ANNEX VISupplementary provisions
ANNEX VI Standard requirements for the submission of national programmes for the eradication of the aquacultures animal diseases listed below: — Viral haemorrhagic septicæmia (VHS) — Infectious haematopoietic necrosis (IHN) — Koi herpes virus disease (KHV) — Infectious salmon anaemia (ISA) — Infection with Marteilia refringens — Infection with Bonamia ostreae — White spot disease in crustaceans Requirements/information needed Information/further explanation and justification 1. Identification of the programme 1.1. Declaring Member State 1.2. Competent authority (address, fax, e-mail) 1.3. Reference of this document 1.4. Date of the submission to the Commission 2. Type of communication 2.1. ☐ Application for eradication programme 3. National legislation ( 1 ) 4. Request for co-financing 4.1. Indicate the year(s) for which co-financing is requested 4.2. Agreement of the managing authority of the operational programme (signature and stamp) 5. Diseases 5.1. Fish ☐ VHS ☐ IHN ☐ ISAV ☐ KHV 5.2. Molluscs ☐ Marteilia refringens ☐ Bonamia ostrae 5.3. Crustaceans ☐ White spot disease 6. General information on the programmes 6.1. Competent authority ( 2 ) 6.2. Organisation, supervision of all stakeholders involved in the programme ( 3 ) 6.3. An overview of the structure of the aquaculture industry in the area in question including types of production, species kept etc. 6.4. Notification to the competent authority of suspicion and confirmation of the disease(s) in question has been compulsory since when? 6.5. Early detection system in place throughout the Member States, enabling the competent authority to undertake effective disease investigation and reporting since when? ( 4 ) 6.6. Source of aquaculture animals of susceptible species to the disease in question entering in the Member State, zone or compartments for farming 6.7. Guidelines on good hygiene practice ( 5 ) 6.8. Epidemiological situation of the disease in at least the previous four years before the commencement of the programme ( 6 ) 6.9. Estimated costs and the anticipated benefits of the programme ( 7 ) 6.10. Description of the submitted programme ( 8 ) 6.11. Duration of the programme 7. Area covered ( 9 ) 7.1. ☐ Member State 7.2. ☐ Zone (entire water catchment area) ( 10 ) 7.3. ☐ 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. 7.4. ☐ Zone (more than one water catchment area) ( 12 ) 7.5. ☐ Compartment independent on the surrounding health status ( 13 ) Identify and describe for each farm the water supply ( 14 ) ☐ 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. Identify and describe for each farm the protection against flooding and infiltration of water from the surrounding area 7.6. ☐ 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 ( 19 ) 7.7. Farms or mollusc farming areas covered by the programme (registration numbers and geographical situation) 8. Measures of the submitted programme 8.1. Summary of the measures under the programme First year ☐ Testing ☐ Harvesting for human consumption or further processing ☐ Immediate ☐ Delayed ☐ Removal and disposal ☐ Immediate ☐ Delayed ☐ Vaccination ☐ Other measures (specify) Last year ☐ Testing ☐ Harvesting for human consumption or further processing ☐ Immediate ☐ Delayed ☐ Removal and disposal ☐ Immediate ☐ Delayed ☐ Other measures (specify) 8.2. Description of the measures of the programme ( 20 ) Target population/species Used tests and sampling schemes. Laboratories involved in the programme ( 21 ) Rules on movements of animals Used vaccines and vaccination schemes Measures in case of a positive result ( 22 ) Compensation scheme for owners Control and supervision on the implementation of the programme and reporting 9. Data on the epidemiological situation/evolution of the disease in the last four years (one table for each year of implementation) 9.1. Data on testing animals Member State, zone or compartment ( *1 ) Disease Year Farm or mollusc farming area 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 Total 9.2. Data on testing farms or farming areas Disease Year Member State, zone or compartment ( 23 ) Total number of farms or mollusc farming areas ( 24 ) Total number farms or mollusc farming areas under the programme Number of farms or mollusc farming areas checked ( 25 ) Number of positive farms or mollusc farming areas ( 26 ) Number of new positive farms or mollusc farming areas ( 27 ) Number of farms or mollusc farming areas depopulated % positive farms or mollusc farming areas depopulated Animals removed and disposed of ( 28 ) Target indicators % farms or mollusc farming areas coverage % 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 1 2 3 4 5 6 7 8 = 9 10 = 11 = (5/4) × 100 12 = (6/4) × 100 Total 10. Targets (one table for each year of implementation) 10.1. Targets related to testing animals Member State, zone or compartment ( *2 ) Disease Year Farm or mollusc farming area 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 Total 10.2. Targets on testing farms or farming areas Disease Year Member State, zone or compartment ( 29 ) Total number of farms or mollusc farming areas ( 30 ) Total number farms or mollusc farming areas under the programme Number of farms or mollusc farming areas expected to be checked ( 31 ) Number of expected positive farms or mollusc farming areas ( 32 ) Number of expected new positive farms or mollusc farming areas ( 33 ) Number of farms or mollusc farming areas expected to be depopulated % positive farms or mollusc farming areas expected to be depopulated Target indicators Expected % farms or mollusc farming areas coverage % positive farms or mollusc farming areas Expected period farms or mollusc farming areas prevalence % new positive farms or mollusc farming areas Expected farms or mollusc farming areas incidence 1 2 3 4 5 6 7 8 = (7/5) × 100 9 = (4/3) × 100 10 = (5/4) × 100 11 = (6/4) × 100 Total 11. Detailed analysis of the cost of the programme (one table per year of implementation) Costs related to Specification Number of units Unitary cost in EUR Total amount in EUR Union funding requested (yes/no) 1. Testing 1.1. Cost of the analysis Test: Test: Test: 1.2. Cost of sampling 1.3. Other costs 2. Vaccination or treatment 2.1. Purchase of vaccine/treatment 2.2. Distribution costs 2.3. Administering costs 2.4. Control costs 3. Removal and disposal of the aquaculture animals 3.1. Compensation of animals 3.2. Transport costs 3.3. Disposal costs 3.4. Loss in case of removal 3.5. Costs from treatment of products 4. Cleansing and disinfection 5. Salaries (staff contracted for the programme only) 6. Consumables and specific equipment 7. Other costs Total ( 1 ) National legislation in force applicable to the application for eradication programme. ( 2 ) A description shall be provided of the structure, competencies, duties and powers of the competent authority or competent authorities involved. ( 3 ) A description shall be provided of the authorities in charge of the supervision and coordination of the programme and the different operators involved. ( 4 ) 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 molluscs 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. ( 5 ) A description shall be provided in accordance with Article 9 of Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals ( OJ L 328, 24.11.2006, p. 14 ). ( 6 ) Information shall be given using the table laid down in Part 9 of Annex VI to this Decision. ( 7 ) A description shall be provided of the benefits for farmers and society in general. ( 8 ) A concise description of the programme shall be given with the main objectives, the main measures, the target population, the areas of implementation and the definition of a positive case. ( 9 ) The area covered shall be clearly identified and described in a map, which should be attached as an Annex to the application. ( 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. ( 13 ) Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is independent on 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 ) Technical information shall be provided to demonstrate that the relevant pathogen is inactivated in order to reduce the risk of the introduction of the disease to an acceptable level. ( 16 ) Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status regarding that disease of surrounding natural waters. ( 17 ) A description shall be provided of the geographical localisation and the distance from other farms/farming areas that make 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. ( 20 ) A comprehensive description needs to be provided unless reference can be made to Union legislation. The national legislation in which the measures are laid down shall be mentioned. ( 21 ) Describe diagnostic methods and sampling schemes. When OIE or Union standards are applied, refer to them. If not, describe them. Name the laboratories involved in the programme (National Reference Laboratory or designated laboratories). ( 22 ) A description is provided of the measures as regards positive animals (immediate or delayed harvesting for human consumption, immediate or delayed removal and disposal, measures to avoid the spread of the pathogen when harvesting, further processing or removal and disposal takes place, a procedure for the disinfection of the infected farms or mollusc farming areas, a procedure for restocking with healthy animals in farms or farming areas which have been depopulated and creation of surveillance zone around the infected farm or farming area, etc.). ( *1 ) Member State, zone or compartment as defined in Point 7 of Annex VI. ( 23 ) Member State, zone or compartment as defined in Point 7 of Annex VI. ( 24 ) Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 7 of Annex VI. ( 25 ) Check means to perform a farm/mollusc farming area level test under the programme 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 should not be counted twice even if has been checked more than once. ( 26 ) 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. ( 27 ) Farms or mollusc farming areas which health status in the previous period was, in accordance with Part A of Annex III to Directive 2006/88/EC, category I, category II, category III or category IV and have at least one positive animal in this period. ( 28 ) Animals × 1 000 or total weight of animals removed and disposed of. ( *2 ) Member State, zone or compartment as defined in Point 7 of Annex VI. ( 29 ) Member State, zone or compartment as defined in Point 7 of Annex VI. ( 30 ) Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 7 of Annex VI. ( 31 ) Check means to perform a farm/mollusc farming area level test under the programme 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 should not be counted twice even if has been checked more than once. ( 32 ) 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. ( 33 ) Farms or mollusc farming areas which health status in the previous period was, in accordance with Part A of Annex III to Directive 2006/88/EC, category I, category II, category III or category IV and have at least one positive animal in this period.