Standard requirement for the submission of programme for eradication, control and monitoring

Transcription

1 PROGRAMME for ERADICATION : ANNEX II - PART A + B Member States seeking a financial contribution from the Community for national programmes for the control and monitoring of salmonellosis (zoonotic salmonella), shall submit applications containing at least the information set out in this form. The central data base keeps all submissions. However only the information in the last submission is shown when viewing and used when processing the data. If encountering difficulties, please contact SANCO-BO@ec.europa.eu, describe the issue and mention the version of this document: Instructions to complete the form: Your current version of Acrobat is: ) Be informed that you need to have at least the Adobe Reader version or higher to fill and submit this form. 2) To verify your data entry while filling your form, you can use the "verify form" button at the top of each page. 3) When you have finished filling the form, verify that your internet connection is active and then click on the submit notification button below. If the form is properly filled, the notification will be submitted to the server and a Submission number will appear in the corresponding field. 4) IMPORTANT: Once you have received the Submission number, save the form on your computer. 5) If the form is not properly filled, an alert box will appear indicating the number of incorrect fields. Please check your form again and try to re-submit it according to steps 3), 4) and 5). Should you still have any difficulties, please contact SANCO- BO@ec.europa.eu. 6) For simplification purposes you are invited to submit multi annual programmes 7) As mentioned during the Plenary Task Force of 28/2/2014, you are invited to submit your programmes in English. IMPORTANT: AFTER SUBMITTING THE FORM DO NOT FORGET TO SAVE IT ON YOUR COMPUTER FOR YOUR RECORDS! Submission Date Monday, October 06, :32:22 Submission Number

2 Identification of the programme Member state : BULGARIA Disease Salmonella This program is multi annual : no Request of Union co-financing from beginning of : 2015 Page 2 of 41

3 ANNEX II - PART A General requirements for the national salmonella control programmes (a) State the aim of the programme The target of the Program is to - determine the health status of poultry of the hen s species in Republic of Bulgaria with regard to Salmonella enteritidis, Salmonella Hadar, Salmonella infantis, S.Typhimurium(including monophasic S. Typhimurium serotype with antigenic formula 1,4/5/,1 2:i), Salmonella virchow and all other types of Salmonella. - reduction to 1 % or less of the maximum percentage of adult breeding flocks of Gallus gallus remaining positive for Salmonella enteritidis, Salmonella infantis, Salmonella hadar, S.Typhimurium(including monophasic S. Typhimurium serotype with antigenic formula 1,4/5/,1 2:i) and Salmonella virchow (the relevant salmonella serotypes). (b) Animal population and phases of production which sampling must cover Demonstrate the evidence that it complies with the minimum sampling requirements laid down in part B of Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council OJ L 325, , p. 1. indicating the relevant animal population and phases of production which sampling must cover Animal population Breeding flocks of Gallus gallus Food business operators have samples taken and analysed for Salmonella in the following phases of production : rearing flocks day-old chicks four-week-old birds two weeks before moving to laying phase or laying unit adult breeding flocks every second week during the laying period every third week during the laying period Page 3 of 41

4 (c) Specific requirements Demonstrate the evidence that it complies with the specific requirements laid down in Parts C, D and E of Annex II to Regulation (EC) No 2160/2003 The National programme complies with the specific requirements laid down in Part C of Annex II to Regulation (EC) No 2160/2003. Objectives of the programme is to monitor, on the basis of sampling in breeding poultry flocks, occurrence of invasive serotypes of S. enteritidis, S. typhimurium, S. infantis, S. virchow and S. hadar, and to take measures aimed in particular at the protection of public health, as well as health of other poultry populations. The aim of the programme is to ensure the reduction of percentage of positive adult breeding poultry flocks comprising at least 250 birds to 1% or less. Minimum sampling requirements with regard to control programme are in compliance with part B of Annex II of Commission Regulation (EC) No 2160/2003 and in accordance with Commission Regulation (EU) 200/2010. Breeding flocks of Gallus gallus: -rearing flocks day-old chicks -four-week-old birds -two weeks before moving to laying phase or laying unit -adult breeding flocks every second week during the laying period (d) Specification of the following points : (d)1. (d)1.1 General A short summary referring to the occurrence of Salmonellosis (Zoonotic Salmonella) A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council OJ L 325, , p. 31., particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes. In Republic of Bulgaria, the Salmonella Control National Programme in breeding flocks has been in operation since 2008 and approved by Commission Decision 2007/873/ЕО. Page 4 of 41

5 The number of breeding flocks positive for Salmonella spp in total is as follow: -In 2008 No Salmonella positive serotypes -In flock positive for Salm. Infantis; 1 flock - Salm. Bareilly; 2 floks- Salm. Senftenberg; 1 flock -Salm. agona -In flocks positive for S. Infantis, 2 flocks - S. hadar, 1 flock- S.Glostrup, 1. flock - S.Seftenberg, 1 flock - S. Corvallis. -In flock positive for S. Typhimurium, 1 flock - S. Agona and S. Livingstone in hatchery. -In flock positive for S.infantis, 2 flocks positive for S.corvalis and1 flock positive for S.Lomnita. The data shows that S.Infantis remains the most commonly isolated Salmonella serotype, followed by S. Hadar, S. Agona and S. Senftenberg in the Republic of Bulgaria as a whole. The % Salmonella positive flock s prevalence for the Salmonella target serotypes included in the program decreased in 2011 and 2012 to 0.84%. The target of the SCNP in breeding flocks was achieved in 2011 and 2012, namely reduction to 1 % or less of the maximum percentage of adult breeding flocks of Gallus gallus remaining positive for S.Enteritidis, S.Infantis, S.Hadar, S.Typhimurium and Salmonella virchow. (d)1.2 The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme. Bulgarian Food Safety Agency (BFSA) is the competent authorities for control of Salmonella and their zoonotic agents. Department Infectious diseases within Directorate Animal health and Welfare at the Headquarters of BFSA has the following responsibilities: 1. To draft surveillance programme for Salmonellosis and to submit it for approval to the European Commission. 2. To control the implementation of the surveillance programme. 3. To collect and analyse the data on the animals tested for salmonellosis 4. To summarize the data on positive holdings. 5. To keep a register in the database of all holdings with breeding hens 6. To send annual report to the European Commission containing the data referred to in points 3-6. At regional level the Regional Food Safety Department (RFSD) and the heads of departments Animal health have the following responsibilities: 1. To control and to implement the Salmonella surveillance programme at regional level. 2. To collect and analyse the data on the poultry tested for salmonella in the region. 3. To summarize the data on positive animals. 4. To summarize the data on the salmonella surveillance costs incurred at regional level. 5. To keep a register in the database of all holdings with breeding hens. 6. To send annual reports containing the data referred to in points 1-6 to Directorate Animal health and welfare at BFSA. Page 5 of 41

6 The municipal veterinarian has the following responsibilities: 1. To control and to implement the programme for surveillance of salmonella in the relevant municipality. 2. To control the sampling of laying hens and the sending of samples to the laboratories. 3. To collect and analyse the data on the poultry tested for salmonella in the veterinary units located onthe territory of the relevant municipality. 4. To summarize the data on positive animals from the veterinary units located on the territory of the relevant municipality. 5. To summarize the data on the salmonella surveillance costs incurred by the relevant municipality. 6. To keep a register in the database of all holdings with breeding hens 7. To send annual reports containing the data referred to in points 1-6 to Directorate Animal health at the relevant RFSD. (d)1.3 Approved laboratories where samples collected within the programme are analysed. Laboratory testing for official and FBO control for Salmonellosis is performed by the accredited to ISO laboratories, as follows: A. within the BFSA system: 1. National Reference Laboratory for Salmonellosis diagnostics, Sofia; 2. the Laboratory for bacterial diseases in poultry at the National Diagnostic and Research Veterinary Institute, Sofia; 3. the testing Laboratory Diagnostic Control (LDC) Laboratory at the Animal Health (AH) Department with the Regional Food Safety Department (RFSD) of Shumen; 4. the testing Laboratory Diagnostic Control (LDC) Laboratory at the Animal Health (AH) Department with the Regional Food Safety Department (RFSD) of Blagoevgrad; 5. the testing Laboratory Diagnostic Control (LDC) Laboratory at the Animal Health (AH) Department with the Regional Food Safety Department (RFSD) of Varna; 6. the testing Laboratory Diagnostic Control (LDC) Laboratory at the Animal Health (AH) Department with the Regional Food Safety Department (RFSD) of Vratsa; 7. the testing Laboratory Diagnostic Control (LDC) Laboratory at the Animal Health (AH) Department with the Regional Food Safety Department (RFSD) of Haskovo; B. Private laboratories: 1. the Laboratory for testing food, feed and biological materials Regional Veterinary Station - Ruse SP Ltd. Any positive isolates obtained within the tests performed therein must be sent for confirmation and typing in the: National Reference Laboratory for Salmonellosis diagnostics at the National Diagnostic and Research Veterinary Institute (within BFSA), 1606 Sofia, # 15 Pencho Slaveikov blvd.; ph. No. ( ) It is absolutely mandatory that any of the laboratories performing Salmonellosis diagnostics must use Page 6 of 41

7 the methodology specified in Commission Regulation (EC) No 213/2009. Any results shall be considered as valid only if compliance with the requirements for testing demonstrated with the Commission Regulation (EC) No 200/2010. The samples for official control shall be tested by state laboratories. The samples by the own control could be tested at the private and state accredited laboratories. The samples tested by the state or private laboratories showed positive or suspect result are forwarded for confirmatory retesting in the NRL in the town of Sofia. All laboratories involved in the programme must participate in proficiency tests. The NRL has to participates regularly in proficiency tests (serotyping and Salmonella isolation) organised by the EU Reference Laboratory (EURL) for Salmonella.The NRL is responsible for training and organisation of proficiency tests for Salmonella isolation for other laboratories involved in the National Control Programme. (d)1.4 Methods used in the examination of the samples in the framework of the programme. Methods used in the examination will be performing in accordance with Annex of Commission Regulation (EU) No 200/2010. Testing methods used by laboratories under the control programme for official sampling and sampling taken on the initiative of the operator are identical. The method recommended by the EU Reference Laboratory for salmonella in Bilthoven, Netherlands shall be used: the method is a modification of ISO 6579 (2002) where a semi-solid medium (MSRV) is used as the single selective enrichment medium. The semi-solid medium should be incubated at /- 1 С for 2 х (24 +/-3) hours. As regards the boot swab samples and other feacal material samples, referred to in paragraph 3.1, it is possible to pool incubated BPW enrichment broth for future culture. To do that, incubate both samples in BPW as normal. Take 1 ml of incubated broth from each sample and mix thoroughly, then take 0,1 ml of the mixture and inoculate the MSRV plates in the usual way. As regards the boot swab samples and other feacal material samples, referred to in paragraph 3.1, it is possible to pool incubated BPW enrichment broth for future culture. To do that, incubate both samples in BPW as normal. Take 1 ml of incubated broth from each sample and mix thoroughly, then take 0,1 ml of the mixture and inoculate the MSRV plates in the usual way. Page 7 of 41

8 (d)1.5 Official controls (including sampling schemes) at feed, flock and/or herd level. Official sampling on the feed stuffs from poultry: According to the implementation of Article 4 of Regulation (ЕО) 882/2004 and in reference with Article 3 (1), point 4 of the Law of the Bulgarian Food Safety Agency (BFSA) the BFSA is the Competent Authority for official control in feed in Republic of Bulgaria.. In reference with the implementation of the requirements of Articles 9, 10 and 19 of Regulation (ЕО) 183/2005 regarding the feed hygiene and the Bulgarian Feed Law, the feed operators must be approved and registered by the BFSA.The registers with the feed operators are updated and kept by the Regional Food Safety Departments (RFSDs). At central level, the Feed control Unit at Animal Health and Welfare, and Feed control Directorate maintains and updates a Nation feed operator register. The register ahs been published at the BFSA website: The official control inspections in the feed premises are carried out by the experts responsible for the Feed control at the relevant RFSD. The sampling in feed premises are as follow: 1. feed sampling done at producers of feed raw materials and wholesale traders in feed raw materials in bulk; 2. feed sampling done at farms. The number of samples has been calculated on the basis of risk assessment in accordance with the provisions of Regulation 882/2004. This Plan involves also a minimum number of Salmonella samples taken from poultry feed consignments imported from third countries. There have not been any positive results identified concerning this indicator. If a positive result is identified, the measures and actions to be undertaken are pursuant to the provision of the Operational Action Plan in emergency cases regarding the feed control,in compliance with Article 42(2)(g) of Regulation (ЕО) 882/2004 and Procedures in case of Salmonella spp detection in feed. Official control at the other stages of the food chain: According to the National legislation (Law of veterinary activity and Food law) the establishments for production, storage and trade of animal products have to be approved registered by BFSA and entered into the national electronic database. The public registers of approved establishments are kept in the RFSDs and the BFSA. The official inspections in establishments for production, storage, and trade of animal products are carried out by the official veterinarians at the BFSA/RFSD. The official inspections in the establishments for production, storage and trade with food are carried out in accordance with the Regulation 882/2004 of the European Parliament and the Council Regulation 854/2004 of the European Parliament and the Council, laying down the specific rules for the organisation Page 8 of 41

9 of official controls on products of animal origin intended for human consumption. The number of samples has been calculated by the official veterinarians on the basis of risk assessment and the type and quality of the materials included in the food processing and the results of the previous inspections. The samples from foods of poultry origin shall be taken and preceded as provided in Regulation 2073/2005. The frequency of sample taking could be increased and decreased on the basis of the results of the sample testing. Annually the Regional Food Safety Directorates (RFSDs) draft a schedule for the number of inspections in the controlled establishments for production, storage, and trade of animal products. Official checks at the level of poultry flocks is carried out by the relevant Regional Food Safety Department (RFSD).The sampling covers all adult breeding flocks of domestic fowl (Gallus gallus) comprising at least 250 birds (breeding flocks). There is a specific Order which officially approve and enter into effect a scheme for sampling of various categories of poultry in accordance with Regulation (EC) No. 2160/2003 and Regulation (EC) No. 200/2010. The scheme specifies the number of samples for the purposes of self-control and official control at hatchery and farm levels. Each year the RFSDs draft a sampling schedule for all poultry farms and hatcheries included in the scope of the programme and located on the territory within its administrative districts. The schedule is drafted for official checks and ownchecks. -Official control sampling at the hatchery level :every 16 weeks -Official control sampling at the farm level a) within four weeks following moving to laying phase or laying unit; b) towards the end of the laying phase, not earlier than eight weeks before the end of the production cycle; c) during the production, at any time sufficiently distant from the samples referred to in points (a) and (b). d) sampling at the holding, following the detection of relevant Salmonella from sampling at the hatchery according to the plan for official control drafted and approved by the Animal Health and Welfare Directorate at HQ. e) based on positive results in one flock, others flocks are officially sampled f) each time when the Regional FSD considers it necessary Official supervision of farms: The competent authority carries out official controls in accordance with the plan for official control drafted and approved by the Animal Health and Welfare Directorate at HQ. The plan is drafted on the basis of risk analysis and is applied to all holdings. Official inspections includes official sampling, verification of the implementation of the SCP and biosecurity measures by the FBO. Sampling carried out by operator: At the hatchery level - every 2 weeks At the farm level a) Day-old chicks: 10 swabs from internal surfaces of boxes or crates used for transportation of the chicks. A sample from the entire consignment of chicks is concerned that is, if appropriate, combined to form a pooled sample; b) Carcasses of chicks found after arrival of a veterinarian (acceptance of chicks). A sample from the entire consignment of chicks (at most 60 birds) is concerned that is, if appropriate, combined to form a pooled sample; Page 9 of 41

10 c) 2 weeks prior to laying phase d) Each 2 weeks during the laying phase. (d)2. Food and business covered by the programme (d)2.1 The structure of the production of the given species and products thereof. The breeding flocks covered in the programme are created from imported consignments of one day chicks or from chicks from hatcheries in the country. Hatching eggs produced by this flocks are exported or moved in the hatcheries. Totally there are 28 hatchery. There are 31 holdings with 208 breeding flocks in the country. The hatching eggs from these holdings are delivered to the hatcheries. The day chicks from hatcheries are moved to the holdings with reared flocks. The flocks at the end of production period are moved to the slaugterhouses. The hatcheries, holdings with reared and adult flocks and slaughterhouses are all under the supervision of the BFSA. (d)2.2 Structure of the production of feed All feed intended for feeding of breeding birds must be produced in feed producing-plants registered and approved in compliance with the Article 9 and 10 of Regulation (ЕО) 183/2005 Page 10 of 41

11 (d)2.3 Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least (d)2.3.1 Hygiene management at farms All farmers are obligated to have their individual Guidelines for good farmer practices, which are subject to approval by the official veterinarian responsible for the control of the holding concerned. In the past several informative brochures titled: How to protect our poultry? ; Six requirements for protection of your poultry and were distributed to all the 28 Regional Food Safety Directorates of the country and have been provided to the owners of all poultry holdings. This brochure lays down all the measures needed to protect poultry against infection. The major point for good farmer practices that should be follow by the farmers are concern to: the hygiene management at farms, themeasures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and the hygiene in transporting animals to and from farms. (d)2.3.2 Measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms In order to implement the principles of good farming practice properly, the FBO shall apply all in/all out system in the holding. Mechanical cleansing of halls and technologies, followed by subsequent efficient disinsection and disinsecton shall be performed on completion of each production cycle. The relevant RFSD shall perform the supervision on efficacy of disinfection carried out by farmers. In order to ensure that bio-security standards on poultry farms, the competent authority carries out official controls in accordance with the annual national control plan. The plan of official controls applies to all holdings and the selection of holdings is made using risk analysis. In order to increase the Page 11 of 41

12 effectiveness of official controls, a special part of the SCNP checklist is used within official controls in the case of official sampling. The document includes questions on bio-security measures applied on the spot, at buildings, during cleaning, disinfection, feed handling, loading and transport. (d)2.3.3 Hygiene in transporting animals to and from farms In accordance with the national legislation the means of transport and facilities may be used if : Meet the requirements for animal transport of the species involved as to the construction, arrangement and equipment, do not affect animal health, do not cause any pain or suffering to animals, prevent the animals from escape or falling out and protect them from unfavourable weather effects; Are protected so that water, feed, litter, faeces or other waste cannot leak or fall out of them; Are cleaned and disinfected both before and after the transport. (d)2.4 Routine veterinary supervision of farms Routine veterinary supervision of farms. Every year the 28th RFSDs on the base of risk assessment present plans for controls of poultry farms within the respective region. Those plans are annually approved by the BFSA. The official veterinary supervision of farms and official sampling is carried out by official veterinarians at the relevant RFSD. The official veterinary supervision consists in clinical examination of individual flocks, inspection of register keeping, records of vaccination, inspection of biosecurity measures and welfare and whether the conditions laid down in programme are fulfilled. All breeding flocks of poultry are checked up at least once per year. (d)2.5 Registration of farms Page 12 of 41

13 All commercial holdings for breeding flocks are registered in accordance with Article 137 of the law of the Veterinary activity. The register commercial holdings are entered into the ational electronic database and maintained by Headquarter at the BFSA. The records on registration of farms are kept at central level (Headquarter at BFSA) and local level (RFSDs). The size limit for poultry to be registered obligatorily is as follow: - flocks more than 500 poultry broilers - flocks more than 250 poultry breeding hens - flocks more than 350 poultry laying hens - flocks more than 250 poultry turkeys (d)2.6 Record keeping at farm Record keeping in holdings shall be performed in accordance with Regulation (EC) No 852/2004. Such records must include at least the following information: -the date of receipt of the poultry, -the origin of the poultry, -the number of the poultry, -death rate, -feed suppliers, -types and duration of use of feed additives, withdrawal periods, -monitoring of feed and water intake, -performed examinations and diagnoses established by the veterinarian in charge, together with results of laboratory testing, if necessary, -types of medicaments used (in particular antimicrobials), start and end of application thereof, -the date of vaccination and the type of vaccine used; -results of all previous health checks of poultry from the flock concerned; -the number of broilers intended for slaughtering; -estimated date of slaughtering; -the date of slaughtering and results thereof (back report from the slaughterhouse on veterinary examination); -results on checks on disinfection efficacy; -results of routine sampling of poultry feeds for the purpose of checks on compliance with withdrawal periods; -results of checks for the detection of Salmonella spp. performed in accordance with requirements of Regulation (EC) 2160/2003 of the European Parliament and of the Council, i.e. the National Programme. Page 13 of 41

14 (d)2.7 Documents to accompany animals when dispatched During transport the live birds shall be accompanied with transport authorization, issued by the BFSA, according to the Council Regulation 1/2005 on the protection of animals during transport. Operators wishing to export more than 20 birds or hatching eggs to another EU member state (or certain third countries) must comply with EU Directive 90/539/EC and ensure that the consignment is accompanied by a completed and signed Intra-trade Animal Health Certificate (ITAHC) for poultry breeding and production. The ITAHC will also require the reference number of the operator s poultry health certificate. Animal health certificate has to be issued by the veterinarian servicing the farm of origin and completed on a pre-printed model form after an appropriate clinical examination performed by this veterinarian. All official veterinary health certificates issued for the export of poultry and hatching eggs are recorded on the Trade Control and Expert System (TRACES). This system allows tracking of exports of live animals and hatching eggs accompanied by veterinary health certification. The TRACES generates ITAHCs issued for intra-community movements. A TRACE is an internet-based service which is owned and maintained by the Commission. (d)2.8 Other relevant measures to ensure the tracebility of animals Each consignment of poultry or hatching eggs must be accompanied by information delivered by the veterinarian of the place of forwarding the consignment to the official veterinarian of their place of their destination. The operators of hatcheries and the keepers of breeding flocks shall keep records of poultry or hatching eggs entering or leaving the premises. The records must contain information on the number, date, and origin or destination. These records must be retained for three years and be available to the Competent Authority for inspection. Page 14 of 41

15 ANNEX II - PART B 1. Identification of the programme Disease Salmonella Animal population : Breeding flocks of Gallus gallus Request of Union co-financing for the period : From To Contact Name : Dr. Pencho Kamenov Phone : Fax. : p_kam@bfsa.bg 2. Historical data on the epidemiological evolution of the disease A concise description is given with data on the target population (species, number of herds and animals present and under the programme), the main measures (testing, testing and slaughter, testing and killing, qualification of herds and animals). The information is given for distinct periods if the measures were substantially modified. The information is documented by relevant summary epidemiological tables, graphs or maps. In Republic of Bulgaria the Salmonella Control National Programme in breeding flocks has been in operation since 2008 and approved by Commission Decision 2007/873/ЕО. Table and graphic in the file attached present data on the total number of tested breeding flocks, number of Salmonella target positive flocks and % Salmonella positive flock s prevalence for the Salmonella target serotypes included in the program, in the time period The number of breeding flocks positive for Salmonella spp in total is as follow: In flock positive for Salm. Infantis; 1 flock - Salm. Bareilly; 2 floks-salm. Senftenberg; 1 flock - Salm. agona Page 15 of 41

16 In flocks positive for S. Infantis, 2 flocks - S. hadar, 1 flock-s.glostrup, 1. flock - S.Seftenberg, 1 flock - S. Corvallis. In flock positive for S. Typhimurium, 1 flock - S. Agona and S. Livingstone in hatchery. In flock positive for S.infantis, 2 flocks positive for S.corvalis and1 flock positive for S.Lomnita. In flocks positive for S.Enteritidis and 1 flock-s.hadar. The number of Salmonella serovars detected in breeding flocks is presented on the table into the attached file. In conclusion S.Infantis remains the most commonly isolated Salmonella serotype, followed by S. Hadar, S. Agona and S. Senftenberg in the Republic of Bulgaria as a whole. The % Salmonella positive flock s prevalence for the Salmonella target serotypes, included in the program slowly increased in 2013 to1.03%. 3. Description of the submitted programme A concise description of the programme is given with the main objective(s) (monitoring, control, eradication, qualification of herds and/or regions, reducing prevalence and incidence), the main measures (testing, testing and slaughter, testing and killing, qualification of herds and animals, vaccination), the target animal population and the area(s) of implementation and the definition of a positive case. The main objectives of the programme are monitoring and control of zoonotic Salmonella serotype (S. enteritidis, S. typhimurium, S. infantis, S. virchow and S. hadar) in the poultry breeding flocks. The aim of the programme is to maintain the prevalence of the 5 Salmonella serovars (S. enteritidis, S. typhimurium, S. infantis, S. virchow and S. hadar) to a level of 1% or lower in adult breeding flocks of Gallus gallus comprising at least 250 birds. Monophasic Salmonella typhimurium, serotypes with the antigenic formula 1,4,[5],12:i:-is included in the programme in the line with Union target. The main measures are monitoring and control of the poultry in the breeding flocks. The target animal population are breeding flocks Gallus gallus for broiler production and for laying hens as well. The positive case is lay down on the basis of the bacteriological investigation. Only named and approved laboratories by the BFSA will carry out the examination and validated methods of bacteriological examination will be used. The testing will be performed in the laboratories listed in point 1.3. Official checks at the level of poultry flocks is carried out by the relevant RFSD, the RFSD also takes measures in the case of positive results. Sampling in poultry flocks is carried out by an operator or by a private veterinarian. Official sampling and samples for the confirmation are taken and sent for the examination by an official veterinarian of the relevant RFSD. 4. Measures of the submitted programme Page 16 of 41

17 Measures taken by the competent authorities with regard to animals or products in which the presence of Salmonella spp. have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination. The measures taken by the competent authorities with regard to animals or products in which the presence of Salmonella spp. have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination are described into the relevant veterinary legislation: COMMISSION REGULATION (EU) No 200/2010 of 10 March 2010 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Union target for the reduction of the prevalence of Salmonella serotypes in adult breeding flocks of Gallus gallus COMMISSION REGULATION (EC) No 213/2009 of 18 March 2009 amending Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Regulation (EC) No 1003/2005 as regards the control and testing of Salmonella in breeding flocks of Gallus gallus and turkeys. REGULATION (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents; REGULATION (EC) No 1177/ 2006, implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry ORDINANCE 9/ on the monitoring of zoonoses in their prevention, limitation and eradication (Published in SG 15/ ), transposing DIRECTIVE 2003/99/EC of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC. 1. Measures taken following the detection of S. enteritidis and/or S. typhimurium and/or S. infantis in faecal samples taken by a farmer: In the case of the presence of S. enteritidis, S. typhimurium or S. infantis in faecal samples taken by a farmer, an official sampling shall be performed by an official veterinarian from the RFSD in each positive flock, in order to exclude false positive initial result from the sample taken by operator. The confirmation method shall be carried out according to Annex II, D, 4 (b) (i) of Commission Regulation No 2160/2003. The confirmation method will be based on the technical specifications referred to in Article 5 of Commission Decision 2004/665/EC (seven samples); The confirmatory sampling shall be performed as follows: 5 pairs of boot swabs (1 pair = 1 sample) or 5 samples of faeces; 2 dust samples collected from multiple places throughout the house (2 x 250 ml) A sub-sample, weighting 25 g and prepared from each faecal and dust sample, shall be used for the analysis; all samples shall be analysed separately. In the case of sampling by the RFSD because of suspicion on salmonella presence and in any other case considered appropriate, the RFSD can satisfy itself by conducting further tests and/or documentary Page 17 of 41

18 checks as appropriate to verify that results are not altered through the presence of antimicrobials or other substances inhibiting the growth of bacteria. The sample of five birds is taken for detection of the inhibition substance. Pending the completion of the confirmatory examination, the RFSD shall impose at least the following measures: bacteriological analysis of feeds and water, if necessary, for the detection Salmonella spp.; in the case of a positive result of the detection of S. enteritidis and/or S. typhimurium and/or S. infantis, hatching eggs shall be suspended pending the completion of the confirmatory analyses; a thorough mechanical cleansing and disinfection of the house, as well as other premises (e.g. stores of feeds and litter), shall be performed. A thorough mechanical cleansing of halls and technologies, followed by disinfection and safe disposal of faeces or litter shall be performed on completion of each production cycle. In the case of a negative result of the confirmatory examination the flock shall be considered negative. b) Measures taken in the case of positive official samples and positive confirmatory examinations for S. enteritidis and/or S. typhimurium and/or S. infantis The RFSD shall perform an epidemiological investigation in the holding, aimed at the detection of the possible source of the infection and shall impose at least that: Bacteriological examination of feeds and water for the detection Salmonella spp. is performed, if necessary; All birds, including day-old chicks, in the positive flock must be slaughtered or destroyed so as to reduce as much as possible the risk of Salmonella spreading. Slaughtering must be carried out in accordance with Community legislation on food hygiene. By-products derived from such birds and not intended for human consumption, must be disposed in accordance with Regulation (EC) of the European Parliament and of the Council No 1069/2009 laying down health rules concerning animal byproducts not indented for human consumption; Non-incubated eggs must be destroyed; Where eggs for hatching are still present in a hatchery, they must be destroyed or treated in accordance with Regulation (EC) of the European Parliament and of the Council No 1069/2009; After slaughtering or destruction of birds from infected flocks, a thorough cleansing and disinfection, as well as disposal of faeces or litter, must be performed in accordance with the instructions of the relevant RFSD; The relevant RFSD performs the supervision on the efficacy of the disinfection carried out by the farmer; the checks on the efficacy of the disinfection shall be performed by means of bacteriological testing of swabs, in accordance with the method specified by the NRL; All others flocks at the holding are officially sampled. The emergency veterinary measures applied by RFSD in the case of detection S. enteritidis or S. typhimurium in faeces include ban of movement infected or suspect flocks with exception of movement the birds to the slaughterhouse. In the case of slaughtering o the positive flocks on the slaughterhouse in other member state the date and the result of testing shall be included in the relevant health certificates provided in compliance with Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra- Community trade in, and imports from third countries of, poultry and hatching eggs. In the case of positive results epidemiological surveys shall be carried out to identify the possible source of contamination. These surveys included a review of biosecurity measures, taking of samples from feed Page 18 of 41

19 and from water and check of the implementation of biosecurity plan and vaccination programme on the holding with parent flock, or where the reared flock has been kept. In order to ensure further reduce prevalence in according to all SCP from shall draw up and comply with plan of hygiene practice on holdings. The SCP set down minimum requirements for the content of this sanitation plan. The implementation of this plan and the biosecurity standards on the holding is checked during inspections planned by risk analysis and in the case of the taking of official samples. Preventive measures: Vaccination against S. enteritidis in the framework of the programme is voluntary. The vaccination shall be carried out in accordance with Commission Regulation (EC) No 1177/2006. Live salmonella vaccines for which the manufacturer does not provide an appropriate method todistinguish bacteriologically wild-type strains of salmonella from vaccine strains are prohibited from use in the framework of national salmonella control programmes. The vaccines used have to have valid registration and must comply with the requirements of Commission Regulation No 1177/2006. Dosage, application methods and age categories are recommended by the vaccine manufacturer. The used scheme shall be approved by the RFSD. Vaccination against S. enteritidis in the framework of the programme is voluntary. 4.1 Summary of measures under the programme Period of implementation of the programme : Measures Control Testing Slaughter of animals tested positive Killing of animals tested positive Vaccination Treatment of animal products Disposal of products Monitoring or surveillance Other, please specify Page 19 of 41

20 4.2 Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme Describe the authorities in charge of supervising and coordinating the departments responsible for implementing the programme and the different operators involved. Descrive the responsabilities of all involved. Bulgarian Food Safety Agency (BFSA) is the competent authorities for control of Salmonella and their zoonotic agents. Department Infectious diseases within Directorate Animal health and Welfare at the Headquarters of BFSA has the following responsibilities: 1. To draft surveillance programme for Salmonellosis and to submit it for approval to the European Commission. 2. To control the implementation of the surveillance programme. 3. To collect and analyse the data on the animals tested for salmonellosis 4. To summarize the data on positive holdings. 5. To keep a register in the database of all holdings with breeding hens 6. To send annual report to the European Commission containing the data referred to in points 3-6. At regional level the Regional Food Safety Department (RFSD) and the heads of departments Animal health have the following responsibilities: 1. To control and to implement the Salmonella surveillance programme at regional level. 2. To collect and analyse the data on the poultry tested for salmonella in the region. 3. To summarize the data on positive animals. 4. To summarize the data on the salmonella surveillance costs incurred at regional level. 5. To keep a register in the database of all holdings with breeding hens. 6. To send annual reports containing the data referred to in points 1-6 to Directorate Animal health and welfare at BFSA. The municipal veterinarian has the following responsibilities: 1. To control and to implement the programme for surveillance of salmonella in the relevant municipality. 2. To control the sampling of laying hens and the sending of samples to the laboratories. 3. To collect and analyse the data on the poultry tested for salmonella in the veterinary units located on the territory of the relevant municipality. 4. To summarize the data on positive animals from the veterinary units located on the territory of the relevant municipality. 5. To summarize the data on the salmonella surveillance costs incurred by the relevant municipality. 6. To keep a register in the database of all holdings with breeding hens 7. To send annual reports containing the data referred to in points 1-6 to Directorate Animal health at Page 20 of 41

21 the relevant RFSD. 4.3 Description and delimitation of the geographical and administrative areas in which the programme is to be implemented Describe the name and denomination, the administrative boundaries, and the surface of the administrative and geographical areas in which the programme is to be applied. Illustrate with maps. The programme shall be implemented on the territory of the whole country comprising 28 districts 4.4 Measures implemented under the programme Where appropriate Community legislation is mentioned. Otherwise the national legislation is mentioned Measures and applicable legislation as regards the registration of holdings The Bulgarian Food Safety Agency is the official competent authority for the registration of animal holdings. The owners of animal-breeding holdings shall submit an application of registration, conformed to a specimen to the director of RFSD. Within a time period of up to 7 days from the submission of the application, the director of RFSD by an order shall appoint a commission for carrying out of a check for compliance of the holdings with the veterinary medical requirements on animal breeding and welfare. The commission shall in a period of 3-days present to the director of the RFSD the opinion with a proposal for a registration or a refusal. When upon the check it is being found out that the holding does not meet the veterinary medical requirements, the commission shall give a written prescription to the applicant, wherein shall fix a deadline for adjustment of the omissions. When the applicant has removed the omissions before the expiry of the indicated in the prescription deadline, he shall inform in writing the director of RFSD, who within a period of seven-days shall send the commission for a re-check of the holding. The commission shall draft a protocol of the results of the check and shall submit it to the director of RFSD. The director of RFSD shall enter the animal-breeding holding in the register and shall issue a certificate of registration or shall justify the refusal of the registration if the holding does not meet the veterinary medical requirements. The register contains the following information: Page 21 of 41

22 1. number and date of the certificate issued; 2. the veterinary registration number of the holding; 3. name and permanent address of the owner of the holding; 4. address/location and type of the holding; 5. capacity of the holding; 6. type, category and use of the birds in the holding; 7. technology of breeding of the birds; 8. number and date of the order for delegation of the registration 9. changes in the circumstances entered. Each animal holding shall keep records with the following information. Total number of birds in the holding The new entered birds The birds for slaughtering. The birds for sale The number of death birds When a farm is inspected by an official veterinarian, the latter has also to perform a thorough check of all the records /logbooks/ that are kept in respective holding Measures and applicable legislation as regards the identification of animals Not applicable for poultry The programme is refer to the birds without individual identification Measures and applicable legislation as regards the notification of the disease The Law on Veterinary Activities, Art.124 and Ordinance No.23 / on the order and the way of notification and registration of infectious diseases in animals, which is harmonized with Council Directive 82/894/EEC Measures and applicable legislation as regards the measures in case of a positive result Page 22 of 41

23 A short description is provided of the measures as regards positive animals (slaughter, destination of carcasses, use or treatment of animal products, the destruction of all products which could transmit the disease or the treatment of such products to avoid any possible contamination, a procedure for the disinfection of infected holdings, a procedure for the restocking with healthy animals of holdings which have been depopulated by slaughter In case of suspicion or conformation of Salmonella enteritidis or S.Typhimurium(including monophasic S. Typhimurium serotype with antigenic formula 1,4/5/,1 2:i) the NRL shall notify immediately the BFSA. The positive result for target serovars confirmed by NRL is a condition to declare a flock as a positive for target serovars of the control programme. 1. Measures taken following the detection of S. enteritidis and/or S. typhimurium and/or S. infantis in faecal samples taken by a farmer: In the case of the presence of S. enteritidis, S. typhimurium or S. infantis in faecal samples taken by a farmer, an official sampling shall be performed by an official veterinarian from the RFSD in each positive flock, in order to exclude false positive initial result from the sample taken by operator. The confirmation method shall be carried out according to Annex II, D, 4 (b) (i) of Commission Regulation No 2160/2003. The confirmation method will be based on the technical specifications referred to in Article 5 of Commission Decision 2004/665/EC (seven samples); The confirmatory sampling shall be performed as follows: 5 pairs of boot swabs (1 pair = 1 sample) or 5 samples of faeces; 2 dust samples collected from multiple places throughout the house (2 x 250 ml) A sub-sample, weighting 25 g and prepared from each faecal and dust sample, shall be used for the analysis; all samples shall be analysed separately. In the case of sampling by the RFSD because of suspicion on salmonella presence and in any other case considered appropriate, the RFSD can satisfy itself by conducting further tests and/or documentary checks as appropriate to verify that results are not altered through the presence of antimicrobials or other substances inhibiting the growth of bacteria. The sample of five birds is taken for detection of the inhibition substance. Pending the completion of the confirmatory examination, the RFSD shall impose at least the following measures: bacteriological analysis of feeds and water, if necessary, for the detection Salmonella spp.; in the case of a positive result of the detection of S. enteritidis and/or S. typhimurium and/or S. infantis, hatching eggs shall be suspended pending the completion of the confirmatory analyses; a thorough mechanical cleansing and disinfection of the house, as well as other premises (e.g. stores of feeds and litter), shall be performed. A thorough mechanical cleansing of halls and technologies, followed by disinfection and safe disposal of faeces or litter shall be performed on completion of each production cycle. In the case of a negative result of the confirmatory examination the flock shall be considered negative. b) Measures taken in the case of positive official samples and positive confirmatory examinations for S. enteritidis and/or S. typhimurium and/or S. infantis The RFSD shall perform an epidemiological investigation in the holding, aimed at the detection of the possible source of the infection and shall impose at least that: Page 23 of 41