Declaration of disease-free status of compartments in accordance with Council Directive 2006/88/EC

Transcription

1 Selfoss, December 16 th 2015 Reference: Mast EFTA Surveillance Authority Rue Belliard 35 B-1040 Brussels Belgium Subject: Declaration of disease-free status of compartments in accordance with Council Directive 2006/88/EC Application is made to the EFTA Surveillance Authority (ESA) regarding approval of a disease-free status for a modified area regarding viral haemorrhagic septicaemia (VHS) with legal basis in conditions laid down in Part II of ANNEX V of Council Directive 2006/88/EC. 1. Applicant (EFTA-Country): Iceland Stofnfiskur Ltd.: Two brood fish landbased farms for Atlantic salmon and connected hatchery and smolt farm: 1) Kalmanstjörn ( 'N, 'W) 2. The geographical zone concerned: 2) Vogavík ( 'N, 'W) 3) Kollafjörður ( 'N, 'W) Arctic Land Ltd.: One brood fish landbased farm for Arctic char: 4) Fiskalón ( 'N, 'W) 3. Competent government agency: The Icelandic Food and Veterinary Authority 4. Date of submission: December 16 th Animal species: Atlantic salmon (Salmo salar L.) Arctic char (Salvelinus alpinus) 6. Disease: Viral haemorrhagic septicaemia (VHS) 7. Relevant legal basis: 2006/88/EC Attached papers: 1) Annex 1: Map of Iceland with focus on Reykjanes peninsula and neighbouring area with the relevant farms of Stofnfiskur Ltd. (Kalmanstjörn, Vogavík and Kollafjörður) and Arctic Land Ltd. (Fiskalón). 2) Annex 2: Bird s eye view of the main Atlantic salmon brood fish farms; Kalmanstjörn and Vogavík. 3) Annex 3: Screening report - Total samplings at Stofnfiskur with focus on ) Annex 4: Screening report - Total samplings at Arctic Land with focus on

2 Introduction Fish disease control measures in Iceland FISH HEALTH STATUS IN ICELANDIC AQUACULTURE The general fish health status in Icelandic aquaculture is favourable. The main reasons for that, in our opinion, is the geographical isolation of the country, strict import policy, secure water supply for the farms and effective fish health surveillance. Icelandic hatcheries rearing fingerlings to the smolt stage are using "pathogen free" ground water without any presence of wild fish and the land based on-rearing farms have all access to filtered seawater from bore holes. The brood stocks are kept in secure land based farms the whole live cycle. All infectious diseases of concern in the aquaculture industry are of bacterial origin. There has never been detected any clinical viral fish disease at all and no clinical symptoms have ever been seen that could indicate that type of disease up to date. Iceland was approved as VHS-free country in 2004 but on 19 October 2015 VHSV was detected for the very first time in routine screening of wild caught lumpfish. The fish were supposed to be used as parents for cleaner fish juveniles used against salmon louse in sea-cage farming. Until the lethal samplings were performed, the wild brood fish were kept for a few weeks in a closed land based facility owned by the Marine Research Institute. The fish never showed any clinical symptoms. After detection and confirmation of the virus with RT-PCR at the European Union Reference Laboratory for Fish Diseases in Denmark all lumpfish at the farm were killed and destroyed for security reasons. The sequence has been trimmed and blasted towards the other known genotypes. Interestingly it appears that the lumpfish VHSV cluster in a separate new group in GIV, maybe as a new GIVd? Therefore, the finding might more reflect a totally new appearance of VHSV and not an introduction of VHSV from e.g. USA or Canada. FISH HEALTH SURVEILLANCE All Icelandic fish farms have been included in the official national health control programme since The surveillance also includes farms dealing with wild salmonids. From 1993 European Union (EU) Directives on disease control measures have been followed. The surveillance is partly by regular "on-site" health inspections, under the supervision of the Veterinary Officer for Fish Diseases, and partly by laboratory work conducted at the National Fish Disease Laboratory at Keldur in Reykjavík, which has a close co-operation with the EU Reference Laboratory on virus diseases in Denmark. The Icelandic authority is also using diagnostic services given by the Food, Veterinary- and Environmental Agency, Department of Fish and Animal Diseases in Torshavn, Faroe Islands and to some extent the National Veterinary Institute in Oslo, Norway and PatoGen Analyse A/S in Ålesund, Norway. The sampling and diagnostic methods regarding viral examination has been a long the lines given in Commission Decision 2001/183/EC, including relevant amendments. Screening of important virus agents causing serious infectious diseases, like Infectious salmon anaemia (ISA), Pancreas disease (PD), Infectious pancreatic necrosis (IPN), Cardiomyopathy 2

3 syndrome (CMS), Viral haemorrhagic septicaemia (VHS) and Infectious haematopoietic necrosis (IHN) has been a big part of the surveillance program. Until spring 2009 the diagnostic methods were mainly based on EPC, BF-2 and CHSE-214 cell-lines in the routine screening, in addition with clinical signs, gross pathology and histopathological examination of vital organs. In the beginning of May 2009 it was started up with examination of ISA and PD (and also of IPN and CMS to big extent) by Real-time RT- PCR technique and almost all stripped males and females in brood stock salmon farms have been tested for those diseases since then. FISH DISEASES DIAGNOSED THE LAST 10 YEARS Annual incidence of new outbreaks; number of farms: Fish disease: Atyp. furunculosis 2* 2* # 7* # 6* # 6* # 7* # 7º* # 7* # 9* # 8* # BKD 0 2* 0 0 2* 1º 0 0 1º 4º* Classical vibriosis # 2 # 3 # 2 # 3 # 4 # 2 # 3 # Cold water vibriosis Enteric Redmouth 0 0 1* 1* 1* 3*º 1 # 2* # 1* 2º # Winter ulcers 2 # 3 2 3* ISA, IHN, IPN, CMS and PD VHS 1 # * On-growing farm - land based (salinity: ) On-growing farm - sea cages (full salinity) º Hatchery/smolt farm (fresh water) # Marine species (full salinity) MONITORING OF CERTAIN FISH DISEASES BY SYSTEMATIC SAMPLING OF THE FARMED FISH POPULATION IN ICELAND Viral Haemorrhagic Septicaemia (VHS) Objective: The purpose of the surveillance is to document freedom from VHS. Historical overview: VHSV was for the first time detected in routine screening of wild caught lumpfish on October 19 th It is a notifiable disease, according to Act no. 25/1993. Routine sampling has been performed since Diagnosis: Method: EPC and BF-2 cell-lines are used routinely. Organs tested: Ovarian fluid and/or internal organs; kidney, heart and spleen. Laboratory: The national fish disease reference laboratory at the Institute for Experimental Pathology at Keldur in Reykjavik, Iceland. During the year 2015 MAST has taken totally 753 samples from 13 farms for VHS (and IHN/IPN) analysis. All farms dealing with salmon of wild origin are included in the samplings (4 farms with 250 samples). The rest of the samples have been taken from salmon, trout, cod, lumpfish and senegal sole, both in land based farms and sea-cage farms. All these samples are already analyzed with a negative outcome (except the positive lumpfish samples). 3

4 Year Number of individuals sampled Number of samples analyzed for VHS since 1985: Number of farms sampled Number of negative samples Number of positive samples Respectfully; ANNEX IV Gísli Jónsson Veterinary Officer for Fish Diseases 4

5 Model for submissions of applications for and declarations of disease-free status Requirements/information needed Information/further explanation and justification 1. Identification of the programme 1.1. Declaring Member State ICELAND 1.2. Competent authority (address, fax, ) 1.3. Reference of this document 1.4. Date sent to the Commission The Icelandic Food and Veterinary Authority Austurvegur 64, 800 Selfoss. Website: Mast December 16 th Type of communication 2.1. X Declaration of disease-free status 2.2. Submission of application for disease-free-status 3. National legislation 1 Acts: Act no. 71/2008 on Aquaculture. Act no. 60/2006 on Prevention Measures Against Fish Diseases. Act no. 66/1998 on Veterinarians and Animal Health Services. Act no. 25/1993 on Animal Diseases and Preventive Measures against them. 4. Diseases Regulations: Regulation no. 401/2012 on Aquaculture. Regulation no. 1254/2008 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals, with later amendments (Dir. 2006/88/EC) Fish X VHS IHN ISA KHV 4.2. Molluscs infection with Marteilia refringens infection with Bonamia ostreae 4.3. Crustaceans White spot disease 1 National legislation in force applicable to the declaration of and application for disease-free status. 5

6 5. Grounds for disease free-status 5.1. X No susceptibles 2 According to listed diseases in ANNEX IV, PART II of Directive 2006/88/EC, both Atlantic salmon (Salmo salar L.) and Arctic char (Salvelinus alpinus) are not defined as susceptible species regarding VHSV and neither of the species are possible vector species in accordance with ANNEX I of Regulation No. 1251/2008/EC Pathogen not viable Historic free-status X Targeted surveillance 5 Method: EPC and BF-2 cell-lines. Organs tested: Kidney + heart + spleen or ovarian fluid. Laboratories: The national reference laboratorium in fish diseases at the Institute for Experimental Pathology at Keldur, Keldnavegur 3, 112 Reykjavik, Iceland. 6. General information The fish disease laboratory at Keldur is accredited as a testing laboratory for detection of Viral haemorrhagic septicaemia virus (VHSV) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) Competent authority 6 In January 1 st 2006 a new Competent Authority (CA) was established in Iceland, with the provisions of the Act no. 80/2005, in the field of food safety, animal health and welfare, control of feed, seed and fertilizers, plant health and water for human consumption The Icelandic Food and Veterinary Authority (Icelandic name: Matvælastofnun MAST). The primary roles of the authority are: 2 Applicable if none of the species susceptible to the disease(s) in question is present in the Member State, zone or compartment, and where relevant in its water source. 3 Applicable if the pathogen is known not to be able to survive in the Member State, zone or compartment, and where relevant in its water source. Provide the scientific information supporting the inability of the pathogen to survive in the Member State, zone or compartment. 4 Applicable if susceptible species are present, but where there has not been any observed occurrence of the disease for at least a period of 10 years before the date of declaration of or application for the disease-free status, despite conditions that are conducive to its clinical expression, and if it complies mutatis mutandis with the requirements laid down in Part I.1. of Annex V to Directive 2006/88/EC. This ground for disease-free status must be declared of or applied for by 1 November Provide detailed information on the compliance with Part I.1. of Annex V to Directive 2006/88/EC. 5 Applicable if targeted surveillance complying with Community requirements has been in place for at least a period of two years without the detection of the disease agent on farm, or in mollusc farming areas that rears any of the susceptible species. Where there are parts of the Member State, zone or compartment in which the number of farms or mollusc farming areas is limited, but in which there are wild populations of susceptible species, information on the targeted surveillance in those wild populations shall be given. Describe diagnostic methods and sampling schemes. When OIE or EU standards are applied, reference must be made to them. If not, describe them. Name the laboratories involved in the programme (National reference laboratory or designated laboratories). 6 A description shall be provided of the structure, competencies, duties and powers of the competent authority involved. 6

7 Food safety, control of primary production of animal products, including fish products, import and export control of all foodstuffs. Supervision of domestic food control by municipal authorities. Veterinary services, including regular and targeted surveillance of all Icelandic fish farms. Authorisation of aquaculture production businesses and audits to follow up that all requirements are fulfilled in accordance with the license. Plant protection services. Feed, seed and fertilizer services. Meat classification services. Administration of organic production of agricultural products. Management, monitoring of supplies and surveillance of animal welfare. MAST is assigned to carry out various inspection and administrative tasks pursuant to law and has taken over the tasks that have been carried out by the following authorities: The Agricultural Authority of Iceland (Chief Veterinary Officer (CVO), Feed, Seed and Fertilizer Services, Meat Grading, Plant Protection Service, Organic production, Administrative tasks carried out by the Farmers Association of Iceland) The food division of the Environmental and Food Agency of Iceland The food division of the Icelandic Directorate of Fisheries The Authority is responsible to the Ministry of Industries and Innovation (former Fisheries and Agriculture). The Chief Veterinary Officer (CVO) is the head of the Office for Animal Health and Welfare of MAST (see organizational chart). The headquarters of MAST is placed in Selfoss, about 50 km east of the capital city of Reykjavík. The Authority has 6 District Offices around Iceland where District Veterinarians and Official Veterinarians render services in accordance with the relevant legislation. At the District Office in the capital area MAST is responsible, in addition to veterinary services, inter alia, for services to individuals and businesses engaged in import and export. MAST is also responsible for operation of Border Inspection Posts (BIPs) for control of import of live animals and animal products from third countries. 7

8 Surveillance of fish diseases 6.2. Organisation, supervision of all stakeholders involved in the programme to achieve disease free status An overview of the structure of the aquaculture industry in the area in question (disease-free Member State, zone or compartment) including types of All Icelandic fish farms have been included in the official national health control programme since The surveillance also includes farms dealing with wild salmonids. From 1993 European Union (EU) Directives on disease control measures have been followed. The surveillance is partly by regular "on-site" health inspections, under the supervision of the Veterinary Officer for Fish Diseases, and partly by laboratory work conducted at the official Fish Disease Laboratory at Keldur in Reykjavík which has a close co-operation with the EU Reference Laboratory on fish diseases in Denmark. Mast is also using diagnostic services given by the National Veterinary Institute and PatoGen Analyse A/S in Norway and the Food, Veterinary- and Environmental Agency, Department of Fish and Animal Diseases in the Faroe Islands. 1. Stofnfiskur Ltd. is operating two on-growing brood fish farms in the area of Reykjanes peninsula (See a map of locations in Annex I). For security reasons the Atlantic salmon brood stock of Stofnfiskur are kept at two separated landbased sites with approx. 20 km distance between. Kalmanstjörn brood stock site has been the main site since 1991 and Vogavík brood stock site was taken into operation in (See a bird s-eye view of the farm sites in Annex II). Both farms are 7 A description shall be provided of the competent authority in charge of the supervision and coordination of the programme and the different operators involved. 8

9 production and species kept closed landbased farms supplied exclusively with filtered fresh- and seawater from boreholes ( meter deep in the earth) without any presence of wild fish and no livestock or gonadal products of a lower health status have been taken into the sites. All smolt for future brood fish at the sites are coming from Stofnfiskur s own fresh-water site in Kollafjörður which is located approx. 20 km outside the Reykjanes peninsula (hatchery, rearing fingerlings up to smolt stage since 1991). Kollafjörður is exclusively supplied by secure ground water without any access of wild fish. Eggs for hatching are only received from family groups in own brood stock farms. No other fish farms in the zone of Reykjanes peninsula are raising Atlantic salmon. 2. Arctic Land Ltd. is operating a brood fish farm at Fiskalón, which is located a little bit outside the Reykjanes peninsula (See Annex I). Fiskalón has been one of the two main brood stock sites for Arctic char in Iceland since 2007 and before that an ordinary ongrowing Arctic char farm. The farm is landbased and exclusively supplied by secure ground water without any access of wild fish. Eggs for hatching are only received from family groups from own brood stock. Other aquaculture establishments in the Reykjanes peninsula and the immediate vicinity (totally 9 farms) are also landbased farms; five of them are on-growing farms with Arctic char, two salmon smolt farms, one on-growing farm for Senegal sole (Solea senegalensis), one lumpfish farm and one small research farm which is a former lumpfish farm but is now empty because of the VHS detection. No sea-cage farming is allowed offshore in the area of Reykjanes peninsula The notification to the competent authority of the suspicion and confirmation of the disease(s) in question has been compulsory since when (date)? Whole Iceland is approved as a disease-free country regarding IHN. The Stofnfiskur brood fish sites are also approved disease-free compartments regarding ISA. VHS has been notifiable since the 18 th of September 1986, according to the regulation no. 403/1986 concerning measures to prevent and control diseases in fish and health inspection of fish farm. Notifiable diseases are arranged into three groups (A, B and C) according to importance. List A diseases: Transmissible diseases which have the potential for very serious and rapid spread and which are of serious socioeconomic importance in the international trade of live fish, eggs and gametes. List A diseases will be met with stamping out procedures as these diseases are considered as exotic in Iceland. Measures are taken immediately and reports submitted to the EU and OIE. List B diseases: Transmissible diseases which are considered to be of socio-economic importance within the country and which are significant in the international trade of live fish, eggs and gametes. Measures are variable, from stamping out to general vaccination. List C diseases: Diseases recorded once a year, no special measures. Viral haemorrhagic septicaemia (VHS) is a List A disease. 9

10 6.5. Early detection system in place throughout the Member State, enabling the competent authority to undertake effective disease investigation and reporting since when (date)? Source of aquaculture animals of species susceptible to the disease in question entering in the Member State, zone or compartments for farming. VHS is a notifiable listed non-exotic disease under 2006/88/EC (Annex IV Part II), and under statute, all fish farms and their representatives are duty bound, under The Act no. 25/1993 on Animal Diseases and Preventive Measures against them (Chapter III, Art. 5) to inform the CA in case of suspicion of the disease or increased unexplained mortality. In accordance with Art. 5 all veterinarians are obliged to be alert and report any suspicion regarding listed diseases to the CA. Furthermore, any person who has reason to believe that an animal is suffering from a contagious disease covered by the act shall immediately report this to any veterinarian who can be reached. The Act no. 71/2008 on aquaculture provides internal control in fish farms which have been developed and followed by the industry and the fish health experts to monitor the health of stock on site. That has been developed to bigger extend on the brood fish farms of Stofnfiskur with a special codes of practice and from June 2010 all practical aspects at the sites have got an approval by the GLOBAL G.A.P. Technical Committee for Aquaculture. All employees at the fish farms of Stofnfiskur must follow an ISO-9001:2008 quality standard of work implemented and approved by the Norsk Veritas. Training awareness is in place via the official fish health veterinarian to ensure that staff at all levels are aware of the clinical signs of VHS and how to report suspicion. Investigation and reporting of disease is achieved through regular inspection of stocks by fish farmers and the veterinary inspector of the Official Service who is always on spot two days a week at the Stofnfiskur farms almost all year around and two times a year at the Arctic Land farm, performing lethal samplings from stripped brood fish. According to Icelandic legislation the CA has a good access to the National Reference Laboratory with the needed facilities for diagnosing and get quick answers from all types of disease testing. Stofnfiskur Ltd.: Eggs for hatching (in Kollafjörður) are only received from own brood stock farms (Kalmanstjörn and Vogavík) and smolts for on-growing are exclusively received back from Kollafjörður. That means that the source of brood fish is from Stofnfiskur s own close circle and no livestock or germplasm products are taken into the sites from other source at all. The origin of the brood stock is from Norway. Imports were allowed 8 The early detection systems shall in particular ensure the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or mollusc farming areas, and in the wild, and the rapid communication of the event to the competent authority with the aim to activating diagnostic investigation with minimum delay. The early detection system shall include at least the following: (a) broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians of aquatic animals health specialists in detecting and reporting unusual disease occurrence; (b) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence; (c) access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases. 10

11 6.7. Guidelines on good hygiene practice 9 7. Area covered by the Icelandic veterinary authorities in 1984 (MOWI-strain) and 1986 (BOLAKS-strain) under strict sanitary requirements closely followed by an official fish disease veterinarian. Eggs, fingerlings and on-growing fish were kept in totally isolation and Stofnfiskur did receive eggs from brood stock of original imports in late In the meantime a lot of virological examinations were made regarding all known viral diseases at that time, VHS included. All tests went out negative and viral fish diseases have never been detected in Iceland up to date, except the VHS virus in the wild caught lumpfish this fall. No clinical symptoms have ever been seen that could indicate those types of diseases so far. Arctic Land Ltd.: The origin of the Arctic char is Icelandic own wild strains from lakes and rivers. The breeding project started up in 1989 with 13 different strains. In 1992 the best individual parents out of the best strains were chosen as the future farming strain. Since then the farming strain has been kept isolated and no livestock or gonadal products of a lower health status have been mixed with the brood fish. Eggs for hatching are only received from family groups from own brood stock. Regulation no. 401/2012 on Aquaculture give guidelines on hygiene practices during suspected or diagnosed animal disease and on the self control, including good hygiene practises in fish farms. Fish farms are inspected to ensure good biosecurity and this will continue to be assessed as part of the risk based inspection regime. Each site of Stofnfiskur and Arctic Land operates good biosecurity practice and is authorised, subject to a biosecurity plan and strict biosecurity measures Member State 7.2. Zone (entire water catchment area) Zone (part of water catchment area) 11 Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area Zone (more than one water catchment area) 12 9 A description shall be provided in accordance with Article 9 of Directive 2006/88/EC. 10 An entire water catchment area from its sources to its estuary. 11 Part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from the lower stretches of the water catchment area. 12 More than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary. 11

12 7.5. X Compartment independent of the surrounding health status 13 Identify and describe for each farm the water supply 14 X Well, borehole or spring Water treatment plant inactivating the relevant pathogen 15 Identify and describe for each farm natural or artificial barriers and justify its capability to prevent that aquatic animals enter each farm in a compartment from the surrounding watercourses. Kalmanstjörn and Vogavík broodstock sites are located in the Reykjanes peninsula with approx. 20 km distance between. Both of them are closed landbased farms supplied exclusively with filtered fresh- and seawater directly with pipelines to the farms from boreholes located in close neighbourhood to the premises ( meter deep). Kollafjörður is a freshwater farm where family smolts for the selective breeding work are made. Freshwater is obtained with pipelines from freshwater wells in the mountains with no access of wild fish. Fiskalón is also a freshwater farm where family groups for the selective breeding work are made. Freshwater is obtained with pipelines from freshwater wells without any access of wild fish. The farm sites of Stofnfiskur and Arctic Land are fenced off with no access of unauthorized persons. The brood stocks of Atlantic salmon (Stofnfiskur) and Arctic char (Arctic Land) have been in closed land facilities for full life cycle. Both Vogavík and Kalmanstjörn are landbased farms with exclusively access of fresh- and seawater from closed and secure boreholes. The wells are completely isolated. The seawater is pumped up from meters deep boreholes in the lava field (35 & C). Freshwater is pumped up from meters deep boreholes in the lava. There is no possibility of access to wild fish in the affluent water. 13 Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is independent of the health status regarding that disease of surrounding natural waters. 14 A compartment which is independent of the health status of surrounding waters, shall be supplied with water: (a) through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or (b) directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe. 15 Provide technical information to demonstrate that the relevant pathogen is inactivated in order to reduce the risk of the introduction of the disease to an acceptable level. 12

13 Identify and describe for each farm the protection against flooding and infiltration of water from the surrounding Kollafjörður hatchery and smolt farm site is exclusively supplied by secure ground water with pipelines from freshwater wells that are lying 250 meters above sea level in the mountains without any access of wild fish. Eggs for hatching are only received from own brood stock farms and Kollafjörður has no connection to other farms. Fiskalón Arctic char site is exclusively supplied by secure ground water with pipelines from freshwater wells without any access of wild fish. Eggs for hatching are only received from own brood stock and the farm has no connection to other farms. There is no possibility of flooding or infiltration of water from the surroundings of neither of the fish farm sites. The boreholes and wells are completely isolated Compartment dependent on the surrounding health status 16 One epidemiological unit due to geographical localisation and distance from other farms/farming areas 17 All farms comprising the compartment fall within a common biosecurity system. 18 Any additional requirements Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status of surrounding natural waters regarding that disease. 17 A description shall be provided of the geographical localisation and the distance from other farms/farming areas that makes it possible to consider the compartment as one epidemiological unit. 18 A description shall be provided of the common biosecurity system. 19 Each farm or mollusc farming area in a compartment which is dependent on the health status of surrounding waters shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors. 13

14 8. Geographical demarcation Farms or mollusc farming areas covered (registration numbers and geographical situation) 4 farm sites (See a map in Annex 1 showing location of each farm): 1) Kalmanstjörn: ( 'N, 'W) Nesvegur Reykjanesbaer Approval number: IS ) Vogavík: ( 'N, 'W) 190 Vogar Approval number: IS ) Kollafjörður: ( 'N, 'W) 270 Mosfellsbaer Approval number: IS ) Fiskalón: ( 'N, 'W) 816 Ölfus Approval number: IS Non-free buffer zone 21 Geographical demarcation 26 Farms or mollusc farming areas covered (registration numbers, geographical situation and health status 22 ) Type of health surveillance 8.3. Non-free zones or compartments Extension of disease-free zone to other Member States 24 Geographical demarcation 26 Farms or mollusc farming areas covered (registration numbers geographical situation and health status 22 ) Geographical demarcation The geographical demarcation shall be clearly described and identified on a map, which must be attached as an Annex to the declaration/application. Any substantial modification in the geographical demarcation of the zone or compartment to be declared free must be subjected to a new application. 21 In connection with a zone or a compartment dependent on the health status of surrounding waters, a buffer zone in which a monitoring programme is carried out shall be established, as appropriate. The demarcation of the buffer zones shall be such that it protects the disease-free zone from passive introduction of the disease. (Part II.1.5 of Annex V to Directive 2006/88/EC). 22 Health status in accordance with Part A of Annex III to Directive 2006/88/EC. 23 Relevant in cases of declaration of disease-free Member States, where minor areas of the Member State are not considered disease-free. 24 Where a zone extends to more than one Member State, it may not be declared a disease-free zone unless the conditions set out in points 1.3, 1.4, and 1.5 of Part II of Annex V to Directive 14

15 8.5. Existing disease-free zones/ compartments in the vicinity. Geographical demarcation 26 Farms or mollusc farming areas covered (registration numbers and geographical situation) 9. Farms or mollusc farming areas which commence or recommence their activities New farm 9.2. Recommencing farm Health history of farm known to Competent authority Not subject to animal health measures in respect of listed diseases Farm cleaned, disinfected and, as necessary, fallowed 2006/88/EC apply to all areas of that zone. In that case both Member States concerned shall apply for approval for the part of the zone situated in their territory. 25 In accordance with Part II.4 of Annex V to Directive 2006/88/EC. 15

16 ANNEX V Model for information to be submitted in relation to submissions of applications for and declarations of disease-free status (One table for each year of implementation) 1. Data on testing animals Member State, zone or compartment (a) Disease: Viral Haemorrhagic Septicaemia (VHS) Year: 2013 Farm or mollusc farming area (b) Number of samplings Number of clinical inspections Water temperature at sampling/ inspection Species at sampling Species sampled Number of animals sampled (total and by species) Number of tests Positive results of laboratorial examination Positive results of clinical inspections Kalmanstjörn ,4-7 C Atlantic salmon Atlantic salmon Vogavík ,2-7 C Atlantic salmon Atlantic salmon Kollafjörður C Atlantic salmon Atlantic salmon Fiskalón C Arctic char Arctic char Lethal stripping of brood fish is performed weekly in Stofnfiskur Ltd. almost all year round and in two periods at spring and autumn in Arctic Land Ltd. each year where an official veterinarian is always present for clinical inspections and samplings. TOTAL: TOTAL: 0 (a) (b) Member State, zone or compartment as defined in point 7 of Annex IV. When the number of farms/mollusc farming areas is limited or no farms/mollusc farming areas are present in whole or parts of the Member State, zone or compartment subject to the application or declaration, and sampling therefore is done in wild populations, the geographical situation of the sampling should be given. 16

17 ANNEX V Model for information to be submitted in relation to submissions of applications for and declarations of disease-free status (One table for each year of implementation) 1. Data on testing animals Member State, zone or compartment (a) Disease: Viral Haemorrhagic Septicaemia (VHS) Year: 2014 Farm or mollusc farming area (b) Number of samplings Number of clinical inspections Water temperature at sampling/ inspection Species at sampling Species sampled Number of animals sampled (total and by species) Number of tests Positive results of laboratorial examination Positive results of clinical inspections Kalmanstjörn ,4-7 C Atlantic salmon Atlantic salmon Vogavík ,2-7 C Atlantic salmon Atlantic salmon Kollafjörður C Atlantic salmon Atlantic salmon Fiskalón C Arctic char Arctic char Lethal stripping of brood fish is performed weekly in Stofnfiskur Ltd. almost all year round and in two periods at spring and autumn in Arctic Land Ltd. each year where an official veterinarian is always present for clinical inspections and samplings. TOTAL: TOTAL: 0 (a) (b) Member State, zone or compartment as defined in point 7 of Annex IV. When the number of farms/mollusc farming areas is limited or no farms/mollusc farming areas are present in whole or parts of the Member State, zone or compartment subject to the application or declaration, and sampling therefore is done in wild populations, the geographical situation of the sampling should be given. 17

18 ANNEX V Model for information to be submitted in relation to submissions of applications for and declarations of disease-free status (One table for each year of implementation) 1. Data on testing animals Member State, zone or compartment (a) Disease: Viral Haemorrhagic Septicaemia (VHS) Year: 2015 Farm or mollusc farming area (b) Number of samplings Number of clinical inspections Water temperature at sampling/ inspection Species at sampling Species sampled Number of animals sampled (total and by species) Number of tests Positive results of laboratorial examination Positive results of clinical inspections Kalmanstjörn ,4-7 C Atlantic salmon Atlantic salmon Vogavík ,2-7 C Atlantic salmon Atlantic salmon Kollafjörður C Atlantic salmon Atlantic salmon Fiskalón C Arctic char Arctic char Lethal stripping of brood fish is performed weekly in Stofnfiskur Ltd. almost all year round and in two periods at spring and autumn in Arctic Land Ltd. each year where an official veterinarian is always present for clinical inspections and samplings. TOTAL: TOTAL: 0 (a) (b) Member State, zone or compartment as defined in point 7 of Annex IV. When the number of farms/mollusc farming areas is limited or no farms/mollusc farming areas are present in whole or parts of the Member State, zone or compartment subject to the application or declaration, and sampling therefore is done in wild populations, the geographical situation of the sampling should be given. 18

19 2. Data on testing farms or farming areas Disease: Viral Haemorrhagic Septicaemia (VHS) Year: Member State, zone or compartment (a) Total number of farms or mollusc farming areas (b) Total number farms or mollusc farming areas under the program me Number of farms or mollusc farming areas checked (c) Number of positive farms or mollusc farming areas (d) Number of new positive farms or mollusc farming areas (e) Number of farms or mollusc farming areas depopulated % positive farms or mollusc farming areas depopulated Animals removed and disposed of (f) % farms or mollusc farming areas coverage TARGET INDICATORS % positive farms or mollusc farming areas period farms or mollusc farming areas prevalence % new positive farms or mollusc farming areas farms or mollusc farming areas incidence individual and independent Compartments of the health status regarding that disease of surrounding natural waters Kalmanstjörn, Vogavík, Kollafjörður, Fiskalón. 8 = (7/5) x = (4/3) x = (5/4) 4 farms x = (6/4) x100 Total

20 (a) (b) (c) (d) (e) (f) Member State, zone or compartment as defined in point 7 of Annex IV. Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in point 7 of Annex IV. Check means to perform a farm/mollusc farming area level test under the programme to achieve disease-free status for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area must not be counted twice even if has been checked more than once. Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas has been checked. Farms or mollusc farming areas in which the health status for the past reporting period was, either category I, category II, category III or category IV in accordance with Part A of Annex III to Directive 2006/88/EC but which have had during this period of reference at least one positive animal for the disease in question. In the case of programmes submitted before 1 August 2008, farms or mollusc farming areas which were not positive to the disease in question in the previous period and have at least one positive animal in this period. Animals x 1000 or total weight of animals removed and disposed of. 20

21 Kollafjörður Vogavik Kalmanstjörn Fiskalón Reykjanes peninsula 21

22 22

23 23

24 24

25 25

26 26

27 27

28 28

29 29

30 30

31 31

32 32

33 33

34 34

35 35

36 36

37 37

38 38

39 39

40 40

41 41

42 42

43 43

44 44

45 45

46 46

47 47