SPECIFIC REQUIREMENTS FOR THE APPROVAL OF DISEASE-FREE STATUS FOR HPAI OR NDV OF POULTRY COMPARTMENTS
ANNEX IISupplementary provisions
ANNEX II SPECIFIC REQUIREMENTS FOR THE APPROVAL OF DISEASE-FREE STATUS FOR HPAI OR NDV OF POULTRY COMPARTMENTS PART I SECTION 1 Detailed description of the poultry compartment to be included in the application 1. The description of the compartment as provided for in Part III of Annex I shall contain details of the types of poultry establishments forming part of the compartment, as well as of the feed processing or feed storage facilities, other material storage facilities, slaughterhouses and processing plants and any other plants that may contain poultry, poultry products and poultry by-products. 2. In addition, the application for approval of the disease-free status of a poultry compartment shall include at least the following: (a) information on the infrastructural and functional factors and their contribution to an epidemiological separation between the poultry in the compartment and animal populations with a different health status, which must include a description of the type of activity and the products or other commodities produced in the compartment, including the total capacities of the compartment; (b) information on the epidemiological aspects and the risk factors regarding HPAI or NDV, including at least the following elements: (i) the health status of the establishments forming part of the poultry compartment for the preceding 12 months, and in particular any information in relation to HPAI or NDV; (ii) the allowed movements into, out of, or within the poultry compartment (inputs and outputs), of persons, products or other commodities, birds or bird products or other animals, products of animal origin or other products in contact with animals, transport vehicles, equipment, animal feed, water supply and drainage; (iii) poultry or captive birds establishments outside the poultry compartment that may affect the health status of the poultry compartment because of their proximity to one or more of the compartment components; the risk factors shall also be evaluated in relation with the type of those establishments, including non-commercial establishments, markets, assembly centres, slaughterhouses, zoos or other premises containing captive birds; (iv) the environmental risk factors such as waterways, wildlife resting and mixing places, including migratory routes of wild birds, the presence of rodents or other pests, and the occurrence in the preceding 12 months of HPAI or NDV in the vicinity of any of the poultry compartment components; (v) the specific risk factors and pathways for the entry and spread of HPAI or NDV in the poultry compartment; (c) information on the early warning system in place to detect HPAI or NDV and to inform the competent authority of findings of risk factors and pathways as referred to in point (b). SECTION 2 Common biosecurity management system of a poultry compartment 1. In addition to the elements set out in Part II of Annex I, under the common biosecurity management system, the specific biosecurity plans of each of the poultry establishments forming part of a poultry compartment shall include at least the following: (a) a rule that the personnel of the poultry compartment shall: (i) not personally keep poultry or captive birds; (ii) not have close contact with birds other than those of the poultry compartment for a period of at least 72 hours before entering an establishment; however, a shorter period may be required in the case of the urgent need of specific staff, but it shall in no event be less than 24 hours and the procedure mitigating the risk shall be described in the biosecurity plan; (b) a rule that external visitors, including auditors or inspectors, must not have had any contact with birds for a period of at least 48 hours before entering the establishment; however, a longer period may be required depending on risk factors, especially for visitors coming from a restricted zone; and a shorter period may be required for official veterinarians or in the case of urgent need of external specific intervention, such as a consultant or veterinarian, in which case the procedure mitigating the risk shall be described in the biosecurity plan; (c) the flows of products and personnel, described on a diagram of all the premises of the establishment with colour-coded levels of biosecurity; there shall be hygiene barriers with changing zones, including where appropriate showers, with separated clean and dirty areas at all entry points to the premises; (d) specific procedures to prevent contamination of poultry, including contamination through the supply, transportation, storage, delivery and disposal of: (i) packing materials, including at least the use of new or disinfected packing materials; (ii) bedding materials, including at least an appropriate storage quarantine time or a disinfection of bedding materials; (iii) feed, including the use of enclosed systems of feed; (iv) water, including an internal water treatment system; (v) animal by-products, including appropriate disposal of carcases, eggs containing dead embryos and manure; (e) a cleaning and disinfection plan of the establishment, including equipment and materials used; a specific protocol for vehicle cleaning and disinfection shall be available; (f) a pest control plan, including rodents and other wild animals, providing for physical barriers and measures in the case of findings of their activity; (g) a critical control points plan, relating to HPAI or NDV, which shall include at least the following elements, ongoing and for the preceding six months: (i) data on the production, data on morbidity and mortality, details of medications used, and data relating to animal feed and water consumption; (ii) information relating to the clinical checks and sampling plans for active and passive surveillance and screening analyses, including frequencies, methods and results; (iii) a register of visitors to the establishment, in sufficient detail to be able to trace and contact any visitor; (iv) information concerning any vaccination programmes applied, including the type of vaccine used and the frequency and dates of administration; (v) detailed information records on the related critical control points not complied with, and the corrective actions performed. 2. The specific biosecurity plans of the establishments forming part of a poultry compartment shall be updated in accordance with Part II, point (h), of Annex I, in particular where an outbreak of HPAI or NDV is officially suspected or confirmed in the Member State or in the area where one or more of the compartment components are situated. PART II SECTION 1 Specific protection and surveillance measures for HPAI 1. All the establishments forming part of the poultry compartment shall be approved in accordance with Article 3(1), point (c)(i), of this Regulation, and comply with the requirements for granting approval of hatcheries laid down in Article 7 of Commission Delegated Regulation (EU) 2019/2035 ( 1 ) or the requirements for granting approval of establishments keeping poultry laid down in Article 8 thereof. In addition, the following requirements shall be complied with: (a) the diagram referred to in Part III, point (b)(iii), of Annex I to this Regulation shall indicate the location of the establishments keeping all types of poultry, as well as hatcheries, rearing sites, laying sites, trial sites, egg stores and all places where eggs or poultry are kept; it shall indicate the flows of products and other commodities between those locations; (b) a detailed procedure shall regulate the movements of poultry, their eggs and other related products; poultry, their eggs and other related products entering any establishment forming part of the poultry compartment shall come from an establishment having a disease-free status as regards HPAI and be checked to ensure that they present no risk of introduction of HPAI; (c) poultry and hatching eggs moved into or within the poultry compartment shall be identified in such a way that they can be traced, and be accompanied with the proper documented identification; (d) in the case of a multi-age site or in other cases where poultry are added at different times of the life span of poultry, a written procedure shall describe the addition and removal of poultry, including the cleaning and disinfection of catching crates and reusable transport boxes. 2. The surveillance referred to in Part I, point (c)(iii), of Annex I, shall be established under the responsibility of the compartment manager, and shall include continuous passive and active surveillance to demonstrate the absence of infection in all establishments forming part of the poultry compartment. In addition, the following requirements shall be complied with: (a) the passive surveillance shall contain clinical indicators and describe related follow-up investigations, including sampling for laboratory testing; (b) the active surveillance shall contain testing carried out on a defined number of samples taken from birds of each establishment, or epidemiological unit if more than one per establishment, providing at least a 95 % level of confidence to detect the infection at a target prevalence rate of 5 %: (i) at least every six months during the production period, where no outbreaks of HPAI in poultry or other captive birds, have been confirmed during the preceding six months in the territory of the Member State; (ii) at least every three months where an outbreak of HPAI in poultry or other captive birds, has been confirmed during the preceding six months in the territory of the Member State; (iii) when any component of the poultry compartment is located within a restricted zone due to an outbreak of HPAI, within one week following the date of the outbreak and at least every 28 days thereafter; in addition, the surveillance shall be updated to include daily clinical examination as well as samples taken weekly on a representative number of birds sick or found dead, for molecular virological testing. (c) The samples shall be sent to a laboratory designated in accordance with Article 37 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( 2 ) by the competent authority to carry out the tests, taking into account the vaccination status of the birds and the types of vaccines used. 3. The early warning system referred to in Section 1, point 2(c), of Part I, shall be based upon a written protocol that specifies the reporting procedures. It shall be adapted to the species of poultry present in the compartment and their susceptibility to HPAI, and it shall: (a) prescribe action levels based on results and defined thresholds of the passive and active surveillance described in point 2; (b) describe the actions to be taken; (c) include a list of the responsible personnel to be notified. 4. Documentation referred to in Part I, point (h), of Annex I shall: (a) be retained for a minimum period of three years; (b) contain the results of the disease surveillance, which shall be reported to the competent authority: (i) every three months when an outbreak of HPAI in poultry or captive birds has been confirmed during the preceding six months in the territory of the Member State; (ii) every 28 days when any compartment component is located within a restricted zone due to an outbreak of HPAI. SECTION 2 Specific protection and surveillance measures for NDV 1. All the establishments forming part of the poultry compartment shall be approved in accordance with Article 3(1), point (c), of this Regulation and comply with the requirements for granting approval of hatcheries laid down in Article 7 of Delegated Regulation (EU) 2019/2035 or the requirements for granting approval of establishments keeping poultry laid down in Article 8, thereof. In addition: (a) the diagram referred to in Part III, point (b)(iii), of Annex I to this Regulation, shall indicate the location of the establishments keeping all types of poultry, as well as hatcheries, rearing sites, laying sites, trial sites, egg stores and all places where eggs or poultry are kept; it shall indicate the flows of products and other commodities between those locations; (b) a detailed procedure shall regulate the movements of poultry, their eggs and other related products; poultry, their eggs and other related products entering any establishment forming part of the poultry compartment shall come from an establishment where there are no outbreaks or restrictions due to outbreaks of NDV and be checked to ensure that they present no risk of introduction of NDV; (c) poultry and hatching eggs moved into or within the poultry compartment shall be identified in such a way that they can be traced, and be accompanied with the proper documented identification; (d) in the case of a multi-age site or in other cases where poultry are added at different times of the life span of poultry, a written procedure shall describe the addition and removal of poultry, including the cleaning and disinfection of catching crates and reusable transport boxes. 2. The surveillance referred to in Part I, point (c)(iii), of Annex I shall be established under the responsibility of the compartment manager and shall include continuous passive and active surveillance to demonstrate absence of infection in all establishments forming part of the poultry compartment: (a) the passive surveillance shall contain clinical indicators and describe related follow-up investigation, including sampling for laboratory testing; (b) the active surveillance shall contain testing carried out on a defined number of samples taken from birds of each establishment, or epidemiological unit if more than one per establishment, providing at least a 95 % level of confidence to detect the infection at a target prevalence rate of 5 %: (i) at least every six months during the production period, where no outbreaks of NDV in poultry or other captive birds, have been confirmed during the preceding six months in the territory of the Member State; (ii) at least every three months where an outbreak of NDV in poultry or other captive birds, has been confirmed during the preceding six months in the territory of the Member State; (iii) when any component of the poultry compartment is located within a restricted zone due to an outbreak of NDV within one week following the date of the outbreak and at least every 28 days thereafter; in addition, the surveillance shall be updated to include daily clinical examination as well as samples taken weekly on a representative number of birds sick or found dead for molecular virological testing; (c) the samples shall be sent to a laboratory designated in accordance with Article 37 of Regulation (EU) 2017/625 by the competent authority to carry out the tests, taking into account the vaccination status of the birds and the types of vaccines used. 3. The early warning system referred to in Section 1, point 2(c), of Part I, shall be based upon a written protocol that specifies the reporting procedures. It shall be adapted to the species of poultry present in the poultry compartment and their susceptibility to NDV, and it shall: (a) prescribe action levels, based on results and defined thresholds of the passive and active surveillance described in point 2; (b) describe the actions to be taken; (c) include a list of the responsible personnel to be notified. 4. Documentation referred to in Part I, point (h), of Annex I shall: (a) be retained for a minimum period of three years; (b) contain the results of the disease surveillance, which shall be reported to the competent authority: (i) every three months when an outbreak of NDV in poultry or captive birds, has been confirmed during the preceding six months in the territory of the Member State; (ii) every 28 days when any compartment component is located within a restricted zone due to an outbreak of NDV. ( 1 ) Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs ( OJ L 314, 5.12.2019, p. 115 , ELI: http://data.europa.eu/eli/reg_del/2019/2035/oj ). ( 2 ) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products ( OJ L 95, 7.4.2017, p. 1 , ELI: http://data.europa.eu/eli/reg/2017/625/oj ).