Final report. EFTA Surveillance Authority Mission to NORWAY October 2005

Transcription

1 Brussels 17 February 2006 Case No: Event No: Final report EFTA Surveillance Authority Mission to NORWAY October 2005 examining the application in Norway of EEA legislation concerning contingency plans for epizootic diseases, in particular foot and mouth disease and classical swine fever Comments from the Norwegian Competent Authority provided in the Addendum. Some of the comments are also included in the report in underlined italic. Some of the information in the addendum was provided in Norwegian only. Rue Belliard 35, B-1040 Brussels, tel: (+32)(0) , fax: (+32)(0) ,

2 Page 2 Contents Page List of abbreviations and terms used in the report Introduction Objectives of the Mission Legal basis for the Mission Other relevant legislation National legislation Background Animal health Main findings National Competent Authorities General information Organisation, legal powers and budgetary allocations Duty outside office hours Cooperation/communication with other national authorities Farm registration, animal identification and registration of animal movements Implementation of contingency plans Legal powers Financial and human resources Central decision-making unit National disease control centre Local disease control centre Expert groups Emergency vaccination programmes Training programmes/disease awareness campaigns Real-time alert exercises Disposal of animals and animal products Procedures for reviewing/updating the contingency plans National reference laboratory National reference laboratory for foot and mouth disease National reference laboratory for classical swine fever Diagnostic teams Section for Pathology Section for Epidemiology Establishments and farms visited Final meeting Conclusions Registration of establishments, identification of animals and registration of animal movements Implementation of contingency plans Expert groups Emergency vaccination programmes Training programmes/disease awareness campaigns National reference laboratory Recommendations to the competent Norwegian authority Addendum: The Norwegian Food Safety Authority's comments to the draft report... 25

3 Page 3 List of abbreviations and terms used in the report Ab-ELISA Ag-ELISA ACP Authority BVD BVDV CA CP CRL CSF DO EEA EEA Agreement EU FAT FMD HO HPAI LDCC MAF MFCA MHCS NCAF NDCC NFSA NPLA NRL NVI OIE PCR PMQ RO RT-PCR Antibody ELISA Antigen ELISA Administrative Contingency Plan EFTA Surveillance Authority Bovine Virus Diarrhoea Bovine Virus Diarrhoea Virus Competent Authority Contingency Plan Community Reference Laboratory Classical swine fever District Office of the NFSA (Distriktskontor) European Economic Area Agreement on the European Economic Area European Union Fluorescent antibody test Foot and mouth disease Head Office of the NFSA (Mattilsynets hovedkontor) Highly pathogenic avian influenza Local disease control centre Ministry of Agriculture and Food (Landbruks- og matdepartementet) Ministry of Fisheries and Coastal Affairs (Fiskeri- og kystdepartementet) Ministry of Health and Care Services National Centre of Animals and Food (Nasjonalt senter for dyr og animalsk mat) National disease control centre Norwegian Food Safety Authority (Mattilsynet) Neutralising peroxidase-linked assay National Reference Laboratory National Veterinary Institute (Veterinærinstituttet) Office International des Épizooties/World Organisation for Animal Health Polymerase Chain Reaction Pre-mission questionnaire Regional Office of the NFSA (Regionkontor) Reverse Transcription-Polymerase Chain Reaction

4 Page 4 1 Introduction The Mission took place in Norway from 17 October to 21 October The Mission Team comprised two inspectors from the EFTA Surveillance Authority (the Authority) and a national expert. The opening meeting of the Mission was held on Monday 17 October 2005 at the Norwegian Food Safety Authority's (NFSA) (Mattilsynet's) Head Office (HO) in Oslo. At that meeting, the representatives of the NFSA, which is the Competent Authority (CA), and of the National Reference Laboratory (NRL) (the Norwegian National Veterinary Institute (NVI) (Veterinærinstituttet)), provided information in addition to that provided in the Norwegian reply to the Authority's pre-mission questionnaire (PMQ). Throughout the Mission, two representatives of the NFSA, one from the HO and one from the National Centre for Animals and Food (NCAF) (Nasjonalt senter for dyr og animalsk mat), accompanied the Mission Team. In addition, representatives from the relevant regional offices (ROs) and the district offices (DOs) of the NFSA participated in the meetings at the ROs and in visits to the establishments and farms visited by the Authority. A final meeting was held at the HO of the NFSA in Oslo on 21 October The Mission Team presented the main findings and some preliminary conclusions from the Mission at this meeting. 2 Objectives of the Mission The main objective of the Mission was to assess the application of the requirements of Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (Council Directive 2001/89/EC), Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-andmouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Council Directive 2003/85/EC) and related legislation (see Chapter 3 and 4) by the Norwegian CA. Particular focus was placed on the management, structures and procedures which have been put in place in Norway to give effect to the contingency plans (CPs) for epizootic diseases for which these Acts provide, focusing in particular on foot and mouth disease (FMD) and classical swine fever (CSF). The meetings with the CA and other authorities and the visits to the establishment, laboratory and farms undertaken during the Mission are listed in Figure 1 below.

5 Page 5 Figure 1: Competent Authority, establishments, farms, and laboratories visited during the Mission Number Comments Competent Authorities 8 Two meetings with the HO (opening and closing meeting), one meeting with the NDCC, two with ROs (Representatives from DOs, the NCAF and the cattle database attended meetings in the ROs), one meeting with the expert group and two meetings with representatives of the county administration and with the police. Laboratories 1 The National Reference Laboratory for CSF and other list A diseases except FMD. Farms 2 One farm with cattle and sheep, and one pig farm Auction market/assembly 1 Adjacent to the slaughterhouse visited centre Establishment 1 Slaughterhouse approved for slaughtering cattle, sheep and pigs 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 Agreement on the European Economic Area (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 3.1.1(a) of Chapter I of Annex I to the EEA Agreement, Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC, as adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. d) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever, as adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement and in particular Article 21 thereof. e) 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.

6 Page 6 4 Other relevant legislation a) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-community trade in bovine animals and swine, as amended. b) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-community trade with a view to the completion of the internal market, as amended and adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. c) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-community trade in certain live animals and products with a view to the completion of the internal market, as amended and as adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. d) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease, as amended and as adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. e) The Act referred to at Point 3.1.9(b) of Chapter I of Annex I to the EEA Agreement, Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever, as adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. f) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals, as amended. g) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products. h) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community, as amended. i) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 64/433/EEC of 26 June 1964 on health conditions for the production and marketing of fresh meat, as amended, updated and adapted to the

7 Page 7 EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. j) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-community trade in meat products, as amended and adapted to the EEA Agreement by the sectorial adaptations referred to in Annex I to that Agreement. k) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter or killing. l) The Act referred to at Point 1.1.7(a) of Chapter I of Annex I to the EEA Agreement, Council Regulation (EC) No 820/97 of 21 April 1997 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products (hereafter referred to as Regulation (EC) No 820/97). m) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Regulation (EC) No 2628/97 of 29 December 1997 laying down detailed rules for the implementation of Council Regulation (EC) No 820/97 as regards transitional provisions for the start-up period of the system for the identification and registration of bovine animals, as amended. n) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Regulation (EC) No 2629/97 of 29 December 1997 laying down detailed rules for the implementation of Council Regulation (EC) No 820/97 as regards eartags, holding registers and passports in the framework of the system for the identification and registration of bovine animals, as amended. o) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Regulation (EC) No 2630/97 of 29 December 1997 detailed rules for the implementation of Council Regulation (EC) No 820/97 as regards the minimum level of controls to be carried out in the framework of the system for the identification and registration of bovine animals, as amended. p) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Regulation (EC) No 494/98 of 27 February 1998 laying down detailed rules for the implementation of Council Regulation (EC) No 820/97 as regards the application of minimum administrative sanctions in the framework of the system for the identification and registration of bovine animals. q) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Decision 93/455/EEC of 23 July 1993 approving certain contingency plans for the control of foot-and-mouth disease as amended. r) The Act referred to at Point of Chapter I of Annex I to the EEA Agreement, Commission Decision 91/42/EEC of 8 January 1991 laying down the criteria to

8 Page 8 be applied when drawing up contingency plans for the control of FMD, in application of Article 5 of Council Directive 90/423/EEC. 5 National legislation The Ministry of Agriculture and Food (MAF), the Ministry of Health and Care Services (MHCS) and the Ministry of Fisheries and Coastal Affairs (MFCA) lay down Norwegian animal health, food safety and quality legislation. The main Norwegian Act creating the general framework for the function of NFSA is the Act of 19 December 2003 No 124 relating to Food Safety and Plant and Animal Health (the Food Act). This Act provides the legal basis for the regulations adopted in this field. 6 Background 6.1 Animal health Figure 2 provides information on the last recorded cases in Norway of diseases notifiable to the Office International des Epizootique (OIE) (former list A diseases). Figure 2: Last recorded cases of List A diseases in Norway 1. African horse sickness (never recorded) African swine fever (never recorded) Bluetongue (never recorded) Classical swine fever (1963) Contagious bovine pleuropneumonia (1860) Foot and mouth disease (1952) Highly pathogenic avian influenza (never recorded) Lumpy skin disease (never recorded) Newcastle disease (2003) Peste des petits ruminants (never recorded) Rift Valley fever (never recorded) Rinderpest (never recorded) Sheep pox and goat pox (1882) Swine vesicular disease (never recorded) Vesicular stomatitis (never recorded) The NFSA publishes a yearly report on The Animal Health and Disease Control Status in Norway. In addition, an annual report on Surveillance and control programmes for terrestrial and aquatic animals in Norway is published in co-operation with the NVI. Animal population density is low in Norway when compared to most other EEA States. The swine population density in the most densely populated municipalities of Norway is less than 230 animals per square kilometre. Total animal density is around 400 animals per square km. The density is much lower in most parts of Norway, the median for the swine density being 1,7 animals per square kilometre. 1 If a disease has ever occurred in Norway, the year in which the last recorded case of this disease occurred is given in brackets.

9 Page 9 7 Main findings 7.1 National Competent Authorities General information A Royal Decree of 19 December 2003 delegates the authority that follows from the Food Act to the MAF, the MFCA and the MHCS and defines the division of that authority between the three Ministries. The MAF is responsible for budgetary allocations to the NFSA. It is also responsible for co-ordination of contact between the MAF, the MFCA, the MHCS and the NFSA, and for adopting legislation covering, inter alia, terrestrial animals. The MFCA is responsible for legislation related to aquatic production. The MHCS is responsible for the food legislation found in Chapter XII of Annex II to the EEA Agreement (e.g. contaminants, food additives and labelling) Organisation, legal powers and budgetary allocations The NFSA, established 1 January 2004, is the Norwegian CA for feed, for animal health and plant health issues. It is also responsible for safety and quality of food throughout the production chain. The NFSA is organised into three administrative levels, a central level with the HO, a regional level with eight ROs, and a local level with 64 DOs. The HO, being located in Oslo, is responsible for co-ordinating the organisation's activities. This includes, inter alia, preparation of new legislation, surveillance and eradication of animal diseases, and inspections on farms and at establishments. Of a total of 1300 employees, approximately 130 are located at the HO, 230 at the various ROs, and 940 at the DOs. Five national centres with special competence related to, e.g., animal health, plant health and fish health, and located at different ROs, have been assigned special tasks. The national centres have no legal power. Although they take instructions from the HO, they are administratively organised under their related ROs. The NCAF, located at the RO in Sandnes, is the national centre for terrestrial animals and products of animal origin. Representatives of the NFSA stated during the Mission that, in a crisis situation, some NCAF personnel would be relocated to the national disease control centre (NDCC) in Oslo to participate in the teams leading the contingency operation at national level. The NCAF is also responsible for preparing the CPs for the relevant diseases. In addition, the NCAF's role is to organise training within the NFSA regarding preparedness for contingencies. According to representatives of the NCAF, however, its role in contingency planning is not well defined. According to information provided by representatives of the NFSA, the principal rule is that individual relevant decisions shall be adopted at the local level. Any appeal following these decisions shall be considered at the regional level. The HO establishes the scope of the budget available to the ROs. This is followed by a budgetary process at the ROs in co-operation with the DOs. Within a framework agreed

10 Page 10 with their related RO, the DOs can allocate the budget in the manner most suitable for their district Duty outside office hours Official duty outside office hours has been established at all three levels of the NFSA. At the HO, a 24 hour contingency duty has been established. The DOs organise duty until 22:00 each day, after which the ROs take over until the following day. In one of the ROs visited during the Mission criteria for competence of persons on duty had been established. As suspicion of contagious diseases, animal welfare and import of animals and animal products were considered to be the main issues to be addressed outside normal working hours, it had been decided that only veterinarians were qualified to undertake such duties Cooperation/communication with other national authorities Contact has been established on all levels between the NFSA and other relevant national authorities organised under the Ministry of Justice. At central level the contact is of a general nature. At regional level, contact has been established through the Contingency Council of the County Governor. This contact is more practically oriented. The County Governor can, through its contacts with other authorities and institutions, provide additional resources to the NFSA, if needed. The County Governor has a coordinating responsibility in the county. Its role is, inter alia, to supervise, and give advice and information on issues of emergency planning. It is also involved in handling of crises. A special council, the Contingency Council, consisting of representatives from different CAs (the police, the NFSA and the civil defence) and units within the county administration has been established in order to discuss up-coming problems like communication and distribution of information in crises. Its role in contingency is to harmonise information provided to the public and organise necessary support. The council has extensive knowledge of resources available within the county. The contingency council meets once a year for exercises or meetings. In one of the regions visited, representatives of the County Governor and the police stated that, in principle, confined crises should be handled at the most local level. Crises of a more extensive character should be handled at the regional level, while crises of a comprehensive or extremely serious character should be handled at national level. Exercises are arranged every second year with all the municipalities within the region. Representatives of the County Governor and the police in this region also stated that all necessary obligations concerning handling of crises were laid down in national regulations. The NFSA cannot instruct the County Governor to provide assistance, but the representatives of the County Governor and the police stated that the necessary support would be provided. The County Governor coordinates the activity of the police, the army and the civil defence in such circumstances. The County Governor has no authority over the NFSA. Disagreement between the two authorities is handled by the Ministry of Justice.

11 Page 11 The representatives of the County Governor and the police stated that, in case of an emergency, control posts and cleansing and disinfection units could be established within one hour. The local disease control centres (LDCCs) are able to contact the local police directly in order to get the necessary assistance for blocking roads and closing of areas. The local police have the legal power to initiate all necessary procedures immediately. 7.2 Farm registration, animal identification and registration of animal movements Cattle, sheep, goat and pig farms are registered in the central animal database (Husdyrregisteret). Due to the scrapie situation in Norway, general restrictions on movement of live sheep have been established. Farmers are, inter alia, only permitted to move rams and these only during the breeding season. The only exception to this is the movement of sheep to and from grazing. However, representatives of the NFSA stated that sheep farms with less than 30 winterfed sheep were not registered in any official register. It follows from the relevant national legislation that cattle shall bear two plastic ear tags indicating the holding of birth. In addition, a separate ear tag shall be applied if the place where the animal is kept differs from the place of birth. Sheep and pigs kept for breeding purposes must have one plastic ear tag. Pig farmers are obliged to tattoo all slaughter pigs with the delivery numbers used at the slaughterhouses, at least 24 hours in advance of transport to the slaughterhouse. All farmers have to keep a register of their animals at their farm. Cattle farmers are obliged to notify any movement of bovines to the central cattle database. The Norwegian cattle database is run by a private company. Movements, births and deaths must be notified to the database within seven days of the occurrence of the event. However, at the bovine farm visited, the farmer informed the Mission Team that notifications from the farm were done within one month after occurrence of the event. The sole exception to this was in case of slaughter, which was, according to a procedure introduced recently, notified when the slaughter was ordered. A computer programme had recently been made available to the official veterinarian at the slaughterhouse visited. The programme should facilitate the registration of errors relating to the identification of animals arriving for slaughter. Furthermore, according to documents provided by the NCAF, there was a delay of at least 40 days in the reporting of movements of cattle in 90% of the notifications received. The NCAF administers a database used for keeping information on transport of groups of pigs. Information should be reported by the farmer within seven days. However, according to representatives of the NFSA, the data is less accurate than the reports received about cattle. Representatives of the NFSA also informed the Mission Team that registers kept at sheep and goat farms were not always accurate. The Mission Team observed that the auction markets/assembly centres that were normally located adjacent to a slaughterhouse had not been granted an approval number by the NFSA that was different from that of the slaughterhouse. Furthermore, they did not have unique holding numbers and were not registered individually in the cattle database. They were rather registered as part of a slaughterhouse. In addition, the register at the assembly centre visited by the Mission Team was not accessible through the cattle database. Finally, representatives of the slaughterhouse visited stated that animals arriving at the

12 Page 12 slaughterhouse were sometimes unloaded, kept in the lairage for some hours and, thereafter, reloaded and transported for slaughter at another slaughterhouse. In the reply to the PMQ, the NFSA stated that the relevant EEA legislation had been implemented in Norway. The sole exception to this concerned certain application texts related to ear tags and traceability of live cattle. These are expected to be implemented on 1 December According to a representative of the NCAF, relevant EEA regulations are implemented into Norwegian legislation in the same manner as directives (i.e., not in their original form). This will be amended when Regulation (EC) No 1760/2000 is incorporated into the EEA Agreement. 7.3 Implementation of contingency plans According to the reply to the PMQ, the NFSA has developed an administrative contingency plan (ACP), both at the HO and at each of the ROs and DOs, outlining the chain of command, the organisation of staff/crisis centre, the early warning systems, internal warning systems and procedures for communication. In addition, an operational manual, outlining the specific tasks to be dealt with at each level, was being developed at the time of the Mission. Furthermore, each of the OIE notifiable diseases should have a special CP. The ACPs, the operational manual, and the technical CPs for the different diseases make up the CPs for the notifiable diseases. However, the Mission Team noted during the Mission that the CP for, inter alia, highly pathogenic avian influenza (HPAI) had not yet been prepared. In cases where specific CPs had not been prepared the ROs and the DOs were directed to use the national general instruction for certain OIE list A diseases. Furthermore, for some of the OIE notifiable diseases, CPs from the former CA were still in use. However, these CPs had not been updated following the establishment of the NFSA. The currently applicable plan for CSF dates from 2003 (from the former CA). The plan is, however, expected to be updated by the NCAF before the end of Templates for the ACPs have been made for application by the ROs and the DOs. However, in the regions visited by the Mission Team the ACPs had not been finalised. Furthermore, they did not fully reflect the actual organisation of the NFSA in the region in a contingency situation, since the possibility of establishing sub-units of the LDCC at the DOs was not reflected in the plan. The ACPs were expected to be finalised before the end of In addition, the Mission Team noted that the ACPs, the disease specific CPs and the operational manual were not, in some instances, sufficiently specific on certain issues, inter alia, the list of personnel, the outline of their functions and competence, cleansing and disinfection at zone-borders, the list of disinfectants to be used in case of outbreak of FMD, and detailed procedures for disinfection. The procedures for disinfection and the list of disinfectants were under preparation at the time of the Mission. Furthermore, sites for burial of carcasses have not been decided. The operational manual was under construction and was expected to be finalised before the end of The CPs available for the OIE notifiable diseases are published on the website of the NFSA, along with the main document of the ACP. The ACP procedures and the

13 Page 13 operational manual are not published on the website of the NFSA, but are available internally on the intranet of the NFSA. Finally, complete CPs for CSF and FMD based on currently applicable EEA legislation have not been submitted to the Authority for approval Legal powers The powers granted by the Food Act to the NFSA concerning its function in "peacetime" and during outbreaks of contagious diseases are the same. Farmers, establishments, private veterinarians and others with information on any suspicious case are obliged to notify this to the CA or their private practising veterinarian. The NFSA has the legal power to, inter alia, place restrictions on farms on suspicion of outbreak of contagious diseases, establish necessary control zones, initiate the epidemiological investigation, and initiate emergency slaughter and culling of contact holdings. However, regarding the implementation of Council Directive 2003/85/EC, representatives of the NFSA stated that it was considered necessary to make some amendments to the national legislation in order to clarify the legal basis for certain actions related to, inter alia, risk zones. The NFSA had, therefore, decided to include legal basis in regulations in order to avoid or reduce the number of individual decisions to be adopted on control measures to be taken within the zones established in order to combat outbreaks of FMD. These amendments had not yet been adopted at the time of the Mission Financial and human resources According to representatives of the NFSA, financial resources for handling a contingency situation are secured through an emergency fund administered by the MAF. The necessary financial resources can be released by a request from the NFSA based on a confirmed outbreak of an OIE notifiable disease. In addition, representatives of the NFSA stated that measures regarding increased levels of awareness due to outbreaks of OIE notifiable diseases in neighbouring countries would be financed through the emergency fund and that initial measures in case of suspicion would be financed through NFSA's own funding. The NFSA has the legal power to request the services of private veterinarians in a contingency situation in addition to the possible relocation of resources within the NFSA. The RO of the most densely populated animal area in Norway had evaluated the need for human resources in a contingency situation. The outcome of the evaluation had been taken into account in the CPs Central decision-making unit Procedures for establishment of a central decision making unit with the relevant persons listed had been included in the operational manual. However, the Mission Team noted that the Chief Veterinary Officer was not listed as a member of this unit National disease control centre The NDCC is located at the HO in Oslo. The NDCC is equipped with fax, telephones, laptops and maps of Norway. However, telephone lines were not reserved for specific communication. Representatives of the NFSA stated that the NDCC could be established within two hours and could be expanded to provide office facilities as needed.

14 Page 14 A shared electronic daily journal is to be established before the end of the The use of electronic maps is under evaluation within the NFSA and a solution is expected to be in place by the end of Some of the required lists, such as a list of staff and other persons who may be called upon immediately that outlines their competence and contact lists, were not fully established. A representative of the NVI stated that the system for communication between the NVI and the NDCC needed to be updated to address weaknesses that had been observed during an exercise on FMD conducted in September Local disease control centre The NFSA stated in the reply to the PMQ, that location of the LDCC in the eight ROs of the NFSA or in one of the 64 DOs was foreseen. This would depend on the geographical location of the outbreak to be contained. In the regions visited by the Mission Team, the physical location of the LDCC was foreseen at the RO. However, representatives of one of the ROs visited stated that it was possible to establish a LDCC in any of the DOs. The RO, normally organised in two units, a disease unit and an administrative unit, would, during outbreaks of contagious diseases, be organised in three units. These would be an information unit, an epidemiology unit and a disease sanitation unit. This way of organising a LDCC was not typical for all the ROs. In the two regions visited, none of the staff would be designated to deal solely with a crisis. In one of the two ROs visited, the representatives stated that no plans as to how to allocate staff from other regions in case of an outbreak of FMD had been prepared. They acknowledged that there was a need to define the tasks of personnel at the office more clearly. In the ROs visited, a list of all farms was not available. A number of accessible registers contain relevant information. However, these were not necessary reliable for the purpose of handling a contingency situation. Furthermore, organisation of phone lines, back up of files and IT-support was still to be considered in at least one of the ROs visited. During a recent FMD exercise, dedicated addresses were established in order to facilitate the handling of the crisis. It was to be considered whether to include this as part of the contingency plan. Representatives of the ROs visited stated that the LDCCs at the ROs could be established immediately. The ACP was available in both electronic form and in paper versions at the ROs. However, procedures for establishing the LDCC outside the RO were not established. A DO representative in one of the ROs visited stated that there was a need to revise the ACP in order to ensure that the plan was in accordance with the actual organisation of the LDCC with sub-units at the DOs. This organisation of the staff was not reflected in the current ACP. During an FMD exercise in September 2005, the DO had established a local administrative unit with its own operation room. Representatives of the NFSA stated that epidemiological teams would be established within the regions. These teams would consist of veterinarians specially trained in basic epidemiology for carrying out epidemiological surveys at holdings at risk. At least one of these specially trained veterinarians would be located in each of the eight ROs and in the 64 DOs. In addition, specially trained veterinarians would be located at the HO and within

15 Page 15 the NCAF. Epidemiological teams were established in the regions visited during the Mission. In one of the ROs visited, it was estimated that each veterinarian could visit four to five farms a day during outbreaks. However, the Mission Team noted that a detailed list of personnel, outlining their competence, had not been established in any of the ROs visited. Furthermore, no plans for recruiting people had been decided on and no list of technical personnel, such as slaughterers, had been established. Recruitment of additional administrative personnel from other ROs and from the County Governor was foreseen. However, in at least one of the ROs visited procedures for contacting the County Governor or the police outside office hours were not described in the plan. In one of the regions visited, equipment was stored in four storage sites at different locations within the region. An emergency box or boxes were stored at every DO. Inventory lists were accessible in the regional ACP. In the other regions emergency boxes were stored at every DO Expert groups Permanently operated expert groups have been established for both FMD and CSF. The groups consist of experts in Virology, Serology, Pathology, Epidemiology and Clinical veterinary medicine. The persons in the expert groups are specified in the CPs. The expert groups assist the NFSA in decisions to be taken and evaluate data collected in the field. However, the role of the expert group in cases of suspicion, or in case of a confirmed outbreak of FMD or CSF, has not been fully specified. Representatives of one of the groups stated that further clarification of the role and organisation of the groups' work was necessary in order to improve their effectiveness and the beneficial output from the group Emergency vaccination programmes Norway does not hold any reserves of FMD vaccine. In the reply to the PMQ, the NFSA informed the Mission Team that it would, as regards vaccination against FMD, rely on access to the Community antigen and vaccine bank. However, that access has not been formalised and a clear and concise description of the routines for accessing the bank is not in place. Access to the Community antigen and vaccine bank for FMD virus was, at the time of the Mission, under evaluation. Following a request from the NFSA, the NVI made an assessment of emergency vaccination in case of an outbreak of FMD. The assessment comprised a decision tree on when to introduce vaccination and an estimate on the number of doses required in given scenarios. This assessment will be used as a basic decision tool on emergency vaccination in case of an outbreak of FMD. However, the assessment did not take into consideration, inter alia, the need for personnel and equipment, logistics and training of personnel. The Mission Team noted that the chapter within the CP on vaccination against FMD has not been finalised and that, inter alia, procedures for preparation of documents related to vaccination and communication between the NFSA and the Authority are in the process of

16 Page 16 being updated. Furthermore, procedures concerning the logistics of vaccine distribution and storage had not been finalised. In addition, contacts/contracts with suppliers of equipment and utensils had not been formalised and criteria for the quality of, inter alia protective clothing and criteria for disposal of utensils were not decided on. Additionally, prophylactic procedures on bio-safety with regard to movements of the vaccination teams in and out of holdings had not been formalised. Finally, special ear tags for identifying vaccinated animals had not been decided on. However, representatives of the NFSA stated that three enterprises in Norway could supply the necessary equipment for vaccination within two to five days. Representatives of the NFSA also stated that there was no intention to introduce emergency vaccination as a control measure in case of an outbreak of CSF Training programmes/disease awareness campaigns According to the reply to the PMQ, it is the responsibility of the HO to ensure appropriate training for the staff of the CA. The NCAF, as part of the HO, organised a course on epidemiology, clinical signs and contingency plans for key personnel in the NFSA in spring However, details concerning further training of personnel were not included in the CPs. General information on FMD is provided on the NFSA's website. Training of farmers, industry, etc., is the responsibility of the RO. Representatives of one of the DOs visited informed the Mission Team that education concerning contagious diseases had been provided to private practising veterinarians in the district. However, both representatives of the ROs and the DOs participating in the meetings during the Mission stated that awareness programmes had not been formalised within the NFSA and that procedures for awareness programmes had not been established in the CPs. Two suspicions on CSF proved unfounded in 2002 and one on FMD. One false serological reaction for CSF was identified in Since then, no suspicion has arisen for these two diseases Real-time alert exercises Since January 2004, three real-time alert exercises have been conducted. A field exercise on CSF was initiated by the MAF in June In 2005, two exercises were conducted. The first, on BSE in June, tested the communication between the different levels of the NFSA and the three ministries. It also rehearsed the cooperation with the industry and the National reference laboratories - both on animal and human health. The second, on FMD, was held in co-operation with the other Nordic countries in September. The Mission Team noted that the notifications of the outbreak to the Authority and to the Commission to be used in the exercise were in Norwegian. The Mission Team observed that experience gained during the exercise on FMD was being used to update the CP. Furthermore, the NFSA stated in the reply to the PMQ that the ROs were supposed to conduct their own exercises. However, in the ROs visited, own-initiative alert exercises had not been performed.

17 Page Disposal of animals and animal products In one of the regions visited destruction of carcasses in rendering plants was considered as the method of choice. The second best option was considered to be burial. Two incineration plants were located in the region. Names of contact persons from the plants and mobile phone numbers were in the ACP of the RO. However, neither a contact nor a contract with any of these plants had been formalised 2. Sites for burial had not been identified, but were expected to be identified during outbreaks, taking into account the actual location of the outbreak. In the region mentioned in the paragraph above the capacity of the rendering plants was limited. Burial would, thus, have to be initiated at an early stage of an outbreak. In the other region visited the method of choice was considered to be burial as close to the affected farm as possible. However, sites for burial had not yet been decided upon Procedures for reviewing/updating the contingency plans In the reply to the PMQ, the NFSA stated that all three levels (the central level, the regional level and the local level) were involved in updating the CPs. This task also included the national centres that were responsible for keeping the CPs up to date. One person at the HO is responsible for co-ordinating work related to contingency plans. The ROs and the DOs are responsible for preparation and up-dating their own ACPs. The NCAF is responsible for, inter alia, up-dating of the CPs for terrestrial animals. Tasks delegated to the NCAF in 2005 were, inter alia, to prepare or up-date CPs for FMD, CSF, HPAI, Newcastle disease (ND) and bovine spongiform encephalopathy (BSE). Furthermore, the NCAF has been assigned responsibility for up-dating the list of disinfectants to be used in case of outbreak of FMD. Not all of these tasks were, however, finalised. According to the CPs, up-dating shall at least take place every third year. In addition, the CPs should be revised after real-time alert exercises, after outbreaks and if there are changes in the legislation. At the HO and both the ROs visited by the Mission Team, the ACP was in the process of being updated following experiences gained during the exercise on FMD carried out in September Persons responsible for updating of the plans had been identified. 7.4 National reference laboratory The NVI is a governmental agency, funded by the MAF, the MFCA and the Norwegian Research Council. In case of a contingency, emergency funds are available which will cover additional costs thus incurred. The institute consists of a central laboratory located in Oslo and regional laboratories located in Sandnes, Bergen, Trondheim, Harstad and Tromsø. There are approximately 310 employees in total. In an emergency situation, the primary role of the regional laboratories will be to collect samples to be transported to the central laboratory in Oslo. 2 See comments from the NFSA in the Addendum.

18 Page 18 The NVI in Oslo consists of four departments and comprises NRLs for different diseases notifiable to the OIE, one of which is the NRL for CSF. The formal approval of the NRL by the CA has not, however, yet been achieved as this was postponed to The NVI's quality assurance system has been accredited by the Norwegian accreditation body. However, the procedures and methods for diagnosing CSF have not yet been accredited. A process for accreditation has been initiated and it is envisaged that accreditation might be achieved within In addition to a general ACP, CPs exist for different contagious diseases (e.g. CSF, FMD) or are under construction (HPAI). These CPs are not yet fully approved and incorporated into the system, but this is expected to be finalised before the beginning of Representatives of the NVI stated that, during the recent exercise on FMD, the exchange of information between the NRL and the NFSA, and the keeping of records of the information exchanged between the CA and the NVI had not been satisfactory. However, the necessary procedures would be updated National reference laboratory for foot and mouth disease In the reply to the PMQ, the NFSA stated that, according to the Norwegian Food Act, the NVI is the NRL for all list A diseases. However, according to the EEA Agreement, the NRL for FMD is the Danish Veterinary Institute, Department of Virology, Lindholm in Denmark. Diagnostic samples for testing on FMD virus cannot, for the time being, be examined in Norway. A P3 laboratory is currently under reconstruction and will be completed before the end of The NVI will then seek approval of diagnostic work in relation to FMD from the NFSA. A possible designation of the NVI as the NRL for FMD requires updating of the EEA Agreement. According to a written agreement with the NRL in Denmark, diagnosis and differential diagnosis on FMD will be performed there. The NVI had also concluded a written agreement with a company specialised in transport of dangerous goods for the delivery of samples to the Danish NRL. Transport of samples within Norway and on to Denmark was considered by the NVI to be critical and could cause considerable delay in the diagnostic work. Measures to reduce the delivery time of urgent samples had not been decided on at the time of the Mission. The Mission Team noted that cooperation with the NRL in Denmark had not been formalised in a mutual agreement between the CAs of the two EEA States National reference laboratory for classical swine fever The laboratory was well equipped and well organised for the diagnostic tests to be carried out on a routine basis. It uses the diagnostic tests laid down in the relevant legislation (Commission Decision 2002/106/EC) (see Figure 3) and has participated in proficiency testing for the diagnosis of CSF (virological, serological and molecular biological techniques) for several years with satisfactory results. 3 See comments from the NFSA in the Addendum

19 Page 19 Virus Genome Antigen Antibody Figure 3: Methods available for the diagnosis of CSF Methods Virus isolation RT-PCR and consecutive sequencing Ag-ELISA (BVDV, panpesti) (FAT) NPLA Ab-ELISA Comments Also real-time RT-PCR available Not specific for CSFV nor for BVDV, panpesti Ag-ELISA Not routinely used, examinations are performed by pathologists Also used for differential diagnosis of BDV and BVDV The personnel was well trained for the tasks assigned to the NRL and a list of each person's competence was available. However, during the visit by the Mission Team it was noted that there were two different documents providing the information (a paper version and a computerised version) with different content. Further education and training on different diagnostic techniques is organised for the personnel. The representative of the NVI stated that efforts had been made to circulate the personnel within the laboratory in order to ensure that the analysing staff is acquainted with the various analysing methods. A representative of the NRL stated that, in case of an outbreak of a contagious disease, it would be possible to relocate staff from other sections of the NVI or from the regional laboratories to the NRL, under the prerequisite that they were trained in the methods, and had the competence to carry out certain tasks. However, it would be difficult to enlarge the molecular biological team as strict safety requirements preventing contamination of the samples had to be fulfilled. In addition, special training would be necessary for the staff using the Polymerase Chain Reaction (PCR) method. Contacts have also been established with other Scandinavian countries. However, at the time of the Mission there was no agreement on the exchange of personnel and no plan was available concerning how the laboratory would be reorganised in a crisis situation. Upon arrival at the laboratories, all samples are registered in the NVI's software system with a unique number. The software system is shared between the regional laboratories and the laboratory in Oslo. The laboratory was prepared to handle primary outbreaks and a smaller amount of secondary outbreaks of a contagious disease, but no precautions had been taken for an epidemic situation. Information on capacity of the NRL for CSF is given in Figure 4.