Final report. EFTA Surveillance Authority mission to NORWAY. 23 to 27 April regarding the application of EEA legislation related to

Transcription

1 Case No: Event No: Final report EFTA Surveillance Authority mission to NORWAY 23 to 27 April 2007 regarding the application of EEA legislation related to the monitoring and control of zoonotic agents in live animals and products of animal origin with emphasis on Salmonella Please note that corrections to the factual content of the report have been included in the body of the report in underlined italic print and the comments from Norwegian Food Safety Authority to the draft report and information on corrective actions already taken are in Annex 3. Comments from the Norwegian Institute for Public Health are in Annex 4. The comments are referred to in footnotes in underlined italic print. Rue Belliard 35, B-1040 Brussels, tel: (+32)(0) , fax: (+32)(0) ,

2 Page 2 Contents Page 1 Introduction Objectives of the mission Legal basis for the mission National legislation Information on production and trade Main findings Transposition and application of relevant legislation Competent Authorities General information Organisation, legal powers and budgetary allocations Financial and human resources Training of personnel Cooperation with other authorities, laboratories and stakeholders Laboratory services National reference laboratories (NRLs)... 9 Visit to the Salmonella NRL Private laboratories Epidemiological situation Specific epidemiological situation concerning Salmonella Antibiotic resistance Food poisoning outbreaks Official controls and monitoring programmes Monitoring programmes for zoonotic agents and control programme for Salmonella Control measures taken in event of flocks infected with salmonella Controls on farms and establishments visited Guidelines on preventive measures and good hygiene practices Traceability of poultry meat products Own-checks systems Final meeting Conclusions Implementation of Acts incorporated into the EEA Agreement Cooperation with other authorities, laboratories and stakeholders National reference laboratory Monitoring of zoonoses and zoonotic agents Official control/own checks Recommendations to the Norwegian competent authority Annex 1 List of abbreviations and terms used in the report Annex 2 Other relevant legislation Annex 3 Comments from the Norwegian Food Safety Authority Annex 4 Comments from the Norwegian Institute for Public Health... 31

3 Page 3 1 Introduction The mission took place in Norway from 23 to 27 April The mission team comprised two inspectors from the EFTA Surveillance Authority (the Authority) and a national expert. The opening meeting was held with representatives of the Ministry of Agriculture and Food, the Norwegian Food Safety Authority (NFSA) and the Norwegian Institute for Public Health (NIPH) on Monday 23 April 2007 at the NFSA's head office in Oslo. At the meeting, the mission team confirmed the objectives and the itinerary of the mission, and the Norwegian representatives provided additional information to that set out in the reply to the Authority's pre-mission questionnaire. This was the first mission to Norway focusing on monitoring and control of zoonoses. Throughout the mission, a representative of the head office of the NFSA and a representative of the national competence centre in Sandnes accompanied the mission team. In addition, representatives of the relevant regional offices and district offices of the NFSA participated during meetings at the district offices and the visits to the different farms and establishments. A final meeting was held at the head office of the NFSA in Oslo on Friday 27 April 2007, at which, the mission team presented its main findings and some preliminary conclusions from the mission. The abbreviations used in the report are listed in Annex 1. 2 Objectives of the mission The main objective of the mission was to assess the application by the Norwegian Competent Authority of Directive 2003/99/EC on monitoring zoonoses and zoonotic agents and Regulation (EC) No 2160/2003 on the control of salmonella and other zoonotic agents. The meetings with the Competent Authorities and the visits to the farms, laboratories and establishments during the mission are listed in Figure 1. Figure 1: Competent Authorities, laboratory, establishments and farms visited during the mission Number Comments Competent Authorities 4 An opening and a closing meeting. Meeting with NIPH, and meeting with representatives of a regional office and a district office of the NFSA. Laboratories 2 NRL for Salmonella and a private laboratory. Establishments 3 A slaughterhouse, a catering establishment, and a feed mill. Farms 2 One farm with egg laying hens and turkeys, and one pig farm.

4 Page 4 3 Legal basis for the mission The legal basis for the mission was: a) Point 4 of the Introductory Part of Chapter I of Annex I to the EEA Agreement. b) Article 1(e) of Protocol 1 to the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice (Surveillance and Court Agreement). c) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Decision 98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States. d) The Act referred to at Point 7.1.8b of Chapter I of Annex I to the EEA Agreement, Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents, as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to that Agreement. e) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-community trade in and imports from third countries of fresh poultry meat, as amended. f) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 89/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products, as amended and as adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to that Agreement. Other legislation relevant for the mission is listed in Annex 2. 4 National legislation The main Norwegian Act creating the general framework for the functioning of the NFSA is Act No 124 of 19 December 2003 relating to food safety and plant and animal health (the Food Act). The Food Act also provides the legal basis for regulations in the relevant fields adopted by the Ministry of Agriculture and Food, the Ministry of Health and Care Services and the Ministry of Fisheries and Coastal Affairs 1. 5 Information on production and trade Key figures for the poultry and egg industry in Norway are given in Figures 2 and 3. 1 The NIPH made note of a national legislation applicable to the NIPH which is not included in the EEA Agreement. See Point 2 in Annex 4.

5 Page 5 Figure 2: Live poultry establishments and farms Establishments No. in the poultry sector No. in the egg sector Chicken: Hatcheries 3 2 Pedigree breeding/ breeding 50 3 Rearing Production flocks Turkey: Hatcheries 3 Pedigree breeding/ breeding 5 Rearing 1 Production flocks 170* * Turkey, ducks and geese Figure 3: Establishments in the poultry meat and egg sector Type of establishments Number Limited capacity Slaughterhouses 6 1 Egg production establishments 5 Egg packing centres 27 According to information received during the mission, Norway traded in 2006 eggs and egg products to some EU Member States and exported some eggs and egg products to third countries. The figures on trade to EU Member States and export figures to third countries in 2006 are given in Figures 4 and 5. Figure 4: Trade to EU Member States in Eggs and egg products Country Kg Product Germany 544 Fresh, cooked, or conserved eggs in shell Denmark 127,751 Fresh, cooked, or conserved eggs in shell Finland 49 Fresh, cooked, or conserved eggs in shell The United Kingdom 932 Fresh, cooked, or conserved eggs in shell Sweden 229 Fresh, cooked, or conserved eggs in shell Denmark 200 Egg products Lithuania 200 Egg products Sweden 12,150 Egg products

6 Page 6 Figure 5: Trade to third countries in Eggs and egg products Country Kg Product China 49 Fresh, cooked, or conserved eggs in shell Croatia 49 Fresh, cooked, or conserved eggs in shell India 49 Fresh, cooked, or conserved eggs in shell Iceland 1,030 Fresh, cooked, or conserved eggs in shell. Russia 797 Fresh, cooked, or conserved eggs in shell The United States 203 Egg products 6 Main findings 6.1 Transposition and application of relevant legislation According to the Norwegian reply to the pre-mission questionnaire, the main acts on zoonoses have been incorporated into Norwegian law. Regulation (EC) No 2160/2003 with the same additional guaranties as Finland and Sweden, and Directive 2003/99/EC entered into force 30 April However, according to the reply to the pre-mission questionnaire Commission Regulation (EC) No 1003/2005, Commission Regulation (EC) No 1091/2005 and Commission Decision 2004/564/EC, which are incorporated into the EEA Agreement, were not yet implemented in Norwegian law. According to the EEA Agreement, the deadline for Norway to implement these acts was 23 September 2006, 1 January 2007 and 30 April 2005 respectively Competent Authorities General information The NFSA is the Norwegian Competent Authority relating to animal health and food safety. It follows from a Royal Decree of 19 December 2003 that the authority to instruct the NFSA is divided between the Ministry of Agriculture and Food, the Ministry of Fisheries and Coastal Affairs and the Ministry of Health and Care Services. The Ministry of Agriculture and Food is responsible for deciding the NFSA s budget, for the co-ordination of the three Ministries' activities in respect of the NFSA, and for the legislation in Chapter I of Annex I to the EEA Agreement covering, inter alia, contagious animal diseases. The Ministry of Fisheries and Coastal Affairs is responsible for ensuring compliance with the national legislation relating to aquatic production and on the production and the placing on the market of fishery products. The Ministry of Health and Care Services is responsible for ensuring compliance with the national food legislation Organisation, legal powers and budgetary allocations The NFSA comprises a head office located in Oslo, eight regional offices and 64 district offices. The head office is responsible for co-ordinating the organisation's activities 2 While drafting the report the Ministry of Agriculture and Food sent information on full implementation of the two regulations.

7 Page 7 including, inter alia, inspections of farms, establishments and undertakings, surveillance and eradication of animal diseases, and preparation of new legislation. Out of a total of 1,300 employees approximately 130 employees work at the NFSA s head office, 230 are employed by the regional offices, and 940 are employed by the district offices. Five national centres of the NFSA, located at different regional offices, have been assigned special responsibilities in relation to, for example, food safety, animal health, fish health and plant health. The national centres have no legal powers and take instructions from the head office. The National Centre of Animals and Food, located at the regional office in Sandnes, is the national centre responsible for issues related to zoonoses in land animals, including poultry and eggs. Within the NFSA, administrative decisions are adopted by the district offices. Any appeal following these decisions is considered by the regional offices. Based on the NFSA s budget, decided by the Ministry of Agriculture and Food, the head office of the NFSA determines the specific budgets for the head office and the regional offices. This is followed by a budgetary process at the regional offices in co-operation with their respective district offices. Within the framework agreed with the regional office, the district offices can allocate their budgets as are most suitable for the districts Financial and human resources Representatives of one of the district offices visited, informed the mission team that an internal workload assessment of the NFSA had revealed that it possessed approximately 70% of the resources needed to perform the tasks it is responsible for Training of personnel According to the reply to the pre-mission questionnaire, veterinarians working in Norway have to have an authorisation given by the NFSA. Veterinarians with this authorisation are qualified for working within the NFSA. At present, no further education is required for working as an official veterinarian. According to information provided in the reply to the pre-mission questionnaire, the NFSA organizes an annual two days meeting with the veterinarians involved in the meat inspection. The agenda includes presentations, updating and harmonization of the decisions taken. According to the information provided by the representatives of the NFSA, more than 70 veterinarians participated at the annual meeting in August 2006, and a new meeting is planned for May In addition, the NFSA offers a two weeks continuing education course for the veterinarians within the NFSA. In December 2006/January 2007, 75 veterinarians participated in the updating course. However, this continuing education is not yet mandatory for the official veterinarians Cooperation with other authorities, laboratories and stakeholders According to information provided in the reply to the pre-mission questionnaire, the NIPH is the main coordinator when outbreaks of human diseases occur, also with regard to food poisoning outbreaks. The NIPH is the national governmental centre for communicable disease prevention and control. The institute performs research and surveillance of communicable diseases in man and advices governmental and municipal authorities and the public on the prevention of communicable diseases, outbreaks and antimicrobial

8 Page 8 resistance. The institute also has responsibilities concerning chronic diseases epidemiology, environmental medicine and forensic toxicology 3. According to information provided in the reply to the pre-mission questionnaire, foodborne outbreaks are defined as incidences observed of two or more human cases of the same disease or infection where the cases are linked or probably linked to the same food source. All suspected food borne outbreaks are notifiable. Laboratory-confirmed human cases are published weekly from the NIPH to all health personnel, the NFSA and the public in a special report, the MSIS report 4. According to the reply to the pre-mission questionnaire, monthly meetings are held on national level, where the head office of the NFSA and the NIPH attend. The Norwegian National Veterinary Institute (NVI) and the Norwegian School of Veterinary Science have the possibility to participate as observers in these meetings. The agenda usually reflects the aim to give updated information, from all participants, on food- and water-borne outbreaks. During a crisis, meetings will be held more frequently. Early warning addresses have been opened at both the NIPH and the NFSA, where outbreaks on the national level can be reported by the personnel of the public health authorities and the NFSA 5. A web-based outbreak notification system, under shared responsibility of the NIPH and the NFSA, was introduced on 1 July 2005, and all municipal medical officers and the personnel of the district offices of the NFSA can report food borne outbreaks into the database accommodated by this system. Monthly reports are published on the NFSA internal website 6. According to the reply to the pre-mission questionnaire, all health personnel, including personnel from the NFSA, shall report suspected food borne outbreaks to the municipal medical officer, who is required to report to the county governor and to the NIPH. Suspected outbreaks should be reported immediately to the municipal medical officer and, if domestic food or animal source is suspected, the municipal medical officer also informs the relevant district office of the NFSA. The municipal medical officer has the responsibility to initiate an outbreak investigation 7. A guidance document, published by both the NFSA and the NIPH, has been in use since The document, which was revised in 2006, describes investigation of food borne outbreaks and zoonoses, and covers responsibilities, cooperation, and stages of investigation. At the time of the mission, a special chapter on the handling of food borne outbreaks on national scale was being drafted 8. 3 The NIPH added detailed information to the information provided in the reply to the pre-mission questionnaire. See Point 3.1 in Annex 4. 4 The NIPH added detailed information to the information provided in the reply to the pre-mission questionnaire. See Point 3.2 in Annex 4. 5 The NIPH added detailed information to the information provided in the reply to the pre-mission questionnaire. See Point 3.3 in Annex 4. 6 The NIPH added valuable information to the information provided in the reply to the pre-mission questionnaire. See Point 3.4 in Annex 4. 7 The NIPH added detailed information to the information provided in the reply to the pre-mission questionnaire. See Point 3.5 in Annex 4. 8 The NIPH added detailed information to the information provided in the reply to the pre-mission questionnaire. See Point 3.6 in Annex 4.

9 Page 9 According to the reply to the pre-mission questionnaire, the NVI, the Norwegian School of Veterinary Science and the National Institute of Nutrition and Seafood Research (NIFES) will supply the NFSA with independent, research-based advisory support and assist during food borne disease outbreaks. The mission team noted that a formalised cooperation had been established between the NFSA, as the risk manager, and the risk assessors such as the NIPH, the NVI, the NIFES and the Norwegian School of Veterinary Medicine. The mission team further noted that the role and the division of tasks and responsibilities between the different bodies was at the time of the mission in the process of being better clarified in the light of recommendations from the external evaluation of the handling of a serious food poisoning outbreak caused by verotoxigenic E. coli in During the mission, the representatives of the NIPH provided the mission team with a copy of a draft memo dated 21 January 2007 on the establishment of a crisis unit, a Committee on food born diseases. The mission team noted that according to the draft, the mandate for establishing the crisis unit was given to the NIPH. Furthermore, the representatives of the NIPH provided a draft agreement on the cooperation on local level between the district office of the NFSA and the municipal medical officers. The mission team noted that the personnel of the district office visited were not aware of an agreement being drafted 9. The mission team noted in the private laboratory, visited during the mission that the NFSA had not informed the laboratory of which laboratory was the NRL for Salmonella. 6.3 Laboratory services The NIPH has a national reference function for human isolates and typing of Salmonella isolates from both the human and the animal population. The NIPH holds a database on isolates of zoonotic agents in Norway. However, the representatives of the NFSA stated that the NVI in Oslo, as designated NRL for Salmonella in animals, food and feed, would be responsible for verification of Salmonella strains from live animals, food and feed. Apart from the NRL in Oslo, regional laboratories within the NVI, analyse samples taken in the monitoring programmes. Furthermore, the NFSA has service agreements with private laboratories, which include analyses of samples taken as part of the monitoring programmes National reference laboratories (NRLs) The mission team visited the NVI in Oslo, which is the NRL for zoonoses including Salmonella. The NVI being an independent scientific organisation has duties of risk assessment and risk communication. The NVI in Oslo underwent reorganisation in It constitutes four departments: the Department for animal health, the Department for fish and shellfish health and the regional laboratories, the Department for food and feed hygiene, and the Department for health surveillance. The Zoonoses Centre and the epidemiology section are part of the 9. See Point 3.7 in Annex 4 for information from the NIPH on additional measures taken after the mission. 10 The NIPH added more detailed information on the function of the NIPH in its comments to the draft report. See Point 4 in Annex 4.

10 Page 10 Department for health surveillance. National reference functions are organised under the Department for animal health. Regarding the task of the NVI in monitoring- and control programmes related to zoonotic agents, and Salmonella and Campylobacter in particular, the NVI has the task of a risk assessor, providing guidance to the NFSA. Furthermore, the NVI is responsible for optimising the monitoring schemes. In addition, the NVI evaluates surveillance programmes for the NFSA, both active and passive ones. Finally, the NVI is responsible for the performance of laboratory tests in some of the programmes, such as the Salmonella programme in poultry. Other laboratories participating in laboratory testing in other programmes are appointed following tender by the NFSA. As far as the relationship with the NIPH is concerned, representatives from NVI stated that the two institutes have separate roles: NVI for food, feed and animals sector, the NIPH for the human sector. The NVI is invited as observer in the NIPH's monthly meetings. Functions of the two institutes are formalised in case of outbreaks, whereas the participation of NVI in NIPH crisis group exists (two members are invited), but it is not formalised. The NVI in Oslo has, according to the reply to the pre-mission questionnaire and information received during the mission, been appointed as NRL for Salmonella and for Campylobacter. The laboratory performs isolation of Salmonella from veterinary matrices (feed/food/animals), but not all the strains isolated from these kinds of samples are typed at NVI, since some private laboratories (dealing with feed and food, for example laboratories that receive samples from slaughterhouses) send the strains directly to the NIPH, which performs serotyping, and also phage typing of S. Typhimurium. Typing of these strains is not confirmed by the NRL. Previously the NRL function was divided. NVI was the NRL for Salmonella detection in live animals and food while NIPH was responsible for serotyping 11, 12. Moreover, the NIPH has established contact with the CRL, whereas the NRL does not participate in serotyping and phage typing collaborative studies organised by the CRL. The NIPH takes part in these ring trials. The NVI does not receive regular feedback about the results of typing performed by the NIPH (reports are sent to the NVI only following specific requests). The NVI started to participate in annual meetings organised by the CRL four years ago, before that, the contact with the CRL was managed by the NIPH. Isolation of Salmonella from primary samples collected within monitoring and control programmes is performed by the NVI in Oslo or in one of the NVI's regional laboratories. All these labs are accredited by Norwegian Accreditation. Recently, the NVI has requested the accreditation of the new procedure for Salmonella isolation from environmental and faecal samples, as prescribed by the CRL (Draft Annex of ISO 6579, using MSRV as unique enrichment media). The Norwegian Accreditation had performed the inspections with positive results, and the NVI was at the time of the visit waiting for the official accreditation of the method. 11 The NVI added information to the information provided in the pre-mission questionnaire and during the mission on the status of the NRL. See introduction in Annex The NIPH added more detailed information on the function of the NIPH in its comments to the draft report. See Point 5 in Annex 4.

11 Page 11 In November 2006, the NRL organised a two days training course for personnel in all the regional laboratories of the NVI that perform Salmonella isolation using the new method. Before that, baseline studies, in which it was compulsory to use this method, were only performed by the NRL. The NVI also analyse meat juice for the detection of Salmonella antibodies in pigs, but these tests are performed by the Section for Virology and Serology. Visit to the Salmonella NRL The mission team inspected the Section for Bacteriology of the NVI, which is responsible for the reference laboratory functions regarding Salmonella. Reception of samples Samples are received mostly by mail, and are accompanied by a form in which all relevant information is reported. If some relevant information is lacking, the samples are in any case analysed, but the head of the laboratory gathers within one day the data by phone. A facsimile of the form can be downloaded from the website of the NVI, but also other forms containing the same information are accepted. In 2006 more that 6,000 samples were received at the NVI for Salmonella detection; part of these (about 2,500) represent samples taken as part of a poultry company's own-checks system. Performance of procedure The working sheet that follows the sample during the analysis reports the date when each "passage" has been performed and the initials of the operator. Traceability of media is guaranteed by a separate register. Media are prepared in a different laboratory, which also performs media quality controls. A control strain (S. bongori) is included in the procedure every working day. Incubation of samples Incubators are located in a separate room. Temperature of incubators is monitored by controlling every day, the first time the incubators are opened in the morning, the temperature registered by a thermometer permanently located in a small jar with liquid in the incubator. The temperature is registered on a sheet. There is no continuous or automatic registration of temperatures of incubators or fridges, since the accreditation body does not consider this as a necessary requirement. Reports Reports specify the date of starting and end of the analysis, the identification of the samples, the method used. The information concerning the method is represented by a reference number of the laboratory, which is not clearly understandable, as it could be if the international reference was reported (e.g.: ISO 6579:2002). In addition, the revision of the procedure is not clearly identifiable. Serotyping Serotyping is performed by means of slide agglutination, using commercially available antisera. No control strains are used for serotyping. Between 100 and 200 strains are serotyped per year on average. Ring trials In order to perform quality control of the isolation procedure, the NRL participates in the ring trial organised by VLA, Weybridge, and since 2000, also in the ones organised by the

12 Page 12 CRL for Salmonella. Results are considered satisfactory by the accreditation body. The VLA ring trial is also used to control serotyping performance. However, it should be noted that this ring trial is not focused on serotyping of Salmonella. Other Training of staff and maintenance of competences, as well as environmental controls, are done in accordance with the requirements of the accreditation body. The main observations by the mission team on the NRL for Salmonella concern the role and the duties of the laboratory, according to Decision 2004/564/EC. In particular, the NRL does not participate in all the relevant collaborative studies, and it is not clear if it receives all the documents sent by the CRL to NRLs, or if parts of this information are received by the NIPH. The NRL has performed some training of personnel of other laboratories involved in Salmonella isolation, but has not yet organised any ring tests in this field. The network of laboratories within the country, to be coordinated by the NRL, is not clearly established, nor are their activities coordinated (e.g.: there is no planning of activities or meetings, a list of contact points, a programme for the verification of the procedures adopted, etc.). It is not clear which laboratory has the responsibility of confirmation of diagnosis of Salmonella (including typing) in samples of veterinary origin (feed/food/animals) as this task seems to be performed sometimes by the NRL and sometimes by the NIPH. Due to the lack of reporting from the NIPH, the NRL does not appear to have a complete picture of the epidemiological situation of Salmonella in the veterinary sector, particularly as far as distribution of the types in different matrices is concerned Private laboratories The mission team s main observations concern the communication with the NFSA and the NRL. The private laboratory visited does not receive from the NFSA or the NRL information concerning the procedures to be used for different aspects, such as the choice of laboratory methods, nor concerning the role of reference laboratories. Moreover, the laboratory was not aware that the NVI is officially appointed as NRL for Salmonella and Campylobacter. The choice of methods to be used for testing official samples depends solely on the initiative of the private laboratory, which uses the methods considered most suitable for its purposes. In the case of Salmonella and Campylobacter, VIDAS method has been chosen, since it has been validated by AFNOR, and checked at the laboratory by means of different ring trials. This is not according to the Norwegian monitoring program for pigs, in which the ISO 6579 is prescribed. From the documentation provided by representatives of the laboratory visited (control sheets related to Salmonella ring trials), from 2002 to 2006 the lab has examined in ring trials 125 samples using both VIDAS and NMKL methods. Among these, two samples resulted positive with NMKL and negative with VIDAS (1,6%). This corresponds to a sensitivity within the lab of 98,4%, which is less than the sensitivity of 100% obtained during the validation by AFNOR. The accreditation body does not require the laboratory

13 Page 13 to prove that the performance of tests routinely applied is equal to what has been declared by the validation certificate. 6.4 Epidemiological situation Specific epidemiological situation concerning Salmonella Representatives of the NFSA informed the mission team that, since the old Salmonella control programme for poultry was fully established in 1996, very few positive samples have been observed in poultry and poultry meat. The surveillance data indicates that the overall prevalence is below 0.1%. In the few cases where Salmonella has been detected, measures for eradication of the flocks have been implemented. According to the representatives of the NFSA, Salmonella enteritidis has never been detected in the Norwegian poultry population. Figure 6 was provided by the NFSA in the reply to the pre-mission questionnaire and describes the isolations in the Salmonella control programmes, from clinical surveillance and other sources. Year Figure 6: Results from the Norwegian Salmonella control programmes and other isolations of Salmonella in poultry and poultry products Number of samples/positive samples in the Norwegian Salmonella control programmes Breeders Other live poultry Poultry products /0 5985/5 6653/ /0 4501/0 7591/ /2 6889/ /0 5180/2 7200/ /0 5457/2 7467/ /1 5516/0 7135/0 Serovar and subpopulation S. livingstone in two broiler flocks S. newport in one broiler flock S. bredeney in one broiler flock S. schwartzengrund in one broiler flock S. diarizonae (38:k:z35) in one layer flock S. livingstone in one broiler flock S. livingstone in one broiler flock S. muenchen in one turkey flock S. aberdeen in one turkey flock S. typhimurium in one turkey flock S. agona in one broiler parent flock (rearing stage) Positive findings in poultry other than those identified in the control programmes 0 S. pullorum / gallinarum in one non-commercial flock S. agona in one layer flock /0 6063/0 6959/ /0 5698/1 7183/0 S. typhimurium in one broiler flock S. pullorum / gallinarum in three noncommercial flocks /0 6132/0 8398/2 S. senftenberg in two layer flocks 0 In the reply to the pre-mission questionnaire, it was further stated that none of the crushed meat samples taken in the Salmonella control programmes in poultry meat processing plants had been positive.

14 Page 14 Norway participated on a voluntary basis in the EU baseline survey on the prevalence of Salmonella in broiler flocks. A total of 320 flocks were included in the survey, and one was identified as positive, giving a prevalence of 0.3%. Vaccination against Salmonella is prohibited in Norway and none of the flocks were treated with antimicrobials Antibiotic resistance According to the reply to the pre-mission questionnaire antibiotic resistance is monitored by testing all Salmonella spp analysed during the year from all animal species, certain amount of Campylobacter jejuni from chicken and turkey, E. coli and Enterococcus spp from turkey and turkey meat, cattle and pigs. Antibiotic resistance in human isolates is monitored in a similar way and the use of antibiotics and the results from the monitoring are published in a yearly report, the NORM/NORM-VET report, published jointly by the NFSA and the NIPH. The monitoring has run since 1999 for human isolates and since 2000 for the veterinary and food production sectors. The monitoring in the veterinary and food sectors is coordinated by the Norwegian Zoonoses Centre Food poisoning outbreaks Outbreaks of food borne diseases are reported by the NIPH in a twice-monthly report. According to information provided by the representatives of the NIPH, 1,813 single cases of salmonellosis were reported to the NIPH in 2006, of which 1,340 were acquired abroad. Nine food poisoning outbreaks caused by Salmonella were reported to the NIPH, of which five were acquired in Norway. The biggest outbreak was an outbreak with S. kedougo where over 70 people were verified infected. The source of the infection was Norwegian produced salami. The source for an outbreak with S. typhimurium DTI93, which was diagnosed in six people, was traced to a restaurant. The last three cases of Norwegian origin were minor outbreaks in private house holdings. The other outbreaks were traced back to travelling abroad. According to the same source, 2,593 single cases of campylobacteriosis were reported in 2006, of which 42% were found to be acquired in Norway. No outbreaks of campylobacteriosis were reported in The most serious food poisoning outbreak in 2006 was an outbreak linked to enterohaemorragic E. coli O103, affecting a total of 17 persons, including 10 children, whom developed haemolytic uremic syndrome. The food involved was dry cured sausages of Norwegian origin and the source was linked to use of lamb meat slaughtered in one specific slaughterhouse. A governmental specialist committee reviewed the handling of the crisis retrospectively and criticised among others the unstructured communication and cooperation, and the unclear split of responsibilities between the different competent authorities in handling of the crisis. As previously mentioned in this report, the mission team noted that the routines for cooperation and communication between the different competent authorities were under evaluation. 6.5 Official controls and monitoring programmes Monitoring programmes for zoonotic agents and control programme for Salmonella Norway has established monitoring programmes for the following zoonotic agents in different animal species; Brucella spp, thermophilic Campylobacter, Echinococcus

15 Page 15 multilocularis and E. granulosus, Salmonella spp., Trichinella spp., Mycobacterium bovis and runs for the time being baseline study on verotoxigenic Escherichia coli in sheep. A monitoring programme for Listeria spp had not been established. However, the representatives of the NFSA informed the mission team that the industry runs programmes for Listeria in milk and milk products and is obliged to control for Anisakis. However, these programmes are not approved by the NFSA. The representatives of the NFSA informed the mission team that the epidemiological situation regarding zoonotic agents was constantly under evaluation and as an example, the need for a monitoring programme for Toxoplasma was under evaluation. The NFSA representatives informed the mission team that a decision on new programmes lies with the NFSA, while the NVI and the Norwegian Scientific Committee for Food Safety have the role as risk assessors, advising the NFSA on the costs and the benefits of running different monitoring programmes 13. The Salmonella control programme for live poultry, poultry meat and eggs is based on Regulation (EC) No 2160/2003. The programme replaces the national control programme, previously approved by the Authority, as far as poultry, fresh poultry meat and eggs are concerned. Although the EU legislation, for the time being, only requires the implementation of national Salmonella control programmes for breeder flocks and laying hens of Gallus gallus, the Norwegian control programme already covers the whole poultry production chain, i.e. domestic fowl, turkeys, ducks, geese and guinea-fowl and their relevant subpopulations, feed, fresh meat, hatching eggs and eggs for human consumption of the above mentioned species. According to information provided by the NFSA in reply to the pre-mission questionnaire, the control programme is foreseen to run continuously and will be revised regularly in order to take into account developments in food safety and microbiology, as well as the EU legislation in the field of control of zoonoses. The mission team noted that the laboratories participating in the programme for analysing samples were not specified in the programme. At the time of the mission, the above-mentioned programme had recently been sent to the Authority for approval. The Authority is in the final stages of assessing the programme. In addition to the Salmonella programme for poultry, the NFSA runs a monitoring programme for Salmonella in pigs and cattle. The programme covers samples and bacteriological examination of live animals and fresh meat. The NFSA maintains overall responsibility for salmonella surveillance and control programmes. The NVI coordinates the surveillance programmes, examines the faecal samples and publishes the results in monthly and annual reports. Norway has furthermore, participated on a voluntary basis in the EU-organised baseline studies on Salmonella, i.e. a baseline survey on the prevalence of Salmonella in laying hen flocks of Gallus gallus, on the prevalence of Salmonella in broiler flocks of Gallus gallus, the prevalence on Salmonella in fattening pigs and the prevalence of Salmonella in turkey flocks. 13 The NIPH added more detailed information on the function of the NIPH in its comments to the draft report. See Point 6 in Annex 4.

16 Page 16 The mission team observed that the new programme for Salmonella in poultry had been running from 1 January According to information provided by the NVI, around 10% of the samples foreseen to be taken in 2007 had been received at the laboratory in the first three months of the year. This was partly due to difficulties in providing the necessary sampling equipment. The NVI had just recently informed the head office of the NFSA of the situation. The staff at one of the district offices visited demonstrated a system to monitor the progress of the sampling according to the sampling plan, and the official veterinarian at the slaughterhouse visited demonstrated a system to ensure correct sampling for the Campylobacter programme. The mission team noted that at the feed mill visited, samples taken by the establishment itself every 14 days as part of the programme, were not taken at the places specified in the monitoring programme. The sampling in the Salmonella monitoring programme for poultry is primarily done by the farmers. The farmers are obliged to sample every flock of broilers at a specific time before expected slaughter and send it to the NVI. The flocks are not accepted for slaughter until the official veterinarian at the slaughterhouse has received the results of the analyses from the NVI. The farmers are also obliged to take samples from egg laying hens at special times of the laying period. Official veterinarians sample one to three times a year in each farm taking into account the production type. Details on the sampling scheme are given in Figures 7 to 9. Figure 7: Sampling of Gallus gallus breeder flocks, and breeder flocks of turkey, duck and geese Production Sampling place Sampling time/sampled by Holding Day old/sampling by farmer Rearing flocks Option 1 - holding Adult flocks Option 2 - hatchery Adult flocks Holding Holding Holding Hatchery. Holding (adult birds) Holding (adult birds) Holding (adult birds) 4 weeks old/sampling by farmer 2 weeks before being moved/sampling by farmer Official veterinarian takes samples once a year in each holding Every 2 nd week/sampling by farmer Official veterinarian takes samples three times: 0-4 weeks after moving, 8-0 weeks before slaughter and once in between Every 2 nd week/sampling by farmer Official veterinarian takes samples every 16 weeks 0-4 weeks after moving/sampling by official veterinarian 8-0 weeks before slaughter/sampling by official veterinarian Positive findings at hatchery/sampling by official veterinarian

17 Page 17 Figure 8: Sampling of Gallus gallus laying hens Production Sampling place Sampling time/sampling by Holding Day old/sampling by farmer Rearing flocks Holding 2 weeks before being moved/sampling by farmer Official veterinarian takes samples once a year in each holding Laying flocks Holding Every 15 weeks/sampling by farmer Official veterinarian takes one of the samples Figure 9: Sampling of broiler flocks and turkey, duck and geese flocks for meat production Production Sampling place Sampling by Slaughter Holding flocks 7 19 days before slaughter /sampling in each flock by farmer Official veterinarian takes samples once a year in each holding Control measures taken in event of flocks infected with salmonella According to the reply to the pre-mission questionnaire, any finding of Salmonella is notifiable in Norway. Sanitary slaughter of poultry infected with non-invasive Salmonella is allowed, and eggs can be used for human consumption or as animal feedingstuffs. However, according to the representatives of the NFSA, sanitary slaughter is regarded as a theoretical option and infection with non-invasive Salmonella is in practice treated as infection with invasive serotypes with killing of the poultry on the farm. The NFSA stated in the reply to the pre-mission questionnaire that, where there is a suspected outbreak of Salmonella, farms are put under restrictions, and when the diagnosis is confirmed, the infected poultry would be killed and the carcasses sent for incineration. The district office visited, had not had any suspicion of a Salmonella infection on a poultry farm for many years Controls on farms and establishments visited The mission team visited two farms, one pig farm and one poultry farm. Both farms were under official supervision with documented inspections performed by the district office according to an inspection plan. The district office took samples for Salmonella according to the monitoring programme. The farms had established bio-security measures and kept the required registers. Both farms participated in the programme on quality assurance in agriculture organised by the Norwegian agricultural sector. The representatives of the NFSA informed the mission team that poultry farmers are obliged to sign a contract with a private veterinary practitioner, which includes one or two visits per year, depending on the size of the farm. The pig farmer visited had a contract with a private veterinary practitioner which contained visit obligations every third week. Both the farmers themselves and the private veterinarians have an obligation to inform the NFSA of any suspicion of contagious disease or hazards to animal or human health. The mission team also visited one catering establishment. The mission team noted that the frequency of the official control of the establishment was not in accordance with the frequency described in the inspection routines of the NFSA. Furthermore, the representatives of the NFSA could not confirm to the mission team that a complete inspection of the whole establishment including evaluation of the routines and the own-

18 Page 18 checks system had taken place from the start of operation of the establishment several years ago. The NFSA had visited the establishment several times in the last two years because of an application from the establishment to get new equipment approved. However, information on inspections of other parts of the establishment was not readily available to the mission team. In this establishment, the mission team noted damaged floors, walls and ceilings, condensation, rust, cracks in aluminium trolleys and worn out cutting boards. Furthermore, the mission team noted packed goods in the chilling room where unprotected ready to eat products were also stored. 6.6 Guidelines on preventive measures and good hygiene practices The NFSA stated in the reply to the pre-mission questionnaire that prevention of Salmonella infection in Norway is based on good farming practises and strict bio-security at the holdings. According to this reply, the Norwegian agricultural sector has established a system for quality assurance in order to both ensure and document the quality of the domestic production of agricultural goods (Quality Assurance System in Agriculture). Guidelines on good farming practises have been issued for operators in the poultry industry as a component part of this system. Among others, these guidelines include an all in all out principle for all categories of poultry production and other precautionary measures against the introduction of infectious agents into the flocks, such as; the establishment of hygiene barriers at the entrance to the houses, codes of conduct such as separation between clean and unclean compartments, changing of clothes, personal hygiene and setting up routines and barriers to protect the birds from Salmonella infection from the environment. Furthermore, that water supply should be of drinking water quality and feed purchased from approved manufacturers only. The NFSA stated that all poultry holdings are obliged to implement the quality assurance system. The mission team noted that the poultry farm visited had established hygiene barriers. The representatives of the NFSA informed the mission team that poultry flocks found positive for Salmonella spp. were not allowed to be brought to the slaughterhouse, but were killed at the farm and sent for destruction in an incineration plant. The official veterinarian and representatives of one of the slaughterhouses visited stated that this system was functioning properly. At the slaughterhouse visited the official veterinarian informed the mission team that Campylobacter positive flocks were slaughtered during the day without cleaning or disinfecting the slaughter line between the contaminated flock and the following noncontaminated flock Traceability of poultry meat products The official veterinarian at the slaughterhouse visited had performed an investigation on the traceability of poultry products with satisfactory result. During the mission, the personnel of the NFSA demonstrated that it was possible to trace back the origin of the ingredients in a feed randomly selected by the mission team at one of the farms visited. Information was provided on where and when the ingredient had been produced. Information on the distribution of the same batch of the feed ingredient to other feed producers was not provided.

19 Page Own-checks systems The mission team observed that an own-checks system, i.e. a system which identifies the steps critical to ensuring food safety and ensuring that adequate safety procedures are identified, implemented, maintained and reviewed on the basis of HACCP (hazard analysis and critical control points) principles, was not in place in the catering establishment visited during the mission. The representative of the establishment informed the mission team that the intention was to have an own-checks system including HACCP up and running in July However, the mission team noted that the establishment had not yet defined any hazards nor started the work on the HACCP plan. The slaughterhouse visited had a more developed own-checks system including procedures for crisis management and withdrawal of products from the market. 7 Final meeting A final meeting was held on Friday 27 April 2007 at the head office of the NFSA in Oslo with representatives from the Ministry of Food and Agriculture, the Ministry of Health and Care Services, the NFSA, the NVI and the NIPH. At this meeting, the mission team presented its main findings and some preliminary conclusions of the mission. At the meeting the mission team also explained that, based on a more detailed assessment of the information received during the mission, additional conclusions could be included in the report. The Norwegian representatives took note of the findings and the preliminary conclusions presented. The representatives of the NFSA did not object to the main findings and the preliminary conclusions presented. Additional information provided by the representatives of the NFSA at the final meeting has been included in the relevant chapters of this report. 8 Conclusions 8.1 Implementation of Acts incorporated into the EEA Agreement According to the reply to the Authority's pre-mission questionnaire, some acts (Commission Regulation (EC) No 1003/2005, Commission Regulation (EC) No1091/2005 and Commission Decision 2004/564/EC) incorporated into the EEA Agreement were not implemented in Norwegian law Cooperation with other authorities, laboratories and stakeholders Compliance with Article 3(3) of Directive 2003/99/EC could not be fully assured, since the cooperation and the flow of information between the NFSA other organisations involved was not fully functioning The NFSA informed on corrective measures taken and due dates for issues still outstanding in its comments to the draft report. See Point 8.1 in Annex The NFSA informed on corrective measures taken and due dates for issues still outstanding in its comments to the draft report. See Point 8.2 in Annex 3.