Dossier of Republic of Bulgaria for the recognition as a ... CSF_Do… · 1 SAFETY EVERY DAY MINISTRY OF AGRICULTURE AND FOOD BULGARIAN FOOD SAFETY AGENCY Sofia, 1606, “Pencho Slaveikov”

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SAFETY EVERY DAY

MINISTRY OF AGRICULTURE AND FOOD

BULGARIAN FOOD SAFETY AGENCY

Sofia, 1606, “Pencho Slaveikov” blvd. 15A

+359 (0) 2 915 98 20, +359 (0) 2 954 95 93, www.babh.government.bg

Dossier of Republic of Bulgaria for

the recognition as a CSF free country, under Chapter 15.2. of the Terrestrial Animal Health Code,

September 2016

CSF FREE COUNTRY

Report of Republic of Bulgaria

CSF FREE COUNTRY /Report of Republic of Bulgaria

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EXECUTIVE SUMMARY

Classical swine fever (CSF) is a disease that has been causing major socio-economic damages in the world during the last decades.

A strategy for CSF prevention, control and surveillance has been implemented in Republic of Bulgaria for many years.

The Central Competent Authority (CCA) in charge of animal health control in Bulgaria is the Bulgarian Food Safety Agency (BFSA). Tasks related to the veterinary peventive measures against infectious and parasitic diseases including zoonoses , monitoring, implementation and supervision of the control and eradication programmes, preparation of contingency plans, guidelines and instructions for the RFSD on implementing animal health measures are mainly carried out by Animal Health, Welfare and Feed Control Directorate at the HQ of BFSA(AHWFeCD).

Since becoming EU country, Bulgaria has started implementing a new surveillance and control strategy/programme for CSF, which includes:

- active clinical monitoring of pigs for CSF and a targeted sampling and testing scheme as regards CSF;

- Tthe ban of prophylactic vaccination against CSF of the domestic pig population, including East-Balkan pigs (since 2005);

- quick and effective application of the required measures for control and eradication of any outbreaks of disease that have emerged meanwhile;

- surveillance and vaccination strategy in wild boar (vaccination in wild boar performed till 2015).

Main objectives of this programme are:

- early detection of a new introduction of CSF; - reducing the risk of spreading CSF; thus improvement of animal health worldwide and

ensuring a safe international trade with respect of CSF; - demonstrating a freedom from CSF virus infection.

The Dossier has been drafted and presented for the purpose of applying for official disease status recognition with regard to CSF. Following the questionnaire laid out in Chapter 1.6.10 of the Terrestrial Code, the dossier:

- provides information on the pig industry, veterinary authority and animal health structure, and animal health situation with regard to CSF in Republic of Bulgaria;

- demonstates the measures for CSF control, surveillance and prevention applied in the country and their full compliance with all provisions set out in Chapter 15.2 of the Terrestral Animal Health Code;

- describes how CSF was controlled and eradicated in the country - demonstrates an freedom from CSFV infection at an acceptable level of confidence.


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TABLE OF CONTENTS:

1. Introduction and general information 4

2. Veterinary system 5

3. CSF eradication 9

4. CSF Diagnois 15

5. CSF surveillance 23

6. CSF prevention 31

7. Control measures and contingency planning 36

8. Compliance with the Terrestrial Animal Health Code 42

9. Recovery of free status 42

CSF FREE COUNTRY

Report of Republic of Bulgaria


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1. Introduction and general information

a) Geographical factors. Provide a general description of the country or zone including physical, geographical and other factors that are relevant to CSF dissemination, countries sharing common borders and other countries that although may not be adjacent share a link for the potential introduction of disease. The boundaries of the country or zone must be clearly defined, including a protection zone if applied. Provide a digitalised, geo-referenced map with a precise text description of the geographical boundaries of the country or zone.

The Republic of Bulgaria, located on the Balkan Peninsula, is bounded on the north by Romania, on the east by the Black Sea, on the south by Turkey and Greece, and on the west by Serbia and Montenegro and FYROM. The area of Bulgaria is 110 980 km2. The greatest distance from north to south is about 330 km and from east to west about 500 km.

Mountains cover much of Bulgaria, interspersed with fertile valleys and plains. The average elevation is about 480 m. The Balkan Mountains cross the country from the north-western corner to the Black Sea.The northern side of the Balkan Mountains slopes gradually to the Danube River to form the northern Bulgarian or Danubian Plateau. Transitional plains lie to the south of the mountains and are an important agricultural region. The Rhodope Mountains forms the boundary with Greece on the south.

Most of Bulgaria has a continental climate, with cold winters and hot summers. The average January temperatures in the country range from 2° C near the Black Sea to -11° C in central Bulgaria. July temperature range between 16° and 27° C. The wettest period is early summer in most of the country and autumn or winter in the southern valleys. Snowfall is generally light except in the mountains.

The interaction of climatic, hydrological, geological and topographical conditions have produced a relatively wide variety of plant and animal species. Bulgaria is one of the countries with highest biodiversity in Europe.

Bulgaria is divided into 28 administrative districtis and subdivided into 264 municipalities.

Becoming EU Member States, Bulgaria is working hard to install the necessary veterinary regulations to comply with EU rules. Once these regulation had been put in place, there were considerable work needed to bring processing plants and animal holdings up to the required standards, so that they can be certified for export to EU markets. The numbers of organizational, structural and legal-regulatory changes made and the corresponding economic environment resulting with many changes in the number of farms, stock and husbandry system.

In terms of animal diseases control, Bulgaria has implemented active prophylactic, surveillance system and eradication schemes.

b) Pig industry. Provide a general description of the domestic and captive wild pig industry in the country or zone.

The swine farming sector accounts for 65% of the total red meat production in the country. A significant part of the swine farms have met the requirements for animal welfare and produce high quality and safety products.


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Significant decrease of the number of domestic pigs has been observed since 2005 when the domestic pig population in Bulgaria was more than 1 million animals.

There was a high proportion of non-professional pigs holding (backyards holdings, farm with low biosecurity measures) which poses challenges for the Veterinary Services in terms of CSF control, having in mind that these holdings would would be CSF Virus reservoir and possible source of infection to the commercial farms.At the end of 2009 there were 60 000 non- professional pigs holding rearing of about 34% of domestic pig population.

In the recent year the statistics show increasing of the industrialization of the sector, which is evident

by the constantly changing structure of the farms. At the end of 2015 the domestic pig population was about 588 507 animals; 88% of the pigs are bread in 56 industrialized farms (please see point 5, table 2) .

As regards wild boar an increase in the population has been observed during the past years from estimated 58000 wild boar in 2006 to more than 90000 animals in the spring of 2015

2. Veterinary system

a) Legislation. Provide a list and summary of all relevant veterinary legislations in relation to CSF.

The Law on Veterinary Activities - provides the legal basis empowering the central competent authority to establish national requirements in the fields of holding registration, animal identification and disease notification and to apply control measure in cases of disease outbreaks;

Ordinance No 4 of 15.02.2007 deals specifically with the prevention, limitation and eradication of classical swine fever and transposes Council Directive 2001/89/EC;

Council Directive 2001/89/EC requires the competent authority to ensure consistency between the vaccination plan in an area close to a border with another EU Member State and measures taken to eradicate CSF from feral pigs in that Member State, where applicable;

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin, and Regulation No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption;

ORDINANCE № 61 on the measures and procedures for identification of animals, registration of animal holdings and the availability to access the data base for identified animals and registered animal holdings;

Commission Decision 2008/855/EC of 3 November 2008 concerning animal health control measures relating to classical swine fever in certain Member States;

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation);

b) Veterinary Services. Provide documentation on the compliance of the Veterinary Service of

the country with the provisions of Chapters 3.1. and 3.2. of the Terrestrial Code and


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Chapter 1.1.3. of the Terrestrial Manual and describe how the Veterinary Services supervise and control all CSF related activities. Provide maps and tables wherever possible.

The Bulgarian Food Safety Agency (BFSA) at the Ministry of Agriculture and Food is the Central Competent Authority (CCA) in charge of animal health control in Bulgaria. The BFSA has its central headquarters in Sofia and an operational structure in 28 regions of the country. Each region has a Regional food safety directorates (RFSD) and is responsible for a number of municipalities.

MAF Ministry of Agriculture and Food BFSA Bulgarian Food Safety Agency RFSD Regional Food Safety Directorate

AOCD Audit of Official Controls Department

VACRFSAD Verification and Administrative Control of the activities of the Regional Food Safety Directorate Department

AHWFeCD Animal Health, Welfare and Feed Control Directorate

LASD Laboratory Activities and Standards Directorate

VOCGD Verification of the Official Control General Directorate

IAD Internal Audit Directorate

NDRVI National Diagnostic and Research Veterinary Institute

RL Regional Laboratories


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Tasks related to the veterinary peventive measures against infectious and parasitic diseases including zoonoses , monitoring, implementation and supervision of the control and eradication programmes are mainly carried out by Animal Health, Welfare and Feed Control Directorate at the HQ of BFSA(AHWFeCD). It is also responsible for the preparation of contingency plans, guidelines and instructions for the RFSD on implementing animal health measures. AHWFeCD is suported by other Departments within the BFSA in supervising and controling and implemented all CSF related activities - Public Safety Directorate, Training and Qualification Directorate, the Internal Audit Directorate, the 28 Regional Food Safety Directorates (RFSD), oficial municipal veterinarinas (OMV) distributed across the country and the Laboratory Activities Directorates which includes the National Diagnostic and Research Veterinary Institute (NDRVI) and its national reference laboratory (NRL) for CSF. The Regional Food Safety Departments (RFSD) enforce the programme on both, the domestic and wild boar population at regional level, monitor the actions of all authorities involved at local level and report to the BFSA HQ. It also supervises the two rendering plants at Varna and Shumen and take samples from dead pigs suspicious of CSF or killed for reasons of CSFeradication. The Public Safety Directorate at BFSA and Public health officials at the RFSD of the BFSA in charge of meat inspection:

- Carry out ante and post mortem inspection in accordance with the rules laid down by Council Regulation (EC) 854/2004, Article 5 and Annex I, in addition carry out the documentary and identity checks in accordance with Commission Decision 2008/855/EC,

- Ensure health marking of the meat in accordance with Commission Decision Commission Decision 2013/764/EC, Article 5 on pig meat of Bulgarian origin,

- Carry sampling of pigs for CSF according to the sampling scheme approved, and ensure the traceability of the samples back to the farm of origin,

- Notify the BFSA in case of suspicion of CSF/ASF and forward corresponding samples to the NRL Sofia,

- In case of CSF declare meat of pigs unfit for human consumption in accordance with Council Regulation (EC) 854/2004, Annex I, Section II, chapter V, 1 e) and seizure the meat accordingly and send for destruction to rendering plant,

- Check the cleaning and disinfection of means of pig transports in accordance with the provisions laid down by Commission Decision 2008/855/EC.

The animal health officials at the Municipal Veterinary Services (MVSs) of the BFSA:

- Enforce the program at local level; carry out clinical surveillance (according to the clinical surveillance scheme updated annually) and sampling of the domestic pig population (according to the sampling scheme updated annually) in cooperation with the registered veterinary practitioners involved in the programme and approved according to the rules laid down by Directive 64/432/EEC, Articles 2, 2m) and 14 (3) B),

- In case of any suspicion of CSF tacking samples in accordance with the rules laid down by Commission Decision 2002/106/EC

- in addition carry out the documentary and identity checks in accordance with Commission Decision 2013/764/EC in the context of movement of pigs inside Bulgaria,

- Ensure the traceability of the samples back to the farm of origin, - Control the results of clinical surveillance in BG’s Traceability database system submitted


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by the registered vets. - Monitor the improvement and enforcement of bio security measures at the farms,

including cleaning and disinfection procedures based on the principles laid down in Council Directive 2001/89/EC, Article 12 and Annex II,

- Control the implementation of the rules on holding registration, identification of the pigs and the control of their movements, including closing of holdings and seizure of pigs in case of breach or violation of rules in accordance with the rules laid down by Article 139a of The Low of Veterinary Activity and Council Regulation (EC) 882/2004,

- Supervise, monitor and control the distribution of baits for oral vaccination of the wild boar population on the areas near to the borders of the country in cooperation with the institutions listed under 3,5,6 and 7,

- Record the results of surveillance measures including sampling of the wild boar population in the wild boar database.

BFSA interacts with the other institutions which are involved in the CSF monitor and control. - The Executive Forest Agency is the central competent authority for inter alia hunting of wild

game and sorts under the same ministry as the BFSA. The Regional Directorates of Forestry are involved in the spreading of vaccine baits and the monitoring of CSF in wild boar, with the help of members of the National Union of Hunters and Anglers.

- National Union of Hunters and Anglers also contribute to the CSF control through providing carcasses and material of wild boar (shot at hunting, fallen stock or crashed in car accidents for the purposes of CSF surveillance.

The National Reference Laboratory (NRL) for CSF and ASF in Sofia: - Processes samples collected from both, domestic pigs and wild boar for CSF virus isolation

and serology testing, records test results in the Traceability database system and reports to the BFSA,

- Tests and methods used are presented in chapter 10 below (Table), - Undertakes confirmation tests on samples with doubtful test results send by the Regional

Laboratories, - Monitors the procedures at the Regional Laboratories and organises ring-tests with them - Forwards virus isolates to the CRL for CSF, Hanover and takes part in ring-tests. - In case of suspicion for ASF performs the necessary diagnosis to confirm or rule out the

disease.

The Regional CSF Laboratories at the Institute in Sofia , Stara Zagora and Veliko Tarnovo - Perform CSF serology testing on samples from domestic pigs collected according to the

sampling plans presented in tables (Chapter 7 below) record test results in the Traceability database system and report to the BFSA,

- Tests and methods used are presented in point 4 below, tests limited to ELISA antibody testing,

- Forward all samples with doubtful and positive test results for confirmation or rejection of the diagnosis to the NRL Sofia;

- Inform for the results the BFSA and the respective RFSD which sends the samples for testing.

The CRL for CSF at Hanover


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- genotyping of virus isolates forward by the NRL, Sofia, - Provides the NRL with test materials on request from the Bulgarian side, - Organises ring tests in which the NRL Sofia will participate.

The Ministry of Internal Affairs: - Assists in the administrative and security measures in case of suspicion or confirmation of

CSF. The Farmers’ Union and the Pig Breeders’ Associations

- Inform their members about the CSF/ASF control program and support the BFSA to perform active clinical surveillance scheme and the sampling and testing schemes where necessary.

The association of veterinarians take part in the active surveillance and clinical observations of the piggery farms.

c) Role of farmers, industry and other relevant governmental and non-governmental organisations in CSF surveillance and control (include a description of training and awareness programmes on CSF).

Farmers, industry and other relevant governmental and non-governmental organisations fully implement the CSF surveillance and control programmes issued by BFSA

d) Role of private veterinary profession in CSF surveillance and control.

In addition, the BFSA signs annual contracts with private veterinarians for tasks related to inter alia identity controls on animals and farms, movement certificates and sampling and clinical checks of domestic pigs for the CSF programme. The Farmers’ Union and the Pig Breeders’ Associations cooperate the BFSA for the purpose of CSF control – they imform their members about the CSF/ASF control program and support the BFSA to perform active clinical surveillance scheme and the sampling and testing schemes where necessary. The association veterinarians take part in the active surveillance and clinical observations of the piggery farms. 3. CSF eradication

a) History. Provide a description of the CSF history in the country and zone, date of first detection, temporal and spatial distribution, origin of infection, date of last case in the country or zone.

Prophylactic vaccinations have been performed in the whole country for many years. Despite this

sporadic outbreaks of CSF occurred in Bulgaria every year in the 90-ies. After a gradual drop in the

number of CSF outbreaks between 1996 and 1999 down to just one outbreak per year in 2000 and

2001, the CSF situation changed drastically in 2002.

Because of serious deficiencies in performing prophylactic vaccination (due to various reasons) and

illegal trade in live pigs, 32 outbreaks of CSF were registered in 14 of the 28 administrative districts

of Bulgaria in 2002 (fig. 1).


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Then, in 2003 16 CSF outbreaks in 4 districts were observed, while in 2004 only two outbreaks were

recorded (fig. 1). However and for the first time since 1996, 48 cases of CSF were identified in the

wild boar population of 2 districts.

Figure 2. CSF outbreaks in domestic pigs, 2000 – 2005

In 2005, serious measures for confinement and containment of CSF were taken. Besides the end of

the regular prophylactic vaccination of all domestic pigs in the country these included the ban of

animal markets under an Order issued by the Minister of Agriculture and Forestry. Furthermore, an

oral vaccination campaign (two placing of baits within two weeks) was performed within the wild

boar (wild pig) population, because of 88 CSF cases found in wild boar of 7 administrative districts

of the country. As a result of the measures taken, no further outbreaks were detected in the

domestic pig population of Bulgaria in 2005.

However, during 2006 seven outbreaks of CSF were found in domestic pigs of which six happened

in the administrative district of Yambol and one in the administrative district of Burgas. The oral

vaccination was continued in 2006 by performing two vaccination campaigns within wild boar

population.

During the first 3 months of 2007, three outbreaks of CSF were notified, of which two were

observed in East-Balkan pig herds in the region of Shumen and one in domestic pigs (family farm of

category B) in the region of Yambol.

In 2008 CSF was detected in one category B farm – without bio security measures applied, located

in the village of Treklyano, region of Kjustendil, 6 km from the Serbian border. The disease was

detected during clinical investigation of the farm using check lists within the framework of

implementation of the programme for control and eradication of CSF. All sick and contact swine

were killed under the animal welfare requirements and buried.


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Since May 2008, no further outbreaks of CSF have been detected in domestic pigs on the whole

territory of Bulgaria.

In 2009 8 CSF cases were detected in wild boar in a 25 km2 forest close to Danube river (State

hunting area Karakuz, Tutrakan municipality, Silistra region). Since then no CSF cases either in

domestic pigs and wild boar have occurred in Bulgaria (fig. 2).

According to the data available from intensive sampling and testing carried out countrywide since

2009 when last cases in wild boar were detected, it became evident that on whole territory of the

Bulgaria neither sero-conversion due to eventually circulating CSF field virus strains nor clinical

signs of CSF have been detected in both domestic pig and wild boar populations.

In table 1 is shown the CSF situation and the significant events related to the disease for the period

2004 – Oct 2015. Figure 2 shows the CSF outbreaks in domestic pigs and wild boar in 2007 – 2009.

Table 1. CSF situation in Bulgaria for the period 2004 – Mar 2016

year

Trade farms1 East Balkan pigs Backyards

Cases

in

Wild

boar

Significant events No of

herds

infected

No of

animals

infected

No of

herds

infected

No of

animals

infected

No of

herds

infected

No of

animals

infected

2004 1 3 1 19 - - 48 First cases in WB since 1996

2005 - - - - - - 88

Start of oral vaccination in WB

End of vaccination in domestic pigs

2006 3 68 - - 4 5 - Dec. 2006/805/EC (ban for BG)

2007 1 41 2 46 - - - EU accession

New strategy for CSF

2008 1 8 - - - - -

Check lists for active surveillance

FVO mission

Dec. 2008/885/EC lifting the ban for pig products

new vaccination strategy in WB

2009 - - - - - - 8

CSF task force group

Last cases in WB,

Game collection centers for WB carcasses

2010 till August 2016 No CSF outbreaks

1 Trade Farms comprise industrial farms, family farms type A, family farms type B in accordance within the definition

given in point 5 b below.


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Figure 2. CSF outbreaks in domestic pigs and wild boar in 2007 – 2009

b) Strategy. Describe how CSF was controlled and eradicated in the country or zone (e.g. stamping-out policy, modified stamping-out policy, zoning), provide time frame for eradication.

Since 2007 Bulgaria started a new surveillance and control strategy for CSF including: - Active clinical monitoring of pigs for CSF and a targeted sampling and testing scheme as

regards CSF; - Continued enforcement of the ban of prophylactic vaccination against CSF of the domestic

pig population, including East-Balkan pigs; - Quick and effective application of the required measures for control and eradication of any

outbreaks of disease that have emerged meanwhile; - Surveillance and vaccination strategy in wild boar

When implementing the CSF surveillance and control programs the competent authorities also took into consideration:

- The different types of pig holdings in Bulgaria described below ( see point 5b ); - The results from the scientific epidemiological analysis conducted for ascertaining the CSF

transfer mechanism and the geographical spread of the disease; - The presence of wild boar population all over the territory of the country, which might have

direct or indirect contact with the herds of East-Balkan pigs bred on the territory of three regions of the country.

- The lack of big natural or artificial barriers as regards the movement of wild boar over the territory of the country;


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- Control over the registration of pig farms, the movement of pigs, their identification and the herd registers linked with the application of a corresponding electronic database;

- Control over the oral vaccination campaign of wild boar population (blood samples for antibodies and organ samples which are negative for the virus presence).

Based on the above components an appropriate CSF surveillance scheme including active

surveillance (clinical surveillance to detect clinical cases of CSF as early as possible and submission

of check lists data into the national database and serological and virological surveillance) and

passive surveillance for the different types of holdings was implemented in the framework of the

annual CSF programmes approved for co-financing by EC.

Surveillance and control of CSF in wild boar includes testing of organ and blood samples from

shot/found dead wild boar from the whole territory of Bulgaria for presence of CSF field virus

(CSFV) and antibodies induced by oral vaccination of the wild boar population. Results are

presented in Table 3, point 5 b.

c) Vaccines and vaccination. Was CSF vaccine ever used? If so, of what type and when was the last vaccination carried out? If DIVA vaccine has been used, provide details of the differential tests.

Prophilactic vaccination of domestic pigs against CSF was ended in 2005. Since then no vaccination against CSF has been applied in the domestic pig sector.

Vaccination in wild boar

From 2005 to the first half of 2008 annual prophylactic oral vaccination in the wild boar population had been carried out on the territory of the country. Schweinepestoralvakzine (REIMSER Arzneimittel AG) was used for wild boar according to the instructions of the manufacturer. The pophylactic oral vaccination included annually two vaccination campaigns with two distributions of bites per campaign. In 2008 there was a change in the programme in relation to wild boar’s vaccination. The second vaccination campaign in the autumn of 2008 was carried out in 40 km north and west border zone by two distributions of bites (20 km high risk zone and 20 km buffer zone on the territory of the municipalities which are located next to the borders with FYROM, Serbia and Romania). This approach was followed until 2012 - three vaccination campaigns per year with two distributions of bites per campaign in the 40 km north and west border zone. In 2013 and 2014 three vaccination campaigns per year with two distributions of bites per campaign were performed in the north and west border municipalities of the Bulgaria (fig. 3a). In 2015 three vaccination campaigns with two distributions of bites per campaign were performed in the west border municipalities of the Bulgaria (fig. 3b). No vaccination in wild boar is planned to be perform from 2016 onwards.


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Figure 3. Area with vaccination against CSF in wild boar in a) 2013 - 2014 and b) 2015

d) Legislation, organisation and implementation of the CSF eradication campaign. Provide a description of the organisational structure at the different levels. Indicate if detailed operational guidelines exist and give a brief summary.

Please see point 2 b.)

e) Animal identification and movement control. Are pigs identified (individually or at a group level)? Provide a description of the criteria and methods for animal identification, herd registration and traceability for all sectors of pig production including free-ranging pig management systems. How are pig movements controlled in different sectors in the country or zone, or between zones of the same or different status?

The Law on Veterinary Activities provides the legal basis empowering the CCA to establish national requirements in the fields of holding registration and animal identification. National legislation, namely, Art.51 of the Law on Veterinary Activities stipulates that animals are subject to identification and the holdings are subject to registration. BFSA is the official competent authority responsible for the identification of the animals. A computerized information system supports the recording and processing of the data concerning the identified animals and their movements as well as the registered holdings and electronic herd register. The BFSA information system is use for the necessary traceability of the sampling and testing process and the recording of the active clinical surveillance of the domestic pig population. Ordinance No 61 transposes Council Directive 92/102/EEC into Bulgarian legislation. Art 3 sets out the details concerning the identification of Animals and the registration of holdings: The registration of the holdings (including the pig-keeping ones) is carried out by the authorities of the BFSA or by veterinary specialists - private practitioners duly authorized by the BFSA. All animal holdings, where large ruminants, small ruminants or pigs are kept are subject to mandatory registering in:

- The registry on animal movement control that is kept by the owner; - The BFSA information system.


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The code (serial) registration number of the holding is provided once and stays the same no matter of the species and types of animals kept in that holding. All data shall be kept at least three years after the cessation of the activity of certain animal holding or after sale, slaughter, death etc. of the last animal kept in that holding. The new categorisation of pig holdings in the context of the eradication of CSF described above has no effect on the obligation of pig farmers or keepers as regards holding/herd registration, the identification of animals and their movements. Pigs are identified by individual ear-tag (bearing either unique serial number or, in case of fattening pigs intended for direct slaughter, the registry number of the pig holding of fattening). Any such ear-tags must be and are delivered and distributed by the BFSA. Displacing or reuse of ear-tags placed on an animal is not permitted. The identification of the animals has to be carried within 5 days after birth or when living the holding at least. Only in case of pigs for fattening in industrial farms the identification can be carried out at the latest before they leave for slaughter with green ear-tags indicating the number of the holding. According to the Law on Veterinary Activities (LVA), owners of farm animals are obliged to:

- ensure availability of their animals to be identified /ear-tagged/, for vaccinations and for diagnostic test purposes;

- ensure access to animal holding and the animals therein for the state veterinarian inspecting them;

- comply with and meet the requirements related moving and transportation of animals. The whole territory of the country has the same status in terms of CSF. In terms if identification, no movement of unidentified animals could be carried out to markets, slaughterhouses, fairs, exhibitions, competitions or other holdings or settlements When live pigs are moved from one holding to another holding or to a slaughter house they must be accompanied by a movement document issued by the private veterinarian of the holding following an inspection of the animals to confirm they are healthy. There is a ban imposed on any movement by movement document issued by contracted private veterinarians proving good animal health status. These document are dully recorded in the BFSA information system and enabling the traceability of the animals .

4. CSF diagnosis

Provide documentary evidence that the provisions in Chapters 1.1.1, 1.1.2., 1.1.3., and 2.8.3. of the Terrestrial Manual are applied. In particular, the following points should be addressed:

a) Is CSF laboratory diagnosis carried out in the country? If so, provide a list of approved laboratories. If not, provide the name(s) of and the arrangements with the laboratory(ies) samples are sent to, the follow-up procedures and the time frame for obtaining results.

See point b) below.

b) Provide an overview of the CSF approved laboratories, in particular to address the following points:


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i) Procedures for the official accreditation of laboratories. Give details of formal quality management systems, such as Good Laboratory Practice, ISO, etc. that exist in, or are planned for, the laboratory system.

ii) Give details of participation in inter-laboratory validation tests (ring tests).

iii) Is live virus handled?

iv) Biosecurity and biosafety measures applied.

v) Details of the type of tests undertaken.

Classical and African Swine Fevers are subject to mandatory notification In Bulgaria according to the Law on Veterinary Activities. Any case of suspicion of a disease or change of the health status of his animals has to be notified by the owner to the municipal veterinary. The CCA reports and make available to other Member Countries whatever information is necessary to notify and alarm them about the disease as well as to ensure the transparancy of the episotic situationa and to minimaize the spread of the diseases. These requirements are lied down in Ordinance No 4 of the 17.02.2007 on prophylactics, containment and eradication of CSF. WAHIS and ADNS are used for the purpose of notification of any epidemiological events occurred on the territory of the country The NDRVI in Sofia is a specialised body of the BFSA on diagnostics and research activities in the

field of animal health. The NDRVI’s reference activities are organised within 18 NRLs that have been

designated the Minister of Agriculture and Food and structurally organised within two ‘National

Centres’, which are the ‘National Centre on Safety of Foodstuffs (16.01.2012 last modified) and the

‘National Centre on Animal Health’(NCAH) and another two ‘Testing Laboratories’.

The NCAH incorporates the following NRLs: NRL Rabies and monitoring the effectiveness of rabies vaccination; NRL for Brucellosis in animals; NRL for TSEs; NRL Parasites (in particular Trichinella, Echinococcus and Anisakis); NRL for Leptospirosis in animals; NRL “Tuberculosis and Anthrax”, NRL for Enzootic bovine leucosis; NRL Animal proteins in feed. The Testing Laboratories’ are: NRL “Fish diseases, mollusc diseases and crustacean diseases“ and ‘Testing Laboratory for exotic and extremely dangerous infections’ that includes NRL „Foot-and-mouth disease and swine vesicular disease; NRL “Classical and African swine fever”, NRL “Avian influenza and Newcastle disease” and NRL for African horse sickness.

In reference with the CSF diagnosis, pursuant to establishment of BFSA, NDRVI encompassed

further two (2) regional ‘Testing Laboratories’ (in the towns of Stara Zagora and in Veliko Tarnovo),

which have been restructured and renamed as such on the basis of the previously existing regional

veterinary institutes in the same towns. Both testing laboratories have their accreditation for

serological diagnostics of CSF.

The NRL analyses all samples from suspect CSF cases and carries out confirmatory tests on

seropositive samples analysed in the two regional laboratories. In addition, all samples from wild

boar for CSF antigen and antibody detection under the CSF-CMP are analysed in the NRL.


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Wild boar samples are submitted to the NRL from the local sampling staff, via the regional

offices,together with a standardised sample submission form. Staff dealing with CSF samples

comprises one veterinarian and four other laboratory employees. One veterinary post in the CSF

NRL is currently vacant but the head of the laboratory stated that it will be filled again through a

competition procedure.

The NRL has well-established cooperation with the EU reference laboratory (EU-RL) for CSF and

scientists from the EU-RL have paid extended visits to the laboratory.

The NRL provides regular training for staff of the two RFSD laboratories and organised inter-

laboratory comparative tests for the antigen-ELISA, using inter alia the samples provided in the

proficiency tests organised by the EU-RL.

The accredited test methods used and successful participation in international and national

comparative tests ensure the the reliability of results for the serological monitoring for antibodies

against CSF.

The results obtained in proficiency tests organised by the EU reference laboratory indicate that the

methods used for antibody detection, virus isolation, virus genome detection and differential

diagnoses are fit for purpose.

v) Details of the type of tests undertaken.

Laboratory test for the detection of CSF antibodies - overview

For serology currently the commercially available ELISA test kits Bommeli E2 – sero and Bommeli ERNS-Marker R are used according to the instructions of the manufacturer. These tests will be performed at the Regional CSF laboratories in Stara Zagora and Veliko Turnovo as well as at the NRL Sofia.

The virus neutralization test according to chapter 3) of the CSF draft Manual (2002) of the CRL Hanover has been installed at the NRL Sofia.

Laboratory tests for the detection of CSF virus, viral antigen and genome - overview

Virus isolation using the PK15 cell culture technique as well as the Immune Labelling for the

detection of CSF virus in cell cultures and the differential diagnosis of virus isolates have been

established at the NRL Sofia. The test is performed in accordance with the CSF draft Manual (2002)

of the CRL Hanover.

Imunofluourescent antibody test on thin cryostat sections of organs (tonsilles, ileum, spleen, kidney

and retropharyngeal lymphnodes) is the current standard procedure. A commercially available

conjugate (Cedi Diagnostics BV, Lelystad) is used for diagnostic purposes as well as the CSF antigen

ELISA produced by Bommeli and a diagnostic PCR as described in the draft Manual (2002) of the

CRL Hanover are in use at the NRL Sofia

The genome typing of Bulgarian CSF virus isolates are sent to the CRL in Hanover.


18

In pigs infected with the CSF virus antibodies can be found in the blood serum two-three weeks after the infection. In pigs that have got healthy again protective and neutralising antibodies can be found for years, even till the end of the pig’s life. In ill animals in the end phase sometimes antibodies can be found too. In chronically ill pigs antibodies can be detected for several days at the end of the first month after the infection.

The infected foetus in the womb of the sow is immune-tolerant to the virus and does not produce any specific antibodies. During the first days after they are born their mother’s antibodies might be detected in them, which are evidenced in the healthy piglets without viraemia for about two weeks. If antibodies are detected in piglets more than three months old, there is little possibility that they originate from the mother.

The detection of antibodies against the CSF virus in serum or plasma samples allows to be confirmed the diagnosis of CSF in facilities under suspicion, to be determined the period from the beginning of the outbreak of the infection and to be taken measures for surveillance and supervision control. The serological tests serve most of all for detection of CSF in recently infected stockbreeding facilities.

A small number of affected pigs with low titre of antibodies serve as an evidence for a recent infection (two-three weeks). A great number of affected pigs with high titre of antibodies mean that the virus has penetrated the stockbreeding facilities for a month at least. The location of the sero-positive pigs in the facilities may offer useful information about the way the CSF virus has penetrated into the facilities.

In spite of this, it is necessary precise evaluation and interpretation of the results from the serological tests to be made taking into account all clinical, virological and epidemiological data within the investigation, which is done in case of suspicion or confirmation of CSF.

The virus neutralisation test reaction (VNR) and ELISA are most suitable for serological diagnostics of CSF. The quality and effectiveness of the serological diagnostics done by the national laboratory are under constant control by means of intra-laboratory comparative test organised periodically by the Community Reference Laboratory, Hanover.

The VNR is based on defining the neutralising action of the antibodies in a serum sample on the virus, expressed as a neutralisation degree of 50%.

A certain quantity of the CSF virus is incubated at 37°C in serum with different degree of diluting. The serum is diluted solution is prepared with a solution to proportion of 1 to 10, 1 to 5 or 1 to 2. When full titration is required, serum solution is prepared in proportions 1 to 2 and 1 to 5. To each of the serum dilutions solutions prepared in this way it is mixed added with an equal volume of suspension of the virus containing 100 infection doses (TCID 50).

After the incubation wit them the mixture is used the cell cultures to be infected and their incubation takes 3 to 5 days. After this incubation period the cultures are fixed and each reproduction of the virus is detected by immune marking (immune-peroxydase or immune-fluorescent reaction).

The results from the VNR are expressed with the reciprocal value of the initial diluting of the serum, whereas half of the infected cell cultures (final titre 50%) do not show any reproduction of the virus (there is no specific marking colouring or beaming). Evaluation of the titre between two dilutions is done. The final dilution is an effective dilution of the serum during the neutralisation reaction after adding the virus, but without adding any cell suspension.


19

VNR is the most sensitive and the most reliable method for the detection of antibodies of the CSF virus. It is recommended a serological testing to be done both of individual animals and of herds. The testing allows also the detection of antibodies with crossed neutralisation.

The application of VNR for detection of antibodies against the virus of the mucous disease – viral diarrhoea /MD – VD/ in beef cattle and the Border disease in sheep is based on the same principles and is used for differential diagnostics of CSF.

The strains of the virus, which are used in the virus neutralisation reaction, shall be in compliance with the recommendations of the Reference Laboratory of the European Union.

Different variants of ELISA have been developed by making use of specific monoclonal antibodies - a competitive (blocking) method and a non-competitive ELISA.

The competitive (blocking) method is usually based on the usage of monoclonal antibodies. If the serum sample contains antibodies against the CSF virus, the binding conjugation of the monoclonal body, in combination with peroxydase, with the antigen of the virus leads to a reduction of the colour extinction.

NRL Sofia works with two types of the aforementioned ELISA: For detection of anti E2 antibodies and for detection of anti Е rns antibodies against the CSF virus which are produced by BOMMELI, Switzerland. The manufacturer’s prescriptions are followed when they are used.

In the non-competitive ELISA the binding of the serum antibodies with the antigen is directly compared with the help of antibodies in combination with peroxydase.

The NRL Sofia together with the National Institute for the control veterinary medicinal products regularly exercises control on the sensitivity and the specificity of all lots of ELISA by making use of a kit of reference sera provided by the Reference Laboratory of the European Union. This kit includes:

- Sera from pigs in an initial phase of infection with the CSF virus (up to 21 days after the infection);

- Sera from pigs that are getting well (after the 21st day of the infection); - Sera from pigs infected by viruses of ruminants.

ELISA tests for serological diagnostics of CSF should recognise all reference sera of pigs that are getting well. All the results obtained are reproduced. It is recommended further tests to identify all the positive sera in the initial phase and to represent minimum cross-reactions with sera from pigs infected with viruses of ruminants.

The results obtained from reference sera of pigs in an initial phase of the infection provide indications about the sensitivity of the ELISA tests.

The sensitivity of the ELISA tests is considered to be lower than that of VNR and is recommended for use for detection of the disease in herds. In spite of that, the ELISA tests require less specialised equipment and they are done much quicker than VNR due to the automated equipment.

The ELISA tests make it possible to be discovered all infections of CSF in the phase of recovery from the illness and should be freed to a maximum degree from cross-reactions with antibodies against viruses typical for the ruminant animals.

The interpretation of the results from the serological tests and differential diagnosis for the infections caused by viruses typical for the ruminant animals (mucous disease - viral diarrhoea in beef cattle and Border disease in sheep):


20

In case of detection of a titre of neutralisation of the CSF virus equal or greater than 10 ND50, in serum samples of one or more pigs or in case of a positive result by ELISA in serum samples of a group of pigs, BFSA immediately introduces the measures envisaged in the Regulation on the Prophylactics, Restriction and Annihilation of the Classical Swine Fever.

The already taken samples from the facilities are subject to a second VNR (comparative final titration of virus – neutralising antibodies against CSF and the viruses typical for the ruminant animals).

If as a result of the comparative tests antibodies against the viruses typical for the ruminant animals are discovered and titres of the antibodies against CSF are missing or they are in a smaller quantity (less than one third), the suspicion for CSF is rejected, except in case there are any other reasons, which justify the application of the measures envisaged in the Ordinance /Regulation/ on the Prophylactics, Containment /Restriction/ and Eradication /Annihilation/ of CSF.

If as a result of the comparative tests titre of neutralisation of the virus equal or greater than 10 ND50 is detected in more pigs and this titre is equal to or higher than the titres related to other plague viruses, the BFSA shall take immediately the required measures for confirmation of the presence of CSF, under the condition that in the respective facilities epizootic occurrence of the disease has been evidenced.

Without violating the provisions of the Regulation on the Prophylactics, Restriction and Annihilation of the Classical Swine Fever, if not a single epizootic occurrence of the disease has been evidenced and the results from previous tests are insufficient, the BFSA shall take immediate measures in the respective stockbreeding facilities, as follows:

- to be continued the action of the measures under the Regulation on the Prophylactics, Restriction and Annihilation of the Classical Swine Fever;

- further additional tests to be made as soon as possible to be confirmed or rejected the presence of the CSF virus.

When the additional control measures and tests mentioned above in item 4 do not allow the presence of CSF to be rejected, it shall be necessary to take new blood samples for serological tests from the respective holding minimum two weeks after the previous controls.

In the context of this measure new samples are taken from the same pigs for a comparative serological study against the previous samples, allowing a sera conversion of the CSF virus or of the Pest virus typical for the ruminant animals to be detected, as the case may be.

If during the repeated tests the presence of the CSF virus is not confirmed, the imposed measures shall be terminated.

Virology Detection of virus antigen by direct immune-fluorescent method and ELISA The principle of this method is detection of antigens of the virus in cryo-sections of organs of pigs, which are under suspicion for an infection with the CSF virus. The intra-cellular antigens are detected with the help of an antibody, conjugated with fluorescein isotiocianate (FITC). The National Reference Laboratory uses FITC – conjugated antibody “Cedicon”, made in the Netherlands. Each positive result should is confirmed by repeating the reaction with the help of a specific monoclonal antibody.


21

The most suitable organs are the tonsils, the kidneys, the spleen, the lymph nodes and the distal parts of colon, of which the National Reference Laboratory prepares cryo-sections.. For wild pigs medulla smear may is used, when the abovementioned organs are not available or are decayed. The method for colouring of the cryo-cuts of internal organs fixed by acetone is presented by the producer.

The test is done within one day. As the samples are taken only from dead animals, their use for detection of the disease is limited. The certainty of the results from the tests may be reduced due to questionable fluorescence, especially when the specialist doing the test is not experienced enough with this method or when the tested organs are decayed.

Different ELISA techniques make it also possible to detect the antigen of the virus. The antigen ELISA should be sensitive enough to allow the achievement of positive results for animals with clinical symptoms for the presence of CSF. The National Reference Laboratory works with ELISA, produced by BOMMELI, Switzerland.

The use of ELISA is recommended for detection of the antigen in samples of animals with clinical symptoms or with pathological changes of the disease. They are not appropriate for individual testing. The NRL Sofia works with blood serum or most suitable are the samples of leucocytes, blood serum, non-clotted blood, as well as suspension of the organs described above and taken from pigs, which are suspected to have an infection of the CSF virus.

ELISA can be done within one day with the help of automated equipment. The main advantage is the possibility to process a great number of samples in a short period of time. All batches of the ELISA kits are subject of intra-laboratory control and are used after satisfactory results are obtained using reference material. All ELISA on sale at the moment are less sensible compared with the method of isolation of the virus in cell culture or RT PCR.

Isolation of the virus, virus genome and genome typing and interpretation of results

The isolation of the virus is based on inoculation of a sensitive cell cultures from pigs with the sample material. If the CSF virus is present in the sample, it gemmates in the cells in quantities, which can be detected by colour reaction of the infected cells with loaded antibodies. It is necessary to have specific antibodies against CSF available to be able to make a differential diagnosis with regard to other viruses.

Most suitable for the isolation of the virus of CSF are the leucocytes; blood plasma and whole blood samples, non-clotted blood or samples of the organs described above.

The method based on isolation of the virus is more suitable for the analysis of samples from a small number of animals, than for mass control. It needs great efforts and the results are obtained in three days as earliest. It might prove necessary two passages of cell cultures to be made in case of the detection of a weak presence of the virus in the sample. Thus the period needed to obtain the end results from the test may be extended to ten days. The decayed samples may prove to be cytotoxic for the culture and thus restrict the use of the method.

Isolation of the virus is recommended, when the presence of the CSF virus has already been confirmed by other methods. It is used as a reference method to confirm the positive results obtained with the ELISA method for the detection of antigen, a polymerase chain reaction (PCR), an immuno-fluorescent method or an indirect immuno-peroxydase method.

The CSF virus isolates obtained in this way are genetically characterized and typified. The genetic typing of virus isolates is used for the purposes of the molecular epizootic studies.


22

All isolates of the Classical Swine Fever Virus taken from primary outbreaks of the disease, from primary cases of infection of wild pigs or by cases of infection with the disease in a slaughterhouse or a means of transportation are forwarded to the CRL Hanover for the identification the genetic type.

The polymerase chain reaction (PCR) serves for detection of the genome of the virus in the samples of blood, tissues and organs. Small fragments of Ribonucleic acid (RNA) of the virus are transcribed in fragments of the Desoxyribonucleic acid (DNA) and are amplified by PCR to determine the quantities. As this test allows only a segment of the genome, PCR may give a positive result even in case of absence of the CSF virus (for instance, in decayed tissues or samples of pigs getting well after an illness).

PCR is used for a restricted number of selected samples of animals under suspicion or material from

aborted fetus. It may be the ideal method for carcasses of wild boar, if the material has decayed

and the isolation of the virus is impossible due to cytotoxicity.

The most suitable material for PCR diagnostics includes the samples taken from the organs

enumerated in the item for isolation of the virus or non-clotted blood.

The polymerase chain reaction (PCR) needs 48 hours to be completed. It requires suitable

laboratory equipment, separate premises and qualified staff. One of the advantages of the method

is that the segments infected with the virus are not subject to reproduction under laboratory

conditions. This method is very sensitive, but the possibility for easy pollution may lead to false

positive results. Therefore it is necessary procedures for quality control to be applied. Some

methods are specific for all viruses and require additional tests for verification, such as

segmentation of the product of the polymerase chain reaction (PCR).

All received organs samples from the wild pig taken for the virus diagnostic in the NRL are tested

with PCR .

The virological tests are necessary to confirm the presence of CSF. The isolation of the virus is a

referent method. It is used for a confirmation too. It is recommended in case with the positive

results of the immuno-fluorescent method, ELISA or PCR have not been detected any clinical

symptoms or changes characteristic for the disease, and in any other case causing doubts.

In spite of that, to confirm the primary outbreak of CSF the presence of the clinical symptoms or

changes characteristic for the disease in the respective pigs is enough, when it is combined with

positive results from at least two of the methods for detection of the antigen or the genome of the

virus.

A further (secondary) outbreak of CSF is confirmed, when besides an epizootic connection with the

already confirmed outbreak or case there are detected clinical symptoms or changes characteristic

for the disease in the pigs under surveillance and when a method for the detection of the antigen

or the genome of the virus has given positive results.


23

A primary outbreak of CSF among wild pigs is confirmed after the virus has been isolated or at least

two of the methods for detection of the antigen or the genome of the virus have given a positive

result. Other cases of CSF in wild pigs can be confirmed if epizootic connection with confirmed

cases has been found and when at least one method for the detection of the antigen or the

genome of the virus has given a positive result.

To give a positive result, the method for detection of the antigen or the genome of CSF is executed

with specific antibodies or primers against the CSF virus. If the method is not specific for the CSF

virus, but only for the Pestivirus genus, the test is repeated by using the specific reactive for the CSF

virus.

As regards distinguishing tests in case of emergency vaccination by live vaccine there is no

appropriate test that would enable pigs vaccinated by live vaccine to be distinguished from those

naturally infected by the CSF disease. For Bulgaria this scenario has to be taken into consideration

only in the context of the oral vaccination of the wild boar and for elderly domestic pigs which were

vaccinated before ceasing the vaccination of the domestic pig population on the 10.01.2006.

5. CSF surveillance

Provide documentary evidence that surveillance for CSF in the country or zone complies with the provisions of Articles 15.2.26. to 15.2.32. of the Terrestrial Code and Chapter 2.8.3. of the Terrestrial Manual. In particular, the following points should be addressed:

a) Clinical suspicion. What are the criteria for raising a suspicion of CSF? What is the procedure to notify (by whom and to whom) and what penalties are involved for failure to report? Provide a summary table indicating, for the past 12 months, the number of suspected cases, the number of samples tested for CSFV, type of sample, testing method(s) and results (including differential diagnosis).

Please see point 7e)

b) Serological and virological surveillance. Are serological or virological surveys conducted? If so, provide detailed information on the survey design (confidence level, sample size, stratification). How frequently are they conducted? Are wild and feral pigs included in surveillance? For both serological and virological surveillance provide a summary table indicating, for the past 12 months, the number of samples tested for CSFV, type of sample, testing method(s) and results (including differential diagnosis). Provide details on follow-up actions taken on all suspicious and positive results. Provide criteria for selection of populations for targeted surveillance and numbers of pigs examined and samples tested. Provide details on the methods applied for monitoring the performance of the surveillance system including indicators.

The CSF Serological and virological surveillance is on the whole territory of the Republic of Bulgaria.

CSF surveillance scheme including active surveillance (clinical surveillance to detect clinical cases of CSF as early as possible and submission of check lists data into the national database and serological and virological surveillance) and passive surveillance for the different types of holdings is implemented in the framework of the annual CSF programme.


24

Basic elements of this Programme are:

Categorisation of Bulgaria’s pig population based on the risk analysis and bio-security measures in place:

The following basic criteria of biosecurity are used for categorizing the holdings - production cycle (closed or open),

- keeping system (indoor/partially outdoor; access to foreign personnel; access to

other pigs or feral pigs), ;

- appropriate means of disinfection at the entrance and exit of buildings, fences around

the holdings ;

- appropriate hygienic measures for persons coming in contact with pigs, ;

- trade patterns (free markets or direct contact of the owner with potential customers) ;

- outdoor keeping, including traditional free ranging systems,

- number and categories of pigs ;

- regular veterinary controls.

The following 5 types of domestic pig holdings are identified:

1) Industrial farms: large farms with a high biosecurity level; 2) Family farms type A: smaller farms with a high biosecurity level; 3) Family farms type B: smaller farms with a low biosecurity level 4) Backyard farms: holdings with a low biosecurity level, up to 5 pigs, no mother sows, kept for

own consumption, not entering into the national trade cycle; 5) Traditional outdoor holdings of East Balkan pigs: particular Bulgarian pig bread, kept outdoor in

the Eastern parts of the country..

Active clinical monitoring of pigs for CSF, including a targeted sampling and testing scheme as regards CSF;

Continued enforcement of the ban of prophylactic vaccination against CSF of the domestic pig population, including East-Balkan pigs;

Quick and effective application of the required measures for control and eradication of any outbreaks of disease that have emerged meanwhile;

Oral vaccination of wild boar

Surveillance in wild boar When implementing this program the competent authorities also take into consideration:

1. The different types of pig holdings in Bulgaria described above; 2. The results from the scientific epidemiological analysis conducted for ascertaining the

CSF transfer mechanism and the geographical spread of the disease; 3. The presence of wild boar population all over the territory of the country, which might

have direct or indirect contact with the herds of East-Balkan pigs bred on the territory of three regions of the country.

4. The lack of big natural or artificial barriers as regards the movement of wild boar over the territory of the country;

5. Control over the registration of pig farms, the movement of pigs, their identification and


25

the herd registers linked with the application of a corresponding electronic database; 6. Control over the oral vaccination campaign of the wild boar population, in particular

concerning the process of the distribution of the baits, their uptake and effects on the CSF status of the population linked with the blood samples for antibodies and organ samples which are negative for the virus presence.

The results for the CSF surveillance in domestic pigs obtained during the implementation of the CSF

programme in 2009 – 2015 are shown in table 2.

Table 2. CSF surveillance in domestic pigs in 2009 – 2015

Year Type of

holding

Number of

Holdings Animals Serological

tests* Virological tests*

Clinical examinations/

Checklists**

2009

Industrial 61 444341 11959 167 5775

Type A 89 24640 3222 37 2145

Type B 1728 41297 17596 202 13118

Backyards 58673 106928 649 5 74244

East-Balkan 98 10104 4570 4 878

Total 60649 627310 37996 415 96160

2010

Industrial 59 432952 6126 118 5377

Type A 104 26413 3181 151 2089

Type B 1680 38287 7889 10 10935

Backyards 48115 77152 69 0 57421

East-Balkan 87 9195 3660 608 846

Total 50045 583999 20925 887 76668

2011

Industrial 55 431310 2444 0 5740

Type A 112 33761 1666 10 2254

Type B 1117 24859 5946 0 6246

Backyards 42355 73829 9 0 57879

East-Balkan 91 9563 3718 68 777

Total 43730 573322 13783 78 72896

2012

Industrial 53 398314 2437 60 6853

Type A 117 38625 3712 38 1848

Type B 1124 18355 6837 60 5342

Backyards 39325 68983 1 1 59184

East-Balkan 82 7675 3270 0 670

Total 40701 531952 16257 159 73897

2013

Industrial 52 424139 2376 0 7703

Type A 118 37518 2917 0 1253

Type B 810 8468 3405 0 2395

Backyards 25856 41843 1 2 12463

East-Balkan 68 5773 2360 0 322

Total 26904 517741 11059 2 24136

2014

Industrial 49 429706 1968 0 5555

Type A 114 27553 1860 0 526

Type B 605 10675 2392 0 2398


26

*All serological and virological tests were with negative results for CSF

** The clinical examinations in combination with serological and virological tests show high confidence of CSF freedom with probability above 99 %

The wild boar surveillance is based on monitoring of the health status of the population and

monitoring of the vaccination.

The size and geographical area of Bulgaria’s wild boar population were taken into account for

establishing the sample size for serological and virological monitoring in accordance with the

principles laid down by Chapter 5.1 of the Community Guidelines on surveillance/monitoring

control and eradication of CSF in wild boar2. In the areas where the oral immunization of wild

boar was completed the monitoring of CSF in wild boar followed strictly the Guidance given in

Chapter 5.2 of the same Community document.

For assessment of the health status of the wild boar population when analyzing the laboratory

results of the tests performed the animals in both vaccinated and non-vaccinated areas were

categorized in 3 groups – young animals from 0 to 12-months of age (most susceptible in the

time-frame between the decrease of maternal antibodies and the following vaccination), boars

within 12-24 months of age, boars above 24 months of age.

The samples are mainly taken during the regular hunting season which usually starts the first

week of October and ends in January the following year. Wild boar were tested serologically by

ELISA to detect Ab due to CSFV or vaccine and virologically by PCR to detect CSFV. All wild boar

shot or found dead are tested in the National Referent Laboratory for Classical Swine Fever (

NRL – CSF) in accordance with Commission`s diagnostic manual (Commission Decision

2002/106/EC3).

The Community Reference Laboratory for CSF is Institute of Virology, Hannover Veterinary

School, Buenteweg 17, D-30559 Hannover, Germany.

2 European Commission /SANCO/7032/2010 (Rev. 4)

3 Commission Decision 2002/106/EC of 1 February 2002 approving a diagnostic manual establishing diagnostic

procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of Classical Swine

Fever, last amended by 2003/859/EC (OJ L 324, 55)

Backyards 21582 28708 1 1 29681

East-Balkan 59 4968 987 2 233

Total 22409 501610 7227 3 38393

2015

Industrial 56 520765 975 0 9705

Type A 118 33487 1605 5 1479

Type B 452 8972 2193 0 677

Backyards 15578 21406 4 0 4547

East-Balkan 58 3877 1193 0 163

Total 16262 588507 5970 5 16571


27

For each animal tested data on age, sex, location (GPS coordinates) are collected. The

laboratory results and the information for the animal are submitted in the Wild Boar EU

Database (http:public.csf-wild boar.eu). The data are also used for mapping.

The results for the CSF surveillance in wild boar obtained during the implementation of the CSF

programme in 2010 – 2015 are shown in table 3.

28

Table 3. Results from the CSF surveillance in wild boar in 2010 – 2015

year 2010 2011 2012 2013 2014 2015

Serological surveillance

Age

of

wild

bo

ar in

mo

nth

s

Vac

cin

atio

n

area

No

n-

vacc

inat

ion

area

Vac

cin

atio

n

area

No

n-

vacc

inat

ion

area

Vac

cin

atio

n

area

No

n-

vacc

inat

ion

area

Vac

cin

atio

n

area

No

n-

vacc

inat

ion

area

Vac

cin

atio

n

area

No

n-

vacc

inat

ion

area

Vac

cin

atio

n

area

No

n-

vacc

inat

ion

area

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

Sero

logi

cally

tes

ted

% s

ero

po

siti

ve*

0 - 12 527 19.9 1567 0.2 331 16 1186 0.08 603 19.4 1254 0.08 529 12.8 1268 0 611 11,62 577 0 466 11.16 1261 0

12 - 24 437 34.6 1182 0.2 401 41 867 0.1 568 37.3 1081 1.1 364 41.8 922 0 578 50,74 532 0 303 26.73 745 0

> 24 346 23.4 1144 0.3 418 43 1507 0.53 611 54.3 1805 0.6 402 53.5 1537 0 627 63,31 904 0 175 39.43 1071 0

Total № of WB

tested

1310 3893 1156 3560 1782 4140 1295 3727 1816 2013 944 3077

5203 4716 5922 5022 3829 4021

Virological surveillance **

Total № of WB

tested

5020 5759 6315 5243 6506 4128

* All seropositive wild boar were considered to be seroconverted due to uptake of vaccine. All of them were tested by PCR with negative results to

confirm absence of CSFV. In the non-vaccinated zones singular seropositive animals were found close but outside the vaccinated areas, however, the

CSFV presence was ruled out by the virological tests performed. These animals were considered as vaccinated.

**All virological tests were with negative results

29

c) Domestic and captive wild pig populations and production. What is the pig population? Provide a description of the different production systems present in the country and zone(s) and production figures in each sector. How many herds are in the country and zone(s)? How are they distributed (e.g. herd density, etc.)? Provide tables and maps as appropriate.

The number of pig holdings and pigs for the different categories of farms are shoun in p. b) above

Figure 4 shows the density of the different categories of pig holdings.

Figure 4. Density of: 1. all pig holdings; 2. Industrial farms; 3. Family farms type A; 4. Family farms type B; 5. Backyards; 6. East-Balkan pigs herds.


30

d) Wild and feral pig populations. Provide estimates of population sizes, geographic distribution and, if available, population trends in the country and zone(s).

Accoring to the spring counting in 2015 the number of wild boar in Bulgaria is 90130. The predicted wild boar density in Bulgaria is shown in figure 5.

Figure 5. Predicted wild boar density in Bulgaria

e) Slaughterhouses and markets. Where are the major pig marketing or collection centres? What are the patterns of pig movement within the country or zone, and between zone(s) of the same or different status? How are the pigs sourced, transported and handled during these transactions? Is any surveillance carried out at slaughterhouses? Provide data on the number of pigs slaughtered and inspected during the past twelve months.

Slaughtering of pigs from farms without adequate biosecurity in slaughterhouses is prohibited. The implementation of this requirement allowed such slaughterhouses to slaughter only pigs from family farms type A or from industrial farms. All pigs intended for dispatch to a slaughterhouse must be subject to a clinical inspection, including temperature checks, within 24 hours prior to the issuing of the movement certificate by the contracted private veterinarian (or by an official veterinarian). The movement certificate is valid for three days and must accompany the pigs to the slaughterhouse, as must the clinical inspection check list, an owner-declaration regarding treatments with veterinary medicinal products and the foodchain information. A derogation for slaughter of East Balkan pigs in an EU approved slaughterhouse was introduced by Order 9-27/15.01.2010 provided that a group of pigs have been isolated from other pigs and wild boar for at least 30 days before dispatch to the slaughterhouse. Within 7 days of dispatch the pigs


31

must be subject to PCR tests for CSF with negative results. The sample numbers should be sufficient to detect a 5% prevalence of CSF with 95% confidence. The meat from East Balkan pig must be marked with a diamond stamp and the meat and meat products can only be used on the domestic market. Those slaughterhouses authorised to accept East Balkan pigs which meet the animal health requirements laid down in Order 9-27/15.01.2010 are listed in Order 11-45/26.01.2010. In conclusion the measures are in place in national legislation to ensure that only meat from farms meeting the EU requirements for biosecurity is dispatched to other Member States.

6. CSF prevention

a) Coordination with neighbouring countries. Are there any relevant factors about the adjacent countries or zones that should be taken into account (e.g. size, distance from adjacent border to affected herds or wild and feral pig populations)? Describe coordination, collaboration and information sharing activities with neighbouring countries. Are protection zones in place? If so, provide details on the measures that are applied (e.g. vaccination, intensified surveillance, pig density control), and provide a geo-referenced map of the zone(s).

Prevention is achieved through effective communication between veterinary authorities, veterinary practitioners and pig farmers, effective disease reporting and animal identification system, a strict import control of live pigs, fresh and cured meat, prohibition of feeding pigs with waste food and virological and serological surveillance.

As mentioned above Classical Swine Fevers are subject to mandatory notification In Bulgaria according to the Law on Veterinary Activities.

Any case of suspicion of a disease or change of the health status of his animals has to be notified by the owner to the municipal veterinary. The CCA reports and make available to other Member Countries whatever information is necessary to notify and alarm them about the disease as well as to ensure the transparancy of the episotic situationa and to minimaize the spread of the diseases. These requirements are lied down in Ordinance No 4 of the 17.02.2007 on prophylactics, containment and eradication of CSF.WAHIS and ADNS are used for the purpose of notification of any epidemiological events occurred on the territory of the country

b) Import control procedures

From what countries or zones does the country authorize the import of pigs or their products? What criteria are applied to approve such countries or zones? What controls are applied on entry of such pigs and products, and subsequent internal movement? What import conditions and test procedures are required? Are imported pigs required to undergo a quarantine or isolation period? If so, for how long and where? Are import permits and health certificates required? What other procedures are used? Provide summary statistics of imports of pigs and their products for the past twelve months, specifying country or zone of origin and volume.

The veterinary border control is a key factor to ensure that the live animals and animal products entering to the country are safe and meeting the specific import conditions.


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The imported live animals and animal products present the highest level of risks as they can transmit serious human and animal diseases.

The import conditions are based on the OIE recommendations in particular, the CSF episootic situation and the disease status of the country of origin officially recognized by the OIE.

All consignments of live animals or animal products must be accompanied by veterinary certificate attesting their animal health status. As an EU Member country such consignment can only enter into the country,if it has satisfactorily undergone the specific checks and a Common Veterinary Entry Document (CVED) is issued from TRACES.TRACES is a centralised database which allows the monitoring of consignments of live animals and animal products checked at the BIPs.

As an EU Member Country, Bulgaria implements the procedures and meets requirements laid down in the EU legislation , as follows :

Council Directive 64/432: The animal healt requirments for intra-Union trade in porcine animals are laid down in Councel Directive 64/432.This Directive, harmonises the rules for intra-Union trade in pigs and establishes the animal health guarantees needed for the trade in these animals between the Member States .The Directive lays down precise rules regarding the health status and rules (e.g. prohibition of contact with other animals during the travel, cleaning and disinfection of means of transport, etc.) to be respected during the movement of pigs from the holding of origin to the final destination (another holding or a slaughterhouse) to try to avoid any possible spread of disease .

Prior to intra-Union trade, the competent authority in the Member State of origin must ensure that porcine animals come from a holding or area that is not subject to any prohibition or restriction for reasons of animal diseases affecting porcine animals.

Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 92/425/EEC

Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC

Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97

Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003

Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31991L0496


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Council Directive 2002/99/EC of 16 December 2002 laying do down the animal health rules governing production, processing, distribution and introduction of products of animal origin for human consumption

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation).

Based on the above mentioned European Commission provides a list of non EU countries which are approved for import of live pigs and swine products .

Since 2008 special orders by the National Veterinary Service has governed the special rules for handling of live swine and products therefrom, as well as restrictions related to transportation and handling of live animals only from EU countries for approved that purpose.

i) Provide a map with the number and location of ports, airports and land crossings. Is the official service responsible for import controls part of the official services, or is it an independent body? If it is an independent body, describe its management structure, staffing levels and resources, and its accountability to the central Veterinary Services. Describe the communication systems between the central authorities and the border inspection posts, and between border inspection posts.

Bulgarian Food Safety Agency (BFSA) is the Competent Authority for import controls of products of

animal origin and live animals.


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MAF Ministry of Agriculture and Food

BIP Border Inspection Post

CA Customs Authorities

AOCD Audit of official controls department

OMBCD Organization and Management of Border Control Department

BCD Border Control Department

VACRFSAD Verification and administrative control of the activities of the regional food safety directorate department

VOCGD Verification of the Official Control General Directorate

IAD Internal Audit Directorate (Audits)

MF Ministry of Finance

BFSA Bulgarian Food Safety Agency

The Border Control Directorate (BCD) within the BFSA is responsible for policy making and co-

ordination of controls. The OMBCD drafts legislation, issues instructions and monitors the activities

of the BIPs. The monitoring programmes, instructions and checklists for import controls developed

by the OMBCD are disseminated and available in all BIPs.

There are twenty five border posts (8 BIPs and 17 non-BIP entry points) designated in Bulgaria.

The BIPs submit monthly reports to the OMBCD on controls carried out. OMBCD carries out

planned supervisory checks on each BIP and verifies the proper implementation of the legislation,

twice per year.

The Trade Control and Expert System (TRACES) registration system is used to record data on all

consignments.

All necessary checks (documentary, identity and physical) are carried out at 8 BIPs listed in the table

below.BIPs staff check import controls on live animals and animal products, imports of animal

feedingstuffs and veterinary medicinal products.

BIP Border Type Approval

Bregovo Serbia Road HC, NHC

Burgas Black Sea Port HC, NHC

Gueshevo FYROM Road HC, NHC

Kalotina Serbia Road HC, NHC, U, E, O

Kapitan Andreevo Turkey Road HC, NHC, U, E, O

Sofia n.a. Airport HC, NHC, E, O

Varna Black Sea Port HC, NHC

Zlatarevo FYROM Road HC, NHC

Co-operation between Customs and the BFSA takes place under a high level agreement. Implementation takes place through a joint instruction between Customs and BFSA. At local level, co-operation takes place through exchange of information in relation to the positive list and regular meetings at entry points between official veterinarians and Customs officials.


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Customs Authorities under the Ministry of Finance support veterinary authorities for identification

and selection of incoming consignments for veterinary checks. Customs officers together with the

officials from BFSA also carry out import controls on personal luggage.

Laboratory tests of imported products of animal origin are performed in the laboratories of the

RFSD, CLVCE and NDRVI and external. All laboratories are accredited according to the requirements

of EN ISO/IEC 17025.

ii) Provide a description on the methods used for the safe disposal of waste from international traffic, who is responsible and provide a summary, for the past twelve months, of the quantity disposed of. Is swill feeding of pigs allowed in the country? If so, provide details on any heat inactivation procedures that are applied.

The BFSA is the central competent authority responsible for supervision and controls throughout the ABP chain. . Three Directorates at the BFSA are mainly involved in the Animal by-products control:

- Food Control Directorate dealing with public health issues in processing establishments for food of animal origin and official control at retail level, official control in case of export of ABP-products, official control of approved establishments for Intra Community trade with food products of animal origin, covered by Regulation (EC) No 1069/2009 (Intermediate plants, Storage plants, Processing plants, Oleo-chemical plants, Pet food plants, Technical plants, Incineration / Co-incineration plants).

- the AHWFeCD is responsible for fallen stock and collection, transport and processing, and - the Border Contorol Directorate - for imports, exports and transit.

Veterinary sanitary controls of Collection, processing and disposal of ABP is organized according to the requirements of Regulation (EC) 1069/2009.

There are two rendering plants (in Varna and Shoumen city) on the territory of the country. Annually a

contract is signed by and between BFSA and these rendering plants.

Disposal of waste from international traffic is carried out in these rendering plants.

The rendering plant in Shumen undertakes the obligation to offer services to 18 administrative

districts (out of 28 in all). From the territory of these districts the rendering plant collects and renders

harmless materials of categories 1, 2 and 3, whereas the materials of categories 1 and 2 and the materials of

category 3 are processed separately in two individual technological lines. The MBM from processing of

materials of categories 1 and 2 is forwarded for final incineration in the cement plant in the village of Beli

Izvor. The by-product fats are used after that as an alternative fuel in the rendering plant itself. The

quantities of MBMs from the processing of materials of category 3 left unused (a small part is used to

prepare foods for home pets) is also to be forwarded for further incineration to the cement plant and the by-

product fats are to be used for technical purposes.

The rendering plant in Varna undertakes the obligation to offer services to the remaining 10 administrative

districts. From the territory of these districts the rendering plant collects and renders harmless materials

categories 1, 2 and 3, whereas the materials of all the three categories are processed in one and the same

technological line. For that reason the enterprise is ranked as category 1 and is obliged therefore to deliver


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all the by-products (MBMs and fats) for destroying. The MBMs are to be forwarded for final incineration in

the cement plant in the village of Beli Izvor.

The costs related the collection, transportation, processing and eradication of the dead animals , as well as

costs for the dead animals, ABP form slaughtered animals from holdings intended to own consumption are

covered by the state budget.

The meat production and meat processing facilities and the commercial sites pay to the rendering plants for the transportation and the processing of the by-products of animal origin they supply to them.

Swill feeding is banned in Bulgaria for many years under the National legislation even before EU accession

and severe penalties are imposed in case of infringements. Article 139 (1) point 7 of the Law on veterinary

activities (LVA) forbids swill feeding.

iii) Describe the regulations, procedures, type and frequency of checks at the point of entry into the country or their final destination, concerning the import and follow-up of the following: – pigs, – genetic material (semen and embryos), – fresh meat, pig products and by-products, – veterinary medicinal products (i.e. biologics).

Please see point 6.b in terms of legislative rules on the regulations, procedures, type at the point of entry into the country.

7. Control measures and contingency planning

a) What are the measures in place to prevent contact between domestic and captive wild pigs, and wild and feral pig populations?

Pig holdings are kept under strict health monitoring programme by the BFSA. The holdings are requested to practise good biosecurity measures. Ministerial Order No 44/20.04.2006 defines the minimum levels of biosecurity for livestock holdings.

On the basis of biosecurity measures introduced the holdings are divided into: Industrial farms / farms with biosecurity measures and closed cycle of rearing pigs, Family farms, type "A" - these are the farms open cycle of rearing pigs with biosecurity measures, Family farms, type "B" - farms with uninitiated or partially implemented biosecurity measures, "back yards" - private farms, which rear to 5 pigs for personal consumption, “East Balkan pigs” - population, which is rear only in the territory of 12 municipalities in 3 regions of the country, under certain conditions that ensure the biosecurity of pigs.

Biosecurity measures, registration of all holdings, in-door way of rearing of pigs, identification,

movement control and active surveillance contribute to the preventing the spread of the disease

avoiding the contact between domestic pigs and wild boar.

During the surveillance, through clinical examinations of holdings a special check-list is drafted for

checking the implémentation of all measures above in the holdings.

b) If DIVA vaccine is used as part of risk mitigation, provide details of the vaccine and the differential tests.


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For the oral vaccination of wild boar population the commercially available RIEMSER Schweinepestoralvakzine (REIMSER Arzneimittel AG) will be used according to the instructions of the manufacturer

c) Describe the procedures applied to ensure disinfection of vehicles and equipment, including verification methods.

The special check-list (pointed in a) ) is used during clinical examination in the farms to verify the implementation of the biosecurity measures introduced in the farm.

Moreover there is a procedure for performing of audits for the purpose of verification of the effectiveness of the official control carried out respectively bythe RFSD and municipal oficials veterianrians and private veterinerians . The procedures has been drafted according the Reglulation 882/2004.

e) Give details of any written guidelines, including contingency plans, available to the official services for dealing with suspected or confirmed outbreaks of CSF.

As all ready described since 2007, the national control and eradication programme for CSF (CSF-EP) has been applied on the whole territory of Bulgaria, taking into consideration several key issues in the epidemiology of the disease. Updated of contingency plans for emergency diseases icluding CSF in Republic of Bulgaria are

available on:

http://babh.government.bg/bg/actualno-department-health&article_id=108.html

For practical purposes the BFSA has based its overall contingency plan on three major types:

Strategy and Resource plan,

Operational manuals for FMD, SGP, BT, PPR, LSD, CSF, ASF, NCD, AI, TSE, SVD

Instructions for practical matters during outbreak management for:

- personal protective equipment - killing of animals - manure and carcass management - disinfection, disinfection, deratisation; - collection and storage of wild boar carcasses, sampling and sending of samples to diagnostic

laboratories in game collection center - biosecurity measures to be applied by hunters

The contingency plan for emergency diseases in Bulgaria (the strategy and resource plan, the

operation manuals of the animal diseases and the practical instructions) is prepared in accordance

with the requirements of national and European legislation, the OIE standards and characteristics of

different diseases.

e) Is quarantine imposed on premises with suspected cases, pending final diagnosis? What other procedures are followed regarding suspected cases?

Quarantine imposed on premises with suspected cases, pending final diagnosis

http://babh/


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Measures in case of suspicion of CSF in domestic pigs: Ordinance No 4 transposes the provisions of Directive ЕС 2001/89 Art 4: The following measures are taken, in particular when the active clinical surveillance and serology monitoring of the CSF give a doubtful result for a particular holding:

- Where a holding contains one or more pigs suspected of being infected with Classical

Swine Fever virus, the responsible registered veterinarian shall prohibit the access to the farm and shall immediately notify the respective official veterinarian for measures to be taken for the diagnosis to be confirmed or the suspicion rejected.

- The official veterinarian shall visit the farm without delay, shall make a check on the spot of the register and the identification marks of the pigs raised on the farm, shall prohibit the access to the farm and shall give instructions, as follows:

all the pigs in the various categories on the pig-breeding farm are to be counted and a list compiled of the pigs already dead, sick or likely to be infected (the contact animals) in each category; the list shall be updated every day to take account of: the pig births, the pigs that have got sick and the deaths during the period of confirmation of the diagnosis or rejection of the suspicion. This list is submitted daily for a check to the responsible state veterinarian.

The movement of all the pigs on the farm shall be forbidden, and the movement of pigs outside the farm, including for slaughter purposes, shall be forbidden too;

no sows or pigs may enter or leave the farm and may, if necessary, extend the ban to cover other species of animals, in case there are any raised on the farm;

no pig carcasses may leave the farm;

no meat, pig products, semen, ova and embryos of pigs, animal feed, instruments and equipment (utensils), materials or wastes likely to transmit Classical Swine Fever may leave the farm;

access shall be denied for any unauthorised persons, that are not engaged in the production;

the movement of the workers to or from the farm shall be done only through a “filter”, and the movement of the vehicles to or from the farm shall be done only through a disinfecting installation;

appropriate means of disinfecting shall be used at the entrances and exits of the buildings housing pigs and of the farm itself; any person entering or leaving a pig farm shall fulfil appropriate hygienic measures necessary to reduce the risk of spread of the Classical Swine Fever Virus. Furthermore, all means of transportation shall be carefully disinfected before leaving the farm. Cleaning and disinfection measures follow the principles as laid down by Council Directive 2001/89/EC Annex II.

- The official veterinarian shall take and send samples for laboratory tests for confirmation of the CSF diagnosis or rejection of the suspicion. An epizootic inquiry shall be made.

- When the pig-breeding farm subject to suspicion concerning the presence of Classical Swine Fever is situated in an area with high density of the population of pigs, the state


39

veterinarian may give instruction for a ban on the movement in the remaining farms too until there is confirmation of the diagnosis or a rejection of the suspicion.

- In areas with a high density of pigs the competent authority may apply Directive 2001/89/EC Art 4 (3) if the epidemiological situation justifies this measure and the conditions laid down by the Directive are fulfilled.

- The official veterinarian shall have the right to impose a control zone both within the pig-breeding farms and at the borders and can introduce measures identical with those imposed on the farm subject to suspicion of CSF infection.

- The official veterinarian shall have no right to lift the measures imposed until the results from the laboratory tests officially rejecting the suspicions for the presence of CSF infection have not been received.

f) In the event of a CSF outbreak:

i) indicate the sampling and testing procedures used to identify and confirm presence of the causative agent;

ii) describe the actions taken to control the disease situation in and around any holdings found to be infected with CSF;

iii) indicate the control and eradication procedures (e.g. policies on emergency vaccination, stamping-out policy, partial slaughter, etc.) that would be taken. Provide details of any vaccine supply scheme and stocks. If DIVA vaccines may be used, also include details on the differential test. Include details on carcass disposal, logistics and methods;

iii) describe the procedures used to confirm that an outbreak has been successfully controlled or eradicated, including any restrictions on restocking;

In case of CSF confirmation the measures listed in Council Directive 2001/89/EC Art 5 (1 a – i) – transposed by Ordinance No 4 are:

- All pigs in the holding have to be killed without delay in such a way as to avoid the risk of spread of the Classical Swine Fever Virus during their transport or killing;

- A sufficient number of samples have to be taken, in accordance with the diagnostic manual, from the pigs killed in order that the manner of introduction of the Classical Swine Fever Virus into the farm and the length of time during which it may have existed on the farm to be established;

- The carcasses of pigs which have died or have been killed have to be destroyed under official supervision;

- The meat of pigs, raw materials thereof and products of pigs slaughtered during the period between the probable introduction of the disease to the pig holding and the taking of official measures have to be traced and processed under official supervision;

- Semen, ova and embryos of pigs collected from the holding during the period between the probable introduction of the disease and the taking of measures have to be traced and the destroyed under official supervision in such a way as to avoid the risk of spread of the CSF Virus;

- All substances and waste likely to be contaminated, such as feeding stuff, have to be subjected to a treatment ensuring the destruction of the CSF Virus;

- All single-use materials, which may be contaminated with the CSF virus, have to be


40

destroyed in accordance with the instructions of the state veterinarian;

- After the pigs have been disposed of, mechanical cleaning and disinfecting of the buildings for housing the pigs and premises used, the vehicles used for transporting them and their carcasses, the equipment, bedding, manure and excrements has to be performed;

- In case of a primary outbreak of the disease, the CSF Virus isolate has to be sent to the EU Reference Laboratory in Hanover (Germany) to identify the genetic type.

- An epizootic inquiry has to be organised.

Measures on the hunting field in case of suspicion/and outbreak of the CSF disease in wild boar are in accordance with Council Directive 2001/89/EC Art 15 and Commission Decision 2008/855/EC and are applied on the whole territory of Bulgaria

- BFSA immediately carries out epidemiological investigation on the situation and establishes the zones in the infected area as laid down by Directive 2001/89/EC

- BFSA immediately orders reduction of the wild pig population in the 3km protection and 10 km surveillance zones to 2 wild pigs with their newborns on the 1km2 during the hunting season. Out of the hunting season for reduction of the wild pig population it is ordered hunting only of newborn and young wild pigs up to one year of age. Trapping will be used as appropriate method for reduction of wild boar population. During the hunt it is important to avoid passing of the wild pig herds to other territories out of the zones.In the hunting season is important and we must to be careful with the wild boar – must not have access to any material that may subsequently come in contact with the pigs on the holding.

- Samples are taken and send to the NRL in Sofia for testing for the presence of CSF virus from all shot wild pigs. The carcasses are identified and kept till the notification of the results. In case of positive result the carcass and the internal organs are send for rendering. In case of negative result the carcasses and the internal organs may be taken by the hunters for own use.

- BFSA immediately organises “oral” vaccination of the wild pigs in the affected area. The vaccine is distributed at least on 2 plains on 1 km2 (with an option for two more plains on the 1km2). Two vaccination campaigns with two distributions of bites are carried out within a period of 30 days.

- BFSA forbids opening the carcasses of all shot and found dead wild pigs on the field. Opening of the carcasses is carried out only in defined for the purpose places. In case of CSF positives BFSA pays compensation to the hunting organisation. Strict documentation is kept for every shot in the 3km and 10 km zones wild pig, including sampling and testing procedure. In this documentation information is kept for: identification of the animals, place of shooting, age, sex, weight and laboratory result.

- BFSA establishes 40km.zone out of 3km and 10km zones where orders 100% sampling of all shot pigs. National borders and wildlife habitats are always taken into account while establishing the zones.

Measures in domestic pigs in case of CSF in wild boar:

1. BFSA immediately notifies for the situation all owners of domestic pigs and hunters in the 3 km

and 10 km zones area.


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2. BFSA carries out audits to verify the effectiveness of the measures adopted to eradicate CSF from

the infected area;

- all pig holdings in the defined area have to be placed under official surveillance and a census has to be carried out; the census has to be kept up to date by the owner. The information in the census has to be produced on request and is checked at each inspection.

- with regard to open pig farming all East Balkan pigs must to be closed immediately in the holdings (no movement outside is allowed), and census of the East Balkan pigs hers in the 3km and 10km zones must be performed.

- all pigs on the holding have to be kept in their living boxes or some other place, where they can be isolated from the wild boar. Wild boar must not have access to any material that may subsequently come in contact with the pigs on the holding;

- no pigs enter or leave the holding without permission of the state veterinarian, who will take into consideration the epidemiological situation;

- appropriate means of disinfecting have to be placed at the entrances and exits of the buildings housing domestic pigs and of the holding as a whole;

- appropriate hygienic measures have to be applied by all persons coming in contact with wild boar, to reduce the risk of spread of the CSF virus. The measures can include a temporary ban to enter the pig holdings on persons having been in contact with wild boar such as hunters, hunter- and forest supervisors;

- all dead or sick pigs with a CSF symptoms on the holding have to be tested for the presence of CSF virus

- no meat or any part of wild boar, whether shot or found dead, as well as any material or equipment, which could be contaminated with the CSF virus has to be brought into the pig holding;

- pigs, their semen, embryos or ova shall not be moved from the infected area for the purpose of trade;

- for collaboration in the establishment of control measures the neighbouring Member States or a third country will be duly notified, when the infected area is near the border

- pigs may be sent for immediate slaughter to slaughterhouse located in the same administrative region, only after the clinical investigation of the pig holding have been carried out. Check lists of the clinical investigation accompanies the batch.

- Breeding pigs may leave holding located in the 3km or 10km zones, only after receiving the negative result of the PCR laboratory tests of blood samples taken 7 days before the pigs transportation.

v) give details of any compensation payments when pigs are slaughtered for disease control and eradication purposes and the prescribed timetable for payments.

The terms and procedures for compensation of owners are described in the national legislation -

the Law of Veterinary Activity (LVA) and Ordinance on the terms and procedures applicable to

effecting expenditures related to epizootic risks (Adopted by CoM decree No. 181 of 21.07.2006,

publicised in the State gazette (SG), Issue No. 62 of 01.08.2006, in effect since the day of

publicising).


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Pursuant to the Ordinance on the terms and conditions for spending the costs for covering the

epizootic risks related expenditures compensations are paid to the owners of dead, compulsory

killed and destroyed animals as well as equipment, destroyed feed and feed products.

The valuation of the animals is determined by the National statistics institute, by average market price per 1 kilogram live weight for the month and the respective region, as the scale of compensation for animals is publicly available

The time table and order concerning the application made by the owner, its consideration by the RFSD and final approvement by the BFSA is dully dedcribed in the above mentioned Ordinance.

8. Compliance with the Terrestrial Code –

Please see the Declaration by Executive Director in terms of the provisions of Articles 15.2.2. and 15.2.3. of the Terrestrial Manual.

9. Recovery of free status

Member Countries applying for recovery of free status of a country or zone should comply with the provisions of Article 15.2.6. of the Terrestrial Code and provide detailed information as specified in sections 3.a), 3.b), 3.c), 5.b) and 7 of this questionnaire. Information in relation to other sections need only be supplied if relevant.

N/A

Documents

Dossier of Republic of Bulgaria for the recognition as a ... CSF_Do… · 1 SAFETY EVERY DAY MINISTRY OF AGRICULTURE AND FOOD BULGARIAN FOOD SAFETY AGENCY Sofia, 1606, “Pencho Slaveikov”