communi- tries, new EU members, the EU candidate coun- cation, and appropriate bodies should be as- tries, so called "third countries" in terms of trade signed to perform these activities. There are, with the EU, underdeveloped countries) and mem- also very functional models where risk assess- bers or candidates for the WTO accession. ment and partly risk management are per- formed by one body, but clear separation of Summary of the best practices identified rec- departments within that body and highly pro- ommended for securing food safety systems: fessional approach to both areas should be se- 1. The responsibility for food safety lies primarily cured. with food producers, rather than with inspec- 9. Number of inspection visits is not the condition tors, although inspectors play an active role in per se which secures that food safety objectives overseeing compliance. This principle should are met. Inspection needs to be risk based, with apply to both domestic and imported products. frequency and fees adjusted to the level of risk 2. The "top-to-bottom" hierarchy in inspection is posed by specific type of product/technology. the most effective way of organization of food Facilities/producers assigned tone risk group control (from the responsible authority at the may change the group if situation in their facil- governmental level to the control at local lev- ity or safety of their products/processes change. el). Methods for assessing the risk associated with 3. A single inspection body would be probably products/processes/facilities should be publicly the most effective solution. But a very inte- available. grated inspection system with authorities close- 10. Import border posts for high risk commodities ly collaborating, sharing information on in- should be determined, properly equipped and spection and respecting other authority's in- operated by adequately trained inspectors. spection and laboratory data is also, a good 11. The budget for the inspection must be secured model for a functional food safety system. in the responsible ministry. It needs to be ad- 4. Central register of FBOs enables accurate justed to the national food safety objectives. planning of inspection activities and provides While some activities (such as continuous su- reliable source for statistical follow-ups. Regis- pervision needed in slaughterhouses) tend to be tration procedures should be simple and prefer- covered partly or fully by businesses' fees, the ably on-line. Registration of facilities should be bulk of the ongoing supervision work has to be mandatory. covered by the general budget fund and food 5. In countries where inspections do not exist or safety supervision as a whole cannot be based need major reconstruction the possible ap- on cost recovery from enterprises. proach would be to start with creating or re- 12. According to the WTO requirements certifi- constructing the sector of inspection which is cates issued by competent authorities working the most important for the country's economy. according to the internationally accepted prac- That could be preferably the major export sec- tices have to be recognized in trade. Recertifi- tor. Experiences gained and structure devel- cation according to national rules is often done oped could serve as a model for other sectors. with food safety concerns given as the reason, Implementing the profound reform in one sec- but is actually income driven or the way to stop tor which is essential to the country's budget free trade of certain commodities. may produce more effective results compared 13. Sampling of imported or domestically pro- to starting the overall reform of the food safety duced goods should be performed according to system and thus persuade the government to the annual plan and in cases when non- continue with broader reform in various as- conformities are observed in documentation, or pects of food safety. if previous experiences with the same impor- 6. Risk assessment is very demanding in terms of ter/producer pose concern, or when notification scientific and analytical capabilities and finan- on food safety risks associated with certain cial costs. Data accumulated at the internation- 7 IFC Ukraine Business Enabling Environment Project product were placed through Rapid Alert Sys- 18. Publicly available inspection reports (or reports tem or some other regional system. accessible by password to FBO whom inspec- 14. Number of inspectors in the country must be tor has been visited) secure objectivity in the adjusted to the number of FBOs and their geo- inspection approach. Additional instruments graphical distribution in each region. such as check lists enhance objectivity and 15. Qualifications of inspectors have to be appro- could be used to assess the quality of inspec- priate to the type of inspection they perform. tor's performance. 16. Private inspection bodies and authorized and 19. Collaboration among authorities should secure trained veterinarians/plant health specialists share of inspection documents and thus help can perform official inspection when autho- lowering costs and number of inspection visits rized by the official body responsible for such to the single entity. inspection. They must audit according to rules 20. Reduction of old and new pathogens is a meas- prescribed by the relevant authority in order to ure of success of the national food safety sys- perform inspection equivalent to those of pub- tem. Health and agriculture authorities must lic inspectors. Authorization of private inspec- collaborate in this area. tion bodies and individuals to perform official 21. Food inspectors have to anticipate that their inspection should be time limited and audit of role is not only in control but also in advising their work should be performed with the same food producers/trade/catering in practices frequency as the audit of work of governmental through which food safety situation could be inspectors. improved. 17. Training of all inspectors in modern inspection 22. Food inspectors must be impartial, free of any practices should be regulated and in accor- conflict of interest, well educated and objec- dance with the annual plan. Such are trainings tive. They are often, the last obstacle between in: in the HACCP system implementation and the unsafe product and consumer. They have to auditing, principles of risk based inspection, be properly paid in order not to be corruptive inspection of GMO, border inspection, plant and their role in protection of public health health, animal health, sampling. When check must be recognized. lists for the inspection are created, training in application of check lists should be provided. Study of Food Safety Inspections 8 2.0 Glossary5: Food safety is secured through legislative and con- Risk based food inspection program is one that trol system. The control is enforced by inspection uses an inspection approach that evaluates and fo- and laboratory control of food. cuses on the reduction of risk factors known to cause or contribute to foodborne illness and to HACCP (Hazard Analysis and Critical Control promote active managerial control of these risk Points) is a preventive food safety management factors and uses the associated risk level of a food system which identifies, evaluates, and controls operation to determine inspection frequency. hazards which are significant for food safety. Foodborne diseases (FBD) can be defined as those Control measure: Any action and activity that can conditions that are commonly transmitted through be used to prevent or eliminate a food safety hazard ingested food. FBD comprise a broad group of ill- or reduce it to an acceptable level. nesses caused by enteric pathogens, parasites, chemical contaminants and biotoxins. Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of Good hygienic practices (GHP) are all practices control. regarding the conditions and measures necessary to ensure the safety and suitability of food at all stages Critical Control Point (CCP): A step at which con- of the food chain. trol can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an Good manufacturing practices (GMP) are practic- acceptable level. es for the control and management of manufactur- ing of foods, pharmaceutical products, and medical Critical limit: A criterion which separates accepta- devices. bility from unacceptability. Food business operator (FBO) ­ any person who Deviation: Failure to meet a critical limit. directly handles packaged or unpackaged food, food equipment and utensils, or food contact sur- HACCP plan: A document prepared in accordance faces and is therefore expected to comply with food with the principles of HACCP to ensure control of hygiene requirements hazards which are significant for food safety in the segment of the food chain under consideration. Primary production ­ those steps in the food chain up to and including, for example, harvesting, Hazard: A biological, chemical or physical agent slaughter, milking, fishing. in, or condition of, food with the potential to cause an adverse health effect. European Community Food and Veterinary Of- fice (EC FVO) report deals with the structure and Hazard analysis: The process of collecting and functioning of the food safety system in the EU evaluating information on hazards and conditions countries of third countries (those intending to ex- leading to their presence to decide which are signif- port food, animals and feed to the EU). icant for food safety and therefore should be ad- dressed in the HACCP plan. Health and Consumer Protection Directorate General (DG SANCO) has a mandate to ensure Monitor: The act of conducting a planned sequence that food and consumer goods sold in the European of observations or measurements of control para- Union (EU) are safe, that the EU's internal market meters to assess whether a CCP is under control. works for the benefit of consumers and that Europe helps protect and improve its citizens' health. Validation: Obtaining evidence that the elements of the HACCP plan are effective. Salmonella, Campylobacter, Shigella, Cryptospo- ridium, E. coli ­ food and water borne pathogenic Verification: The application of methods, proce- bacteria. dures, tests and other evaluations, in addition to monitoring to determine compliance with the CARDS program ­ The EU Community Assistance HACCP plan. for Reconstruction, Development and Stabilization. 5 Definitions according to Codex Allimentarius Commission document: CAC/RCP 1-1969, Rev. 4, 2003 9 IFC Ukraine Business Enabling Environment Project 3.0 Methodology: In order to assess different experiences and models The author choose to analyze data from 2007, since of regulation of food safety, nine countries from in most of the countries included in this report these different regions in the world were selected. Coun- data were systematically processed. Where possible tries differ, in terms of the history of food safety data for 2008 were presented. The FVO and DG systems, present food safety systems, economical Sanco inspection reports proved to be the very sys- strength, cultural and political heritage and present tematic and reliable sources, and officials always state of participation in the world food trade. Data addressed the author to these reports in countries for this study were collected from different sources: where such inspections were performed. In cases data from country reports made by the FVO, Dg where data from 2007 lacked because no database Sanco, FAO, WHO was created before 2008, (as was the case in Ugan- official data on food inspections available to da), data from 2006 were used. Also, there because public at official web sites of the lack of any data base prior to 2006, no com- direct interviews with officials parison with the previous period could be made. official data on laboratory inspection provided to public at official web sites It has to be emphasized that each country has a dif- data provided by officials or relevant sources ferent type of data collection and reporting and from selected countries i.e. consultant compa- though the same set of questions was sent to each nies or individuals working in the field of food country, replies differed substantially. Some data safety and having reliable information. The set couldn't be compared to other countries, since the of questions was sent to them by the author of methodology for acquiring such data were not based the study. on the internationally recognized models (in Serbia and Croatia data on sanitary inspection control). Study of Food Safety Inspections 10 4.0. Findings: Food safety is nowadays a key element in terms of Table 1: Comparison of economic data between 8 the country's economy, health situation and de- countries fense. Agriculture and food production participate Coun- GDP GDP per Population Share in different percentage in the Gross Domestic try (PPP) capita of agri- in 2007 (PPP) in culture Product, with 1.3-4.5% in developed countries and (billion 2007 in in GDP 4-12% in the medium sized economies. In the un- $) $ (%) derdeveloped countries, share is even greater, being Croatia 70 15.700 4.443.000 5.9 37% in Uganda. It is important to notice that in the Den- 203.7 37.391 5. 515. 287 1.3 USA, which is high at the list of the most devel- mark oped countries, agro-business sector plays a very New 172 30.000 4.213.418 4.4 important role with 10% of the GDP being acquired Zealand from the sector (Table 1). Poland 637 16.500 38.500.000 4.0 Agriculture, food production and food trade are Serbia 80.7 10.900 7.379.000 12.3 very vulnerable due to high potential for uninten- Slove- 54 23.000 2.000.114 2.0 tional contamination, risk of fraud or even bioter- nia rorism. As population tends to agglomerate in ur- Sweden 346.2 38.300 9.200.000 1.5 ban areas, the exposure to risk becomes even higher Uganda 33.57 1.100 32,369,558 37 than before. Industrialization and global trade pose USA 14.110 46.800 307.212.000 10 specific burdens for contamination of food and dis- semination of contaminants at long distances. Fast Food safety systems should be posed on three pil- transport nowadays, adds to potential risk of trans- fer of contaminants. lars ­ regulations, enforcement control and labora- tory testing: Food security, being one of the major issues in un- derdeveloped countries could be jeopardized by Regulations provide necessary basis for food pests, plant and animal health diseases. Supply of control and they empower control bodies to food in those countries relays mostly on domestic check the approach to food safety which pro- production and in some of them even basic com- ducers and handlers have applied; modities are lacking and have to be supplied in Food control being in the past exclusively the form of the food aid. Underdeveloped countries are role of the government authorities, is trans- dependent of export of certain types of food com- ferred, more and more, to private inspection bo- modities (fish, coffee, cocoa) and their production dies and to producers themselves. Roles of in- and storage are usually associated with poor food spectors, division of authorities, inspection safety practices. They often fail to pass high scruti- practices and effectiveness of inspector's con- ny tests in import countries, are recalled or even for trol still vary greatly from country to country. a long time banned for import, and this can further Sometimes inspection practices pose a great aggravate the poor economic situation in the export burden in terms of costs of taxes, laboratory country. tests, working days lost due to inspection, unne- cessary certification costs, overlapping of in- spections, sometimes unclear demands given by different inspections, etc; Laboratory testing requires scientifically sound basis, must reveal real hazards, be reliable and performed according to the internationally ac- cepted best principles. 11 IFC Ukraine Business Enabling Environment Project 4.1. Results of the study: safety control system in the EU and other de- veloped countries was anticipated. It resulted in The study showed some common principles Denmark with a reform of the food inspection around which inspections were organized which produced a centralized inspection system and are functioning, but also, differences in with the hierarchy in implementation of food approach and results from country to coun- regulations conducted from the top to the local try. level. The Danish Ministry of Food Agriculture and Fisheries at the central level takes the over- 4.1.1. Legislative basis all control over work of the Regional Offices In order to secure the solid basis for the food safety (veterinary, plant protection and fish inspection) system legislation should be: in order to secure food safety from "farm to ta- ble". It controls the performance of local labora- based on the internationally recognized stan- tories, too. This system is based on control of dards and recommendations and regularly up- risks and the authority provides guidance to dated producers in application of so called " self con- clear trol" and government inspection deals directly not contradicting in very precise areas. The central level keeps an basic laws should be followed with sub-law exhaustive record of FBOs. The system is a documents and guidelines for the implementa- very good example of functional and tion, thus fully regulating one area straightforward organizational model. in countries which are or will be candidates for the EU accession and in third countries whish- the decentralized model ­ in Sweden, we antic- ing to export to the EU, relevant EU regulations ipate decentralized system with three levels of should be consulted when updating food regula- authorities: central, regional and local. The pri- tions. mary production control is performed at the re- gional and local level, and authorities at the cen- In Sweden and Denmark laws and sub-law docu- tral level control major producers and import of ments regulating food safety area are fully harmo- high risk products. The local bodies being aware nized with the EU regulations, directives and codes of their own lack of capacities for the extensive of practice. In Slovenia, Poland, Croatia, Serbia job they are responsible, are willing to transfer major laws are harmonized with the EU, but there their authorities to the regional level. Control are sub-law documents which still need harmoniza- bodies at the regional level are independent in tion. In the USA legislation is very fragmented, their work and report once per year to the cen- with number of decrees and amendments. In order tral body, in some cases they do not fully follow to overcome this situation a new low document is recommendations in inspection practices given submitted to the Senate, with the aim to strengthen by the central body. Inspection in Sweden the over-fragmented US legislation framework and should be risk based, according to acting regula- to introduce risk based inspection in facilities, ob- tions. The register of FBOs is not centralized lige manufacturers to take more responsibility for and different bodies approve establishments. the prevention of food-borne illnesses and hand the The Swedish inspection system originates from Food and Drug Administration (FDA) further puni- the country's constitutional organization where tive powers. In Uganda, only regulations in the area independent local administrative units unified of fish production are harmonized with internation- under Swedish crown. In terms of functionality, al principles, and work in harmonization was it would be better if the food inspection follows started in the coffee production area. one directive given by the responsible authority. 4.1.2.Division of responsibilities: In Denmark and Sweden clear division of responsi- Control of food safety should be performed by pro- bilities between different ministries responsible for fessional bodies trained in import/export and inland food safety was performed. In both countries the inspection. Division of responsibilities should be as ministry in charge of agriculture has the overall clear as possible, taking into consideration the level responsibility for the food safety. of expertise, capacities of each inspection body, number of premises to be inspected and the level of the application of the "self control" in the de- development of the food safety system in a particu- centralized system ­ New Zealand has not yet lar country: fully consolidated food safety system control. The food regulatory model is based on applica- the well organized centralized model with "self tion of the current 'Regulatory Model' (i.e. the control" ­ as a result of the BSE crisis need for three-tier model where the government in- the enhancement of the efficacy of the food volvement is relatively small, the control agen- cies on the local level manage the system, but Study of Food Safety Inspections 12 the most important role is the self-control role and sampling. An important number of food exercised by producers themselves). It is impor- processing facilities still operate in poor sanitary tant to underline that major differences are ob- conditions and there is a serious concern about vious between the approach to food inspection their future. Some 21.000 FBOs are small scale at the regional level (where an advanced form of operators with less than 9 employees. They fre- risk based inspection is applied in larger size quently have no strength to implement the prop- operators according to the food safety law) and er HACCP system. By January 2010 producers at the local level (where only basic GMP and which were given the grace period have to ad- GHP practices are checked in small and me- just their facilities and procedures according to dium sized FBOs according to outdated rule- the EU hygienic requirements or they should books). The duality of existing regulations close their operations. This is an example of two should be overcome by applying the food safety tier system (one level of standards for export law on the whole territory of the state. There is and another for domestic production) which can an obvious shortage of trained inspectors at lo- be tolerated for a certain period of time in order cal level and they need to be properly trained in to give smaller scale producers time to adjust to order to inspect according to risk based prin- stricter standards or to close. In Poland the ciples. grace period was 3 years. reform of legislation and inspection of one In Slovenia the reform started in 1990 from the type of commodities serving as a model for previous ex-Yugoslavia model with a number of other types of commodities within the same authorities involved in food safety and huge over- country ­ model for the underdeveloped coun- lapping in responsibilities. Still, some duplication tries ­ the Uganda's economy is dependent on of inspection over the same production or operation finances coming from the export of fish and cof- are present (import of food of plant and of animal fee. The export of fish was twice banned due to origin and animal feed, production of animal feed, presence of contaminants in products exported control over hygiene in food establishments). The to the EU. That was the reason to develop fish coordination among ministries is achieved through inspection and train inspectors in control of raw so called "panels" and is institutionalized by a spe- fish and products. Besides building of an in- cific piece of legislation through which are go- spection, the regulatory area for fishing and fish vernmental bodies obliged to collaborate and share processing and control was created and the reg- information on food safety among themselves. ister of FBOs in this area was made. The per- Each ministry keeps its own register of FBOs and formance of this inspection and capacity build- same FBOs may be registered in both registers. The ing in this sector serve as a model for other sec- similar situation to the Polish situation is here also tors (honey production, fruit). observed, all producers must apply food safety practices based on the HACCP system and all Other models: when coordination among re- products produced in facilities which were regis- sponsible bodies is still weak ­ in Poland minis- tered for domestic production only, must be re- try in charge of agriculture and Ministry of moved from the market by January 2010 (again 3 Health share responsibilities in food safety. In- years grace period). spection's responsibilities do overlap in the area of food hygiene where both authorities inspect Croatia's chart of division of responsibilities looks premises and practices. Also, the overlapping is pretty streamlined, but in practice the overlapping visible in the control of hygiene of transport ve- is noticed in control of food of plant origin in im- hicles and animal welfare, where Ministry of port and in control of hygiene and practices in food Transportation and ministry in charge of agri- processing establishments. There is an evident lack culture perform control independently. There is of coordination of inspection activities among re- an evident lack of veterinary inspectors at the sponsible authorities and no common FBOs register local (district) level and this is partially over- exists. Both ministries for health and agriculture come by allowing licensed veterinarians to per- authorize production premises. The system is still form duties of inspectors. There is a centralized in the phase of reconstruction, number of state of- register of FBOs at the country level. The food ficers is decreasing (veterinary inspectors) and safety system in Poland underwent serious some responsibilities will be transferred to autho- reform from the ex-Soviet model of regulations rized veterinarians. Being the candidate for the EU and inspection to the nowadays model based on accession, Croatia is succeeding in adopting new the EU regulations and precautionary principle. regulations harmonized with the EU, but the im- Poland succeeded in implementation of the risk plementation process is demanding more time and approach in veterinary inspection, but sanitary resources both from the governmental and private inspection still works according to ordinances entities. which prescribe frequency of inspection visits 13 IFC Ukraine Business Enabling Environment Project In Serbia the new organization of food control has sessment process through various scientific pa- been installed according to the new Law on Food nels. Members and candidate countries use rec- Safety being operational since June 2009. The min- ommendations and risk assessment data pro- istry in charge of agriculture is the principal author- vided by EFSA for basis of their national regu- ity in the food safety area and performs control of lations. National food safety agencies in the EU primary and secondary production through the so countries follow the model of EFSA, they im- called" General Inspectorate". Retail and catering plement recommendations provided by EFSA are controlled by the Sanitary Inspection. The divi- into drafts of the national legislation and per- sion of responsibilities as given in the Food safety form risk analysis only in cases where some na- Law is clearly defined. The register of FBOs was tional specifics exist. made by both ministries separately and would have to be centralized and updated. Previously, no colla- In Croatia the Croatian Food Agency was created boration between ministries in charge of food safe- with the same mandate, it works in close collabora- ty existed. Transfer of responsibilities was abrupt tion with the EFSA and performs risk assessment (in one day when the new Food Safety Law came by itself only in cases which are very specific for into force), database on inspection of facilities the country. Otherwise it uses the expertise ga- which were under Ministry of Health and Social thered at the EU level. This Agency is a model for Welfare did not exist and Ministry of Agriculture other countries in the region, and it was followed and Rural Development is for months working on by the Food Safety Agency in Bosnia and Herze- register of FBOs and on collection of data on food govina with which it collaborates extensively. The contaminants out of records of officially authorized Swedish National Food Authority (NFA) is a risk testing laboratories. assessment body with risk management in veteri- nary area, only, and the place where data on the The USA model ­ in the United States, federal overall inspection activities are collected and used regulations covering food safety are fragmented when risk assessment process is undertaken. It col- and complicated. There is also, high level of laborates closely with the EFSA and provides overlapping in inspection jurisdictions. FDA has scientific data for the EFSA panels. a responsibility for inspection over 80% of all food products at the market as well as numerous New Zealand is a very good example of separation producers. The shortage of FDA inspectors ex- of risk assessment, management and communica- ists and state inspectors perform inspection in- tion in one national agency outside the EU: stead of the FDA. Almost, 20% of state inspec- tors do not follow instruction for inspection giv- 1. risk assessment, and only a part of risk man- en by the FDA. The USDA has a very good or- agement (some inspection activities, see the ganized meat inspection and plant protection chapter 4.3) are performed by the NZFSA service where guidelines for inspection practic- 2. risk communication and standard setting is es are followed from the central to the local lev- performed by the Food Standard Agency Aus- el. Both ministries control border posts. HACCP tralia and New Zealand. This is a model of one system is mandatory according to legislation. common agency serving two countries and The USDA has guidelines and trainings for pro- having the advisory role, helping governments ducers and inspectors in HACCP. It is imple- and their responsible bodies in issuing stan- mented in large and medium size produces, but dards and requirements, providing expert opi- the number of small scale producers still have to nions in cases of non-conforming commodities, implement it. food emergencies, recalls, providing informa- tion to consumers, etc. 4.1.3. Separation of risk assessment from 3. risk management is performed by inspection risk management and risk communica- authorities. This segment needs to be streng- tion: thened by better integration of inspection au- The internationally recognized independent scien- thorities, but division of responsibilities within tific opinion should be the ground for the national risk assessment-management-communication risk analysis system. area is performed in the ideal way. Food safety agencies: in order to create inde- In the USA, risk assessment is performed by num- pendent bodies in the EU and in New Zealand ber of scientific and non-governmental bodies. In agencies for risk assessment (scientific evalua- Poland, Slovenia, Serbia risk assessment is per- tion of all known and potential health risks as- formed by scientific community upon request of sociated with foodborne hazards) were created. governmental bodies, but in Poland and Slovenia In the EU countries there is a central European being the EU member countries recommendations Food Safety Agency (EFSA) where delegates from the EFSA are usually followed with exemp- from all member states participate in the risk as- tions of some specific situation where scientific Study of Food Safety Inspections 14 explanation for the deviation of the internationally system for data collection of inspections results is recommended ranges for pollutants exist. functioning, data from the check lists which inspec- tors use are imported in the hand computers during 4.1.4. Inspection practices: inspectior's visit. The system is covering about The responsibility for food safety in most of se- 70% of municipalities and allowing the central lev- lected countries lies primarily with food producers, el (NFA) to have insight into data from the major rather than with inspectors, although inspectors part of the territory. play an active role in overseeing compliance. This principle applies to both domestic and imported Other models: In Slovenia, the risk based plan for products. inspection is made and the process of implementa- tion is under way. In New Zealand and the USA A. Domestic production ­ Inspection practices frequency of inspection of imported food is based should be based on risk determination for each on risk. In the USA, the need for the risk based in- producer: in Sweden and Denmark a comprehen- spection approach was recommended by scientific sive, risk-based approach to inspection is obtained community, and even, by President Obama, him- with the focus on the entire food supply chain, self. Inspection of smaller scale producers at the placing primary responsibility for food safety on local level in New Zealand is covering mostly hy- food producers with the government providing giene of premises and risk based inspection ap- oversight. proach is applied to medium size and large produc- ers and performed by regional inspection level. In Denmark a very good system of self inspection of facilities overseen by inspectors, exist. Danish Poland succeeded in implementation of the risk Veterinary Food Authority has a scheme for deter- approach in veterinary inspection, but sanitary in- mining the general level of risk to be attributed to spection still works according to ordinances which each facility. Facilities are classified in six risk prescribe frequency of inspection visits and sam- groups based on seven risk factors (microbiological pling. and chemical). Retailers are visited by inspector from 3 times per year to once in five years. Inspec- In Croatia and Serbia risk based inspection ap- tors apply the so called: Fourth item approach. proach is under development and respective capaci- They always check: ties have to be built. 1. the display of the inspection report with the In Uganda no capacities for risk based inspection sign "Smiley" (chapter 5.3.4) which illustrates exist. weather the promise is excellent, good, mod- erate or bad 6 B. Imported commodities ­ successful model 2. hygiene (of premises and equipment) of "equivalency" of inspection: In the EU, USA 3. weather the premises have their own self- and New Zealand imports of live animals and checking products of animal origin, which are considered at 4. the fourth item is always changing (labeling, high risk, enter through approved border inspection additives, composition of food). posts. These shipments cannot clear the port or border crossing without veterinary approval. Ship- They control implemented HACCP system through ments containing products the EU considers lower the system based on check lists. risk, such as: fruits, vegetables, cereals, and spices, must meet less strict requirements. Almost 80% of inspections in Sweden are per- formed as risk based inspection and only some The EU and the US approach to import of high risk smaller municipalities do not perform risk based products of animal and plant origin is based on the inspection (they inspect smaller scale producers, "equivalency" or control of the performance of in- mainly restaurants, catering services and perform spection bodies and producers in countries which traditional control based on the annual control plan are potential exporters, in order to comply with of their municipality based on number of FBOs and practices applied in the EU countries or the USA, number of inspectors).In Sweden, an electronic themselves. In the EU, an inspection body ­ Food and Veterinary Office (FVO) performs audits of 6 According to the Danish Food Act "the enterprise will be fined, if the enter- regulatory and control bodies, as well, as controls prise omits displaying the control report, or the streamer, if the enterprise of practices implemented in production units in refuse to show appendix to control report to the customer, if the enterprise order to allow export from those countries and fa- unrightfully displays an élite smiley at the its website, if the enterprise omits displaying the control report at the its website, or if the enterprise misleads cilities to the EU. The FVO published numerous the customers. A possible exception to the above is that the food control annual reports on control of inspection systems in authority may except an enterprise form the requirement to display the con- trol report in case the report is faulty." the EU and so called Third countries (those wishing http://www.webreg.dk/magnoliaPublic/UNB/Ansoeger_NY/Selv- to export to the EU). The US Department of Agri- studie_UK/Fodevarelovgivning/SmileyOrdningen.html 15 IFC Ukraine Business Enabling Environment Project culture established the practice of inspecting pro- or more frequent. Importer is paying only in cessors in their country of origin and has inspection cases when non-conformities are found, other- offices in countries where major importers to the wise fees are charged from the budget. In New US come from. This practice proved to be success- Zealand and USA, importers pay for the labora- ful in preventing contagious animal and pest dis- tory testing only if some non-conformities are eases and contaminated products to be introduced found on testing. into the USA, and as a result of this practice, the FDA plans to follow the same path. Other principles: In Uganda, producers pay for laboratory testing, while inspection control is fi- 4.1.5. Fees: nanced from the ministry's budget. Laboratories accumulate substantial financial sums from testing Good practices in inspection of domestic pro- of samples. duction: Comparing percentage of the ministry's budget fees calculated according to the real time used for inspection it is seen that 76% in New needed for the inspection: in Denmark, Swe- Zealand and 48% in Serbia are spent on financing den, New Zealand and USA the inspection of of inspection performance. In the USA some 16% domestic facilities is paid by facilities them- of the USDA budget is earned from inspection fees selves, according to the duration of time inspec- and charges and in Sweden 0.01% of the national tors have spent in the facility, with the exemp- budget is used for the NFA activities (part of these tion of the USA where domestic inspection is activities are performing veterinary inspection in paid from the USDA budget. In Sweden and large and some medium size producers). Having in Denmark fees for inspection control are charged mind the size of the USDA, New Zealand or Swe- mostly from the budget. If inspection was re- dish budget it is obvious that food inspection has a quested from producers or if some non- good financial basis and that food safety is an im- conformities are found during inspection, than portant issue in these countries. facilities are charged and there is a defined rate per hour of inspector's work to be paid. In Serbia and Croatia in import of food, each lot is sampled and samples sent to laboratory for testing Other practices: In Slovenia and Serbia domestic on sensory, microbiological and in majority of cas- inspections are paid from the ministry's budget and es chemical analysis. These analysis are paid by only fines are charged. In Croatia checks are importers (directly to the laboratory), and this prac- charged according to the quantity and type of prod- tice proved to be inappropriate, since it leaves the ucts. Checks performed by authorized veterinarians space for corruption of inspectors. In domestic pro- are paid by producer to the veterinary organization duction inspectors either accept laboratory analysis whose veterinarian performed the check (85% of (samples taken by producers and tested by some the sum, and 15% are redirected to the state Fund third part accredited laboratory), or inspectors sam- for Animal Health Protection). ple by themselves and send them to the laboratory of their choice for testing. Good practices in import: mutual recognition of certificates and analysis ­ In Slovenia, Sweden, Denmark and Poland, 4.1.6. Number of inspectors: according to the EU principles, documents on Lack of inspectors could be overcome by: products coming from the EU countries are reg- training and authorizing private veterinarians to ularly checked and lots are not sampled at bor- perform inspection der posts, with exemption when some non- accrediting private inspection bodies conformities in documents were observed, or if self inspection performed by food producers through the FAO's Rapid Alert system the noti- themselves fication concerning specific producer or product is sent. If some non-conformities in results of In New Zealand, USA and Poland there is an evi- analysis are found, than the next shipment dent lack of inspectors at the local level. in Sweden, should be mandatory checked and sampled and inspection is performed by private inspection agen- if compliant, the inspection returns to the annual cies as well as by governmental inspectors. In check plan. Commodities coming from so called Croatia there is a shortage of sanitary inspectors at " third countries" non ­ EU countries, are tested the local level, while in order to decrease the num- according to the testing scheme of each minis- ber of governmental employees, one third of vete- try, but mandatory the first time the producer rinary inspectors who have to retire will be re- sends a shipment and than in 3-6 months pe- placed by trained and authorized county veterina- riods if no non-conformities were found. In case rians. The authorization for veterinarians to per- they were found, the inspection becomes regular form inspection will be issued on 5 years. (Table 2) Study of Food Safety Inspections 16 Table 2: Comparison of number of inspectors and in the same time in countries where such practices average number of inspection visits in nine coun- are not so widely spread, the number of FBOs per tries inspector must be lower. Country No of No of No of No of FBOs FBOs FBOs/f inspec- /full /full ull time tion 4.1.7. Training: time time phyto- visits/ Inspectors need both basic and continuous training. em- Ministry sanita- premise/ ployed of ry in- year The basic training is needed at the beginning of veteri- Health spector their work in order to prepare them for their indi- nary inspec- vidual work. They need to acquire principles of inspec- tor inspection performance as required by the authority tor they work for. Croatia 12.7 205 1-1.2 Denmark 37 1:117.5 0.35-0.5 Curricula and specific training: training of New Zeal- 5.7 73.4 1 public veterinarians to perform official control and is provided in Sweden and Croatia and this is a Poland 5 46.6 66 1.9 good example how a lack of inspectors can be Serbia 8.5 92.5 0.4-1.5 overcome by using professionals adequately trained to perform inspections. In the same time Slovenia 1.6 236 33 0.35-1.6 inspectors have to be trained in specific aspects Sweden 2.75 (NFA) 7 0.65 of the inspection of drinking water and food. It 73.4 8 -163 9 is usually not enough only to instruct them how Uganda 0.27 to inspect food in general, but they have to spe- (Fish in- spection) cialize in the inspection of certain types of food (inspectors for food of animal origin, inspectors USA 0.84 151 0-0.4 for food of plant origin, phytosanitary inspec- tors). Data on number of FBOs per inspector show that situation in veterinary inspection in 9 countries is In underdeveloped countries there are obvious rather compensated either with adequate number of human capacity needs in food inspection as state inspectors or combination of private and state could be seen in Uganda. When starting food inspection services. On the other side, inspections inspection services, or reconstruction of existing within ministries of health in all countries except in ones, a close attention should be paid to curricu- Denmark, suffer from lack of trained inspectors and la and specific training of future inspectors. high number of FBOs per inspector. The reason for this situation is that ministries of health are mostly Continuous training: since the food industry is responsible for small and medium size producers, one of the fastest developing, new technologies retail and catering sector and the number of such and risks specific for certain types of products FBOs is high in each of selected countries. On the or technologies are emerging. In order to keep other side, veterinary inspection deals with lower pace with these problems inspectors need conti- number of enterprises and inspectors have a smaller nuous training. The HACCP system was intro- list of facilities they have to take care of. Data from duced in order to identify risks and to keep them Denmark show the high number of facilities per under control and food industry profited a lot inspector, but this is only relative shortage of in- from it. In order to understand and use the exist- spectors, since producers perform self inspection, ing HACCP system or some other system of and inspectors mostly perform audits of the food food safety implemented in the company, the safety system documentation, provide guidance in inspector must have a good command of prin- development of HACCP plans and rarely have to ciples and practices associated with this system. visit plants. In phytosanitary inspection, due to high number of smaller producers, a single inspector has Training in the HACCP system principles, im- to take care of 33 (Slovenia), 66 (Poland) or even plementation and auditing is now the practice in up to 117 (Denmark) producers. Having in mind the most developed countries with functional that this is a lower risk area it is manageable to or- food safety systems. ganize the inspection with smaller number of in- spectors. It is obvious that in Denmark where self In Denmark veterinarians receive classroom inspection is a practice, one inspector can be re- training in veterinary public health and food in- sponsible for the large number of producers, while spection as part of their veterinary degree course of study. Veterinarian when applying for 7 in counties number of veterinarians who also perform inspection varies the inspection job receive on-the-job training at from 0.5-4 per county the establishment level. Veterinary technicians 8 without primary producers 9 with primary producers often have experience as a slaughterhouse 17 IFC Ukraine Business Enabling Environment Project workers. They are educated at the Danish Meat 4.1.8. Quality control of inspection per- Trade College. The course consists of 14 weeks formance: of theoretical training and seven weeks of prac- Quality control of inspectors' performance is one of tical training. Ongoing training needs are de- the means for the enhancement of the efficacy of termined and scheduled by the official veterina- the control system. It is best performed as: rian or the head veterinarian through consulta- tion with the RVFAC. Special emphasis is Internal quality supervision: In Denmark there placed on HACCP, SSOP and supervisory train- is a set of internal audit systems for control of ing. quality of inspection work in all directorates. Regional offices control effectiveness and accu- The FSIS has a practice to train food inspectors racy of inspector's work by checking samples of from countries from which food is exported to their reports thus controlling their clarity, uni- the USA in modern aspects of food inspection: form approach, accuracy in terms of legal re- HACCP system implementation and control, quirements. A yearly performance conference sampling practices, risk based inspection. The for each DVFA employee is required by Danish idea is to train those who could be future train- law. There are written guidelines describing ers in their own countries. This practice pro- how the performance conferences should be vides safer food for export in those countries, conducted. The performance conferences are but also, has a beneficial effect to domestic food documented and retained by the supervisor of' safety in countries where FSIS trained inspec- the employee in a confidential personnel file. tors. The same practice is applied by the EU au- Quality supervision, consisting of an adminis- thorities which use resources (for example: trative component and a program component, is Swedish NFA or Danish DVFA) in the EU conducted for veterinarians and non-veterinary countries to train inspectors from "new mem- technicians at least once every two years. The bers" and "third countries". quality supervision report is maintained at the RVFAC. This is required by an official contract In the EU countries according to the EC regula- between the RVFAC and the DVFA. Each vete- tions member states are obliged to make annual rinary inspector is supposed to participate in one training plans for inspectors and to organize educational conference per year, and Records them (Denmark, Sweden, Poland, Slovenia). on inspections are kept on the regional level, but Since regulations have to be transposed into the the software is uniform, so the Head office of member countries' legal documents, continuous DVFA can have insight in their data. "Expert improvements in inspectors practices and know- groups" meetings of CEOs from regional offices ledge are secured. In Serbia and Croatia, inspec- and central level officials serve as forums where tors from FVO and DG Sanco come to inspect experiences in the approach to the implementa- the inspection systems, control of epizootics, tion of legislation are exchanged. This is a part control of plant diseases, GMO, control in of the technical assistance from the central to emergency cases legislation, laboratories and the regional level. food producers/companies (which could be po- tential exporters to the EU). In Sweden there is a "internal audit system" where National Food Administration and SBA Ministries have to provide finances for training audit performance of each County administra- of inspectors and in the EU and USA, some 5% tive board, and every CAB makes audits on of the ministry's budget is allocated for these every municipality in their region. They per- purposes. form audits using data which each municipality must send electronically to CAB and CAB must Use of check lists: The modern approach to forward it to the NFA. Three groups of parame- inspection audit is to use specific check lists and ters sent are used for assessing performance: guidelines. This helped made more quantifiable microbiological, chemical contaminants and inspection reports, provided common approach labeling. SBA performs audits on border post to the inspection practices and secured higher inspection according to the same parameters. level of objectiveness in the inspectors' work. In all countries we studied, check lists for food in- In Slovenia Veterinary Administration and In- spection are either in use or under preparation spectorate for Agriculture, Forestry and Food and guidelines for inspection are created at the have implemented internal audit systems. national level. In the EU member countries, in- VARS is dealing exclusively with control of in- cluded in our study, those guidelines are created spection work (are inspectors following rules according to the EC Regulations 854/2004 and and guidelines for inspection work and are they 882/2004. inspecting promises according to acting laws and regulations). Study of Food Safety Inspections 18 sample in case of non-compliance or accord- Director of the VARS regional office or Head of ing to the annual sampling plan: in Denmark, a section according to authorization of Director Sweden, New Zealand, USA and in Slovenia of VARS regional office is checking perfor- sampling is done only if inspector presumes that mance of each veterinary inspector at least once some non-compliances are existing or upon in 3 years (this is called verification of inspec- complaint from consumers. tor's performance). They verify weather each inspector performed control over program for The annual sampling plans have to result from self inspection in premises he is responsible to collaboration between responsible authorities, control. and to address the real risks for the population and environment. In all EU countries these External quality assessment: in the USA ­ an plans are submitted to the FVO for approval. In external review is organized according to data Serbia and Croatia such plans are approved by which FSIS acquires on the annual level. Two the FVO for products of animal origin, while in boards: the National Advisory Committee on the same time, ministries of health make their Meat and Poultry and the National Advisory own annual sampling plans which are not so Committee on Microbiological Criteria For much risk driven and are broadly covering all Foods assess data and provide impartial, scien- groups of commodities. Such plans sometimes tific advice to Federal food safety agencies for lack the product specific pathogens or some use in the revision of their work and further de- other characteristic types of contamination. velopment of food safety and inspection prac- tices. When preparing the annual sampling plan it is important to adjust the number of samples and Combination of internal and external model: frequency of sampling according to the size of In New Zealand the quality of the inspection production or according to severity of contami- services performance is assessed through inter- nant. The annual sampling plant has to be a tool nal and external third party audit. Assessors' for monitoring of certain contaminants, and competence is controlled by peer review, dual each year plans have to be adjusted to the actual audits, audit report evaluation, internal auditing situation (incidence i.e. presence of contami- and auditor training. nants in certain food, prevalence of animal or plant diseases in the country, prevalence of hu- Other models: man food and water borne diseases). The good The procedures for inspection performance au- examples are from Denmark and Sweden where dit can be provided through the ISO 9001 sys- each year a sampling plan is adjusted to results tem implementation in inspections. This is the of the previous year. The annual sampling plan case in Poland and Slovenia in their sanitary in- is financed by the state budget in all countries spections, and in Serbia this type of the auditing we studied since it helps the state to keep under system is under construction in the General In- control human, animal and pest diseases. spectorate. Internal controls of the work of vete- rinary inspection in Poland are performed at The end spot sampling is still performed in Croatia, least once per year. There are overall quality Serbia, Poland as the regular practice. checks and some specific performance checks (are inspectors working in accordance with act- 4.1.10. Transparency ing instructions). Producers and consumers are entitled to in- formation regarding the status of the inspec- Special governmental body organized for con- trol of inspection's performance: in Croatia, the tion report or recalls. Good practices are: State Inspectorate controls the performance of all inspections and this is a specific model Internet access: Denmark, New Zealand and where a special governmental body collaborates the USA have very transparent systems of in- and audits work of all inspections in the coun- spection work with reports of inspection being try. accessible on the internet in all stages of activi- ties related to the certain case. Also, data on re- calls are very easily accessible either from offi- 4.1.9. Sampling: cial sites or from sites of consumers' associa- The best results are achieved when companies im- tions. In Sweden data are accessible electroni- plement the preventive approach based on the cally, while in Slovenia, only partially accessi- HACCP system and inspectors: ble. 19 IFC Ukraine Business Enabling Environment Project In the USA detailed information about recalls, inspection body are not recognized by another two, inspection activities and annual reports are so financial costs and lost of working hours is sig- available to the public. nificant. The same mutual non-recognition of food inspections reports could be noticed in the USA, Transparent inspection work is a safeguard from Croatia, Slovenia and was the case in Serbia until subjective approach and corruption. Also, as in clear division of responsibilities came into force. Denmark and in New Zealand, if producers can assess electronic copies of reports and indicate in which stage is the correction of non- 4.1.12. Foodborne diseases: conformities, this could lower the frequency of Several elements of food safety systems are critical follow ­up visits to facilities and subsequently in control of foodborne illnesses. lower the costs of inspection (Table 3). They are: Other methods: traceback procedures, or the ability to trace In Croatia and Serbia they cannot be assessed pub- products "one step forward and one step back" licly and only FBOs in question get the printed which in the EU member states is mandatory. copy of the inspection report. In Poland data on Food and feed business operators must be able inspection (annual reports, periodical reports) are to document the names and addresses of the shared between inspection but are not available to supplier and customer, the nature of the product the public. and date of delivery. They must have systems and procedures in place that allow for this in- Table 3: Percentage of follow up visits of total No formation to be available to inspectors upon of annual visits their demand. Exporters in non-EU countries do Country Follow up visits (%) not need to meet this requirement, but EU im- Croatia 20-30 porters should be able to identify their direct supplier in trading partner countries. Also, in Denmark 18 trading countries mandatory animal identifica- New Zealand 3 tion programs for certain livestock species must Poland 25 be installed. In the EU countries from our study, Serbia 10-20 as well as in New Zealand, USA, Croatia, Ser- bia animal identification is mandatory and trace Slovenia 20 back is secured for products of animal origin. Sweden Not available For products of plant origin trace back is effi- Uganda Not available cient in USA, New Zealand and the EU coun- USA Not available tries, while in Serbia and Croatia it is under de- velopment; 4.1.11. Number of inspection authorities cooperation between government veterina- visiting FBOs: rians and public health officials is important Good practices are: in prevention, eradication and control of numer- ous animal diseases or pathogens which could Clear division of responsibilities and recogni- be transferred to humans (avian influenza, BSE, tion of results between inspections ­ in Sweden strains of Salmonella, E.coli and other patho- only food inspectors visit FBOs regularly gens). The ability to test new pathogens and to Functional common food inspection body ­ connect specific strains found in human material should be the most efficient and the most finan- with the food that caused the epidemic is essen- cially justified both from the governmental and tial in prevention and eradication of sources of producers' perspective. infection. Well equipped laboratories with trained personal, accredited methods, proficien- Slovenia and Serbia other inspections visit food cy testing among laboratories and information producers, too. Such are: ecological inspection, exchange between authorities are essential in inspection on workers safety, fire inspection, me- control of food pathogens. Also, results from tronomy inspection. The more different inspections annual monitoring plans and information from visit each premise, the more working days are the international community (international spent, this adds to production costs and limits ca- agencies and authorities in neighboring coun- pacities for development of new products or im- tries) could greatly enhance capabilities of a plementation of new procedures, standards, etc. On country to control food pathogens. the other hand, case of New Zealand shows that even though only food inspectors regularly visit premises, both analysis and fees charged by one Study of Food Safety Inspections 20 Food borne diseases are numerous worldwide Data on recalls for domestic products are not pub- and inspection performance could be measured licly available in Slovenia and Denmark, while they by trends in food borne diseases during certain are not easily accessible for imported goods in Pol- period of time. Only scientifically based and and, USA and New Zealand. In Croatia no data on fully functional food and water control systems recalls were publicly accessible. (Table 4) provide significant improvement in foodborne diseases epidemiological data. Otherwise, these Fig 10. Risk based approach data either show the constant number of food- borne infections or even worsening during time. There is no common principle in gathering or presenting the epidemiological data, so compar- RISK BASED APPROACH ison between countries is difficult to make. Nevertheless, in Denmark real breakthrough was obvious in terms of Salmonella control with first, government organizing the national action COMMUNICATION plan and second, transferring the responsibility MANAGEMENT ASSESMENT for maintenance of this plan to producers. The Swedish food and feed production and control system proved to be very effective in control of Salmonella in domestic production and in iden- tification of pathogens in imported goods. In New Zealand annual plans for several food pa- thogens are functioning. The practice to trace also, Campylobacter, Listeria monocytogenes, E.coli O157:H7 in food and feed proved to be very important in pathogen reduction in New Zealand, the USA, Denmark, Sweden. recall procedures which provide the ability to In the EU countries and in the USA there are data- stop products that could be hazardous to human bases of non-governmental organizations keeping or animal health. Information about recalls be- records of food recalls (both domestic and imported ing easily assessable help strengthening the pub- goods). They are good examples of public taking lic awareness on food safety. part in the food safety system. Accessibility of re- ports on recalls and foodborne risks is the way to Table 4: Data on recalls perform the risk communication which is the third Country Recalls pillar of the risk based approach to food safety (Fig.1) Croatia Not available Denmark 0.7 (import) New Zealand 1.2 (import) 0.3 (domestic) Poland 2.4 (domestic) Serbia 3.8 (import) 12 (domestic) Slovenia 1.2 (import) Sweden 0.3 (domestic) Uganda Not available USA 0.9 (domestic) 21 IFC Ukraine Business Enabling Environment Project 5.0. COUNTRY REPORTS The most functional model is the Danish risk based Slovenia, Croatia and Serbia emerged from the food safety system with the centralized inspection same model of the food safety system and trans- model. formed their systems according to the EU model (with Slovenia being the most harmonized with the The Swedish and New Zealand models are showing EU). They are good examples of transitional coun- particularities of decentralized systems with good tries still remodeling inspection and Croatia and coverage of the food safety systems at the central Serbia going towards one inspection agency. Pol- level and gaps at the local level. These two coun- and is a model of the transitional system, too. These tries, on the other hand, have very good food safety four countries are good examples for the reform of agencies where expertise in development of regula- the food safety system in the CIS countries, since tions and their implementation is gathered. Both the historical background is similar. countries are good examples of the regional colla- boration in matters of food safety. The USA model is a good example of the organiza- tion of import inspection. The Uganda model can be recommended for coun- tries which develop their food safety system de novo. Study of Food Safety Inspections 22 5.1. CROATIA The State Inspectorate, is competent for the overall Croatia is a Western Balkan country, a candidate inspection over the economic entities. The State country for accession to the EU, with population of Inspectorate coordinates the work of other inspec- 4.443.000 inhabitants (2007), GDP (PPP) of $ 70 tions with work of inspections directly involved in billion (according to Croatia Statistical Office data) food safety. and GDP per capita of $15.700 (according to EU- ROSTAT). The value of agriculture and food pro- All inspectors (and thus inspectors dealing with duction in 2007 was 5.9% of the GDP. Agriculture food safety, also) in Croatia work according to the and food production sector is increasing but much Law on State Inspectorate which prescribes the area slower than other sectors since 2005. The export of inspector's work and authority. Inspectors can (being 8.420 million Euro) markets for agricultural initiate the inspection, conduct it, issue opinion, and food products from Croatia are Bosnia and prescribe different measures (fines, closing of facil- Herzegovina, Serbia, Montenegro, Macedonia and ities or parts of facilities, recall products from the from the EU Member States ­ Italy, Slovenia, market, and initiate the legal offence procedure ­ Germany, Austria. The main export commodities submit to court a request for trial). In case when are sugar, processed products, fish and moluscus, business entity complains to the inspector's deci- cereals and tobacco. The majority of import (value sion, the complaint is to be submitted to the State of 18.601 million Euros) came in 2007 from Italy, Inspectorate, where the Chief Inspector nominated Germany, Brazil, and Hungary. The agro-food sec- a specific committee to deal with complaints. In- tor provided 9,6% of the net export and 8.1% of the spectors perform announced and non-announced net import in 2007. 10 visits (upon their own decision). There is a pre- scribed amount of fines depending on type of non- conformities met. Within this law, a general me- 5.1.2. Legal framework thodology of sampling performed by inspectors is A. In Croatia the Food Act (46/07) ­ basic food defined (sampling of feed food of animal origin is safety law, harmonized with the EU Regulation precisely defined in Veterinary Law 41/07 and ru- 178/2002 was adopted. This Act sets general over- lebooks and for phytosanitary purposes in the Plant view and requirements on food and animal feed Health Act 75/05). If a complaint is found to be safety defining: obligations of the food business justified, the inspector has to revise his decision in operators, the official control system, food labora- 8 days, if not justified the decision is final and the tory operation requirements, obligation for food inspector has to oversee the implementation of de- manufacturers to implement HACCP (all FBOs by cision. January 1, 2009), establishment of the Croatian Food Agency, crisis and emergency situation man- C. Rulebook on the Official Inspection of food, agement, and clearly defines responsibilities of re- feed and animal health (46/07) prescribes in de- levant authorities regarding food control (food of tail: inspection procedures, possibilities of transfer animal origin is the main responsibility of the min- of certain inspection work to other bodies or indi- istry in charge of agriculture and food of plant ori- viduals (see later in the 4.1.1.) and ways of control- gin of the ministry in charge of human health). ling these bodies or individuals, inspection reports, sampling, laboratory testing, crisis management, B. According to the Law on State Inspectorate control of good coming from import, recall proce- (1999) there is one central administrative body dures, collaboration with customs, guidelines for called the State Inspectorate, responsible directly to the development of the multiannual control plan, the Government of Croatia, which integrated the activities of the EU bodies in the food control (re- performance of 12 various inspection which before quirements for training of inspectors, payment scale this integration were dispersed in four ministries. for the permanent inspection control over slaugh- The State Inspectorate covers: commerce and crafts tering, fishing, milk production, import of goods). supervision, catering and tourism, quality of products, supervision in agriculture (wine-growing, D. Law on Sanitary Inspection (2008) gives the fishing industry and cattle breeding) and forestry, authority to sanitary inspectors to initiate and per- labor relations and occupational safety, electric form: inspection, sampling, recall, confiscate, clo- power supply and mining and pressure vessels sure, prescribes fines. This Law is in accordance supervision. The Headquarters are located in with the Law on State Inspectorate and the Law on Zagreb ­ the capital, and five Regional Units, their Official Procedures (2009) which prescribe the headquarters being in Rijeka, Split, Osijek, same authorities to inspectors. Varazdin and Zagreb. Regional Units have 44 Branch Offices. 5.1.2. Responsible authorities for food safety (Fig.2): 10 The Ministry of Agriculture has responsibility for http://server01.globaldizajn.hr/mps.hr/UserDocsImages/publikacije/Bro%C 5%A1ura%20Hrvatska%20poljoprivreda.pdf food of animal origin and the Ministry of Health 23 IFC Ukraine Business Enabling Environment Project has responsibility for food of plant origin. The The Agricultural Directorate ­ in charge of regula- mandate of the Croatian Food Agency relates main- tion and within it the Division of Agriculture and ly to risk assessment and risk communication. Phytosanitary inspections controls plant protection products in primary production and plant health at A. Ministry of Agriculture, Fisheries and Rural the border and inland, and Development (MAFRD) ­ according to the Food Act is the central authority and national contact The Food Industry Directorate ­ in charge of point in the field of food safety. Since 2004 Croatia regulation of food quality, labeling, wine regu- is included in the Rapid Alert System for Food and lations, traditional food products, natural miner- Feed (RASFF) 11 of the FAO and contact point is in al and table water. MAFRD. B. Ministry of Health and Social Welfare There are three Directorates involved in Food Safety: (MHSW) The Veterinary Directorate ­ responsible for Directorate for Sanitary Inspection is respon- regulation within which the Veterinary Inspec- sible for regulation and control of food safety of tion Directorate is responsible for control of an- products of non animal origin, novel and dietet- imal health, welfare, safety and hygiene of pro- ic products in food production ­ control exhi- duction of food of animal origin, and disposal of bited in production, retail and in import. Total animal by-products. Inspection covers border number of sanitary inspectors in the country is and inland inspection with: state veterinary in- 205 13. They are organized in the head office at spectors, border veterinary inspectors, 20 coun- the central level and in 21 counties as 81 field ty offices and Zagreb (the capital) city office. "Operative Units" at the county level. Total number of veterinary state inspectors is 164 12. It is planned that the number of state in- C. Ministry of Ecology ­ responsible for regula- spectors should decrease to 96 and that 180 au- tion and inspection of waste (solid and water). thorized private veterinarians should receive training in order to be able to perform inspec- tion (authorization to be valid through the 5- year period). Fig. 2. Organization of the food safety inspection in Croatia Government Croatian Food MHSW MAFRD MoEcology Agency Agriculture and Food safety and Veterinary Ecological Sanitary inspection phytosanitary quality directorate inspection inspection Inspection directorate (coordinating body) 11 Rapid Alert System for Food and Feed (RASFF) is a system put in place in 1979 as a network that allows the EC and EU member states to share infor- mation and take immediate actions in case some food presents danger to health. Legal basis for the system is made in Regulation EC 178/2002. 12 13 www.mps.hr www.mzss.hr Study of Food Safety Inspections 24 D. Croatian Food Agency was founded in 2004. 5.1.3. Register of FBOs: The main tasks of the Agency are risk assessment There is no central register of FBOs. Each ministry and risk communication. It is organized according has its own register. Total number of registered to the European Food Safety Agency model and FBOs is 45.700. According to the official Veteri- has 8 scientific boards covering different issues nary Office Register (2009) 14 there are 1321 active from animal and plant safety, animal welfare, to producers. There are some 449.896 agricultural food safety and residues in food and feed. They holdings according to the Official Statistical Office provide scientific opinion and risk assessment to data from 2006 (the register should be updated in regulators and public. 2009) 15. Collaboration of inspection services is obtained In this moment there is no coordinated control plan directly through their monthly meetings and or coordinated monitoring plan and inspection is through the Croatian Food Safety Agency. not yet done on the risk basis. According to obliga- tions which Croatia has in the process of associa- The Agency is a model of similar agencies in the tion to the EU, monitoring plans have to be coordi- region, for example the Bosnia and Herzegovina nated in order to identify the real treats for food Food Safety Agency. safety. Until the new Law on Sanitary Inspection (2009) was issued, both sanitary and veterinary Table 5. Division of inspections inspections were controlling the area of production Area Inspection authority of food of animal origin. Animal health State veterinary officers and authorized veterinarians in 5.1.4. Frequency of control and fees counties Both ministries have their annual inspection plans. Food of animal origin State veterinary officers The annual monitoring plan for residues in food of Sanitary inspectors MHSW animal origin was accepted by the FVO. Inspectors Import of animals and Border state veterinary inspec- visit each FBO at least once a year and if non- food of animal origin tors compliances with regulations are identified addi- Feedingstuff and ani- Border state veterinary inspec- mal nutrition ­ import tors tional inspection visits may follow (1-2). Duration Phytosanitary inspectors, Cus- of inspection visit is from 0.3-3 days depending on toms office the type of inspection (60-70% of working time per Feedingstuff and ani- State veterinary officers year inspectors spend in field work according to the mal nutrition ­ produc- Phytosanitary inspectors, tion official Report on control activities in 2007). Vete- Animal byproducts State and county veterinary rinary inspectors are always present at the slaugh- inspectors tering line (on slaughtering days). Veterinary medicines Veterinary inspection authorization and dis- Coordination between inspections is performed tribution through the State Inspectorate and Croatian Food Veterinary medicines State veterinary inspection, residues Sanitary inspection MHSW Agency, but also directly, through the monthly Food and Food hy- State and county veterinary coordination meetings of sanitary and veterinary giene inspection, Agriculture inspec- inspectors at the regional level. tion, Sanitary inspection MHSW Food safety inspection at the MHSW is financed GMO Agriculture inspection Sanitary inspection MHSW from the governmental and the county budget ac- Ecological inspection cording to the Framework Plan of Food Inspection. Import of food of plant Agriculture inspection, Sanitary origin inspection MHSW, Customs MAFRD sets fees for veterinary-sanitary checks, authorities, Phytosanitary in- spection health protection and issuing of animal health cer- Plant protection prod- Phytosanitary inspection, Sani- tificates. Out of that money 15-30% remains in the ucts authorization and tary inspection MHSW central ministry budget, while the rest is returned to sale the regional office that performed a service. Income Plant protection prod- Sanitary inspection MHSW, from these fees represents 39.3% of the ministry ucts residues Veterinary inspection, Phyto- sanitary inspection annual budget. All veterinary inspectors are civil Animal welfare State veterinary inspectorsand servants employed in the MAFRD and inspection authorized county veterina- services are paid directly from the budget of the rians ministry. Plant health Phytosanitary inspection Restaurants, shops Sanitary inspection MHSW, Agriculture inspection 14 http://www.mps.hr/default.aspx?id=6677 15 www.dzs.hr 25 IFC Ukraine Business Enabling Environment Project Table 6. Data on inspection in 2008 16 accordance with the previous Law on Sanitary In- spection (1999) which allowed sanitary inspection Total number of inspectors 369 to control all types of FBOs. (veterinary +sanitary) No FBOs in sanitary inspection register 45.700 5.1.6. Visits of controlling bodies other No FBOs in veterinary inspection 13809 than those participating in the food register safety system control to FBOs: No of veterinary inspectors 1649 Fire inspection No FBOs per veterinary inspector 12.7 Safety on work Average No of veterinary inspector 1.2 Metronomy (inspection of measurements) visits per FBO No of inspection visits as percent of 97% Audit Plan (%) 5.1.7. Quality control of food inspections: No of sanitary inspectors 205 One of the roles of the State Inspectorate is to con- trol the performance of inspections. It is merely the No FBOs per sanitary inspector 210 performance according to legal requirements and to Average No of sanitary inspection 1.5 visits per FBO financial output. Quality assurance systems in in- spections dealing with food safety have to be im- Percentage of visits with registered Not available nonconformities plemented and regularly assessed and that will be a Annual number of Follow ­up visits 20-30% basis for further improvement in inspection work. (% of all audits) Also, that will help obtain higher level of objectivi- Annual No of appeals Not available ty in inspection work. Annual No of recalls 5.81% 5.1.8. Transparency: 5.1.5. Sampling: Data on control of residues in food of animal origin are regularly sent to the European Commission. Sampling is performed by veterinary and sanitary Other types of food are sampled according to the inspectors. Total number of samples taken for mi- monitoring plan which was not significantly up- crobiological analysis was 40.900 in 2007, of dated since 1990. Results of this monitoring can be which 5.81% were non-compliant with the national acquired only if official request is proceeded to the regulations, also 31.308 samples were analyzed on Sanitary inspection. chemical parameters and 3.51% of samples were non-compliant. 17 It is important to stress that the Integration of data in the central IT system for in- number of inspection samples is not the sum of spections was recommended in the report of the EU both microbiological and chemical samples, since control mission when Croatia applied for the candi- the same specimen can be analyzed on both. Com- date status to the EU.7 In 2008 the central IT sys- paring with results from 1996-2006 no significant tem was introduced in the sanitary inspection. Cen- changes could be observed (5.81-7.44% of micro- tral IT system is under development in the MHSW. biological and 3.51-6.12% of chemical non- compliances were found). 18 5.1.9. Training: Laboratory analysis of samples taken by inspectors Annual training of inspection is responsibility of in import control are paid directly to laboratories by each inspection according to the Croatia Food Act. importers. Testing of samples in production and Sources of funding are merely from the EU pre- retail is paid by the respective ministry, with ex- accession funds and from these sources the capacity emption when samples prove to be non-conforming building and training of the Sanitary Inspection was with regulations when producers or retailers pay the done in the period 2002-2006, capacity building in laboratory fees. Samples tested for purposes of the prevention of zoonosis and control over pesticide annual monitoring plan sampling are financed from Residues. the budget of the ministry (either of agriculture or health depending which one took samples). Separate trainings in the HACCP were organized for inspectors and for producers. Since the HACCP Overlapping of sampling by two ministries existed is mandatory in production of food of animal origin until latest version of the Law on Sanitary Inspec- since 1999, numerous premises improved their per- tion (2008) was issued, since Food Act was not in formance and this resulted in licensing them for export to the EU. Yet, a significant number of pre- mises doesn't comply with the EU requirements. 19 16 Obtained through personal interview with officials and from official web Training on implementation of check lists for grad- sites 17 Annual Report of the Institute of Public Health 18 19 http://www.seefsnp.org.yu/documents/croatia/Croatian%20Country%20profil http://ec.europa.eu/enlargement/pdf/press_corner/key- e.pdf documents/reports_nov_2008/croatia_progress_report_en.pdf Study of Food Safety Inspections 26 ing establishments was conducted in 2005 and 5.1.11. Summary: check lists are in use. 20 In 2008/2009 veterinary Since 1990 Croatia has made a lot of changes in the inspectors were trained in assessment of HACCP. food safety inspection. Starting from the end-point checking prescribed by the ex-Yugoslav legislation It has to be emphasized that State Inspectorate had to the process control in food of animal origin ex- trainings organized for inspectors dealing with food port facilities and facilities which have HACCP. quality, but since food quality and safety are differ- The process of negotiations with the EU has im- ent issues that cannot be taken into consideration proved coordination between different institutions when dealing with food safety. in the way of more frequent meetings and discus- sions of a control plan. They collaborated in prepar- 5.1.10. Food borne diseases: ing DG SANCO missions 23, CARDS projects 24, Number of food borne infections ranges from 8000- adjusting legislation process etc. They, also colla- 10.500 per year, with salmonelosis representing the borated in development of the National Food Safety 50% of the total number of infections. Data from Strategy 25 where a comprehensive analysis of the 2007 show 3500 cases of salmonelosis. Number of situation in Croatia was made and directions for outbreaks ranges 50-100 per year and besides Sal- further work indicated. monella species causes are frequently Streptococus species and parasite Trichinella. There are still important issues to be addressed such as: complete harmonization of legislation with According to the official data number of food asso- the EU (secondary legislation mainly), to improve ciated outbreaks varies between 50-100 annually, coordination among authorities, to ensure impar- with the total of 8000 ­ 10.500 cases, of which tiality of inspection work, to proceed with training salmonellas are registered in 3500 cases in 2007 (or of inspectors and implementation of skills especial- almost 50%). The main sources of Salmonella were ly towards risk based inspection control, to reform eggs and meat. 21 sampling schemes for food of non-animal origin, to strengthen foodborne diseases surveillance and to There is no significant difference between data for support the introduction of own-check systems 2007, 2008 or 2009 as reported by the Institute of based on HACCP principles and good hygienic Public Health 22. practices. 23 DG SANCO ­ EU Directorate General for Health and Consumers checks the situation in the EU and third countries in terms of practices and harmoni- zation to the EU rules 24 CARDS program ­ The EU Community Assistance for Reconstruction, 20 Veterinary Directorate data 2009 Development and Stabilization 21 25 Strengthening food safety and nutrition policies and services in South- eastern Europe, WHO 2009 http://ec.europa.eu/enlargement/pdf/croatia/screening_report_12_hr_internet_ 22 http://www.hzjz.hr/epidemiology/news/index0702.htm en.pdf 27 IFC Ukraine Business Enabling Environment Project 5.2. Denmark The reform of the food safety system started in The Kingdom of Denmark consists of five regions 1997 and resulted in centralization of the Danish and 98 municipalities. It is estimated that there are food safety system. A new agency ­ The Danish 5. 515. 287 inhabitants (2009) and GDP in 2008 Veterinary and Food Administration (DVFA) con- was $203.7 billion (PPP). Agriculture participated solidated practically all food safety functions and in the GDP with 1,3%, industry 25,7% and services including inspections in the of control of food of 73%. According to IMF the GDP per capita was 38 animal origin. Before inspection functions were 400 $ in 2008 and 37.391 $ in 2007. distributed among the Ministry of Health, the Min- istry of Fisheries and Municipalities. The main Approximately 65% of Denmark's total land mass purpose of the reform was to improve the system is used for agricultural purposes and production is and make it less burdensome by reducing overlaps extensive, so that Denmark produces enough food in responsibilities which were previously distri- to feed four times its population. In 2008 export of buted among several state agencies. Since before food and agricultural products valued 17.6% of the the reform municipal inspectors used to be a part of total export value. More than two thirds of agricul- small system, to foster the acceptance of new ap- tural production is exported to over 200 countries proach and reinforce the new agency's mission was and 61% goes to the EU with Germany, UK, Italy one of the main challenges of the reform. In order and France being the biggest buyers. Also, USA, to solve the problem DVFA moved employees to Japan and the Eastern Europe are very important centralized locations and held monthly meetings on export markets for Danish food and agricultural mew system. products. Main agricultural products are meat, milk, grains, seeds, fish and shellfish of which 4.5- So, now Danish food system has following struc- 5 million metrics tons of milk, 25 million pigs, 120 ture: million broilers and vast quantity of eggs, beef and dairy products are exported annually. 26 5.2.2. Responsible bodies for regulations and control of food safety 5.2.1. Legal framework A. Ministry for Food, Agriculture and Fisheries (MFAF) ­ is the main body responsible for regula- A. The Law on foodstuffs 27, fully in line with EC tion and control of food safety. In Denmark the Regulation 178/2002. hierarchy in implementation of food regulations is conducted from the top to the local level. The Min- B. Law on self-control in food-producing under- istry itself and the permanent Secretary are respon- takings 28 with amendments that treat matters as the sible for determination of policy in agriculture, fi- traceability of products, the maintenance, cleaning sheries and food production, as well as for devel- and disinfection of premises, and personal hygiene opment of the food safety policy. The so called in primary production and food processing under- "Department" is divided into four separate bodies ­ takings. There are Annexes, dealing such as: fish "Directorates". They are: the Veterinary and Food and fishery products, meat products, and crusta- Administration, the Plant Directorate, the Danish ceans and mollusks. Food Industry Agency and the Directorate for Fi- sheries. The fourth level of the organization are the C. Orders dealing with: materials that come in con- individual labs and institutes under these directo- tact with food, contaminants, on special provisions rates ­ they are responsible for research, develop- for the organization of the official control of animal ment, and analysis for the Danish government. products (defining official inland and export/import control, penalties). 26 http://www.dst.dk/ 27 Denmark (Greenland). Decree No. 523,2004 28 Denmark (Greenland). Order No. 888,2005 Study of Food Safety Inspections 28 Fig 3. The organizational structure of the Danish Ministry of Food, Agriculture and Fisheries Policy Minister Inspection and Directorate administration The Danish The Danish Food Directorate of Veterinary and Plant Directorate Industry Agency Fisheries Food Administration The Directorate's responsibility is to cover the whole food chain "from farm to table" and to ensure that basic food law (Danish Food Act) is implemented. It executes its authority through four agencies which have both administrative and control function: a. The Veterinary and Food Administration (DVFA) mission is to promote safety, health and quality. It is responsible for: animal health, animal welfare, zoonosis protection, safety of food of animal origin, healthy eating habits of population, quality of food, control of residues, control of organic food, ethnical considerations. 29. The DFVA is, responsible for issuing regulations, food inspection, feed inspection, provision of informa- tion and advice in primary and secondary production of food. The Danish Food Act provides the founda- tion for one overall national food and veterinary inspection authority. Within the 12 divisions of the Head office 8 are dealing with food safety, animal health and welfare and feed safety. The control role of DFVA is decentralized and executed by 3 Regional Offices (fig. 3) and their 11 region- al units ­ each one is Regional Veterinary and Food Control Authority which is important in streamlining the national policy from top to bottom (Fig 4). The Regional Authorities are knowledge centers that pro- vide information and guidance concerning legislation, practices and information through the veterinary and food area. They handle the inspection of food and veterinary matters from farm to table. Fig 4. Structure of the DVFA Head office (12 Divisions) Region East Region South Region North 29 www.fwm.dk 29 IFC Ukraine Business Enabling Environment Project Fig 5. Structure of the Regional DVFA office Regional Director Secretariat Control Control Animal Health enforcement enforcement Laboratory Unit office office District District District District veterinary officer veterinary officer veterinary officer veterinary officer The DFVA employs about 540 full-time em- action plans to ensure that regulations are observed ployees, while the 10 Regional Authorities employ in the handling of food products and livestock. A about 1.370 full-time employees.14 company's self-inspection program have to ensure ­ at minimum, that statutory requirements regarding Two specialist research institutions are also con- the handling and treatment of foodstuffs are res- nected to the DVFA: The National Veterinary La- pected (general food safety requirements, food ad- boratory (SVS) and the National Institute for Virus ditives, packaging and labeling), and that the foods- Research (SVIV). Their role is in the veterinary tuffs do not pose a risk to human health under nor- emergency service. SVS mission is to prevent and mal use. The self-inspection program must be or- combat both livestock disease and food-borne hu- ganized in accordance with the principles of the man diseases originating in primary livestock pro- HACCP system. The self-inspection programs of duction (zoonoses). SVIV prevents and combats individual companies must be approved and regis- viral infections in mammals, including (exotic) vir- tered by the authorities. It is important to differen- al infections originating outside Denmark. These tiate between government control and self- institutions serve both the government and the pri- inspection programs. 30 vate sector. Each institution has the reference la- boratory which instructs local private control labor- Food industry companies and companies handling atories in methods and problem-solving techniques non-food animal products are required to imple- for carrying out control analyses. In collaboration ment self-inspection programs in accordance with with the accrediting authority, the DVFA evaluates EU-legislation, national legislation, and possible whether the quality of the control laboratory's work legislation from third parties (other countries). is acceptable. Primary producers and companies that transport The Food Inspection's Flying Squad is located in livestock must have a self-inspection program in all three regional offices and works with the control place to ensure compliance with the regulations on and enforcement offices to check the accounts and animal welfare, animal care, and livestock health. documents of enterprises with particular thorough- ness. Roles of the inspection: information to producers on how to implement The official control and inspection of food and an- regulations imals in Denmark is based on the principle that registration of food business operators and as- companies and primary producers are responsible sessment of the company by inspection of pre- for ensuring that regulations are observed and fol- conditions for the production unit (authoriza- lowed. The companies and producers must have so- called self-inspection programs with systematic 30 http://www.uk.foedevarestyrelsen.dk/Inspection/Self_inspection_ pro- grammes/forside.htm Study of Food Safety Inspections 30 tion, approval or registration must be performed The activities of the control and enforcement offic- prior to production or selling of food products) es include the following: sampling (determined by the inspection authori- ty or at the central level ­ for example the resi- Registration, approval and authorization of due monitoring scheme or monitoring of certain herds, food enterprises, non-food enterprises pathogen at the national level) and transporters risk based inspection ­ on the need basis Inspection, including inspection for approval, to trace the source of the problem along the inspection of herds, food enterprises and non- production line food enterprises, and the inspection of labeling sanctions sufficient to enable that regulations and traceability of live animals. are respected Meat inspection at abattoirs and meat product uniformity of effects ­ at the national and sector enterprises. level Border control of imports/exports of live ani- mals, foodstuffs and non-food products of ani- The DVFA is moreover required to co-ordinate the mal origin at 15 border posts. control process ­ such as by harmonizing profes- Sampling for analytical control. sional assessments and techniques, and by ensuring Follow-up on confirmed violations. that guidelines for the prioritization, reporting, and Case processing relating to registration, labeling frequency of inspections are complied with. Evalu- and traceability of live animals. ation of regional follow-up in special areas ­ new Issuing of certificates, e.g. in connection with inspection methods (i.e. organic, inspection for ex- export, and sealing of trucks. port to USA). Thus the DVFA conducts annual Nutritional information under the "All about visits to regions in order to be acquainted with their Diet" mobile team. work and sometimes takes part in the inspection visit in order to harmonize the inspection work on the national basis. Fig. 7 Danish Plant Directorate Plant Directorate Department of Department of Department of Department of Department of Department of Control Co- Feeding-stuffs Plants and Plant Seed Environ-ment EU control organic farming ordination Unit and Fertilizers Health b. The Danish Plant Directorate is responsible for B. The Environmental Protection Agency is re- inspections of companies and farms and controls: sponsible for control of nitrosamines and their re- seeds, animal feed production and safety, health lease to the environment. and quality control of plants, production of fruit and vegetables, organic farming and EU agricultur- C. Danish Tax and Customs Administration al schemes. Plant Directorate is engaged in policy, manages the register of food, feed and plant impor- legislation, control and provision of services to au- ters to Denmark. Performs also, check of docu- thorities and private sector. Inspections are con- ments regarding organic food and feedstuffs. ducted by six district offices. There are 428 em- ployees in this Directorate of which 115 are in re- Table 7. Division of inspections gional offices. Area Inspection authority Animal health Regional Veterinary Food Authority c. The Danish Directorate for Fisheries is re- Food of animal Regional Veterinary Food Authority sponsible for hygiene inspections at sea and fresh origin water (vessels except freezing and cooking vessels) Import of animals Regional Veterinary Food Authority and where the fish is landed, at auctions, and the and food of animal & premises of the first buyer. The Directorate has two origin Customs Services regional inspectorates and seven regional offices. Feedingstuff and Plant Directorate The total stuff is 245 of which 95 are in the inspec- animal nutrition torates. There are, also four inspection vessels with Animal byproducts Regional Veterinary Food Authority 80 employees. Veterinary medi- DVFA and Regional Veterinary 31 IFC Ukraine Business Enabling Environment Project Area Inspection authority (ban, required correction, training, consultancy), cines authorization Food Authority administrative fine (prescribed when it is the first and distribution time and when it is not serious problem) and report- Veterinary medi- Regional Veterinary Food Authority ing to police for prosecution (complicated or re- cines residues peated frauds). Food and Food Regional Veterinary Food Authority hygiene Quarterly regions have to report to the Head office GMO Regional Veterinary Food Authority and thus system of control and effectiveness is Plant Directorate maintained. Facilities are inspected according to the Danish Environmental Protection level of risk and frequency of inspection is lowered Agency as the level of risk decreases or if at four visits Import of food of Regional Veterinary Food Authority within the same year there were no remarks on hy- plant origin giene or safety. Such establishments are called ­ Plant protection Regional Veterinary Food Authority "Elite", and will receive fewer inspections. One products authoriza- Plant Directorate tion and sale Danish Environmental Protection third of all food and feed producing establishments Agency has the "Elite" status. Plant protection Regional Veterinary Food Authority products residues DVFA has a scheme for determining the general Animal welfare Regional Veterinary Food Authority level of risk to be attributed to each facility. Facili- ties are classified in six risk groups based on seven Plant health Plant Directorate risk factors (microbiological and chemical). Retail- Restaurants, shops Regional Veterinary Food Authority ers are visited by inspector from 3 times per year to once in five years. Inspectors apply the so called: 5.2.3. Register of FBOs: Fourth item approach. They always check: There is a detailed register of facilities producing food of animal origin for export and local con- 1. the display of the inspection report with the sumption. Total of all such premises is 4400. Total sign "Smiley" which illustrates weather the number of food and feed producing establishments promise is excellent, good, moderate or bad 32 is 49.600 and there are 69.730 registered shops and 2. hygiene (of premises and equipment) restaurants (as of January 2008). 3. weather the premises have their own self- checking 5.2.4. Frequency of control and fees: 4. the fourth item is always changing (labeling, The Danish Veterinary and Food Administration additives, composition of food). checks that everyone selling food complies with the law, so that consumers health and rights are pro- Wholesalers are inspected from seven times per tected and that consumers were not misled by pro- year to once in every two years. ducers' descriptions of their goods. The FBOs re- sponsibility is that food is safe. The monitoring of So called "Smiley approach" was introduced in food in Denmark is the task of the 3 regional food Denmark in 2001. It has become one of the most authorities that regularly check on all food produc- well known public schemes. Now smiley-reports ers. Checks typically take place in the form of an are to be posted in all supermarkets, at groceries, unannounced visit. In certain cases, the regional bakeries, butchers, greengrocers, in kiosks, restau- monitoring authorities may warn of the inspection rants, pizzerias, canteens, hospital kitchens and in advance. Irrespective of whether the inspection elderly homes. Even the outdoor hot-dog stands is announced or unannounced, the company must have them. At each inspection a number of control be prepared to devote the time necessary to review areas are checked. The Smiley given by the inspec- its activities in cooperation with the inspectors. tor equals the result for the worst area. All results During their visit, the inspectors will often take and the inspectors' remarks are published on the samples of raw materials, semi-finished goods, inspection report. There are four different Smileys. packaging or additives. 31 They symbolise that the inspector either: There are no prescribed values of fees and fines. Fines are prescribed according to values that pre- vious similar case was fined for. There are four 32 According to the Danish Food Act "the enterprise will be fined, if the sanction instruments: warnings (no legal status but enterprise omits displaying the control report, or the streamer, if the enter- prise refuse to show appendix to control report to the customer, if the enter- important for risk ranking), enforcement notice prise unrightfully displays an élite smiley at the its website, if the enterprise omits displaying the control report at the its website, or if the enterprise misleads the customers. A possible exception to the above is that the food control authority may except an enterprise form the requirement to display 31 the control report in case the report is faulty." http://www.uk.foedevarestyrelsen.dk/Inspection/The_monitoring_of_food/for http://www.webreg.dk/magnoliaPublic/UNB/Ansoeger_NY/Selv- side.htm studie_UK/Fodevarelovgivning/SmileyOrdningen.html Study of Food Safety Inspections 32 had no remarks, or Total No of FBOs registered by DVFA 50.302 has emphasised that certain rules must be Annual No inspection visits by DVFA 61.434 obeyed, or No of visits / DVFA inspector 38 issued an injunction order or a prohibition, or Average No of DVFA inspection visits 0.5 per year/ premise issued an Administrative Fine, reported the Annual number of inspection visits to 16.050 Company to the Police or withdrew an ap- FBOs by DPD proval. No of inspections per DPD 37.5 inspector/year The elite-smiley is awarded to enterprises No of DPD inspections per FBO/year 1.0 who have received the happy smile on the No of fishery inspectors per FBO 0.35 last four inspection-reports ­ and no remarks Number of inspection audits con- Over 95% during the last 12 months. ducted as a percent of Audit Plan (%) Annual number of inspection reports 42.000 At each inspection a number of control areas are (all inspections) checked. The Smiley given by the inspector equals the Percentage of audits with registered 7,5% result for the worst area. All results and the inspectors' nonconformities remarks are published on the inspection report. In Annual number of follow up visits (%) 18% Denmark inspections are carried out on a need- Annual number of appeals Not available oriented basis. Thus, the areas controlled may vary Annual number of recalls ­ domestic Not available from inspection to inspection and from shop to products shop. 33 Annual number of confinements at 13.000 border inspected by DVFA and DPD In 2008 DVFA performed 250 checks in transport Annual number of recalls ­ import 100 of animals (targeted at loading places, each year Annual No of samples (food and 2119 + 250.000 another group is selected for control). meat at slaughtering) according samples on BSE to the National sampling plan and TSE 35 Animal feed is control by DPD twice a year in pro- duction establishments and once a year on farms 5.2.5. Quality control of inspection which have HACCP implemented. The focus is on performance: control of: Activities of inspections vary from monitoring, HACCP/GAP implemented sampling, inspection, auditing and actions in case Traceability of non-compliance. There are internal audit systems Control of the end products for control of quality of inspection work in all di- Storage, separation, transport rectorates. Regional offices control effectiveness Cleaning. and accuracy of inspector's work by checking sam- ples of their reports thus controlling their clarity, In import feed is controlled only if arriving form uniform approach, accuracy in terms of legal re- the source that proved historically to be unsafe, quirements. The RVFAC is responsible for the ini- otherwise only check of documents is performed. tial hiring, training and payments of inspectors. The DPD controls seeds, planting material in inland Veterinarians receive classroom training in veteri- production and in export/import. Usually, they visit nary public health and food inspection as part of each FBO they control, once per year. their veterinary degree course of study. Veterina- rian when applying for the inspection job receive Table 8. Data on inspection (2007): on-the-job training at the establishment level. Vete- rinary technicians often have experience as a slaughterhouse workers. They are educated at the Total number of inspectors 2220* 34 Danish Meat Trade College. The course consists of No DVFA inspectors 1617 14 weeks of theoretical training and seven weeks of No of inspectors at DPD 428 practical training. Ongoing training needs are de- No of inspectors at Directorate for 175 termined and scheduled by the official veterinarian Fisheries or the head veterinarian through consultation with No FBOs for veterinary inspection 4400 the RVFAC. Special emphasis is placed on No of registered FBOs at DVFA 49.700 HACCP, SSOP and supervisory training. No FBOs for inspection of Directorate 502 for Fisheries 33 "Smileys keep food safety high in Denmark." 35 http://www.uk.foedevarestyrelsen.dk/Inspection/Smiley/forside.htm BSE-Bovine Spongiform Encephalopathy; TSE ­ Transmissible Spongi- 34 Full time employees form Encephalopathy 33 IFC Ukraine Business Enabling Environment Project A yearly performance conference for each DVFA for 2007-2010 was approved by the EC. In 2007 employee is required by Danish law. There are DVFA took 56.252 samples as a part of the nation- written guidelines describing how the performance al monitoring plan for various contaminants and conferences should be conducted. The performance components, and 22.000 samples were taken at the conferences are documented and retained by the regional level. Some 370 samples were taken on supervisor of' the employee in a confidential per- GMO analysis. Also, 600-700 samples per year of sonnel file. 36 feed are taken by DPD. Eight laboratories are in- volved in the realization of the National plan for Quality supervision, consisting of an administrative control of residues: three in Denmark and five in component and a program component, is conducted the EU. for veterinarians and non-veterinary technicians at least once every two years. The quality supervision The sampling plan for each year is prepared to be report is maintained at the RVFAC. This is required respective to the projected annual production of by an official contract between the RVFAC and food stuff which will be sampled. Also, it must take the DVFA. Each veterinary inspector is supposed into consideration new pathogens, or threats from to participate in one educational conference per known pathogens. Thus in 2008, Denmark was year, and Records on inspections are kept on the suggested by the DG Sanco to enhance number of regional level, but the software is uniform, so the samples of salmon and to take into consideration Head office of DVFA can have insight in their data. the new pesticides on the market. 38 "Expert groups" meetings of CEOs from regional offices and central level officials serve as forums 5.2.7. Training where experiences in the approach to the imple- Training of veterinary inspectors and those control- mentation of legislation are exchanged. This is a ling food of animal origin and feed is an obligation part of the technical assistance from the central to according to the Regulation EC 854/2004. The an- the regional level. Also EC FVO conducts regular nual training plan is existing. In the 2009-2010 pe- audits of facilities and inspections providing them riod all food inspectors for DVFA will be trained with insight in harmonization of the country ap- on general control issues and on specific based on proach to the EU practices. competence needs. DPD has also a training scheme for all inspectors in this authority. DVFA also, co- Despite very extensive action taken by all authori- ordinates and carries out in-service training pro- ties involved in the food safety, there are still areas grams in dialogue with the regions, and organizes where additional action is needed. According to the experience Exchange Meetings among inspection report made by DG Sanco in 2008, when they vi- personnel in the regions. sited selected slaughterhouses and milk processing establishments comments like: 5.2.8. Transparency There are information available at the Internet on "reporting system should be assessed in order the status of the inspection report and general pub- to ensure that the official reports reflect the real lic is informed at retail points about the results of situation in the establishments; authorities the "Smiley" campaign. There is a monthly report should re-assess the approvals for all approved on food recalls at the European food and feed recall food establishments to ensure that they comply site and information based on Rapid Alert System with relevant Community legislation; and to could be found at the site of the Danish Ministry training of inspectors should be improved". 37 for Food, Agriculture and Fisheries. The annual sampling plan is submitted to the EC FVO and DG 5.2.6. Sampling: Sanco and adjusted to the situation in the country. During inspection visits, inspectors take samples of The example of this is the extending of the moni- raw material, additives, semi-finished material, toring plan for border inspection posts for 2010 send them to laboratories affiliated to the DVFA in according to recommendations of the DG Sanco order to check if the company is observing the reg- control in 2009.23 Reports on sampling are availa- ulations. ble at the DVFA Intranet. Sampling can be a part of the National plan which 5.2.9. Food borne diseases is created at the central level with suggestions from Salmonella control program the regional level. The multi-annual control plan The national Salmonella control program for eggs was launched in 1996-2002. The main source of 36 Salmonella were eggs and poultry production. In http://www.fsis.usda.gov/OPPDE/FAR/Denmark/Denmark2008.pdf 37 Final report of a mission carried out in Denmark from 21 October-31 1995, 60% positive flocks were identified, while October 2008 in order to evaluate the follow-up action taken by the compe- tent authorities with regard to official controls related to the safety of food of animal origin, in particular meat and milk. DG Sanco 2008. 38 www.ec.europa.eu/food/fvo/act http://ec.europa.eu/food/fvo/ap/ap_denmark_8083_2009.pdf Study of Food Safety Inspections 34 after only one year of application of this program to follow results and report to DVFA) and re- the percentage fell to only 10% and than remained mained at the level of 2-5% in pig production, in the range 2-10% by 2002 (Picture 1). In 2002 the while in poultry production it staid at 5% in 2005, responsibility for Salmonella control was trans- and fell to 1% in 2006-2009 in all industrial hold- ferred to producers (and Danish poultry council is ings. Picture 1. Sources of the human salmonellosis in Denmark 1988-2005. Source: Official web-site of the Danish Pork producers association. Picture 2. Salmonella in pork cuts in Denmark 2006-2009. Source DVFA. In 2007, 1649 laboratory confirmed episodes of Probably owning to the small size and population salmonellosis were reported corresponding to 30.2 of Denmark, and to the vigilance of the Danish sys- cases per 100,000 inhabitants. This is similar to the tem, there have only been few documented cases of 2006 findings. An outbreak of 1054 cases was reg- minor incidents. There does not appear to be any istered in 2008 probably associated with production large scandals, and the minor cases have involved of pig meat hams. 39 diseases that have afflicted the rest of Europe as well. The five year (until 2010) plan is to decrease the number of Salmonella and Campylobacter out- breaks and to improve microbiological situation in food production. 39 Eurosurveillance Edition 2008: Volume 13/ Issue 44 35 IFC Ukraine Business Enabling Environment Project 5.2.10. Summary: A new consolidated approach to Food Safety system It is important to emphasize the practice of "self in Denmark showed number of benefits. Such as: inspection" implemented by Danish producers where plans for "self inspection" are approved by Reduce of overlap in inspections. Before the reform the relevant food safety inspection. Along with ap- one inspection was performed by several inspectors proval of plans of establishments which is also per- from different agencies. Today one inspector is formed by inspection, this is a model of advisory able to complete the inspection of a single food inspections' approach to producers. processing facility. Being one of the biggest exporters of food in the The frequency of inspection is now being based on EU, Denmark is implementing all principles and an individual food product's safety risk and on an practices required by the EU legislation, and re- individual company's food safety record. That re- marks from the EU control missions are respected duced number of inspections in general and has as guidelines how to harmonize the approach to made more resources available for inspections of food safety with acting EU legislation and real situ- higher risk companies and foods. As a result a new ation in Denmark and the EU. Governmental and "Smiley approach" was introduced and has proved private sector collaborate closely as shown in case effective in raising food safety. of eradication of zoonosis where government in- itiated the process which was further followed with Besides the consolidation made, enforcement of actions made by the private sector, since they rea- food safety regulations is more consistent and im- lized the importance of food safety for their busi- proved the food safety system's effectiveness. It nesses. also streamlined communications, made clearer responsibilities, and improved service delivery as a result of having a single contact. Study of Food Safety Inspections 36 5.3. New Zealand ucts, and certain secondary processors of animal New Zealand has the population of 4.213.418 inha- products for human or animal consumption, to op- bitants. The country is divided in 16 regions and erate under registered and independently verified one territory and also has three dependent islands. risk management programmes suitable to their own GDP (PPP) in 2007 was $172 billion according to particular animal material, products, and opera- the IMF with GDP per capita $30.000. Agriculture tions, unless they are regulated by other regula- participates with 4.4% in the GDP and industry tions, or unless they pose negligible risk. Also, this 26%. Act regulates animal product standards, export of animal material and products and home kill and Nearly 80% of the food produced in New Zealand recreational catch. 41 is exported, providing almost the half of all export earnings. Main agricultural products are: dairy D. The Australia New Zealand Food Standards products, lamb and mutton; wheat, barley, potatoes, Code 2002 and additional Food Standards in New pulses, fruits, vegetables, wool, beef, and fish. Zealand only, treating different areas (residues, Main export partners are: Australia 22%, US imported goods, cheeses produced from raw milk, 11.5%, Japan 9.2%, China 5.3%, UK 4.6% (2007). food of uncooked meat, fortification of bread with Main import partners are: Australia 20.7%, China folic acid). 42 13.4%, US 9.7%, Japan 9.5%, Singapore 4.9%, Germany 4.7% (2007). Imported food participates E. The Dietary Supplements Regulations 1985 with 20% in the whole consumption of food. define "dietary supplements," state the maximum daily doses for some nutrients, list food additive permissions and labeling requirements. As with 5.3.1. Legal framework other foods, it is the manufacturer's/importer's re- In New Zealand there are numerous legislation sponsibility to ensure their products are safe and documents that are linked with each other in the comply with the legal requirements (no approval is area of food safety. required, the Food Act 1981 refers). A. The Food Act 1981 (amended several times, the 5.3.2. Food safety system last done in 2007), which defines: Food safety system in New Zealand was reformed relevant terms, such as, food and sale, in 2002 when a new consolidated approach to food outlines prohibitions on sale (including unfit safety was presented by establishing the New Zeal- food), and Food Safety Authority (NZFSA). Before the prohibits misleading labeling and advertising, reform 2 ministries (the Ministry of Agriculture and Forestry and the Ministry of Health) were responsi- provides powers of enforcement and offences, ble for food safety. Such approach resulted in ap- contains provisions to make regulations and pearance of inconsistencies between the two minis- food standards. 40 tries' food programs and in order to make the sys- tem effective and efficient New Zealand's govern- This regulation was amended in 2002 and the risk ment consolidated food safety responsibilities of based component of food inspection was incorpo- the two ministries into one autonomous govern- rated in the document, thus letting authorities to mental agency the NZFSA. adjust frequency of inspection according to the risk level attributed to the specific FBO. Today food safety system is managed by: B. The Food Hygiene Regulations 1974, still en- Ministry of Agriculture, Forestry and Fisheries forced in counties and setting rules for registration Ministry of Health of temporary or permanent FBOs and allowing in- New Zealand Food Safety Agency (NZFSA) spections in these FBOs. The Food Act 1981 per- Food Standard Agency Australia and New Zeal- mits counties to enforce the Food Hygiene Regula- and. tions 1974. Also, in counties (Napier City Council, Hastings District Council, Auckland City Council A. Ministry of Agriculture and Forestry (MAF) and others) there are "Bylaws" which treat qualifi- ­ provides information, analysis and advice to the cations of food handlers and their training in food Government on issues affecting the economic and safety. environmental performance of the sectors. MAF's department ­ the Biosecurity Authority Clearance C. The Animal Products Act (1999) defining "in- Services coordinates numerous governmental agen- dividual risk management programmes" for all cies (Ministries of Tourism, Economic Develop- primary processors of animal material and prod- ment, Foreign Affairs and Trade, Health, private 41 http://www.legislation.govt.nz/act/public/1999/0093/latest/DLM33511.html 40 http://www.legislation.govt.nz/act/public/1981/0045/latest/DLM48687.html ?search=qs_act_the+food+act+1981_resel&p=1#DLM33511 42 ?search=qs_act_the+food+act+1981_resel&p=1&sr=1 http://www.nzfsa.govt.nz/policy-law/legislation/food-standards/index.htm 37 IFC Ukraine Business Enabling Environment Project sector, regional councils, environmental groups, Control of food safety in New Zealand is organized etc). Its primary goal is to identify and manage any across three levels: potential biosecurity risks at the border and to pro- 1. Central government through NZFSA; vide domestic and offshore technical inspection and 2. Regionally through 12 Public Health Units (in clearance services including control of animal wel- District Health Boards); fare, pests and diseases of plants and animals. The 3. Locally through 73 Territorial Authorities. Authority has 1000 employees: veterinarians, scientists, quarantine inspectors, and general staff ­ NZFSA is responsible for New Zealand's food pol- across New Zealand and overseas. 43 icy and regulation in the domestic production and trade, import and export sectors. The role of the The national budget for 2007 was $10.688.276.000 agency is in proposing regulations, management of of which for MAFF 0,5% was named. The budget risks, dissemination to public the information about of the MAFF is built on 1/3 from the governmental risks, education of industry and public in applica- budget and 2/3 from non-tax revenues. tion of precautionary approach to safety of food, minimizing the costs of regulatory actions/ inter- Around $500 million is spent annually on biosecur- ventions for domestic producers and impor- ity in New Zealand, with activities undertaken by ters/exporters, utilization of capacities in order to central government, regional councils, industry and improve business opportunities for domestic and private landowners. It is estimated government export focused food industries, work at the multila- agencies are responsible for $304 million of this teral and bilateral level to ensure neither interna- sum. tional standards nor importing country standards pose unjustified technical barriers to trade and ex- New Zealand spent in 2007 almost $318.million for port certificates. funding of the Biosecurity Agency (governmental funds along funds from local councils and lan- In managing of the food safety, the agency con- downers taxes) of which $32 million was spent on tracts with Public Health Units of the Ministry of pest management, and $19 million on Tuberculosis Health to implement and monitor state food safety prevention and eradication program. programs, recalls, investigations, inspection of cer- tain types of food businesses, and inspections of B. Ministry of Health ­ through a system of con- imported food. trol of food safety at the regional (council) level securing: Territorial Authorities currently implement food A system for routine and regular surveillance safety plans they developed by themselves with and monitoring of risks, based on risk assess- limited assistance from the central government. ment methodology. Ministry of Health pub- When some initiatives have been taken by individ- lished guidelines how to implement the HACCP ual Territorial Authorities, the benefits have been system in FBOs. The Environmental Health Of- limited to the particular Territorial Authority. This ficials perform inspection of FBOs at the local situation is recognized as not ideal, and presently, level and report to the council's health authori- 70% of Territorial Authorities work more closely ties. with central government in voluntary implementa- Surveillance and control of foodborne illnesses. tion of the new food risk-based regulatory docu- ments and collaborate through cluster groups of C. New Zealand Food Safety Agency (NZFSA) geographically close Territorial Authorities with was founded in 2002 and until 2007 operated as a NZFSA as a lead and central coordinating agency. semi autonomous body attached to the New Zeal- and Ministry of Agriculture and Forestry. Since The Structure of the NZFSA is: Policy Group, 2007 it is an independent governmental agency Science Group, Standards Group, Market Access with the overall management responsibility for the Group, Agricultural Compounds and Veterinary food safety system. NZFSA is the controlling au- Medicines and Approvals Group, Compliance and thority for: imports and exports of food and food- Investigation Group, NZFSA Verification Agency related products as well as controlling authority for: (NZFSA VA), Finance Group, and the Communi- food for sale (imported, locally produced and cations Group. 44 distributed and food produced for export) primary processing of animal products and offi- NZFSA VA audits the risk management programs cial assurances related to their export of food producers and processors, and provides exports of plant products, and export certification for products of animal origin use of agricultural compounds and veterinary (meat, game, honey) and seafood covering around medicines. 1200 premises. 43 44 http://www.maf.govt.nz/mafnet/index.htm http://www.nzfsa.govt.nz/ Study of Food Safety Inspections 38 The agency has 210 veterinarians located in 80 of- In Australia, FSANZ takes national coordination of fices throughout the country including all export food surveillance and food recall systems, provid- meat processing premises. Circuit staff cover ing food handling advice to consumers, conducting smaller processing operations that have no perma- research and supporting the Australian Quarantine nent presence. The agency is completely self fi- and Inspection Service in the control of imported nancing with an annual turnover of about $22 mil- foods. lion, all recovered from industry. 45 FSANZ has offices in Canberra and Wellington, D. Food Standard Agency Australia and New New Zealand and staff of 130 employees from the Zealand. New Zealand and Australia have a very Australian Public Service, and 16 employees in good collaboration in a number of issues according New Zealand. 46 to bilateral treaties and agreements. In the food safety area that is the Agreement between the Gov- FSANZ and other government agencies in Austral- ernment of Australia and the Government of New ia and New Zealand monitor the food supply to Zealand concerning a joint food standards system ensure that it is safe, and that foods comply with (the Food Treaty). An Australia and New Zealand standards for microbiological contaminants, pesti- Food Regulation Ministerial Council, supported by cide residue limits and chemical contamina- official committees such as the Food Regulation tion. FSANZ has a Bi-National Surveillance and Standing Committee (FRSC), and the Implementa- Enforcement Strategy which allows food/health tion-Sub-Committee, provides oversight of the sys- agencies in Australia and New Zealand to discuss tem and policy guideline to the standards setter, and share information about monitoring and sur- Food Standards Australia New Zealand (FSANZ). veillance of the food chain in Australia and New The Food Regulation Standing Committee advises Zealand. FSANZ acts as the central point for col- Ministers on policy matters and the Implementa- lection of Food surveillance data from public health tion-Sub-Committee develops and oversees a con- units in Australia and to the lesser extent in New sistent approach across jurisdictions to the imple- Zealand. This data include results of general com- mentation and enforcement of food regulation. pliance testing, and specially targeted surveys con- FSANZ is funded by the New Zealand and the Aus- ducted in the various jurisdictions. tralian governments. 5.3.3. Division of responsibilities and New Zealand participates at all levels of the joint register of FBOs food standards system. Areas of collaboration in- The regulatory systems and measures applied to clude policy development, standards and systems, domestic food underwent a significant review in incident response, science, communications, local 2002, so that government involvement and com- government operations, and compliance and en- pliance costs imposed on the food sector are mini- forcement. It provides not only for the sharing of mized. Any government involvement and regulato- information but also the generation of information ry controls are risk based and science-based as far to the mutual benefit of both agencies. as possible, producers have responsibility for pro- ducing safe and suitable food, regulatory require- FSANZ is an independent statutory agency estab- ments are applied consistently and equitably across lished by the Food Standards Australia New Zeal- sectors and groups and trade and commerce of food and Act 1991 and the Parliamentary Secretary to and associated products are facilitated. the Minister for Health has executive responsibility for FSANZ. Due to a wide range of inspectors coming from the NZFSA, Public Health Officers, Environmental The goal of the FSANZ is: A safe food supply and Health Officers and third party auditors participat- well-informed consumers. FSANZ develops food ing in the control of the food safety system, it is standards, joint codes of practice for industry, cov- difficult to estimate correctly the number of audi- ering the content and labeling of food sold in Aus- tors per FBO (since some of them may work only a tralia and New Zealand. The FSANZ develops part of their working time in official inspection) Australia-only food standards that address food Table 9. safety issues ­ including requirements for primary production ­ and maximum residue limits for agri- cultural and veterinary drug residues. 46 http://www.foodstandards.gov.au/monitoringandsurveillance/foodsurveillanc 45 http://www.nzfsa.govt.nz/verification-agency/ e.cfm 39 IFC Ukraine Business Enabling Environment Project Table 9. Data on New Zealand control of food safe- The grading scheme is very popular with the pub- ty of domestic products ­ NZFSA and agencies lic, showing the hygienic conditions in the premises 47 under it's jurisdiction in 2007-2008 and helping them to choose place to eat or buy ac- Sector Control body Number cording to the food safety level it has. of regis- tered FBOs An inspection will be carried out by an Environ- Primary processors NZFSA Verification 1076 mental Health Officer prior to registration and a (e.g. meat ­ Agency for Meat, grading of the premises will be provided as fol- slaughter and Seafood and Poultry lows: dressing, dairy ­ sectors processors incl. dairy farms and Table 10. The model for grading premises applied egg producers) in Auckland County Secondary proces- Third party verifier 1076 Grade Description sors of animal (NZFSA approved) product may opt for for Dairy i.e. "Assure A Premises being of superior standard coverage of third Quality" scheme for B Premises meeting the minimum statutory party inspection or dairy industry requirements. in NZFSA regime. D Premises being just below standard. Wine producers Third party auditors 251 (NZFSA approved E Premises being well below standard. 40 auditors) N Grading not applicable. Retail and restau- Control of Registra- 25000 rants tion per Food Hygiene Regulations A 'C' grade is not available so that is clearly sepa- 350 Environmental Health Officers (from rate those that comply with requirements and are 73 Councils) highly graded, from the lowly graded premises. Manufacturers and Operation of a Food 2171 big retailers Safety program ­ The standard grade must be disposed on a publicly Third party auditors visible place in order to inform customers on the (40 approved) hygiene status in premises. At the Porirua County NZFSA presently 350 FBOs the officers evaluate the premises taking the follow- operating a trial for applied for food service sector ­ this control ing into account: 49 209 Environmental The suitability of the premises layout, wall, Health Officers floor and work surfaces, the adequacy of hy- trained by NZFSA giene facilities including hot and cold water supply and the toilet and waste facilities includ- 5.3.3.1. Example of food hygiene control at the ing grease trap. local level (examples from different counties): Food practices ­ The degree of food manufac- Control of Registration and food hygiene is per- ture, preparation or handling carried out on the formed by the Council Environmental Health Offi- premises. cials according to the Food Hygiene Regulations Hygiene cleaning programme. (1974). It is performed in according to hygienic Staff training. standards implemented in the premise. Officers carry out inspections in addition to those In the Auckland County a Performance Assessment set by owner's premises grading if hygiene compli- System (PAS) score for setting license fees exists ance is an issue. The owner may be required to pay since 2002. The assessment is based on: a fee for these inspections and premises risk as- the Food Hygiene Regulations 1974, sessment may be downgraded. the Bylaw 15 (2008) on Food Premises (defin- ing actions to be taken if premises are unhygie- The Porirua Council's Environmental Health Offi- nic and defining trainings and qualifications in cers assess establishments in order to identify: food safety for FBOs personal) and The possible risk or risks to the public inherent best food hygiene practice. 48 in the type of operation being carried out on the premises. During assessment the following is examined: The size of the business. the physical condition of the premises The food handling practices employed on the the conduct of the operator and staff premises. cleaning and sanitizing of the premises The time officers spend inspecting the premises training of staff and frequency of those inspections. food safety procedures. 47 49 NZFSA Annual Report 2007-2008 www.pcc.govt.nz/A-Z-Services/Food-Premises---Registration/Food- 48 http://www.aucklandcity.govt.nz/Council/services/foodpremise/grading.asp Premises---Inspections Study of Food Safety Inspections 40 Registration fees are based on the premises risk $48 for the clearance request plus $96 per hour assessment. Registration fee will reflect premises payable in 15 minute units after the first 15 mi- risk assessment. The system is devised to encour- nutes, with a minimum charge of $24. Some other age responsible and safe food practices. The grad- activities undertaken by employees of the New ing system is designed to allow to improve risk Zealand Food Safety Authority are charged at grading and reduce the annual fee payable. $137.25 per hour payable in 15 minute units with a minimum charge of $34.30. Inspection is based on risk and there is a scale which determines the frequency of inspection and European Community and New Zealand sanita- registration fee levels according to grade assessed: ry agreement for animal products. Council Deci- sion 97/132/EC. EU charges only apply to clear- Table 11. Porirua county the frequency of inspec- ance applications relating to products as specified tion and registration fee levels in Council Decision 97/132/EC Annex VIII ­ Ani- Inspections A B C mal Products for Human Consumption exported No. inspec- Premises Fee Fee Fee directly from the European Union. tions/year Grading Lev- Lev- Lev- el el el EU charging rates are $33.75 for the clearance plus 1 Excellent A1 B1 C1 $73.12 per hour. 2 Very Good A2 B2 C2 3 Ungraded A3 B3 C3 5.3.6. Recalls and food with high risk: 4+ Ungraded A4 B4 C4 Domestic production: according to the NZFSA data (High Risk) there were 14 official recalls of domestic products and 11 voluntary (industry driven) in 2007-2008. 5.3.5. Frequency of control and fees: Also, 14 incident situations where recorded which Table 12. Data on inspection performed by NZFSA required action and specific measures from 42 2007-2008 NZFSA, Public Health Service of Ministry of For- eign Trade. No veterinary inspectors in NZFSA 210 The number of recalls due to microbiological con- No FBOs under veterinary inspection 1200 jurisdiction tamination or inadequate labels decreased compar- ing to 2006 when 20 recalls were registered. No of inspectors/FBO 0,2 No of approvals on persons, facilities, 3575 Import: NZFSA processed 9,381 import permits in food safety plans submitted by FBOs 2007. Almost 32% were not on the risk priority list, Annual No of audits to premises due to 228 complaints, breaking the legislation, etc. and 13% of all permits were for high risk food coming from the USA, China, Thailand and Malay- Annual No of visits in order to approve 22 food safety plans/inspector sia. There were 114 confinements that didn't re- Total annual No of visits to FBOs 1180 ceive import permit and were returned to the coun- try of export.42 Average number of visits/FBO 1 % of non-compliances 2.9% 5.3.7. Funding of the food safety inspec- % of the annual audit plan realization 100% tion is performed by NZFSA itself: In 2008/09, food safety line of the budget is appro- Data from the Annual Monitoring Plan show that priated to $63.5 million. Government funding producers in New Zealand have a very high level of represents 36% and the remaining 64% will be self control over the production of food and appli- mostly cost recovered from industry. Of the cost cation of agrochemicals, veterinary medicines and recovered functions almost 80% comes from audit- hormones and that a very low number of foodstuff ing and verification functions provided to animal have higher levels of contaminants than those al- products sectors. Costs are charged on an actual lowed by legislation. The data for the 2006-2007 cost for services provided (time taken plus any dis- show only one sample of food of animal origin to bursements, travel etc). The rest of the budget be non conforming on residues of chemical conta- comes from compliance functions, the organic offi- minants. In 2007-2008 the monitoring was per- cial assurance program, services provided to the formed on food of plant origin, and only 14 sam- industrial sector, and agricultural compounds, and ples were non conforming. These data do not differ veterinary medicine services and these costs are significantly from the period of 2001-2002.42 recovered by levy based on a businesses production or throughput. 50 5.3.5.1. NZFSA Fees and charges are based on: Food (Fees and Charges) Regulations 1997 50 According to World Bank "The levy system formally requires that a fee be Fees and charges for most activities are charged at paid by any enterprise whose effluent discharge exceeds the legal standard. NEPA regulations specify variations in effluent standards by sector and fees 41 IFC Ukraine Business Enabling Environment Project 42 Table 13. Budget of the NZFSA for 2007-2008 proposals given in the report. FBOs can register Name Sum in $ % of their facility online, too. total Budget of NZFSA 59.055.697 100 Number of media releases, publications, e-mail Budget for primary production 18.022.480 30.52 information on food safety and inspection are pro- inspection and monitoring of vided throughout a year. pathogens ­ Regulatory pro- gram Veterinary inspection + inspec- 23.823.397 40.34 5.3.11. Visits of controlling bodies other tion of Public Health Institute than those participating in the food abilities to perform according to safety control to FBOs: NZFSA standards ­ Regulatory standards Three levels of authorities exist-central, regional and local with subsequent list of approvals, regis- Inspection audits of premises ­ 3.002.506 5.1 System audit and enforcement trations, verification, and official assurances. Au- Sum used for emergency 220.225 0.4 thorities are excludable and rival (their use by one situations agency or governmental body does not detract from Sum used for the activities 76.36 their use by another), and benefits can be directly related to inspection attributed to those persons requiring the particular Consultation and food safety 2.724.588 function. information to FBOs FS policy advise to the 2.452.253 5.3.12. Foodborne diseases: Government The rate of campylobacteriosis significantly dropped since in May 2006 a new strategy for re- 5.3.8. Quality control of inspection work: duction of campilobacteriosis was launched. The Quality of the inspection services performance is number of cases was 80-85/100.000 inhabitants in assessed through internal and external third party 2006 and fell to 25-30/100.000 inhabitants in 2008 audit. Assessors' competence is controlled by peer (about 1050 cases per year). Still the problem is not review, dual audits, audit report evaluation, internal yet solved and in May 2008 some 380 cases were auditing and auditor training. Control of assessors reported, while in June 275 new cases appeared. competence was performed by third party auditing Salmonellosis has a steady downfall since 2005 in 25% of all audits performed in FBOs and with 1300 cases in 2008. The plan for reduction of showed that auditing process was completely per- Salmonella species and Lysteria species in food for formed according to guidelines prescribed by 2008/9 is in place. 51 NZFSA. 5.3.13. Summary 95% of investigation files were prepared for prose- New Zealand's food regulatory regime has not been cution with sufficient evidence to initiate criminal thoroughly reviewed (documents were only proceedings. In 2007, eleven such cases were pre- amended, but their original structure and the struc- pared and all proceeded to prosecution and all cases ture of the whole legislative system was not were won.32 changed) for over 30 years. Since 2002 NZFSA has been conducting a major review of New Zealand's 5.3.9. Training domestic food laws in order to: Training of local authorities to exhibit the inspec- address inequities in the way the food industry tion audit according to requirements of the NZFSA is regulated across the country is underway. In this moment they perform control clarify the roles of the regulators (NZFSA, Pub- of hygiene in premises according to Food Hygiene lic Health Units and Local Councils) Regulation from 1974, but they will have to build stem the continued rise in the number of re- human capacities to audit processes and implemen- ported foodborne illnesses. tation of the risk management (HACCP) food safe- ty system in production. The consolidation of food safety system and trans- fer of inspection responsibilities at the central level 5.3.10. Transparency to the NZFSA helped the New Zealand government There is an online instant answering service for to streamline communication between the food in- FBOs on the status of the auditor's report on in- dustry and regulators. The establishment of one spection and all FBOs can insert online into that agency for which food safety has become a top report all activities they have undertaken regarding priority enabled the system to be more efficient. The system became more responsive to food safety by pollutant. With the approval of NEPA, local areas may raise both stan- crises by establishing a network that quickly deliv- dards and fees above the nationally-mandated levels (in the latter case, these are called over-standard fees). Levies are charged only on the `worst case' 51 pollutant from each source." http://www.nzfsa.govt.nz/about-us/accountability-documents/statement-of- http://www.worldbank.org/html/prddr/prdhome/peg/wps06/indexp3.htm intent/2008-2011.pdf Study of Food Safety Inspections 42 ers information to notify the public of food safety The establishment of the Food Standard Agency issues. As a result, improved communication has Australia and New Zealand is a good example of enhanced consumer confidence and improved food the regional collaboration. It enables adoption of safety in the country. The NZFSA is training local same standards in many areas of food safety and inspection authorities in principles of implementa- quality, thus facilitating trade and using common tion of the risk management approach in food safe- resources in the development and control of stan- ty (the HACCP system) and thus providing them dard enforcement and gathering of information on with knowledge and guidelines in order to establish food safety issues. the uniform approach to food safety control across the whole country. 43 IFC Ukraine Business Enabling Environment Project 5.4. POLAND full time employees there are 5200 practicing Republic of Poland is organized in 16 regions, 279 veterinarians who perform ante and post mor- districts and 2478 municipalities. Population in tem inspection in slaughterhouses, supervise 2009 is estimated at 38,5 million with GDP (PPP) certain establishments, issue veterinary health in 2007 of $637 billion and GDP (PPP) per capita certificates, take samples, take care of animal $16.500. Agriculture participates in GDP with 4% health. Out of this number in 2008, some 700 (but 17.4% of working force is employed in agri- were paid from the central budget (budget for culture), industry 19,2% and services 53.4%. Main the General Veterinary Inspectorate) to per- domestic agricultural products are: potatoes, fruits, form their services ­ this was a way of over- vegetables, wheat; poultry, eggs, pork, dairy. Food coming shortage in veterinary inspectors in dis- and live animals produced for food participated in tricts. gross export with 7.6 % (2003). Increase in export b. Main Inspectorate of State Plant Health and of food and agricultural products is constant and Seeds Protection Inspection (SPHSIS) ­ at results from 2008 show increase of 14% comparing central level responsible for control of plant to export value in 2007. The main market for Polish health and use of pesticides, preparing control food and agricultural products (80% of export) is plans, training, guidelines and instructions for the EU market. The export to Commonwealth of lower levels. There are 16 regional, 269 district Independent States (CIS) states was 9.4% of the and 12 boarder inspection posts. Some 1600 total food and agricultural export. Local production inspectors are employed in control at all levels. satisfies 85% of local needs and imported food In each region there is an official laboratory another 15%. Imported food mostly comes from the which carries testing of samples taken from in- EU, Argentina, Ukraine (chocolate, meat, cereals, spectors and samples from the monitoring plan. palm oil, sugar). Balance of import to export is pos- At boarder stations there are 12 diagnostic itive with most of the EU states. units. c. Main Inspectorate of Agricultural and Food Quality Inspection ­ quality and labeling of 5.4.1. Legal framework GMO (control of traceability) with 17 inspec- National Strategic Plan for 2007-2013 is aimed to tors (1 at the central level and 16 in regions). enhance competitiveness of the Polish food and d. Agency for Restructuring and Moderniza- implementation of the preventive measures in food tion of Agriculture ­ keeps central official chain. Also, it will support full harmonization of register of FBOs and agricultural holdings. Polish legislation with the EU. According to acting legislation, the HACCP system is mandatory in all B. Ministry of Health (MH) ­ preparation of leg- objects by January 1, 2010. 52 islation and control in areas of: food hygiene, pesti- cide residues, contaminants, import control of food 5.4.2. Authorities responsible for the food of non-animal origin. safety system: e. Chief Sanitary Inspectorate of the State Sa- A. Ministry of Agriculture and Rural Develop- nitary Inspection (SSI) ­ control of: import of ment (MARD) cooperates with Ministry of Health food of non-animal origin, materials which on central, regional and district level. Department come in contact with food, food additives, of Food Safety and Veterinary Matters issues regu- GMO in food, food supplement, novel food. lations and control function is implemented through Sanitary inspection also, has responsibility for 3 central competent authorities -inspectorates: overseeing food processing. It prepares annual a. General Veterinary Inspectorate (GVI) ­ in plan, guidelines, training for lower levels of in- charge of animal health and welfare, foodstuff spection and collects their reports. There are 16 hygiene of animal origin, animal feed, pharma- regional Sanitary Epidemiological Stations ceuticals, rendering. The inspectorate has 10 with 1000 inspectors, 318 district with 2500 in- Boarder inspectorates, 16 region (Voivodship) spectors and 10 boarder stations. In each region inspectorates and 304 district (Poviat) inspecto- (16) there is an official laboratory which car- rates. General Veterinary Inspectorates pre- ries testing of samples taken from inspectors pares annual plans, guidelines and instructions and samples from the monitoring plan, there for regional and district inspectorates and col- are 3 Institutes nominated by MH to analyze lects and analyzes reports on their work. The official samples. network of official laboratories is supporting f. Main Pharmaceutical Inspectorate ­ with 15 this system. There are 2107 veterinary inspec- inspectors who control authorization and im- tors: 44 in the GVI, 215 in regions, 1476 in dis- port of veterinary drugs. tricts and 68 in border inspectorates, and 304 feed inspectors (one in each district). Besides C. Ministry of Finance ­ provides financing for inspections. 52 http://www.un.org/esa/agenda21/natlinfo/countr/poland/agriculture.pdf Study of Food Safety Inspections 44 g. Customs ­ controls import of food and plants D. Ministry of Transport with responsible inspections from Ministry of h. Road Transport Inspection ­ control of ani- Agriculture and Ministry of Health. mal welfare during transport (checks vehicles for transport). Fig. 8 Organization of the Food safety system at the central level Government Ministry of Ministry of MARD MH Finance Transport Agricultural Agency for Pharmace-utical GVI SPHSIS And Food Quality Restructuring and SSI Customs Road Transport Inspectorate Inspection Modernizing Table 14. Division of inspections own registers. Total number of FBOs in 2008 ac- Area Inspection authority cording to REGON Register was 33.000 of which Animal health Regional and district VI almost 20.000 were small operators (employing Meat production Regional and District VI less then 9 workers). 53 This register is not accurate Food of animal origin Regional and district VI since almost 30% of these enterprises either Regional and district SES stopped to work or never started. According to the Import of animals Regional, district and boarder VI same bulletin there were 6428 FBOs controlled by and food of animal Customs veterinary inspection. origin Feedingstuff and Regional, district and boarder VI animal nutrition Customs SSI doesn't have a centralized register (it is under Animal byproducts Central, regional and district VI construction ­ district SES are registering FBOs are Regional and district SES keeping register now). According to data in the Veterinary medicines Pharmaceutical inspectorate official statistical bulletin in 2007, there were authorization and 11.200 industrial food producers and al- distribution most150.000 manufacturers (small producers ­ so Veterinary medicines Regional and district VI residues called "nourishment plants").48 Food and Food hy- Regional and district SES giene An important number of food processing facilities GMO Agricultural and Quality Inspec- still operate in poor sanitary conditions and there is tion a serious concern about their future. By January State Sanitary Inspection 2010 producers which were given the grace period Import of food of Regional and boarder SES have to adjust their facilities and procedures ac- plant origin Customs cording to the EU hygienic requirements or they Plant protection Regional Plant Protection In- products authoriza- spection should close their operations. tion and sale Plant protection Regional, district and boarder 5.4.4. Frequency of control and fees: products residues SES Veterinary inspection: According to risk analysis Animal welfare Regional, district and boarder VI Road transport inspection and relevant EC Regulations (852/2004, 853/2004 Plant health Regional PPI and 178/2002) official control plan is made. Inspec- Coldstores, catering Regional and district VI tion has check lists for inspection visits. Traceabili- Regional and district SES ty in meat production and production of food of Production of infant Central VI animal origin is controlled by veterinary inspection, formula while traceability of animal products in retail is Baby food production controlled by sanitary inspection. Feed producers Distribution and sales Central Sanitary inspection of infant formula and are inspected twice a year, traders of feed once a baby food year, and 5% of farmers who keep food producing Retail (both meat and District SES animals are controlled once a year. Food processors plant products) still struggle with poor basic conditions in facilities and some ź of dairies and 1/3 of poultry processing 5.4.3. Register of FBOs: According to regulatory requirements all FBOs 53 Statistical yearbook of agriculture and rural areas 2008. must be registered. Both GVI and SSI keep their http://www.stat.gov.pl/bdren_n/app/strona.indeks 45 IFC Ukraine Business Enabling Environment Project facilities are in poor hygienic condition. This also, influences the frequency of inspection visits. Percentage of audits with regis- Example: 25.4% dai- tered nonconformities ­ Veteri- ries nary inspection Sanitary inspection: Frequency of inspection per- Average number of Follow up 2.5 formed by sanitary inspectors is not determined visits ­ Veterinary inspection according to risk based criteria (the risk based sys- tem is under development), but specific instructions Number of inspection audits Not available conducted as a percent of Audit and ordinances determine the frequency. The sani- Plan (%) sanitary inspection tary inspection approves FBOs self inspection re- Percentage of audits with regis- 0.5% fruit and vegeta- ports and guidelines for implementation of GHP tered nonconformities ­ sanitary ble processing and HACCP. inspection 3.8 %bakeries Annual number of recalls ­ do- 2.4% Table 15. Data on inspection in 2007-2008 : 54 mestic products Fines collected from unfit prod- $125.000 Total number of inspectors 5505 ucts (incorrect labeling and law (veterinary+sanitary) quality) Total No of FBOs Aprox. 19.000 No veterinary inspectors ­ VI 2005 + 700 private 5.4.5. Sampling plan: (domestic control) 55 veterinarians autho- rized to perform in- There is a multi annual sampling plan authorized spection by the EU FVO. According to that plan regional, No FBOs for veterinary inspec- 6428 industrial facili- district veterinary inspectors and practicing veteri- tion ties + 3500 manufac- narians take samples. In 2007, 27.425 samples were turers analyzed of which 124 were non-compliant. No of FBO per state veterinary 5 inspector Annual number of VI inspection 5200 PPI took 209 samples on GMO, 410 samples of visits to FBOs pesticides in order to control quality of pesticides No of follow up visits VI 2.7 (combat of fraud) and 1800 samples of plants for Samples taken by VI-annual 27.425 pesticide monitoring.39 sampling plan Total annual number of samples Aprox. 200.000 5.4.6. Training taken by VI % of samples with nonconformi- 3-4% Training is an obligation according to EU Reg ties 852/2004 and Reg 853/2004. There is an annual No of veterinarians participating 4268 training plan for each inspection. Training in tra- in the annual sampling plan ceability is organized continuously. Training for No samples taken by VI (state 6.5 chosen Regional VI and District VI is performed on and private veterinarians) per a cascade way, so that they transmit knowledge to annual sampling plan the lower level. Training is financed from the No of FBO for sanitary inspec- About 12.500 industri- tion al and almost 150.000 budget of the ministry. Training for SPHIS was manufacturers organized, by foreign donors, in improvement of No sanitary inspectors (domestic 3500 the food safety control (600 inspectors) and training control) in GMO for 300 inspectors. SSI had training on No of FBO/sanitary inspector 3.57 industrial + residue monitoring funded by PHARE funds. Re- 43 manufacturers port of the DG Sanco control mission states that the Annual No of Sanitary inspector 11.200 industrial + visits to FBOs 110.000 manufactur- harmonization of SSI inspection work at all levels ers is underway, and that the overall performance is Annual No samples taken by 16.254 better than in the previous years. 56 sanitary inspectors % of samples with nonconformi- 5.8% 5.4.7. Transparency: ties No of Plant Protection Inspec- 1600 Data on inspection controls, status of inspection tors -PPI visit statements, number of recalls are shared be- No PPI controls 105.000 tween inspections but they are not publicly accessi- Average annual No controls/PPI 66 ble. There is an IT system installed for storing of Annual No samples per monitor- 2419 information of inspection visits (reports) in the ing plan General Veterinary Inspectorate. Results of the an- Number of inspection audits Almost 100% nual monitoring plan are regularly published by the conducted as a percent of Audit EC FVO. Plan (%) veterinary inspection 54 EC FVO: Final country profile on food and feed safety, animal health, animal welfare and plant health: Poland, 2008. 55 56 http://www.wetgiw.gov.pl/ DG Sanco 7596/2007 Study of Food Safety Inspections 46 5.4.8. Quality control of inspection per- 5.4.10. Summary formance: Polish legislation is mostly harmonized with the In SSI the ISO 9001 system is implemented. The EU model. Frequency and scope of inspection is annual work quality control assessment is per- still not based on the risk analysis approach, but formed. There are guidelines for inspection perfor- this system is under development. Two ministries mance published by the SSI and the performance is are obliged to share information on inspection re- assessed according to adherence to these lines. sults, but stronger cooperation and one single regis- There is an online inventory of satisfaction of pub- ter of data would be beneficial. The HACCP sys- lic with the SSI services. tem implementation is obligatory according to leg- islation, but comments from the FVO and the FSIS Internal controls of the work of veterinary inspec- indicate that the situation with food safety, GHP tion at each level is performed at least once per and GMP in facilities differs among those facilities year. There are overall quality checks and some which are allowed to export to the EU and other specific performance checks. Monthly meetings in producing for the national market, only. The time- field offices are held in order to communicate re- line for implementing the HACCP in all facilites is quests from the central level to regional and local set to 3 years after accession to the EU. The epide- levels. miological data indicate the triple incidence of food pathogens comparing to the EU, thus signaling that 5.4.9. Number of foodborne outbreaks the practices in food safety have to be strengthened per year: following the best international models. Total number of outbreaks in 2007 was 576, or 1,5 outbreak/100.000 inhabitants which is triple EU average number. The main vehicle of foodborne outbreaks in 2007 were food prepared meals from various (>3) raw materials of animal sources (15.3% outbreaks, 17.8% cases) and milk and eggs (17.5% outbreaks, 13.3% cases). 57 Salmonella was causative pathogen in 86.7% of cases. 58 It doesn't differ significantly from the 1994-1998 period when 82-97% of cases of foodborne diseases were registered as salmonelosis. 59 There were 3 regis- tered Campilobacter outbreaks in 2007 (in the same time in Austria 108 and in Germany 259). There is a probability that reporting methods differ between countries. 57 Baumann A, Sadkowska-Todys M: Foodborne infections and intoxications in Poland in 2007; Przegl Epidemiol. 2009;63(2):213-20. 58 http://www.eurosurveillance.org 59 http://www.fao.org/docrep/MEETING/004/X6912E.HTM 47 IFC Ukraine Business Enabling Environment Project 5.5. SERBIA of laboratories and guidelines for food sam- Serbia is a Western Balkan country, administrative- pling. All ordinances issued after 2000 are har- ly organized in the central part and one province, monized with the EU regulations and Codex further subdivided in 24 counties plus the capital standards. Belgrade. The population of 7.379.000 inhabitants (2009) lives in 161 municipalities, GDP (PPP) 5.5.2. Responsible authorities for food $80.7 billion and GDP per capita (PPP) of $10.900 safety ­ (in 2008 according to official statistical data). The According to the Law on Food Safety, regulation value of agriculture and food production in 2008 and control of food safety is provided by (Fig.5): was almost 12.3% of the GDP. Main agricultural products are wheat, maize, sugar beets, sunflower, A. Ministry of Agriculture, Forestry and Water raspberries, beef, pork, milk. Agricultural products Management (MAFW) ­ it is the competent au- and food are exported to Bosnia and Herzegovina, thority and national contact point in the field of Montenegro, Macedonia Albania, Slovenia, Ger- food safety system. many, Russia. The agro-food sector provided 16.1% of the net export and 6.8% of the net import The Veterinary Office ­ responsible for issuing in 2008. It is estimated that 1.5 million inhabitants regulations in the area of veterinary health, ani- are employed or have the sole source of funding mal welfare, safety and hygiene of animal prod- from the agriculture or agro-industry. ucts and import and export of food (certification of export facilities), production and safety of 5.5.1. Legal framework feed, registration of FBOs, In June 2009, a Food Safety Law harmonized The Plant Protection Directorate ­ regulation of with the EC Regulation 178/2002 was adopted. plant protection, plant health, regulation on pes- This law sets a basis for the implementation of ticides and fertilizers the precautionary principle, HACCP in FBOs, The General Inspectorate ­ control of safety central register of FBOs, division of inspection and quality of food and agricultural products responsibilities and defines responsibility of (border control and domestic production). producer in terms of food safety. It provides a - Veterinary inspection ­ control of hygiene ground for the risk based approach to food safe- and safety in facilities producing food of an- ty, organization of the network of laboratories imal origin, animals for food, feed, facilities for testing of food, traceability, management of where veterinary drugs and sanitizing mate- crisis and the establishment of the National rials are produced, residues, animal repro- Council for Food Safety, a body which will deal duction centers, animal welfare, animal with risk assessment. 60 health. Inspectors are divided in 7 border Veterinary Law Laws prescribes provisions on and 25 inland control units. The number of animal health protection and treatment of dis- inspectors was 355 in 2008 of which 33 eases. 61 were permanently on boarder inspecting Law on Plant Protection, states that a list of pes- shipments in import. Animal health is fur- ticides and fertilizers that are approved for mar- ther secured and controlled by registered keting has to be updated annually. 62 veterinarians (1824) coming from 655 state The Law on Health Protection from Communic- and private registered institutions, private able Diseases includes provisions for surveil- practices, veterinary stations. lance of foodborne diseases. 63 - Phytosanitary inspection (106 inspectors) The Law on Medicines and Medical Devices ­ boarder (7 units) and inland (6 units). includes provisions for pre-market approval for Control of soil, spreading of pests, plant qu- veterinary drugs. 64 arantine, registration of facilities producing Number of ordinances that cover issues on the seed and plant propagation material, import microbiological criteria for food safety, methods and use of GMO, control of residues, con- for microbiological food safety control, limits of trol of production of pesticides and fertiliz- pesticide residues, residues of mycotoxins, resi- ers. dues of veterinary drugs and other contaminant - Agricultural inspection (117 inspectors) ­ residues in food, provisions on irradiated foods, quality of agricultural and food products, drinking-water quality, dietary products safety, wine and spirits, tobacco, organic produc- consumer goods safety, including safety of ma- tion, hygiene and safety of production of terials in contact with food staff, competencies food of plant origin, feed, novel food. - Water inspection ­ four units for control of 60 water pollution (release of waste waters). Sl. glasnik RS" No 41/2009 61 Sl. glasnik RS", No. 91/2005 B. Ministry of Health (MoH) ­ issues regulations 62 63 Sl.glasnik RS No 101/2005 on food additives, dietetic products and provides Sl glasnik RS No 125/2004 64 Sl glasnik RS No 85/05 Study of Food Safety Inspections 48 opinion on regulations in food safety and control of Agency for Drugs and Medical Devices ­ con- contaminants. trols production of drugs, certification of drugs. Sanitary Inspection ­ responsible for control of C. Ministry of Ecology ­ responsible for regula- food safety in retail, catering, additives, prod- tion and inspection of waste (solid and water). ucts in contact with food, drinking water, min- eral waters and table water. Total number of sa- D. Customs Directorate ­ customs control of ex- nitary inspectors is 270. They are organized in port and import. the head office at the central level and in 25 re- gional offices. Fig. 9. Organization of the food safety inspection in Serbia Government Ministry of MoH MAFW Ecology Plant Sanitary General Veterinary protection Inspection inspection Inspectorate office directorate Veterinary inspection Agricultural insp. Phytosanitary insp. Water inspection Table 15. Division of inspections Area Inspection authority Area Inspection authority Plant protection prod- Sanitary inspection, Veterinary ucts residues inspection, Phytosanitary in- Animal health State and private veterinary spection officers Animal welfare Veterinary inspectors Food of animal origin Veterinary inspectors Plant health Phytosanitary inspection Import of animals and Border veterinary inspectors food of animal origin Restaurants, shops Sanitary inspection Feedingstuff and ani- Border veterinary inspectors mal nutrition ­ import Boarder phytosanitary inspec- 5.5.3. Register of FBOs: tors, Customs office Feedingstuff and ani- Veterinary inspectors There is no common register of FBOs. Each minis- mal nutrition ­ produc- Phytosanitary inspectors try has its own register. Sanitary inspection regis- tion tered 25.000 FBOs. Veterinary inspection regis- Animal byproducts Veterinary inspectors tered almost 3000 FBOs. Of that number 1200 are Veterinary medicines Veterinary inspection slaughterhouses and other are meat processing fa- authorization and dis- Agency for control of drugs cilities, dairies, fish farming and processing facili- tribution ties. According to the new Food Safety Law the Veterinary medicines Veterinary inspection residues Veterinary institutes register of FBOs will be centralized. Food and Food hy- Veterinary inspection, Agricul- giene ture inspection, Sanitary inspec- There are some 778.000 individual farmers of tion which only 125.000 are registered. GMO Phytosanitary inspection Import of food of plant Customs authorities, Phytosani- 5.5.4. Frequency of control and fees origin tary inspection Plant protection prod- Phytosanitary inspection In this moment there is no coordinated control plan ucts authorization and or coordinated monitoring plan and inspection is sale not done on the risk basis. Also, a central register 49 IFC Ukraine Business Enabling Environment Project of data doesn't exist. Lack of coordination between Veterinary Law, Law on Plant Protection and Phy- ministries is visible. tosanitary Law. Both ministries have their annual inspection plans. Table 16. Data on inspection (2008) The annual monitoring plan for residues in food of animal origin was accepted by the FVO. Veterinary Total number of inspectors (veterinary +sanitary) 848 inspectors visit each FBO at least once a year and if 65 No FBOs 28.000 non-compliances with regulations are identified additional inspection visits may follow (1-2). No of veterinary inspectors 66 355 No FBOs per veterinary inspector 8.5 Sanitary inspection, historically, was in charge of No of inspections in veterinary inspection 31.229 all premises producing food of plant origin and in Average No of veterinary inspector visits per 1.1 charge of inspecting hygiene in premises producing FBO food of animal origin. Also, they inspected food of No of veterinary inspection visits as percent of 90% both plant and animal origin at borders. Since the Audit Plan (%) number of FBOs registered at Ministry of Health No of sanitary inspectors 67 270 was high (25000) inspectors visited plants from once in a year to once in five years. The plan of No FBOs per sanitary inspector 92.5 visits was not made on a risk basis. Average No of sanitary inspection visits per 0.4 FBO/year Imported goods are sampled only if some notifica- Percentage of visits with registered nonconformi- 40% tion through the RASFF or the EFSA system is ties placed. Otherwise, only documentary checks are Annual number of Follow ­up visits (% of all 10- performed. If some non-conformities in results of audits) 20% analysis are found, than the next shipment of com- Annual No of appeals (veterinary service) 2318 ing from the same producer or importer should be Percent of recalls in domestic production 12% mandatory checked and sampled and if compliant, Percent of recalls in import 3.8% the inspection returns to the annual check plan. * Register doesn't distinct clearly active FBOs from those which stopped their Commodities coming from so called "third coun- activities or were never active tries" non ­ EU countries, are tested according to the monitoring plan of each ministry, but mandato- 5.5.5. Sampling: ry the first time the producer sends a shipment and Sampling was performed by veterinary and sanitary than in 3-6 months periods if no non-conformities inspectors. Total number of samples taken by sani- were found. In case they were found, the inspection tary inspection for microbiological analysis was becomes regular or more frequent. 83.986 of which 9.27% were non-compliant with the national regulations, also 59.596 samples were Total budget of the MAFW for 2009 is $500 mil- analyzed on chemical parameters and 4.64% of lion of which 25% will be earned from animal samples were non-compliant. It is important to health protection services and from taxes (export stress that the number of inspection samples is not certificates, animal health certificates, registering of the sum of both microbiological and chemical sam- FBOs). Out of the total budget, almost 48% are ples, since the same specimen can be analyzed on planned for financing of the General Inspectorate. both. 68 It must be emphasized that from June 2009 due to transfer of large number of inspection activities Sampling of food according to the National Resi- from Ministry of Health to the MAFW, budget for due Plan in products of animal origin and meat is the General Inspectorate must be higher than in performed by veterinary inspectors and samples are previous period. All inspectors are civil servants analyzed by laboratories belonging to the network employed in the MAFW and inspection services are of 12 Veterinary Institutes (public and private). 69 paid directly from the budget of the ministry.48 Laboratory analysis of samples taken by inspectors Food safety inspection at the Ministry of Health is (boarder or inland) are paid directly to laboratories financed from the government budget and from the (state or privately owned) by producers, with the municipality budget according to the Annual plan exemption of the annual monitoring plan sampling for inspection. when analysis are financed from the budget of the In case of non-compliances met either in border control, production, catering or retail inspectors in 65 Register doesn't distinct clearly active FBOs from those which stopped charge determine which level of sanctions should their activities or were never active 66 http://www.minpolj.gov.rs/download/informator09.pdf be applied, but having in mind that the prescribed 67 http:/www.zdravlje.gov.rs 68 list of sanctions is given in the Food Safety Law, 69 Institute of Public Health Annual Report 2008 Veterinary Directorate Annual Report 2008 Study of Food Safety Inspections 50 ministry (either of agriculture or health depending general public has no access to data. Data on non- which inspection took samples). conformities found in sampling are not released to the public. Also, data which could be found in the 5.5.6. Visits of controlling bodies other Institute of Public Health Annual Report are not than those participating in the food safe- representative for the whole number of samples ty system control to FBOs: taken by sanitary inspectors, since they also, send Fire inspection samples to private laboratories and these data are Safety on work not gathered in any database. Results on samples Metronomy (inspection of measurements) teken by veterinary inspection are stored in the Ve- Ecology terinary Directorate database. 5.5.7. Quality control of inspection: 5.5.10. Food borne diseases: In the MAFW there is a plan to implement ISP Number of food borne infections increased from 9001 in the General Inspectorate in 2009. The in- 2002-2006, with salmonelosis decreasing and spection procedure for all inspections is given in representing only 9.41% of the total number of the Law on Official Procedures. 70 It deals with au- food borne infections. In food borne outbreaks thorities of inspectors and procedures he can apply: Salmonella species, Staphylococus species and pa- inspections, reporting, prescribing fines, closing of rasite Trichinella are the most common. According FBOs, recall. to official data number of food associated illnesses varies between 36-50 per every 100.000 inhabitants The Sanitary inspection acts according the same annually. In 2008 71 Law on Official Procedures. Data from 2007 show that Salmonella was found in In this moment, there is no proper auditing system 0.04% of samples taken by inspectors. The main of the quality of inspection performance and the sources of Salmonella were eggs and meat. control is covering only the realization of the planned number of inspections. Also, inspections Data from 2007 survey on food in retail in province results show the same number of non-conforming Vojvodina showed 18% of samples to be no- samples for almost 10 years and yet no improve- compliant from the microbiological standpoint ment in inspection performance was made in that (Salmonella species, Campilobacter, Lysteria mo- period. nocitogenes). 72 Check lists are under construction in the MAFW These results indicate that spot checking performed (there are drafts of check lists for dairy and for by inspectors cannot be representative for microbi- meat production). Check lists for production of ological contamination. The same situation could food of plant origin are also under construction. be found for chemical contaminants. In order to Central register of objects and of testing laborato- overcome this situation, safety in production, retail ries is under construction. and catering should be established on the HACCP principles, and inspectors have to check the effica- 5.5.8. Training: cy of the food safety system applied. A new Rule- Annual training plans for veterinary inspection book on Microbiology of Food is drafted and is were made and executed by Veterinary Office (38 supposed to enter into force by end 2009. This ru- days in 2008). Among those were trainings in the lebook will establish a new sampling system which HACCP system auditing. Trainings of other inspec- will take into consideration results acquired during tors from the MAFW are planned for 2009. Sources certain period (over one month, 2 months, or one of funding are merely provided from the budget of year ­ depending on vulnerability of product in ministry and partially from donor funds. Sanitary scope). The rulebook is made in line with the EU inspection doesn't have budget for training in food regulations on microbiology (Reg. 2073/2005 and safety for 2009. 1441/2007). 5.5.9. Transparency: 5.5.11. Summary Data on inspection frequency are not publicly Since 2000, the reform of food safety is underway available. Status of control documents cannot be in Serbia. The new division of the inspectors' re- accessed electronically and producers must get in sponsibilities finally resolved the overlapping of direct contact with inspectors in order to provide inspections. New laws and ordinances are harmo- them information on corrective measures they have nized with the EU regulations and Codex Alimenta- taken, or to get information on their appeal. The rius standards. The legislative basis for the risk 71 Institute of Public Health Annual Report 2008 70 72 Zakon o upravnom postupku, Sluzbeni list SRJ 33/97 Cent Eur J Public Health 2007; 15 (4): 167­171 51 IFC Ukraine Business Enabling Environment Project analysis (assessment, management) is made, but Food safety inspection is still relying on the end this approach should be developed in the future product testing and is not risk based. Capacity period. The HACCP system is required for all pro- building in inspections is underway (training, build- ducers of food of animal origin and for all other ing of registers, databases, check lists, guidelines). FBOs will be mandatory by June 2011. Study of Food Safety Inspections 52 5.6. SLOVENIA Since 2004, Republic of Slovenia is a full member 5.6.2. Authorities responsible for the food of the EU. In 2007, Slovenian GDP (PPP) was es- safety system: timated at $54 billion. The nation has GDP per ca- Three ministries are dealing with food safety, ani- pita higher than other transitioning economies of mal health and welfare and plant health: Central Europe, estimated at $23,000. Total number of inhabitants in 2007 was 2.000.114. The Budget A. Ministry of Agriculture, Forestry and Food of the government represents 1.55% of the GDP. (Fig. 10) ­ where there are three Directorates (for The share of agriculture in GDP is around 2%. In Agriculture, for Food Safety and for Forestry, 2005, the production of food and drinks contributed Hunting and Fisheries) of which the Directorate for 1.7 % to the GDP which is a decline from the pre- Food Safety ensures co-operation within control vious period. bodies from this ministry: Veterinary Administration (VARS) responsi- 5.6.1. Legal framework ble for regulation and control (at border posts Agricultural Act73 and in domestic production) of safety of food of Act Regulating the Sanitary Suitability of animal origin, animal health, welfare, safety of Foodstuffs, Products and Materials Coming in feed; Contact with Foodstuffs 74 amended in 2004 and Inspectorate for Agriculture, Forestry and 2007 and fully harmonized with the EC Food (IRSAFF) which is responsible for safety Regulation 178/2002. A number od sublaw of food of plant origin and control of pesticide's documents (ordinances) regulating: residues; microbiological control, residues, aditives, Phytosanitary Administration (PARS) re- dietetic products, labeling, quality of food sponsible for regulation of pesticide use and products, potable water, etc; are subordinated to regulation and control of plant health, seeds, this Act. According to amendments of this Act plant propagating material, fertilizers (at border all producers must apply food safety practices posts and in domestic production and use); based on the HACCP system and all products Food Quality Inspection Service (FQIS) re- produced in facilities which were registered for sponsible for control of quality of food and domestic production only, must be removed labeling. from the market by January 2010 (again 3 years grace period). B. Ministry of Health Veterinarian Act 75 treating animal health and The Health Inspectorate (HIRS) ­ main au- animal welfare, with respective sublaw thority for official control of processing, whole- documents subordinated to this Act. sale, retail and catering of food of plant origin, Act on inspection control 76 treating processed food of animal origin in retail and ca- education/knowledge of specific inspectors tering, pre-packed raw meat in retail (among them veterinarians, plant protection The Agency for Medicinal Products and inspectors, sanitary inspectors)-basic Medical Devices which regulates and inspects requirements, official identification, authorities production and trade of medical and veterinary (to inspect, close, prescribe fines, recall) health products and manages risk from use of Act on official procedures 77 defines how the these products. official procedures in inspection are undertaken, National Chemicals Bureau ­ responsible for procedures and authorities to deal with cases of packaging, labeling and classification of pesti- apeal, defines which cases to be submeted to cides. court for further prosecution Act on plant products protection; 78 C. Ministry of Environment and Spatial Decree on coordination of the working of Planning ministries and bodies within them with Inspectorate for Environment and Spatial responsibility in the area of food and feedstuffs Planning (IRSEP) ­ control of water sources safety, in their incorporation into the process of and regulation of environmental issues, risk analysis 79 (Official Journal of the RS, Environmental Agency (EARS) ­ responsible 56/03); for waste, disposal plants for pesticides and is- sues permits for rendering of animal by- products. 73 Zakon o kmetiljstvu, Uradni list 45/08 74 Zakon o zdravstveni ustreznosti zivil in izdelkov ter snovi, ki prihajajo v stik z zivili (ZZUZIS), Uradni list 52/00 75 Zakon o veterinarstvu, Uradni list RS 33/01 76 Zakon o inspekcijskem nadzoru (ZIN), Uradni list 43/07 77 Zakon o inspekcijskom postupku, Uradni list 44/06 78 Zakon o zdravstvenom varstvu rastlin, Uradni list 45/01 79 Uradni list 56/03 53 IFC Ukraine Business Enabling Environment Project Fig 10. Organizational structure of the food safety inspection system in Slovenia Government Ministry of Ministry of Health Agriculture, MoEcology Forestry and Food VARS IRSAFF HIRS 10internal+ 7 internal+ FQIS PARS IRSEP EARS 9 local offices 6border 6 border 7 laboratories in 1 Agricultural Central Vet lab Public Health Institute = 7 regional Institutes + 7 labs Inter ­ ministerial cooperation: Area Inspection authority Legal obligation according to the Decree on Plant Directorate coordination of the working of ministries and Danish Environmental Protec- bodies within them with responsibility in the area tion Agency of food and feedstuffs safety, in their incorporation Import of food of plant HIRS, IRSAFF, Customs au- into the process of risk analysis. Achieved through origin thorities, PARS two "joint panels" ­ a panel on pesticide residues Plant protection prod- IRSEP, IRSAFF and a panel on preparation of the multi annual con- ucts authorization and sale trol plan to be submitted to the European Commis- sion (EC). The plan for 2007-2010 was made and Plant protection prod- HIRS, IRSAF, ucts residues accepted by the EC. Animal welfare Regional office VARS VARS is collaborating with the Customs Office of Plant health IRSAFF, PARS, Agricultural Republic of Slovenia in control of transport of food Institute of animal origin and animals across borders, and Restaurants, shops Regional Veterinary Food VARS organized training for customs officials in Authority new methods of veterinary border inspection. The two agencies held regular monthly meetings and 5.6.3. Register of FBOs: discuss matters of common interest. Ministry of Agriculture and Ministry of Health have their separate registers of FBOs. Some estab- Table17. Division of inspections lishments are approved for export to the EU and Area Inspection authority other are registered for domestic production and Animal health Regional office VARS they export to non-EU countries. There are some 77.000 agricultural holdings, 426 food processing Food of animal origin Regional office VARS IRSAFF, ISQF, HIRS companies and 55.842 feed producing operations registered at the Ministry of Agriculture. 80 At the Import of animals and Border office VARS food of animal origin Ministry of Health Register there are 20.528 FBOs. 81 Feedingstuff and ani- Regional office VARS mal nutrition ­ import IRSAFF, FQIS, Customs of- fice 5.6.4. Frequency of control and fees: Feedingstuff and ani- Regional office VARS Both controlling authorities have an annual control mal nutrition ­ produc- IRSAFF, FQIS plan. In the Ministry of Agriculture VARS there is tion an risk criteria based control plan (2-12 visits per Animal byproducts Regional office VARS year) with control over traceability included in the HIRS, IRSEP plan, and they, also, have the multiannual control Veterinary medicines Regional office VARS plan (2007-2010) approved by EC FVO. authorization and dis- AMPMD tribution Frequency of control of food safety is determined Veterinary medicines Regional office VARS in the Ministry of Health according to the level of residues risk attributed to each FBO. Those with low risk Food and Food hygiene Regional office VARS, HIRS, IRSAFF, FQIS level are audited once in 24 months, medium risk GMO Regional Veterinary Food Authority 80 http://www.vurs.gov.si/en/establishment_registers/ 81 http://www.zi.gov.si/si/zdravstveni_inspektorat_rs_zirs/ Study of Food Safety Inspections 54 level FBOs are audited once in 15 months and high risk FBOs once in 9 months. Number of sanitary inspection audits 78.7% conducted as a percent of Audit Plan Inspection is financed from the government budget (%) and from registration fees. When sampling is per- Percentage of audits with registered 10% formed for monitoring purposes it is financed from nonconformities the ministry's budget, except when non- BIPs control ­ total No of samples 752 compliances are found, in that case the owner pays (VARS+HIRS) for the laboratory analysis. Sanctions are deter- BIPs control ­ recalls 9 mined according to the prescribed list, but inspec- 62, 63 tors themselves may decide which level of sanc- Table 19. Number of inspectors in Slovenia tions should be applied in certain case. Authority Number of inspectors MAFF head office 34 In border inspection, documents on products com- ing from the EU countries are regularly checked VARS 319 and lots are not sampled at border posts, with ex- IRSAFF 22,5 emption when some non-conformities in documents PARS +regional plant protec- 43.3 + 36 third party were observed, or if through the FAO's Rapid Alert tion and phytosanitary inspec- inspectors system the notification concerning specific produc- tion er or product is sent. If some non-conformities in Feed 3 results of analysis are found, than the next shipment Food hygiene inspection 12.5 should be mandatory checked and sampled and if Border inspectors 19 compliant, the inspection returns to the annual check plan. Commodities coming from so called " HIRS 88 third countries" non ­ EU countries, are tested ac- Total 576 fte cording to the testing scheme of each ministry, but mandatory the first time the producer sends a ship- 5.6.5. Sampling: ment and than in 3-6 months periods if no non- Implementation of monitoring takes place on the conformities were found. In case they were found, basis of a two-year program. The selection of the inspection becomes regular or more frequent. foodstuffs and agricultural products, and of the ac- 82 tive substances, is determined in line with recom- Table 18. Data on inspection in 2007 mendations from the EU (Commission recommen- dation 99/333/EC), WHO, national priorities and Total number of inspectors 576 on the basis of the professional opinions of autho- No FBOs registered at VARS 313 rised performers. No of veterinary inspectors per FBO 1.6 Permanent groups of foodstuffs monitored are: let- Annual No of visits of veterinary inspec- 5271 + regu- tuce, potatoes, apples and milk. Variable groups of tors lar presence in slaughter- foodstuffs monitored are: fruits, vegetables, cereals houses and products. Average No of visits per veterinary in- 16.5 spector Approximately 300 samples of agricultural prod- No PARS + IRSAF inspectors 72 ucts (150) and foodstuffs (150) are investigated each year. 83 Average No of visits per inspector (plant 55 protection + phytosanitary inspectors) According to the monitoring plan results values of No of export /import controls performed 15.242 by PARS+IRSAF inspectors pesticides higher than allowed per legislative doc- uments are found in 1% of food products and 5% of No of FBOs registered at PARS 1189 agricultural products. The aim of the program is to No of premises visited by sanitary in- 16.146 have products without residues of pesticide.65 spection No sanitary inspectors 87 5.6.6. Inspections which control Total No of premises registered at sani- 20.528 processing of food other than food safety tary inspection inspections: Number of follow-up visits in 2007 4869 Fire inspection Average No of visits per sanitary inspec- 238 Safety on work tor Metronomy (inspection of measurements) 82 83 DG Sanco Final Country Profile of Slovenia, 7706/2008 Institute of Public Health Slovenia data 55 IFC Ukraine Business Enabling Environment Project Each of these inspections visits food processing 5.6.9. Transparency: facility once a year. In Slovenia data on food safety are not accessible from official sites. Check lists and their updates are 5.6.7. Quality control: mounted at the VARS web portal. 84 Data on moni- The Health Inspection, Veterinary Administration toring could be assessed through the EC FVO re- and Inspectorate for Agriculture, Forestry and Food ports on situation in Slovenia, or through the EFSA have implemented internal audit systems. Quality documents. Assurance and Internal Audit Service is a depart- ment at VARS is dealing exclusively with control 5.6.10. Food borne diseases: of inspection work (are inspectors following rules Official data show that an annual number of food- and guidelines for inspection work and are they borne illnesses (incidence) according to Ministry of inspecting promises according to acting laws and Health data is 600-800/100.000 inhabitants of regulations). Director of the VARS regional office which 1520 are caused by various strains of Salmo- or Head of a section according to authorization of nella and 940 by Campilobacter. In 2007 there Director of VARS regional office is checking per- were 17 outbreaks, of which 16 from pathogens formance of each veterinary inspector at least once isolated in food and one from pathogens in drinking in 3 years (this is called verification of inspector's water. In 2008 no significant change in data on performance). They verify weather each inspector food borne diseases was reported. 85 performed control over program for self inspection in premises he is responsible to control. Also, the 5.6.11. Summary EC FVO controls perform insights into inspection's Slovenia reformed the food safety system starting work (all food inspections) and accordance of their from the traditional model of spot-checking to the procedures with the EU practices. HIRS has ISO risk based model of inspections. The goals of the 9001 implemented and procedures for inspection reform of the food safety system were defined in work control are established. the National food safety strategy (2002). By the time when Slovenia joined the EU, all legislation in 5.6.8. Annual training: this area was harmonized with the EU require- Ministry of Agriculture has a budget line for train- ments. In 2006 they incorporated practices and rec- ing of VARS inspectors. Training in import con- ommendations of the EU "Hygienic package" 86 of trols, implementation of the European Community legislation and started developing check lists for legislation and practices, training in official feed inspection, along with orientation towards self control, implementation of check lists in slaughter- checking of facilities and inspection control of houses were organized in 2008. Guidelines in good these programs. From the very beginning of the practice for producers of primary products, animal food safety reform in Slovenia, full harmonization welfare were developed. Ministry of Health will with the EU legislation and practices was per- have support from EU funds for training of inspec- formed. tors in 2009-2010. 84 http://www.mkgp.gov.si/si/o_ministrstvu/direktorati/direktorat_za_varno_ hrano/starasektor_za_ var- nost_in_kakovost_hrane_in_krme/varnost_hrane_in_zascita_potrosnikov/ 85 http://www.eurosurv.org/ 86 Set of EU regulations defining hygiene of food, official control, require- ments for production under hygiene principles, namely EC regulations 852/2004,853/2004,854/2004 and 882/2004. Study of Food Safety Inspections 56 5.7. SWEDEN C. The National Food Administration Code of Sweden is a constitutional monarchy with popula- Statutes which consists of documents which direct- tion of 9, 2 million inhabitants (est. 2009). The ly transpose the EU Directives. country is divided in 21 counties. The GDP (PPP) in 2007 was $346.2 billion with GDP (PPP) per The system in Sweden has three levels: the national capita of $38,300 (2007 est.). Agriculture accounts (ministries and authorities), regional level (21 for only 1,5% of the GDP (11.760 million USD) counties) and local level (290 municipalities). The and the whole industry segment of 28.9% of the government allocates responsibilities at the general GDP. Main agricultural products in Sweden are level, but municipalities are autonomous in imple- barley, wheat, sugar beets, meat and milk. Fishery mentation of national regulations and determination is also, important as a source of food for domestic of fees for controls and other charges. Laws are population. Export of fish is low due to chemical issued by the Parliament and regulations by compe- contamination of Baltic fish. Sweden is importing tent authorities. food products, mainly fruit and vegetables, but also a range of consumer oriented agricultural products 5.7.2. Ministries responsible for food (processed fruits and vegetables, nuts, wine, beer, safety are: sauces, cake mixes, rice, confectionary) and fish At central level: products. Main import markets are those from the A. Ministry of Agriculture which has the overall EU, USA, Brazil, Malaysia. The import exceeds responsibility over the agricultural sector, animal export almost by 50%. health and welfare, plant health, food and feed pro- duction, fishery. The ministry gives the policy 5.7.1. Legislative framework: orientation, proposes a budget according to annual A. Food Act applies to all stages of food produc- reports received from authorities which are under tion and distribution and is fully harmonized with its jurisdiction. There are 9 departments in the min- the EC Regulation 178/2002. It describes the re- istry of which four are dealing with food safety: sponsibilities of food control authorities and con- tains provisions on penalties and appeals. 87 a. National Food Administration (NFA) is the authority responsible at the central level to: pre- B. The Food Decree which complement the Food pare legislation in the food area, implement di- Act and defines in detail responsibilities of authori- rect official control, co-ordinate control of other ties and specific acts and ordinances which regulate authorities and report to the government on is- specific issues (drinking water, treatment of food sues of food. It directly performs controls on 5 with ionization, labeling, personal hygiene, etc). border posts (3 ports and 2 airports), all slaugh- This document is a sort of synthesis of where in terhouses and cutting plants (Except Stockholm specific legal documents certain issues are ad- and Gothenburg). It performs controls on all egg dressed, and which body is responsible for issuing establishments, and on larger milk and fish es- such documents. 88 tablishments. The NFA has 540 employees (320 in the head office in Uppsala and other through- out the country). 89 87 Livsmedelslagen SFS 2006:804 88 89 Livsmedelsförordningen SFS 2006:813 http://www.slv.se/en-gb/ 57 IFC Ukraine Business Enabling Environment Project Fig. 11. Organizational structure of the NFA NFA Food Standards Research & Development Department Food Control Department Department Nutrition Department Administration (25 employees- preparing (300 employees) (4 labs) legislation) International Trade Local Authority Support Meat Inspection Division Control Program Division Food Inspection Division Division Division (200 employees) Food Control Department has a stuff of 300, of Under Research and Development Department are which 200 are in meat inspection. Other inspect four reference laboratories for food and veterinary food of non-animal origin. The Department imple- residues: 2 for chemistry, one microbiological and ments control over 550 food plants and 5 border one toxicology. posts. It is also responsible for preparing and im- plementing annual control programs. The National b. Swedish Board of Agriculture (SBA) respon- Food Administration charges a fee for import con- sible for animal and plant health, control of con- trols on certain foods from third countries (non-EU tagious diseases, feed and animal by-products. countries). Fig.12 Organizational structure of the SBA SBA Animal Health and District Veterina- Inspection and Rural Developm- Market Develop- Customer Crop Production Financial Support IT Welfare rian Deapart. Control ent ment Develop-ment District vet. Distric vet. Stations Plant Protection Division (DVD) (100 stations) (9 inspectors) District Veterinarian Department has 430 veterina- f. Swedish Institute of Infectious Disease Con- rians in headquarters and District Veterinary Sta- trol tions (responsible for direct control of animal health, import of live animals and control of veteri- C. Ministry of Finance ­ this ministry is responsi- nary residues; they also provide services to far- ble for monitoring of the collection of fees from mers). municipalities and regulations which municipalities issue regarding fees. Control over the import/export Crop production Department has 100 employees, of is performed through: which 21 are plant protection inspectors. Depart- g. Customs Service ment controls GMO, organic production, seed. D. Ministry of Environment Department for Inspection and Control is responsi- h. Swedish Chemical Agency ble for phytosanitary control (pests), quality control i. Swedish Environment Protection Agency of fruit and vegetables, feed control, meat classifi- k. Swedish Coast Gard cation, animal by-products. c. National Veterinary Institute ­ the expert ve- l. Regional Level: terinary body. Prevention of outbreak of animal County Administration Boards-CAB ­ (21 diseases and zoonosis, production of vaccines, counties) ­ they perform official control of ani- control of contaminants in food and feed. The mal health and welfare, food and feed hygiene largest veterinary laboratory in Sweden. in primary production, animal health, animal d. Swedish Board of Fisheries identification, audits of municipality perfor- mance in control of food safety, training for B. Ministry of Health and Social Affairs municipality inspectors, they manage appeals to e. Medical Products Agency Study of Food Safety Inspections 58 decisions of municipality control. They report hygienic status, so that the authority estimates annually to NFA, SFA and Ministry of Finance. number of hours that inspector needs to spend for that establishment. Than the number of hours is m. At Local level: multiplied by the hourly rate. Municipality Administration Boards ­MABs- (290 boards) ­ they control food, hygiene and For businesses controlled by municipalities, the environment. They control establishments deal- municipality council defines hourly rate. ing with food of animal (small establishements) For the primary production an annual tax is paid to and plant origin. If one municipality doesn't the CAB. have capacities for all control it may collaborate with neighboring municipality. Sanctions in case of nonconformities are prescribed Municipality Public Health Officies (290 offic- by NFA, but municipality officials may decide on es)control food of plant origin. their own how to approach implementation of sanc- tions. In general, detection of non-compliance in- Table 20. Division of inspections tensifies the control, and more follow-up controls Area Inspection authority may be a part of the annual control plan. 90 Animal health SBA 70,91 CAB Table 21. Data on inspection 2007-2008 : Food of animal origin NFA CAB Total number of inspectors 1195 Import of animals and food SAB No plant protection inspectors 21 of animal origin NFA No inspectors at NFA 300 Feedingstuff and animal SBA nutrition No FBOs controlled by NFA 550 Animal byproducts Regional & District Vete- No veterinary inspectors in NFA 200 rinary Food Authority CAB veterinary inspectors 43 Veterinary medicines autho- Medical Products Agency No inspectors in municipalities (total) 847 rization and distribution No FBOs 65.715 +80.000 Veterinary medicines resi- NFA primary producers dues Annual number of inspection audits 42.485 Food and Food hygiene NFA to FBOs CAB Average number of visits/FBO 0.65 GMO SBA Annual No audits/inspector 35.4 Import of food of plant origin NFA No NFA veterinary inspectors / 1.7 large& medium size FBOs Plant protection products Swedish Chemical authorization and sale Agency Number of inspection audits Not available conducted as a percent of Audit Plant protection products NFA Plan (%) residues Percentage of audits with 49% Animal welfare SAB registered nonconformities CAB Annual number of Follow up Not available Plant health SBA visits ­ (%) of all audits Restaurants, shops Self control Annual number of appeals 197 Annual number of recalls ­ domestic 44 5.7.3. Register of FBOs: products There is no national register of FBOs, approvals of establishments are performed by different authori- Table 22. Number of inspectors (full time em- 70 ties according to the new hygiene legislation (EC ployed) Reg 882/2004). All establishments have to be ap- Authority Number of inspectors proved by end 2009. Total number of FBOs NFA 250 (200fte) 92 (2007/2008) was 65.715, and 80.000 additional SBA 36 veterinary inspectors primary producers. NFA controls about 500 estab- National Veterinary Institute 198 lishements.69 CABs 43 (36 fte) MABs 847 (529 fte) food control 5.7.4. Frequency of control and fees (food Total 1195 and feed) There is an annual control plan according to which premises are visited at 0.2-12 times a year. Both 90 DG Sanco Country profile 7705/2008 frequency and fees to be paid by the FBO are de- 91 http://www.slv.se/en-gb/Group3/Publications/ 92 termined on a risk base ­ according to the risk level fte ­ calculated on a full time equivalent basis. The number of stuff are part time employed as inspectors and the rest of the working time provide services of the type of business and according to previous to farmers. 59 IFC Ukraine Business Enabling Environment Project Lack of capacities exists in municipalities. Some the NFA web site. NFA also, produced check lists 180 full time employees equivalent are needed. for different types of food producing operations. Both recruiting and training of inspectors were These check lists are supported with the computer started since 2006, and expected to be realized to programe where data from inspection visits are the optimal level by end 2009. Also, some jurisdic- stored. Over 70% of municipalities have already tions like animal welfare and hygiene are to be implemented computer based programs. 95 This a transferred to CABs. good way for having insight in inspector's perfor- mance and efficacy. The annual budget of the NFA is made of 50% of finances coming from the state budget and 50% There is a "internal audit system" where National from fees for inspection. The total budget is about Food Administration and SBA audit performance 52 million dollars. 93 of each County administrative board, and every CAB makes audits on every municipality in their 5.7.5. Sampling: region. They perform audits using data which each The Annual Control Plan is the obligation of the municipality must send electronically to CAB and EU country according to the Regulation EC CAB must forward it to the NFA. Three groups of 882/2004. parameters sent are used for assessing performance: microbiological, chemical contaminants and labe- The sampling plan for border inspection (microbio- ling. SBA performs audits on border post inspec- logical, chemical control) is made according to tion according to the same parameters. Regulation EC 134/2004. 5.7.8. Transparency of data on Official control on residues requires about 5500 inspection: samples for veterinary medicines and hormones in Authorities are obliged to publish annual reports food annually. Also, 1500 agricultural products and disseminate them to the superior level. Publicly have to be sampled in 2008. NFA itself, analysis available data are published on official web sites. 96 6000 samples of all food products, of which 693 There is a link to the "Black list" of products and (2007) came from sampling of imported agricultur- countries of origin of products here consumers can al and food products from the border inspection. find information on contaminants in food. 97 Some 130 samples are analyzed annually on the presence of GMO. Levels of residues in fruit and 5.7.9. Visits of controlling bodies other vegetables from countries outside the EU were than those participating in the food safe- higher than allowed in 3-8,1% of samples depend- ty control to FBOs: ing on the country of origin. There are no other regular auditing in food produc- ing premises beside food inspection. Instead, au- Due to high level of pesticides in products of plant thorities make different campaigns where they visit origin 44 noncompliences were found on the mar- different premises and sometimes make audits ket in 2007.70 (workers safety for example). A food producing factory (milk plant, slaughterhouse) is inspected by 5.7.6. Budget for inspection: the NFA if being the large size producer or by mu- There is no central budgeting for the food safety nicipality inspectors if it is a small size producer. system. The overall national budget in 2007 was $ 5.748.729.000, and the budget for NFA itself was $ 5.7.10. Number of food borne outbreaks 53.000.000. The annual budget of the NFA is made per year of 50% of finances coming from the state budget There were 4024 food born cases reported to and 50% from fees for inspection. 94 healthcare. There were 11 salmonelosis -human outbreaks with 330 cases reported in 2007. Municipalities fund inspections through their own funds. It is important to stress that a national plan Data for Salmonella found in different food and for training of inspectors at all levels is the obliga- feed in Sweden in 2007 show that it was found in tion according to EC rules, and for that purposes 4182 samples of which 681 came from domestic approximately 5% of the budget from each food production, 3466 from imported goods. regulating and control authority is planned. In 2008 there was an outbreak of Salmonella infec- Quality control: tion with one hundred of cases in Denmark, Nor- NFA prepared guidelines for municipalities how to perform control. These guidelines are available at 95 According to data obtained from the supplier of programs Edpconsult 96 http://www.slv.se/en-gb/Group2/Food-Control/ 93 97 S. Slorach: According to NFA data http://www.slv.se/en-gb/Group2/Food-Control/The-National-Food- 94 S. Slorach: According to NFA data Administrations-Black-list/ Study of Food Safety Inspections 60 way and Sweden, but the source in Sweden was Recommendations form the central level (from the from imported food (pork from Denmark). 98 The NFA) in some cases are not fully followed at the Rapid Alert System functions among Nordic coun- regional (CAB) level. The NFA provides legisla- tries, but also, at the European level (the RASFF). tion, guidelines, check lists, laboratory testing, pro- There was an outbreak with meat from Ireland, too. ficiency testing for other food safety laboratories and connection with the EFSA. The centralisation 5.7.11. Summary of the inspection services may be a good solution Swedish food safety system is divided on the cen- for the Swedish food safety system, this idea was tral, regional and local (municipality) level. Plant advocated by experts in Sweden, but has not yet protection, control of use of pesticides and contreol been officially recognized. In the meantime, the over almost 80.000 producers was transfered in risk based inspection approach is applied in 70% of 2009 from the municipality to the regional level, municipalities and their inspections are connected since municipalities lacked resources for control of on-line with the NFA. Thus, data from inspections such a big number of FBOs. are available to the officials at the central level. 98 http://www.eurosurveillance.org 61 IFC Ukraine Business Enabling Environment Project 5.8. UGANDA 5% of the Ministry of Health's annual budget. Uganda is the sub-Saharan, East Africa country The Division's mandate is provided under Food with the population of 32,369,558 inhabitants, and and Drug Act issued in 1964 which doesn't with the GDP (PPP) of $33.57 billion (2007) and cover current issues in the field (i.e. risk man- the GDP per capita of $1.100. Major domestic agri- agement, traceability, etc.). The Division, work- cultural products are: coffee, fish, tea, cotton, to- ing in collaboration with other agencies and bacco, cassava (tapioca), potatoes, corn, millet, stakeholders, recently drafted a Food Safety pulses, cut flowers, beef, goat meat, milk, poultry. Bill. The Bill makes provision for the Division The major agricultural export commodities are: to serve as a central body on food safety issues, coffee, fish and fish products, tea, while cereals are to be supported by technical working groups major imported agricultural products. Countries to dealing with specific topics. which products are exported: Rwanda, Libya, Ja- pan, India, Pakistan, Britain, Italy, Spain and Health and Food Inspectors focus on the hygie- Egypt. Agriculture has for several years been the nic and safety standards of the premises, sanita- ground of Uganda's economy contributing to 37% ry fittings, utensils, workers health. Inspection of the GDP. Coffee contributed with 19% to the of food establishments cover the following: country's exports. food processing plants, eating places, markets, bakeries, fish or meat shops or stalls, grocery The Economic growth of 8.9% puts Uganda among stores, milk shops and slaughterhouses. the fastest growing economies in Africa. Over the last ten years, the economy has greatly transformed National Drugs Authority (NDA) ­ controls the moving away from subsistence-based agriculture use and sale of drugs (medical and veterinary) which used to constitute greater share of economic and importation of food supplements. activity to a mixture of commercial agriculture, services and industry. B. Ministry of Agriculture, Animal Industry and Fisheries (MAAIF) has various departments with specifically defined roles and responsibilities in Legal framework relation to food safety and agricultural health. A. In Uganda the main law that regulates food safe- These include the following: ty is the Food and Drug Act (1964). In 1993 the drug element was taken out of this law and trans- Department of Livestock and Entomology is formed into the Drug Act under the National Drug responsible for the development of policies and Authority (NDA). In 2003 the Food Safety Bill was regulations on animal diseases, the development issued but it does not address the new technological of veterinary inspection procedures, and the in- developments in the food industry, e.g. safety of spection and certification of imports and exports genetically modified foods, international food regu- of animal products. The Department coordinates lations as required by the World Trade Organisa- national programs to manage rabies, CBPP, tion (WTO), or by the European Communities and Rinderpest, and Food and Mouth Disease, and is other international food markets. For example, for involved in the implementation of regional ani- food additives and contaminants, packaging and mal disease control programs. It provides tech- other sanitary and phytosanitary requirements are nical support to the 700 to 800 veterinary offic- not covered in it. 99 ers working at local levels, in part to inspect and certify animal products. The Department is also B. The Plant Protection and Helath Bill (2003) sets the designated competent authority for honey. standard in phytosanitary control. Department of Animal Production and Mar- 5.8.1. Authorities responsible for the food keting ensures compliance with the Animal safety system: Disease Act and Regulations. The department is A. Ministry of Health, Environmental Health responsible for formation of standards regarding Division the quality and safety of livestock and livestock Department of Environmental Health ­ prima- products. In this area it provides training, super- ry body in food safety, co-ordinates food safety vision, and other technical back-up to local gov- matters and supervises (on training and policy ernments related to plans and programs for li- matters) the activities of semi autonomous local vestock and livestock product handling and government units (Districts, Town Councils, marketing. This function is expected to be trans- Municipalities and a City) who employ Health ferred soon to the Department of Livestock and Food Inspectors and who are in charge of Health and Entomology in an expected restruc- food inspection. The Division receives less than turing. This will help to avoid duplication/ over- laps. 99 Study of Food Safety Inspections 62 The Veterinary Department ­ with the veteri- Codex Allimentarius standards. The body oper- nary inspection on the central level yet to be de- ates four laboratories ­ for microbiology, che- veloped. mistry, building materials, and electrical matters ­ while a fifth, for testing petroleum products, is The Crop Protection Department is responsible being developed. Only the microbiological la- for formulating and enforcing regulations re- boratory is internationally accredited. lated to seeds, agro-chemicals and the manage- ment of phytosanitary risks. The Department It has developed new standards for: carries out inspections of imports and exports of - Milk & Milk Products (US 164: 2000) planting materials and plant based products, - Fortified Food Products (US 500: 2003) mostly checking for pests and diseases. Where - Drinking (potable) water (US 502:2003) interceptions are made, tests might be con- ducted at the Kawanda Agricultural Research D. Directorate of Water Development ­ respon- Institute. The Department issues phytosanitary sible for the development and improvement of wa- certificates when these are required for exports. ter sources for communities. Sources have to be Crop protection officers are located at MAIFF accessible, affordable and safe for the user com- headquarters, at zonal stations, and at an in- munities. Though the mandate of the water suppli- creasing number of border/entry posts. The De- ers is to ensure safety of water through "water qual- partment is the so-called competent authority ity control". responsible for the inspection and regulation of horticultural commodities for local and interna- E. Ministry of Local Government tional markets. A new draft Bill would desig- nate the Department as the National Plant Pro- F. National Environment Management Authori- tection Office. ty ­ In charge of the National Profile on Manage- ment of Chemicals and on Development of Envi- The Department of Fisheries Resources (DFR) ronmental Standards. is responsible for the inspection, certification, and control of fish and fish products consumed G. Uganda National Council of Science & Tech- locally and abroad. It is responsible for enforc- nology. Provides expert opinion in Biotechnology ing fisheries regulation, including carrying out and Bio­safety e.g. Genetically Modified Organ- inspection of factory premises, processing lines, isms or foods produced through biotechnology. landing sites, fish transport and export points for adherence to safety and quality requirements, as H. Ministry of Labor has an occupational health well as maintaining a national fish inspection unit that periodically examines health and safety and quality control system. The DFR issues a issues for agricultural workers. certificate for each consignment of fish prior to export. The Department is responsible for regu- 5.9.1.1. Interministerial collaboration: lating and overseeing the emergent development Food Hygiene Advisory Committee ­ The of aquaculture in Uganda. The DFR, in collabo- Committee is composed of technical experts ration with local government (District Coun- drawn from key stakeholders in the Food Indus- cils), directs fisheries resource conservation and try ­ provides support to the Ministry of Health. management initiatives. Budgetary and other National Codex Committee was founded in constraints inhibit the effectiveness of the DFR. 2000. Members: Ministry of Health, the Nation- al Agricultural Research Organization, the Na- Directorate of Animal Resources (DAR) has tional Bureau of Standards (the National Codex invested substantial human resources in enhanc- Contact Point). ing its legislative and policy direction capacity, Uganda Cleaner Production Center (UCPC) an effort that has produced a number of impor- Established in October 2001 with the support of tant outputs such as the animal diseases act, an- UNIDO100, the UCPC helps firms to become imal welfare act and others. more competitive and to improve environmental management by making more efficient use of C. Ministry of Trade and Industry ­ Under this raw materials and resources. Firms are taught to ministry there are: Directorate of External Trade, use water and energy more efficiently and to the Uganda National Bureau of Standards and the implement better waste management to reduce Uganda Export Promotion Board. Directorate for operational costs. The UCPC also helps firms to External Trade handles WTO matters such as noti- implement cleaner production technologies by fications under the SPS and TBT Agreements. assisting companies to achieve ISO 9000 and 14000 certification. As of 2005, the UCPC has Uganda National Bureau of Standards ­ Food standards developed by this body are equal to 100 UNIDO ­ The United Nations Industrial Development Organization 63 IFC Ukraine Business Enabling Environment Project 102 worked with more than 40 enterprises in areas Table 23. Data on inspection such as fish processing, sugar, leather, tea and tourism. Total number of food Aprox. 1170 Commodity Development Boards and Other inspectors Public Institutions ­ quality management for No of veterinary inspectors Aprox. 800 several traditional export commodities is gov- No of ministry of Health 320 inspectors ernment by particular agencies or Boards for Fish inspectors 50 example: Uganda Coffee Development Authori- No of Health inspectors per 0.01 ty, the Cotton Development Organization. FBO No of laboratories testing food 7 chemicals, 8 microbi- 5.8.2. The food safety system: ology, 8 biotoxins Laws and regulations since 2000, were developed No of premises to be visited 32.000 according to the recognized international models by Health inspection and following Codex Allimentarius standards, but No FBOs registered 12 fish processors 30 honey processors ­ the food safety system is severely obstructed by 3000 honey farmers obsolete food law from 1964 and the lack of re- 15 dairies sources required for building a sound food safety 10 milk collection cen- ters control infrastructure, including an adequate force, 12.000 producers of laboratory facilities, and necessary scientific exper- organic cotton and se- tise and research. same Activities for food safety and control are uncoordi- 5.8.3. Sampling: nated and scattered in ministries and are imple- The three main laboratories (ChemiPhar, SGS and mented by different agencies and authorities whose UNBS) provide the majority of the laboratory ser- mandates are provided under various laws and reg- vices in Uganda. These laboratories have similar ulations. capacity and capabilities. All three have ISO 17025 certification, provide similar services, and support The food safety and quality problems with food groups of clients. In general these laboratories are from Uganda intended to export are 101: operating at about 50% of their capacity. Microbio- High moisture content especially for grains; logical laboratories have facilities for both sample Contaminants especially sprayed chemicals, collection and logistic system for sample collection drug residues and foreign matter; and dispatch. Foods tested by microbiological ex- Most exports are not graded. aminations are mainly diary products and meats. Chemical laboratories are equipped to undertake The food safety and quality problems with products testing of: pesticide residues, additives, heavy met- coming from import are: als and other chemicals, toxins of fish & shellfish, Low quality products; toxic plants & mushrooms, mycotoxins, antibiotics, Expired products; hormones and radioactive contaminants. Risk importing diseased products ­ BSE; Risk importing genetically modified products There is a national monitoring program for conta- especially beans, meats and maize. minants such as pesticide residues, heavy metals and mycotoxins in fish and similar programs are now developed for honey, fruit and vegetables. Currently, some $1.4 million of testing revenue is generated from the testing of Ugandan food and agricultural products. Fish for exports and maize for regional sale or sale to the World Food Pro- gramme account for some 60 percent of this testing revenue. The testing of bottled water also generates significant revenues for certain laboratories. Most other testing is for quality parameters, mainly: cof- fee, tea, cotton, seeds, and other products. 101 102 http://www.afro.who.int/des/fos/country_profiles/uganda.pdf DG Sanco 8246/2006 Study of Food Safety Inspections 64 5.8.4. Risk assessment buted to food and water contamination (cholera, Capacities for risk assessment and risk manage- typhoid, dysentery, para ­ typhoid, intestinal ment are very limited in Uganda. Systematic data worms). Food borne disease are not mandatory re- collection and analysis is not performed and nor- ported. 105 mally not sustained over time. Responsibilities are fragmented among various institutions, at the levels 5.8.9. Fish industry ­ the case of standard of central and local government. Local government setting and development of inspection 106 in before 2005 didn't obey the recommendations or services : law requirements set by the central government. The Uganda fish processing industry was started in Still, crisis management is mainly performed usual- 1988. At present, there are 12 registered companies ly with support from the international community. for fish processing and export and of them 10 com- panies are operational. All of them are situated on 5.8.5. Register of FBOs the banks of Lake Victoria and Nile Perch is their Exists in the MAAIF but only for food processors main raw material. (neither producers, nor retailers or distributors are listed). There is a separate register in the Ministry The total investment by private investors in fish of Health, Environmental Health Division, but in- sector in Uganda is around US$100 million. The dustrial capacities are scarce, while majority of fisheries industry employs over 700,000 people operators inspected by this ministry are in fact very involved in various fishing activities including fi- small scale operators (1-5 employees). shermen, fishmongers, fish transporters and boat builders. 5.8.6. Annual training: Fish exports have grown from a value of US$ 5.308 There are no provisions for continuing education million in 1991 to US$ 39.78 million in 1996, but according to the WHO country profile 103. fell to US$ 28.8 million in 1997 due to fish export ban by the European Union over fish quality and The government and non-governmental agencies safety concerns. This ban was lifted in 1998, but are willing to provide extension and advisory ser- then in 1999 another ban was imposed on fish and vices to the food industry and trade. There is an fishery products originating from Lake Victoria active USDA program running "Livelihood and because of the concern that some fishermen were Enterprises for Agricultural Development (LEAD)" suspected of catching fish using pesticides. This working on increasing rural productivity, increas- ban was lifted in October 2000 after the Depart- ing trade capacity and enhancing competitiveness ment of Fisheries Resources (DFR), made a pro- of selected agricultural value chains. gram of monitoring of the levels of pesticides and heavy metals in fish, water and sediments from Training in legislation, control and testing for in- Lake Victoria, and also intensified monitoring and spectors from 10 districts was held in 2009, yet surveillance of fishing activities on the lake. there is need for "The certificate course in food inspection trained inspectors in international stan- Companies have been exporting most of their fresh dards, regulations and laws, which will help in pe- or frozen fillets to European Union, Japan, Hong netrating developed countries' food markets" as Kong, Singapore, Australia, Dubai, Israel and Unit- expressed by the State Minister of Water. 104 ed States of America. 5.8.7. Transparency: Factories in Uganda are estimated to produce al- There is not a formulated approach to data gather- most 400 tonnes of fish per month. The smallest ing and exchange of information among govern- unit exports 50 tonnes of fillets per month and 400 mental agencies. Various inspections exhibit in- tonnes are exported by big units on a monthly ba- spection in premises. There are no publicly availa- sis. ble data on inspection reports, sampling. Annual sampling plans for In 1997, Spain and Italy detected high levels of bacterial contamination including Salmonella in 5.8.8. Food borne diseases: fish from Lake Victoria. Following an outbreak of Notification of cases of food-borne diseases is not cholera in East Africa, the EU banned importation required by law. Statistics of foodborne diseases is of fresh and chilled fish and imposed mandatory compiled nationally. tests on frozen fish, fruits and vegetables from East According to Ministry of Health data from 1997- African countries. The second and longest ban was 2001 show that 2 million cases per year or 16% of imposed in March 1999 for pesticide residues. The all registered diseases are those that can be attri- 103 105 http://www.who.int/countries/uga/en/ Building a food safety system in Uganda. WHO publications 2004. 104 106 http://allafrica.com/stories/200908311098.html ftp://ftp.fao.org/es/esn/food/meetings/2005/italy_crd6_en.pdf 65 IFC Ukraine Business Enabling Environment Project Government requested that the Department of Fi- The fish inspection services with help of the EU sheries Resources and the Uganda National Bureau have been streamlined and the capacity of the of Standards develop a comprehensive monitoring Competent Authority (DFR) strengthened programme, which would determine levels of orga- through 107: nochlorine pesticides, organophosphate pesticides, training of fish inspectors (fish inspection, PCBs, and trace elements in fish, water and sedi- HACCP auditing and documentation) and pro- ments from the lake. This ban was officially lifted vision of fish inspection equipment; in 2000 and fish exports to the EU resumed on bila- preparation of a fish inspection manual, inspec- teral basis. tion guides and records; establishment of a documentation system at the Situation in the sub-sector: central, district and landing site levels Regulations were lacking or not upgraded in introduction of an IT software for fish inspec- order to meet the fish industry's and interna- tion benchmarking and monitoring. tional market's requirements and were not fully enforced; Achievements in this sub-sector are used as a mod- Fish inspectors did not receive training in Good el for other sub-sectors and the is used as a model Hygienic Practices and HACCP; in development of the Food Control System. No laboratory was accredited and none was ap- plying Good Laboratory Practices; As a result of strengthening of the fish inspection Design/operation/maintenance did not meet services, Uganda fish accessed the US market. Fac- GHP requirements; tories exporting to the USA implemented the ISO Fish handling throughout the chain was not in 9001:2000 system and the HACCP. Experiences in accordance with GHPs (the ice used for preserv- these pilot enterprises will also act as a model for ing fish was the source of contamination). other sub-sectors. Three main steps were taken in order to cure this 5.8.10. Summary situation: Uganda needs reform of legislation, strengthening of 1. Regulatory area and fish inspection authority official control and testing, as well as capacity build- were strengthened/developed ing for surveillance of food and waterborne diseases. 2. Technical support to research and training in- Knowledge of food producers and regulators in in- stitutions, standardization bodies and laborato- ternational requirements in food safety is limited. ry facilities was provided 108 Very good example of enhancing capacities in the 3. The private sector (fishermen, fish processors fishery sector (both of producers and state agencies) and traders, consumers/clients) were, also sup- is a model for restructuring of the food safety system ported. in Uganda. At the same time, experiences with reform of the Uganda fishery producing and control sector are a good model for other underdeveloped countries. Implementing profound reform in one sector which is essential to the country's budget may produce more effective results compared to starting the overall reform of the food safety system and thus persuade the government to continue with broader reform in various aspects of food safety. 107 DG(SANCO)/8240/2006 ­ MR Final 108 http://www.eprc.or.ug/pdf_files/occasionalpapers/op29.pdf Study of Food Safety Inspections 66 5.9. USA D. Numerous Directives, Notices and other legal USA is a constitution based federal republic orga- documents on different issues (Verification of Less nized in 50 states and one district with population than Daily Sanitation Procedures, Safe and Suitable of 307.212.000 inhabitants with GDP (PPP) $14.11 Ingredients Used in the Production of Meat and trillion and GDP per capita $46.800.(2007). The Poultry Products, on HACCP procedures, Inspec- share of agriculture in GDP is about 10% according tion performed by inspection bodies, Laboratory to the USDA with one person in eight working in services, Sanitation Standard Operating Procedures, some area of agriculture or food production. Main equipment, etc). agriculture products in USA are: wheat, corn, other grains, fruits, vegetables, beef, pork, poultry, dairy 5.9.2. Responsible authorities for the products, fish; while major export commodities are: food safety system: soybeans, fruit, and corn representing 9.2% of the A. Department of Agriculture (USDA) total USA export value. The 15% of all food con- sumed in USA is from import. Those are mostly a. Food Safety Inspection Service (FSIS) ­ has processed products, seafood, fresh fruit and vegeta- 10 offices of which Office of Field Operations bles coming from all around the world, yet the ma- manages inspection and enforcement of activi- jority from Mexico, South America and Canada. ties nationwide through 15 district offices, and 7700 inspectors. FSIS controls domestic produc- 5.10.1. Legal framework: tion and import of meat, poultry, and egg prod- A. Federal Food, Drug, and Cosmetic Act109 is ucts regarding safety, wholesomeness and label. the major law dealing with food production and This office is responsible for food recalls, too. control performed by the FDA. In slaughter plants, inspection involves examin- ing, before and after slaughter, birds and ani- B. Food Safety Enhancement Act of 2009 110 is mals intended for use as food. In egg processing still waiting in the Senate for adoption. It was de- plants, inspection involves examining, before signed as an amendment to the Federal Food, Drug and after breaking, eggs intended for further and Cosmetic Act. The aim of this document is to processing and use as food. strengthen the over-fragmented US legislation framework and to introduce risk based inspection in A number of U.S. states have their own meat in- facilities, oblige manufacturers to take more re- spection programs that substitute for USDA in- sponsibility for the prevention of food-borne ill- spection for meats that are sold only in-state. nesses and hand the Food and Drug Administration Certain state programs have been criticized for (FDA) further punitive powers. It would give the bad practices. FSIS is also responsible for as- FDA the authority to recall contaminated food sessing whether State inspection programs that products, the capacity to quarantine food suspected regulate meat and poultry products are equal to of being tainted and to impose criminal and civil the Federal program. Products produced under sanctions on transgressors. the State programs may be sold only within the State in which they were produced. The 1967 C. Federal Meat Inspection Act 111, Poultry Pro- Wholesome Meat Act and the 1968 Wholesome duction Inspection Act 112, Egg Production In- Poultry Act established the "at least equal" stan- spection Act 113 describe authorities of inspector in dard. FSIS assumes responsibility for inspection different meat and egg production operations. Ex- if a State chooses to end its inspection program ecutive Orders, Small Business Protection Laws & or cannot maintain the equivalent standard. Other Guidance 114 on how to appeal an FSIS regu- latory decision, and how to use the Small Business FSIS plans and administers a national control Administration's Office of the National Ombuds- plan based on risk assessment and implements it man. in domestic control and in import "reinspection program". Annually, FSIS reviews inspection systems in all foreign countries eligible to ex- port meat and poultry to the United States to en- 109 21 USC 301 sure that they are equivalent to those under U.S. 110 H.R. 2749, Prepared for the Congress 111th session, from August 3rd, 2009 laws. After the U.S. Customs Service and US- 111 http://www.fsis.usda.gov/regulations_&_policies/Federal_Meat_Inspection_ DA-APHIS requirements are met, shipments Act/index.asp 112 imported into the U.S. must be reinspected by http://www.fsis.usda.gov/regulations_&_policies/Poultry_Products_Inspectio FSIS at an approved import inspection facility. n_Act/index.asp 113 FSIS has about 75 board inspectors who carry http://www.fsis.usda.gov/regulations_&_policies/Egg_Products_Inspection_ out reinspection in approximately 125 official Act/index.asp 114 import establishments. http://www.fsis.usda.gov/regulations_&_policies/Executive_Orders_Small_B usiness_Protection_Law 67 IFC Ukraine Business Enabling Environment Project Besides inspection FSIS sets requirements for food safety standards. International Audit Staff meat and poultry labels and for certain slaughter within this office is responsible for verifying and processing activities, such as plant sanita- that foreign countries previously approved to tion and thermal processing, that the industry export meat, poultry, or egg products to the U.S. must meet. FSIS tests for microbiological, are maintaining inspection programs that pro- chemical, and other types of contamination and vide food safety protection at a level equivalent conducts epidemiological investigations in co- to that in the U.S., and actively participates in operation with the Centers for Disease Control the planning and conducting of initial team au- and Prevention (CDC) based on reports of dits in countries seeking first-time approval to foodborne health hazards and disease outbreaks. ship to the U.S. All products under FSIS' jurisdiction receive the USDA mark of inspection after inspectors con- c. Animal and Plant Health Inspection Service firm its safety and wholesomeness. Denying the (APHIS) ­ where The National Animal Health mark of inspection due to insanitation or a lack Surveillance System (NAHSS) integrates animal of process control, closes down a regulated es- health monitoring and surveillance activities tablishment. conducted by many Federal and State govern- ment agencies; and Plant Protection and Qua- b. Office of International Affairs ensures that rantine (PPQ) prevents risks associated with the meat, poultry and egg products imported are entry, establishment, or spread of animal and produced under standards equivalent to U.S. plant pests and noxious weeds. Fig. 13. USDA organization chart Secretary Inspector General Natural Farm and Foreign Food, Nutrition Research, Marketing and Rural Food Resources and Agricultural and Consumer Education, Regulatory Development Safety Environment Service Services Economics Programs FSIS APHIS Department of Health and Human Services own laboratories for testing samples but can al- a. Food and Drug Administration (FDA) ­ so, outsource testing. where Center for Food Safety and Applied Nu- trition controls almost 80% of the whole USA Several states that are major producers of fresh food supply. It covers all other products which fruits and vegetables (including California, are not controlled by FSIS and a part of the egg Arizona and Florida) have their own state pro- products both in domestic production and in grams to test products for pesticide residues. import. FDA covers also, live animals intended to be used for food, animal feed, approval and FDA organized Incident Command System surveillance for new veterinary drugs, medi- training and Rapid Response Teams to enable cated feed, all food additives, food packaging, rapid, localized response to incidents. It keeps sanitizers. FDA is responsible for ensuring that the detailed of records. Records are performed food products under its jurisdiction are safe, from different reasons: biological, chemical, nutritious, wholesome, and adequately labeled. physical contamination, inadequate labeling, In import it introduced a preventive screening presence of allergens. system with FDA inspectors stationed in coun- tries from which important quantities of food Data on all shipments are submitted through are imported to the U.S. the electronic systems of the U.S. Customs and Border Protection (CBP) and FDA. The data Inspections are risk-based and there is an an- are screened electronically to determine wheth- nual sampling plan according to risk of micro- er the food appears to present a significant risk biological or chemical contamination. FDA has to public health. Some foods are then inspected Study of Food Safety Inspections 68 physically based on perceived risk. Food prod- of Sciences to review FSIS data initiatives in order ucts of greater concern are physically inspected to ensure that Agency decisions are science-based more frequently. and data driven. The goal for 2008 was to imple- b. State and local health departments ­ enforce ment the system for auditing of performance of state laws and control restaurants and retail es- inspection in terms of quality. tablishments. They inspect design of premises, best food handling practices and certify food Table 23. Division of inspections handlers. In some places a letter grade or nu- Area Inspection authority merical score must be prominently posted fol- Animal health APHIS and Federal and State lowing each inspection or inspection deficien- agencies cies and remedial action have to be posted on Food of animal origin FSIS, FDA, State and local the Internet. health departments c. Centers for Disease Control and Prevention Import of animals and APHIS food of animal origin FSIS (CDC) ­ it has a public non-regulatory role in conducting disease surveillance and occurrence Feedingstuff and animal APHIS, Federal and State nutrition agencies, FDA of food and water borne diseases. Animal byproducts C. Environmental Protection Agency (EPA) ­ Veterinary medicines FDA authorization and distri- responsible for safe drinking water, regulates use of bution pesticide products and establishes tolerances or Veterinary medicines FSIS maximum legally permissible residue levels for residues FDA pesticides in all types of food and feed. FDA and Food safety plans in FSIS FSIS enforce the pesticide residue standards set by premises EPA for products under their respective jurisdic- GMO APHIS tions. EPA Import of food of plant APHIS ­ PPQ origin D. Agricultural Research Service Plant protection prod- EPA ucts authorization and APHIS E. Department of Homeland Security sale a. Customs and Border Protection ­ in collabo- Plant protection prod- FSIS ration with all other federal agencies checks ucts residues FDA imported food. Animal welfare APHIS Plant health 5.9.3. Training: Restaurants, shops FDA, State and local health To qualify for an entry-level position at the FSIS, departments the candidate must pass a written test and have ei- ther a Bachelors degree or 1 year of job-related 5.9.5. Register of FBOs: experience (in the food industry), demonstrate The Bioterrorism Act 116 since 2003 requires do- knowledge of sanitation practices and control mestic and foreign facilities that manufacture, measures used in the commercial handling and process, pack, or hold food for human or animal preparation of food products for human consump- consumption in the U.S. to register with the FDA. tion, skill in applying, interpreting, and explaining Foreign facilities that manufacture/process, pack, or standards in a food product environment. 115 FSIS hold food also are required to register unless food inspectors have regular training according to the from that facility undergoes further processing (in- annual training scheme. USDA collaborates with cluding packaging) by another foreign facility be- number of scientific institutions which organize fore the food is exported to the United States. There training for inspectors. Trainings in risk based in- is a possibility to register online. spection, HACCP, control of meat at import/export are conducted almost every year. FDA trains state FDA registered 117: inspectors in principles and practices of the FDA 136,000 domestic food facilities including more inspection work according to the annual plan. than 44,000 food manufacturers and processors and approximately 113,000 food warehouses, 5.9.4. Quality control of the inspection including storage tanks and grain elevators performance: (some of facilities have several functions). In order to satisfy recommendation for having the 189,000 foreign facilities which manufacture, external review, FSIS asked the National Academy process, pack, or store food 115 116 http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm 117 http://www.fsis.usda.gov/Careers/Food_Inspector_&_Consumer_Safety_Insp http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/FoodProtection ection_Positions/index.asp Plan2007/ucm132565.htm 69 IFC Ukraine Business Enabling Environment Project FDA or state and local authorities registered tensified sampling exist) are included in the nation- more than 2 million farms, roughly 935,000 res- al residue program data. To analyze these samples, taurants and institutional food service estab- FSIS has three laboratories, and supports 25 Food lishments, and 114,000 supermarkets, grocery Emergency Response Network labs. This network stores, and other food outlets. FDA provides of laboratories consists of Federal, State, and local guidance, model codes, and other technical as- governmental laboratories, which are performing sistance to state and local partners. analysis on l biological, chemical, and radiological contamination. FSIS registered 6500 producers/processors. Residue frequent VIOLATOR LIST is present on 5.9.6. Frequency of control and fees: internet and serves as a good indicator of safety of Table 24. Data on inspection in 2007 products coming from different producers. 120 Control of microbiological pollutants is performed Number of inspectors FSIS 118 7700 in order to prevent Salmonella and new pathogens No FBOs registered at FSIS 6500 (Lysteria, E.Coli O157:H7, Campilobacter). No of veterinary inspectors per FBO 1.2 Total No of activities performed by FSIS 10.500.000 inspectors annually (all activities taken verification FDA controls registered and not-allowed pesti- including sampling, control of each procedures cides, additives and environmental contaminants. carcass) EPA sets tolerance levels for registered pesticides. Annual No of food safety assessments 1500 FDA registered 7380 producers as high-risk estab- (detailed insight in food safety plan and situation in premises) lishments. Those are producing foods with the Average No of inspection visits to FBOs 0.4 greatest risk for microbial contamination and those per veterinary inspector foods requiring specific components for a safe and Realization of the FSIS annual control plan 94.5% nutritious product. High-risk establishments are: No of FDA inspectors 119 About 900 manufactures, packers/repackers, and warehouses No of premises registered by FDA 136.000 processing products that include: modified atmos- inspection phere packaged products; acidified and low acid No of premises per FDA inspector 151 canned foods; seafood; custard filled bakery prod- Annual No of State inspection visits under 10.000 ucts; soft, semi-soft, soft-ripened cheese and cheese contract with FDA products; un-pasteurized juices; sprouts or Annual No of State inspection visits under 40.000 processed leafy vegetables; fresh vegetables shred- State regulations ded for salads and processed root and tuber vegeta- bles; sandwiches; prepared salads; infant formula; FDA has a responsibility of inspection over 80% of and medical foods. all food products at the market as well as numerous producers. It is visible that there is a shortage of Table25. Official sampling 2007 121 FDA inspectors, so they rely on the network of Type of sampling No of samples state inspectors. By 2007 only 80% of state inspec- FSIS Annual monitoring plan for 20.853 tions follow FDA recommendations for inspection. chemical pollutants (veterinary Other implement inspection practices developed by drugs and pesticides) their state office. No of samples with nonconformities 64 Sampling at regular veterinary 149.590 Inspection is funded from the state budget, but they control of slaughtering earn some 16% of their budget on "user fees". No of nonconformities 1360 (mostly Those are fees charged for the reinspection due to antibiotics and sample failure and additional inspection performed sulfonamides) to check if corrective measures are applied and ef- FSIS Annual monitoring plan on 70.300 microbiological pollutants ficient. Also user fees are charged for inspection overtime work, holidays and voluntary inspection. Recalls by FSIS 58 + 4 public alerts Annual No FDA sampling at import 5570 5.9.7. Sampling No of nonconformities 4550 National Residue Program ­ residues of veterinary Annual No FDA sampling domestic 10.700 drugs, pesticides and environmental contaminants No of nonconformities Not available are controlled by FSIS in milk, meat eggs. Samples No of FDA recalls 220 are gathered as per plan and as per inspection sam- No of samples collected by State 300.000 pling. Also, data from samples from board inspec- inspectors tion (normal sampling, increased sampling and in- 118 120 http://www.fsis.usda.gov/Fact_Sheets/index.asp http://www.fsis.usda.gov/PDF/Residue_Violators_List.pdf 119 121 http://www.fda.gov/Food/FoodSafety/default.htm Study of Food Safety Inspections 70 5.9.8. Budget 5.9.10. Foodborne outbreaks: The USDA budget for 2007 was $127 billion of Fig 14. Relative rates compared with 1996-1998 which 2% was used in order to increase food safety baseline period of laboratory-diagnosed cases of and security. The FSIS budget was $865 million infection with Campylobacter, STEC O157, Listeria, (2007) which represents 0.7% of the total annual Salmonella and Vibrio, by year. Source: FDA ­ Food Protection Plan 2007. USDA budget. APHIS budget was 1% of the US- DA budget. Of the whole FSIS budget 83% was spent on feder- al inspection activities, 7% on State inspection and 1.6% on international inspection. FSIS gained 154 million for "user fees" and 1.2 million from 177 indictments and 223 convictions regarding food safety. The major part of the USDA budget is used in re- In 2008, a total of 18,499 laboratory-confirmed ducing food safety and security program vulnera- cases of infection were identified. The number of bility and increase of effectiveness and efficiency. infections and incidence per 100,000 population This means education of producers how to imple- were reported as follows: Salmonella (7,444; ment precautionary principles in food production 16.20), Campylobacter (5,825; 12.68), Shigella (among them HACCP system, traceability, applica- (3,029; 6.59), Cryptosporidium (1,036; 2.25), E. tion of animal health and plant health procedures) coli O157:H7 (513; 1.12), E.coli non-O157 (205; and how to increase production. 0.45). 124 The Food and Drug Administration (FDA) perfor- The percent-positive rate for Salmonella in raw mance budget request for 2007 was $1,947,282,000 broiler chicken fell from 11.4% in 2006 to 7.3% in and 9.2% was used for food inspection purposes 2008. Additionally, the percentage of broiler chick- ($178.225.000). en slaughter establishments with Salmonella con- tamination is declining. The percentage of ground In 2010 FDA plans the budget of $3.2 billion, beef samples yielding E.coli O157 increased from where $473 millions will be addressed to food safe- 0.24% in 2007 to 0.47% in 2008 -whether the in- ty (14.8%). 122 crease was related to focused sampling of higher risk facilities or improved laboratory detection, or 5.9.9. Transparency whether the microbial load was actually higher, is Detailed information about enforcement and recalls unknown. In August 2008, the FDA published a could be found on sites: rule allowing irradiation of fresh iceberg lettuce http://www.fda.gov/Safety/Recalls/EnforcementReports and fresh spinach to help protect consumers from http://www.fsis.usda.gov/FSIS_Recalls/Open_Federal_Case Salmonella and E.Coli O157:H7 (as a lesson s/index.asp learned from outbreaks). 125 FSIS is planning to develop a new IT system to 5.9.11. Summary track domestic inspection activities, including egg In the United States, federal regulations governing products processing. food safety are fragmented and complicated,. There is also, high level of overlapping in inspection ju- There is an Investigations Operations Manual for risdiction (FDA and USDA inspections). FDA personnel how to perform inspections and special investigations. 123 Also enforcement actions, In order to overcome the fragmented food safety legal actions are described in manuals. legislation a Food Safety Enhancement Act of 2009 is prepared which defines roles of FDA inspectors, gives legal basis for the risk based inspection and basis for their administrative actions. The area of veterinary inspection control remains with numer- ous legal documents, guidelines, codes of practice in force. 122 http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetRepor 124 ts/default.htm http://www.aamp.com/news/documents/Notice44-09.pdf 123 125 http://www.fda.gov/ICECI/default.htm http://www.fsis.usda.gov/PDF/RBVS_Risk_Assess_Jun07.pdf 71 IFC Ukraine Business Enabling Environment Project The federal FDA regulations are not always fol- Good practices of training of inspectors, implemen- lowed at the state level. Recent outbreaks of food- tation of the HACCP and risk based approach that borne diseases resulting from both animal and non- FSIS applies proved to be very useful. Also, the animal food sources raised great concern about the APHIS is a well consolidated agency. food safety system efficacy in the USA. Also, Pres- ident Obama criticized the food safety system as The recent problems with food of non-animal ori- being too spread out, making it difficult to share gin have serious effects on consumers trust in the information and solve problems. "Protecting the USA food safety system. safety of our food and drugs is one of the most fun- damental responsibilities government has" ­ he said. 126 The underfunding and understaffing at FDA that has left the agency unable to conduct an- nual inspections of more than a fraction of the 150,000 food processing plants and warehouses in the country was, also his great concern. 126 http://www.cbsnews.com/stories/2009/03/14/politics/100days/domesticissues /main4865488.shtml Study of Food Safety Inspections 72 6.0. LIST OF ABREVIATIONS APHIS ­ United States Animal and Plant Health MAF ­ New Zealand Ministry of Agriculture and Inspection Service Forestry CAB ­ County Administration Board MAFW ­Serbian Ministry of Agriculture, Forestry and Water Management CAC ­ Codex Alimentarius Commission MAFRD ­ Croatia Ministry of Agriculture, Fishe- CDC ­ United States Center for Disease Control ries and Rural Development and Prevention MARD ­ Polish Ministry of Agriculture and Rural CIS ­ Commonwealth of Independent States Development DFR ­ Uganda The Department of Fisheries Re- MFAF ­ Danish Ministry for Food, Agriculture sources and Fisherie DVFA ­ Danish Veterinary and Food Administra- MH ­ Polish Ministry of Health tion MoH ­ Serbian Ministry of Health DPD ­ Danish Plant Directorate MHSW ­ Croatia Ministry of Health and Social EARS ­ Slovenian Environmental Agency Welfare FAO ­ Food and Agriculture Organization of the NDA ­ Uganda National Drugs Authority United Nations NFA ­ Swedish National Food Administration FBO ­ Food Business Operator NZFSA ­ New Zealand Food Safety Agency FDA ­ United States Food and Drug Administra- tion NZFSA VA ­ New Zealand Food Safety Verifica- tion Agency FVO ­ Food and Veterinary Office OIE ­ International Organization for Control of EPA ­ United States Environmental Protection Epizootics Agency PAS ­ Auckland County Performance Assessment FQIS ­ Slovenian Food Quality Inspection Service System FSIS ­ Food Safety Inspection Service PARS ­ Slovenian Phytosanitary Administration Fte ­ full time employees RASFF ­ Rapid Alert System for Food and Feed GAP ­ Good Agricultural Practices SBA ­ Swedish Board of Agriculture GHP ­ Good Hygienic Practices SES ­ Sanitary Epidemiological Service GMP ­ Good Manufacturing Practices SPHSIS ­ Polish State Plant Health and Seeds Pro- GVI ­ Polish General Veterinary Inspectorate tection Inspection HACCP ­ Hazard Analysis and Critical Control SSI ­ State Sanitary Inspection Points VARS ­ Slovenian Veterinary Administration HIRS ­ Slovenian Health Inspectorate VI ­ Veterinary Inspectors IPPC ­ International Plant Protection Convention UCPC ­ Uganda Cleaner Production Center IRSAFF ­ Slovenian Inspectorate for Agriculture, USDA ­ United States Department of Agriculture Forestry and Food WHO ­ World Health Organization IRSEP ­ Slovenian Inspectorate for Environment and Spatial WTO ­ World Trade Organization MAB ­ Municipality Administration Board SPS ­ Sanitary and Phytosanitary Agreement TBT ­ Technical Barriers to Trade