EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2011)922581 DG(SANCO) 2011-6225 - MR FINAL FINAL REPORT OF A MISSION CARRIED OUT IN SERBIA FROM 10 TO 20 MAY 2011 IN ORDER TO EVALUATE ANIMAL HEALTH CONTROLS OVER LIVE CATTLE

Executive Summary The report describes the outcome of a mission carried out by the Food and Veterinary Office (FVO) in the Republic of Serbia from 10 to 20 May 2011. The objective of the mission was to review the Serbian authorities capability to provide adequate animal health guarantees for the potential import of live cattle into and their transit through the EU. In general, the Serbian competent authority (CA) has put in place a robust and comprehensive system of animal health controls and, according to the information provided by the CA, the animal health situation appears to be favourable. The CA was not in a position to provide adequate guarantees for the import of live cattle into the EU due to: implementation of the new on-farm register being in progress; the CA has not yet granted herds the status of officially free from TB, BB and EBL; contingency instructions are still to be developed or finalised; NRLs have not yet been designated for all relevant diseases and national ring testing has not been initiated for some tests; laboratory reports may omit the identity or incorrectly identify animals subject to official testing. Recommendations were made to the Serbian authorities with a view to rectifying the shortcomings identified and described in this report. I

Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES...1 3 LEGAL BASIS...1 4 BACKGROUND...2 4.1 REQUEST OF THE SERBIAN AUTHORITIES FOR IMPORT INTO THE EU OF LIVE ANIMALS...2 4.2 INFORMATION ABOUT THE CATTLE POPULATION IN SERBIA...2 4.3 TRADE PATTERN...2 4.4 ANIMAL HEALTH SITUATION FOR CATTLE IN SERBIA...2 5 FINDINGS AND CONCLUSIONS...3 5.1 COMPETENT AUTHORITIES PERFORMANCE...3 5.1.1 LEGAL REQUIREMENTS...3 5.1.2 FINDINGS...3 5.1.3 CONCLUSIONS...4 5.2 MOVEMENT CONTROLS AND RESIDENCY...5 5.2.1 LEGAL REQUIREMENTS...5 5.2.2 FINDINGS...5 5.2.3 CONCLUSIONS...7 5.3 DISEASE PREVENTION AND CONTROL...7 5.3.1 LEGAL REQUIREMENTS...7 5.3.2 FINDINGS...7 5.3.3 CONCLUSIONS...11 5.4 LABORATORY PERFORMANCE...11 5.4.1 LEGAL REQUIREMENTS...11 5.4.2 FINDINGS...11 5.5 CERTIFICATION...12 5.5.1 LEGAL REQUIREMENTS...12 5.5.2 FINDINGS...12 5.5.3 CONCLUSIONS...13 6 OVERALL CONCLUSIONS...13 7 CLOSING MEETING...13 8 RECOMMENDATIONS...13 ANNEX 1 - LEGAL REFERENCES...15 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation Explanation ABP Animal By-Product ADNS Animal Disease Notification System AGID Agar Gel Immuno Diffusion AI Artificial Insemination BB Bovine Brucellosis BIP Border Inspection Post BSE/TSE Bovine/Transmissible Spongiform Encephalopathy BT Blue Tongue CA Competent Authority CCA Central Competent Authority the Veterinary Directorate of the Ministry of Agriculture, Forestry and Water Management CDB Central Data Base CBPP Contagious Bovine Pleuro Pneumonia CFT Complement Fixation Test CP Contingency Plan CSF Classical Swine Fever CVED Common Veterinary Entrance Document CVO Chief Veterinary Officer DG SANCO European Commission's Directorate General for Health and Consumers EBL Enzootic Bovine Leucosis EHD Epizootic Haemorrhagic Disease ELISA Enzyme-Linked Immuno-Sorbent Assay EU/EC European Union/European Community EU-RL European Union Reference Laboratory FMD Foot-and-Mouth Disease FVO Food and Veterinary Office FYRoM Former Yugoslavian Republic of Macedonia GBR Geograghical BSE Risk IBR/IPV Infectious Bovine Rhinotracheitis/Infectious pustular vulvo-vaginitis - Bovine herpes viruses (BHV-1,4) IDT Intra-dermal Skin Test ISO International Organisation for Standardisation MAFWM (CCA) Veterinary Directorate of the Ministry of Agriculture, Forestry and Water Management MBM Meat-and-Bone Meal 'Model certificates Certificates "BOV-X, and BOV-Y" set out in the Annexes to Regulation (EU) No 206/2010 MS Member State NRL National Reference Laboratory OG RS Official Gazette of the Republic of Serbia OIE World Organisation for Animal Health OIE Terrestial OIE's Manual of Diagnostic Tests and Vaccines for Terrestial Animals Manual OIE Terrestrial Code OIE's Terrestrial Animal Health Code OV Official Veterinarian PCR Polymerase Chain Reaction III

PPD RB RVF SAT SOP SRM SVS TRACES TB TC VD VID VS WAHID (OIE) Purified Protein Derivative Rose Bengal Test Rift Valley Fever Serum Agglutination Test Standard Operating Procedure Specified Risk Material State Veterinary Service Trade Control and Expert System Bovine Tuberculosis Third Country Veterinary Directorate (the CA within MAFWM) Veterinary Inspection Department (within the Veterinary Directorate) Vesicular Stomatitis OIE World Animal Health Information Database IV

1 INTRODUCTION The mission took place in Serbia from 10 to 20 May 2011 and was an addition to the FVO's planned programme. The mission team comprised two FVO inspectors and was accompanied throughout the mission by representatives from the Central Competent Authority (CCA), the Veterinary Directorate (VD) of the Ministry of Agriculture, Forestry and Water Management (MAFWM). 2 OBJECTIVES The objective of the mission was to evaluate the measures taken by the CA to provide adequate animal health guarantees for the export of live cattle to the EU and in particular to review (1) the ability of the CA to establish the standards set out in Chapter II of Council Directives 2002/99/EC and 2004/68/EC, (2) the animal health control system in place for cattle diseases and on the residency and movements of cattle as required by the certificates "BOV-X and BOV-Y" set out in the Annexes to Regulation (EU) No 206/2010 (hereinafter referred to as model certificates ) and (3) the procedures for certification in accordance with the requirements of Council Directive 96/93/EC. In addition to the standards established by Union legislation against which the evaluation was carried out, account was taken of other international standards, in particular the standards, guidelines and recommendations developed by the World Organisation for Animal Health (OIE). This report refers, where appropriate, to the OIE s Terrestrial Animal Health Code (hereinafter referred to as OIE Terrestrial Code ) and its Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (hereinafter referred to as OIE Terrestrial Manual ). In pursuit of these objectives, the following meetings were held and sites visited: Visits Comments Competent Authority Central 1 Opening and closing meeting. Operation of the Central Database (CDB). District 2 District Veterinary Office Local 2 Vet Stations BIPs 1 Animal Holdings 5 Including two export farms, a quarantine centre and a market Feed stuff company 1 Slaughterhouse 1 Laboratory 3 3 LEGAL BASIS The mission was carried out under the general provisions of EU legislation and, in particular Article 46 of Regulation (EC) No 882/2004. Legal references are provided in the Annex to this report. Legal acts quoted in this report refer, where applicable, to the last amended version. 1

4 BACKGROUND 4.1 REQUEST OF THE SERBIAN AUTHORITIES FOR IMPORT INTO THE EU OF LIVE ANIMALS Following the request by the MAFWM on 2 March 2011 to DG SANCO to approve Serbia for the import of certain live animals (cattle and poultry) into the EU, the FVO undertook two concurrent audits (this one and 2011-6224). 4.2 INFORMATION ABOUT THE CATTLE POPULATION IN SERBIA The North of Serbia (Vojvodina) is flat with intensive agriculture and livestock production comprising milk, pork and poultry production. Central Serbia is hilly & mountainous with a combination of intensive & semiintensive agriculture and livestock production comprising milk, beef, sheep, and pork production. The Livestock Sector (including dairy farming) represents 32% of the contribution to Gross Agricultural Production, nearly half of which is attributed to the cattle industry. An extract from the central database, shows that at the time of the mission, there were 905,499 cattle on 183,784 registered holdings, linked mainly to small producers with farms of less than 15 hectares. There are 5 Artificial Insemination (AI) centers in Serbia and more than 80% of cattle are produced under an AI programme. Cattle breeds include Simmental (the predominant breed), Black-White & Hereford, local breeds (Podolian and Busa) and beef breeds with various crosses. 4.3 TRADE PATTERN According to the information provided by the CCA, live cattle are imported into the Republic of Serbia primarily from the EU with smaller numbers from the neighboring countries of Croatia, Bosnia and Herzegovina and the Former Yugoslavian Republic of Macedonia (FYRoM) with whom they have bi-lateral agreements Centres for artificial insemination import semen of elite bulls for planned insemination of Simmental dams, or borrow young bulls from abroad (waiting bulls) whose semen is used for insemination of the main population (source: mainly Austria and Germany). 4.4 ANIMAL HEALTH SITUATION FOR CATTLE IN SERBIA The general health status of livestock and wildlife appears to be favourable in relation to exotic, notifiable diseases, with the exception of rabies in fox, for which an (aerial) vaccination campaign began during the first week of the mission. The CA acknowledges that bovine tuberculosis (TB), bovine brucellosis (BB) and enzootic bovine leucosis (EBL) are endemic but occur at relatively low levels. In Serbia according to the information about cattle diseases provided by the OIE (WAHID interface: http://www.oie.int). 2

Table - Diseases situation as of 2010 Diseases never reported Diseases reported in 2010 Diseases reported Pre- 2010 Year Bovine spongiform Bovine brucellosis Blue tongue (BT) 2002 encephalopathy (BSE) (brucella abortus) Contagious bovine pleuro TB Foot and mouth disease 1996 pneumonia (CBPP) (FMD) Vesicular stomatitis (VS) EBL Rinderpest 1883 Rift Valley Fever (RVF) Rabies Anthrax 2008 Haemorragic septicaemia Infectious bovine rhinotracheitis (IBR) Bovine viral diarrhoea (BVD) 5 FINDINGS AND CONCLUSIONS 5.1 COMPETENT AUTHORITIES PERFORMANCE 5.1.1 Legal requirements Article 4 of 2004/68/EC and Article 8 of Council Directive 2002/99/EC require the Commission to take particular account of the following aspects of CA performance when drawing up or updating approved lists: The legislation of the third country; The organisation of the CA and its inspection services, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively. 5.1.2 Findings 5.1.2.1 Legislation The Veterinary Directorate of MAFWM is responsible for establishing legal requirements and operational standards relevant to the scope of this mission. Animal health legislation, in line with EU legislation regarding animal identification, TB, BB and EBL was adopted in 2009 in the form of national "Rulebooks". The CCA informed the FVO mission team that the Regulation on the Programme of Animal Health Measures for 2011 has been adopted, which establishes amongst other things, the national testing scheme for the diseases cited above. When appropriate, the national legislation is referred to in the relevant chapters of this report and includes: Law on Veterinary Matters (OG RS, No 91/2005, and 30/2010) Law on Food Safety (OG RS, No 41/2009) Law on Drugs and Medicinal Products (OG RS, No 84/2004) Law on Animal Welfare (OG RS, No 41/2009) 3

5.1.2.2 Structure and organisation of the CA In July 2009, the Veterinary Inspection Service and Border Inspection Service was re-integrated into the Veterinary Directorate and there have been no significant changes since. In brief, the Veterinary Directorate (the CA) comprises 4 departments (International trade and certification, border inspection, veterinary inspection and animal health and welfare), 3 groups (legal and general affairs, internal audit and quality management, and finance/administration) and 2 units (veterinary public health and veterinary services). The Veterinary Inspection Department (VID), and in particular the inspection group for animal health and welfare, is responsible for supervising the delivery of the annual programme of measures for animal health and has 277 inspectors at district level. Practical implementation of the programme falls mainly to the 318 contracted "veterinary stations", who are assessed to ensure that they have the necessary resources (i.e. equipment and official veterinarians). 5.1.2.3 Supervision, audits and inspection The director of the VID makes at least one supervisory visit (which includes a report and follow-up) to each of the 25 district offices each year. These visits are supplemented by additional visits by representatives from one of the four VID "inspection groups" (animal health and welfare, food safety, quality and animal by-products (ABPs), export establishments and trade control of veterinary drugs and feed). In turn, veterinary inspectors at district/local level make regular supervisory visits at the veterinary stations and submit monthly reports on their activities and findings to the VD. The control includes a review of the execution of the annual programme of "animal health measures". There are additional supervisory visits by the district/local veterinary inspectors at farm level to check on identification and registration of animals (3% of holdings/year), sampling under the residue control programme and feed sampling to check on the application of the ruminant feed ban. Where checked by the audit team, the arrangements described above had been followed. Approval of export holdings for the EU requires a 3 step inspection process by a 3 man Commission comprising representatives from the central, district and local inspection services. Step one is approval for the internal market, step 2 third country exports (excluding the EU and the USA) and step 3 EU approval. An audit unit has also been created. The audit programme for 2011 and audit procedures had not been established. 5.1.2.4 Means at the competent authorities' disposal, including staff capacity The CA had adequate staff/resources in 2010 to complete the annual programme of health measures. In FVO report 2010-8505, it was reported that there were insufficient resources in 2009 to complete training as planned. To overcome this problem, ad-hoc training is complemented by a "cascade" system where training provided to district managers is conveyed to all staff at district/local level. 5.1.3 Conclusions National legislation is in place regulating technical aspects within the scope of this mission. The CA has a defined chain of command and adequate powers to implement the law. The responsibilities for animal health controls on live cattle are clearly allocated. The inspections carried out are effective and have ensured that procedures and instructions in the field are followed, with the completion of 4

the annual programme of animal health measures. Thus the CA has put in place a robust and comprehensive system of veterinary controls which deliver, in general, the standards required by Council Directives 2002/99/EC and 2004/68/EC. However, there is not yet a system of internal/external audits in place. 5.2 MOVEMENT CONTROLS AND RESIDENCY 5.2.1 Legal requirements Articles 3 and 14 of Commission Regulation (EU) No 206/2010 drawing up a list of third countries from which the MS authorises imports of live cattle requires them to come from an approved territory listed in Part 1 of Annex II to that Regulation. The model certificates lay down the animal health requirements to be met for live cattle intended for export to the EU in respect of : the indication of the identification and registration of cattle which are intended to be exported to the EU; the residency of these animals in the territory and in the holding of origin prior to dispatch or slaughter, and the movement conditions for these commodities into the territory and the border controls thereof. 5.2.2 Findings 5.2.2.1 Holding registration, animal identification and movement control According to the Veterinary Law, all cattle holdings (irrespective of size), must be registered in the central database (CDB). Cattle from these holdings can only move to another farm (or to a livestock market or slaughterhouse) if they are accompanied by an animal health certificate issued by an official "authorised" veterinarian (OV) from the relevant veterinary station. A health certificate cannot be issued unless the farm has completed the annual programme of measures for the preceding year. For cattle leaving or entering a holding, the OV fills in an identification and registration document which is used to update the CDB. For movement between one of the 12 epizootiological regions, a movement document (VS 40) is also required. Cattle are identified with two identical ear-tags by an OV. According to the bovine Rulebook, keepers are to notify births to the OV within 7 days. Entry of this data into the CDB by the OV must also be performed within 7 days of the date of tagging. Lost ear tags are replaced with a duplicate ear tag containing the same individual animal code and a version number printed in Roman numerals. Cattle passports are issued by the VD within 14 days from entry of data into the CDB. These are sent weekly by mail to the district offices, who forward them to the OVs. Movements (arrivals only) are recorded on a panel on the rear of the passport. The movement is verified by the signature of the owner, countersigned by the OV. The passports of dead/slaughtered animals are marked as "canceled". Replacement passports are marked as duplicates. Data on the dam and the herd (holding) of birth/origin is obligatory to facilitate tracing back. Residency is established through the recording of the date and place of birth and record of movements. The mission team noted that: The CDB was in operation and all farms/animal selected by the audit team could be traced using the system. For one premises an additional 3 animals were shown in error (corrected by the CA); 5

During the farm/market visits the audit team saw the correct implementation of the holding register in a number of cases. The CA explained that due to the recent distribution of the document, some keepers had not started using this register yet. Movement documents and cattle passports were found to be in order. The bovine animals seen in all holdings were individually identified with 2 ear tags (only one animal had a tag missing and the CA confirmed that a replacement had been ordered). There were on farm logs (maintained by the OV from the veterinary station) for dead animals. Where checked, those over 30 months old had been subsequently tested for BSE and results provided to the audit team. at the slaughterhouse visited, a system was in place to link carcasses to the live animals. 5.2.2.2 Border controls and imports of cattle from other countries The Department for International Trade and Certification within the VD is responsible for the 15 Border Inspection Posts (BIP) and 5 administrative posts (5 railway crossings, 7 road crossings, 2 river ports and one airport). The MATFW is responsible for issuing a decision on the animal health requirements for the import, export and transit of cattle (on a case by case basis). Import and transit authorisations are given if the animal health status of the country is satisfactory (taking account of OIE data) and if there is deemed to be no risk to animal or human health. As a minimum, the following tests are required at the place of departure: BB, EBL, TB, IBR/IPV and BT. According to information provided by the CA live cattle are imported into the Republic of Serbia primarily from the EU with smaller numbers from the neighbouring countries of Croatia, Bosnia and Herzegovina and FYRoM with whom they have bi-lateral agreements The CA require 24 hour notice for incoming consignments and the CA utilise the EU Common Veterinary Entrance Document (CVED). Original health certificates are retained at the BIP. The BIP visited by the audit team at Horgos had facilities for examining animals & taking laboratory samples. The CA is preparing to use TRACES, the integrated web-based veterinary system, maintained by DG SANCO to manage intra and extra community trade of live animals and animal products. All imported cattle must then travel directly to a quarantine station where they remain for a minimum of 30 days and obtain satisfactory results to any additional laboratory tests required by MATFW before release to the holding of destination. The mission team noted that: For 2010, breeding cattle were imported from Austria, the Netherlands, Germany and Romania (958 animals) and 68 cattle for fattening from Hungary. Since 2006, some animals had originated outside the EU (e.g. Canada, Switzerland and Croatia). The certification accompanying an imported consignment of cattle from Bosnia and Herzegovina in April 2011 was in line with EU requirements and in a few instances stipulated more strict animal health requirements. 5.2.2.3 Welfare during transit The Law on Animal Welfare (OG RS, No 41/2009) lays down in a rulebook the conditions for 6

transport vehicles and movement of cattle. Requirements are laid down for handling (loading, unloading and transhipment), feeding, water, space allocation and rest intervals. OVs are present during the loading of animals for export and movements between epizootiological regions. 5.2.3 Conclusions The system in place for the identification and registration of cattle allows cattle to be identified and traced back to the herd of origin (if moved) and their period of residency. The introduction of the new holding register, will require clear records to be maintained by the animal keeper, further improving the reliability of the system. Import certification and procedures (including the use of the CVED) have been broadly aligned with those of the EU and the system for veterinary import controls at border posts on live cattle appears to be adequate. 5.3 DISEASE PREVENTION AND CONTROL 5.3.1 Legal requirements Article 4 of Council Directive 2004/68/EC and Article 8 of Council Directive 2002/99/EC require account to be taken of the following issues when drawing up or updating the approved lists: The health status of livestock, other domestic animals and wildlife in the third countries, with particular regard to exotic animal diseases; The regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases on its territory, particularly the notifiable diseases listed by the OIE; The rules on the prevention and control of these diseases and their implementation. The model certificates lay down the animal health requirements to be met for live cattle intended for export to the EU in respect of : The freedom of the territory, and the surrounding of the holding itself from certain diseases. Testing procedures and methods, including laboratory tests, for TB, BB and EBL are laid down by both the OIE Terrestrial Manual and the Annexes to Council Directive 64/432/EEC. Annex IX to Regulation (EC) No 999/2001 establishes that imports of bovine animals or products of bovine animal origin from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that the requirements in respect of the enforcement of the ban of feeding of ruminants with meat-and-bone meal (MBM) or greaves are met and that the meat products are not derived from specified risk material (SRM). 5.3.2 Findings 5.3.2.1 The health status of livestock, other domestic animals and wildlife with particular regard to exotic animal diseases The animal health situation for cattle in the Republic of Serbia has been summarised above in section 4.4. According to the OIE, the country is currently free from FMD, BT and anthrax and has 7

never recorded BSE, CBPP, VS or RVF. Rinderpest was last identified in 1883. Rabies is endemic in the fox population, however, there was only 1 case in cattle in 2010. The CA confirmed that TB, BB and EBL are endemic, with 14, 7 and 343 animals being infected in 2010 respectively. 5.3.2.2 Disease notification The CA publish a list of mandatory notifiable contagious animal diseases in the Official Gazette (RS No. 49/2006) and Article 61 of the Law on Veterinary Matters, requires animal keepers to inform the veterinary services. The list distributed by the chief veterinary officer (CVO) excludes epizootic haemorrhagic disease (EHD), which is now to be added. The CA submits animal disease reports to the Commission through the animal disease notification system (ADNS) since November 2010, and has sent the 6 monthly (http://web.oie.int/wahis/public.php) and annual reports for 2010 (on time) to the OIE. In particular the CA notifies the OIE according to the requirements and recommendations of this organisation, including any changes in the epizootic situation (via immediate notifications, follow-up messages etc). 5.3.2.3 Disease surveillance Structured non-random surveillance activities, as described in the "OIE Terrestial Code", are carried out in respect of both official supervision of cattle holdings and the implementation of disease control programmes. In particular the annual "programme of animal health measures" carried out by the VD includes the implementation of TB, BB and EBL surveillance/control plans. This is supplemented by information gained during routine ante and post mortem inspection (observed during the mission audit), testing during post import quarantine and routine veterinary observation and examination. Although Serbian legislation lays down the conditions for the implementation of the TB, BB & EBL programmes and the establishment of officially disease free status, the CA has not yet designated any, although consideration is being given to identifying suitable farms on a "pilot" basis. The total number of samples for transmissible spongiform encephalopathies (TSE) will be significantly increased in 2011, based on new rules and the obligation to sample of all animals over 30 months that are slaughtered for human consumption. Bovine Tuberculosis All animal older than six weeks are tested for TB once a year, including cattle reared in fattening herds for slaughter. The CA utilise the single intradermal skin test (IDT), and the the CA stated that the Rulebook laying down the testing procedures and methods (OG RS 51/2009) is in line with those laid down by both the OIE Terrestrial Manual and the Annexes to Council Directive 64/432/EEC. In 2010, 972,805 animals were tested and 15,568 retested following inconclusive results. The mission team noted that: While the CA can deploy the ancillary in vitro blood based γ-ifn test (Veterinary Scientific Institute of Belgrade) to enhance the detection accuracy of M. Bovis infected herds and animals, confirmation is based on the primary skin test. Microbiology for M. Bovis is not performed routinely; On farm re-tests (at a minimum of 6 weeks) involved the district veterinary officers and a epidemiologist from the Veterinary Institute responsible for that epizootiological region; 8

Cattle that have been confirmed to have a positive or a suspected reaction to TB and are sent to slaughter, have the entry "Bovine TB" in their animal health certificate; Reactors are to be slaughtered at the latest, 30 days after the owner or keeper has been informed. This period may be extended for pregnant animals or when whole herd slaughter is required and there is not adequate local slaughter capacity. Bovine Brucellosis All animals older than 12 months old are tested for BB once a year. The CA utilise the RBT and enzyme-linked immuno-sorbent assay (ELISA) test, and the CA stated that the Rulebook laying down the testing procedures and methods (OG RS 55/2009) is in line with those laid down by both the OIE Terrestrial Manual and the Annexes to Council Directive 64/432/EEC. In 2010, 568,252 animals were tested (blood samples analysed for both EBL and BB) and 3,264 retested following inconclusive results. The mission team noted that: Cattle are considered to be infected with BB if it had a positive reaction on at least two serological tests and whose microbiological test results confirm BB; Cattle are not vaccinated against BB; In the case of positive results, the veterinary inspector requires the separation and isolation of cattle, killing and safe disposal of carcasses under supervision. Enzootic Bovine Leucosis All animals older than 6 months old are tested for BB once a year. The CA utilise the agar gel immuno-diffusion (AGID) or ELISA test, and the CCA stated that the Rulebook laying down the testing procedures and methods (OG RS 51/2009) is in line with those laid down by both the OIE Terrestrial Manual and the Annexes to Council Directive 64/432/EEC. In 2010, as detailed above, 568,252 animals were tested. The mission team noted that: Cattle are considered infected with EBL if there is a positive reaction to a EBL/ELISA test or there are morphologic and pathological changes characteristic for EBL found in organs and tissues during slaughter; Cattle with EBL are not treated and there is no vaccination; Cattle that have been confirmed to be EBL positive and are sent to slaughter, have the entry "Enzootic Bovine Leucosis" in their animal health certificate. 5.3.2.4 Vaccination Concerning the implementation of programmes for the eradication and monitoring, including preventive measures for infectious diseases in wild animals, the CA has just started, in cooperation with the EU, oral vaccination of fox against rabies. Baits are to be deployed throughout the Republic of Serbia at a density of 23 baits per km 2. There is compulsory vaccination for dogs and cats. 5.3.2.5 Contingency planning National legislation (Rulebooks) is in place establishing measures for the early detection, diagnosis, prevention of spread, suppression and eradication of epizootic disease. In particular, a draft FMD 9

contingency plan has been drawn up in accordance with the Law on Veterinary Matters (OG 91/2005, 30/2010) and associated Rulebooks laying down detailed instructions in respect to the action to be taken for the prevention and control of FMD. The main elements of contingency planning (clear chain of command, planning for crisis centers, treatment of infected animals and products) was demonstrated in their recent (successful) response to Classical Swine Fever (CSF) in November 2010. Losses for culled animals in the course of an outbreak of epizootic disease are compensated, as required under Article 69 (compensation of damage) of the Law on Veterinary Matters. The mission team noted that: Detailed instructions are provided in Rulebooks for other diseases of cattle (including Blue tongue and TSE); Staff from the VD attend training on exotic disease outbreaks which included a desk top simulation exercise for FMD in February 2010. A simulation exercise for CSF is planned between September to November this year; There is an equipped national co-ordination center at Kraljevo which is supported by 3 other veterinary institutes. The CA acknowledged that they need to obtain carcass incineration equipment. 5.3.2.6 Feeding ban of ruminant protein An assessment of the Geographical Risk of BSE (GBR) has not been done for the Republic of Serbia and according to the OIE, Serbia has an undetermined BSE risk. Legislation was introduced in 2001 introducing a feed ban for ruminants, only permitting the use of milk, whey, albumin or casein in the production of compound feeding stuffs for bovine animals. In 2006, MAFWM introduced microscopy for the detection of meat-and-bone meal in feed for ruminant, and data from their monitoring programme is available in subsequent years. At this time, it was also determined that Category 1 ABPs or specified risk material (SRM) was to be incinerated and Category 2 and 3 material could be used for pet, pig and poultry feed production when approved on a case by case basis (in practice only 6 approvals were given). The CA stated that from 1 April 2011, legislation came into force laying down measures for the early detection and diagnosis of BSE/TSE, methods for enforcement, including measures for the preventing spread, control and eradication. The CA stated that these additional measures and stricter requirements bring their total feed ban in line with Regulation (EC) No 999/2001. Sampling and testing for BSE is done in the case of clinical suspicion (7 cases in 2010 all found negative) in fallen stock/emergency slaughter over the age of 24 months, and on a risk basis for animals over 36 months of age and certain categories of imported animals that subsequently die. Data and laboratory results (all negative for BSE) were provided to the audit team for fallen stock selected at random. The mission team noted that: There are five plants processing meat and bone meal (MBM) and greaves from category 3 material and two rendering plants processing category 1 and 2 material; The CA acknowledge that they have a problem regarding incineration of MBM in cement factories, because of certain requirements of the Ministry for Environment Protection. As a consequence, some Category 1 MBM is stored near a rendering plant and the remainder was 10

used in exceptional cases for the production of feed for pigs and poultry; There is a requirement to prevent of cross-contamination in feed mills producing feed for both ruminants and non-ruminants. In the mill visited, there was a system of flushing between batches of food for poultry, ruminants and pigs. However, as complete cleaning is difficult in a single line, the feed mill has elected not to use any products of animal origin, including milk thus eliminating any possibility of contaminating ruminant feed with protein of animal origin. From 2011, there is to be an increased frequency of testing in feed mills (2 samples/trimester where cattle feed is produced). 5.3.3 Conclusions According to the data provided by the CA the health status of cattle is favourable, and although TB, BB and EBL are regarded as endemic, these occur (particularly for TB and BB) at relatively low levels. While rabies is endemic in the fox population, the limited impact on cattle should be further reduced with the advent of aerial vaccination of wild carnivores. Supervision of cattle herds is carried out in the course of frequent veterinary interventions by the OV. In general, the control programmes for TB, BB and EBL are well implemented in terms of number and types of animal tested. Tracing back of positive samples to the animals from which they were taken is possible with the CDB and the compulsory system of animal identification and registration. Concerning contingency planning, the CA has recently demonstrated their ability to deal with a limited outbreak of epizootic disease. However, they have not yet finalised the contingency plans (CP), are to confirm the arrangements for local disease control centers and find a solution for carcass incineration. A ban on the feeding of ruminants with MBM and greaves from ruminants has been in place from 2001, this requirement was enforced from 2006 and in practice, limited qualities of this material are used in feed manufacture. Full implementation of measures in line with Regulation (EC) No 999/2001 and increased feed testing, further reduce the risk of non-compliance with the feed ban. 5.4 LABORATORY PERFORMANCE 5.4.1 Legal requirements Article 4 of Council Directive 2004/68/EC requires the Commission to take particular account of the regularity, speed and accuracy with which third countries (TCs) supply information on the existence of infectious or contagious animal diseases on their territories when drawing up or updating the lists of countries approved to export to the EU. Access to reliable laboratory facilities is a technical prerequisite for eligibility. 5.4.2 Findings In the republic of Republic of Serbia there is a laboratory network, comprising the Faculty of Veterinary Medicine and 12 veterinary scientific institutes and veterinary specialist institutes. One of the responsibilities of these institutes is the planning of the implementation of the "Programme of 11

Measures" for infectious/zoonotic diseases in their respective epizootiological area. The laboratory of the Faculty of Veterinary Medicine is responsible for TSE/BSE testing. All the laboratories are designated by the CA, operate ISO 9001:2000 quality managements systems (except for the Faculty of Veterinary Medicine) and are accredited ISO 17025 for animal health by the Accreditation Body of Serbia (re-accreditation required every 5 years). In the event of unsatisfactory results from an accredited laboratory, they are obliged to perform internal quality assessment procedures and based on the findings, perform appropriate corrective measures. Measures taken are assessed by technical experts from the Accreditation Body of Serbia, and if unsatisfactory the accreditation of the method is suspended. The mission team noted that: The Accreditation Body of Serbia is awaiting recognition by the European Accreditation Cooperation (assessment planned for June 2011); The scope of accreditation for all laboratories in the network covers the cattle diseases (TB, BB and EBL) included in the programme of animal health protection measures; The laboratories apply standard ISO methods, methods recommended by the OIE defined in Union legislation and recommended by EU reference laboratories (EU-RLs); The CA authorisation includes an annual contract defining the terms and conditions, in particular for work carried out under the programme of animal health measures; The NRL for FMD, BT and SVD has had acceptable results in recent ring tests organised by the EU-RL. Within Serbia, there is no national reference laboratory (NRL) for EBL. However, the Scientific Veterinary Institute of Serbia, New Belgrade, arranged ring testing within the laboratory network in 2009 and 2010 and inter-laboratory trials are organised within the network. For BB, there is no NRL and at present no ring test is arranged for the relevant tests (rose bengal test (RBT), fluorescent polarisation and ELISA); Results from the routine diagnostic work for BB and EBL may be reported for more than one farm on a single document or as an (overall) negative result with no reference to ear tag numbers. Where checked, there were transcription errors in relation to the animal identification numbers. 5.5 CERTIFICATION 5.5.1 Legal requirements Article 14 of Commission Regulation (EU) No 206/2010 requires the veterinary health certificates accompanying live cattle imported from third countries to be completed in accordance with the notes provided in the Annexes to that Regulation, which specifically refer to the equivalence with the principles established by Council Directive 96/93/EC on the certification of animals and animal products. 5.5.2 Findings The CA already undertakes certification for products of animal origin destined for the EU. Live cattle exports from 2006 to 2010 were destined for Montenegro, Bosnia and Herzegovina and 12

Croatia, with small numbers also being transported by air from Belgrade airport to Israel for slaughter. Sequentially numbered tamper proof certificates obtained from the Veterinary Chamber are issued by an OV from the the relevant district office. Before dispatch, an OV controls the loading of animals on the transport vehicle and checks that the vehicle meets the veterinary requirements. The CA has prepared translated certificates for the export of live cattle for breeding and production, or immediate slaughter after importation to the EU based on the model certificates set out in the Annexes to Regulation (EU) No 206/2010. Exports may only take place from authorised premises and have fulfilled all testing required under the annual programme animal health measures. If required by the importing country, additional testing is undertaken on these premises. 5.5.3 Conclusions The procedures in place for issuing veterinary certificates are considered sufficient. 6 OVERALL CONCLUSIONS In general, the CA of the Republic of Serbia has put in place a robust and comprehensive system of animal health controls and, according to the information provided by the CA, the animal health situation appears to be favourable. The CA was not in a position to provide adequate guarantees for the import of live cattle into the EU due to (1) implementation of the new on-farm register is in progress (2) the CA has not yet granted herds the status of herds officially free from TB, BB and EBL (3) contingency instructions are still to be developed or finalised (4) NRLs have not yet been designated for all relevant diseases and national ring testing has not been initiated for some tests (5) laboratory reports may omit the identity or incorrectly identify animals subject to official testing. 7 CLOSING MEETING A closing meeting was held on 20 May 2011 in Belgrade with the representatives of the CAs during which the mission team presented its main findings and preliminary conclusions. 8 RECOMMENDATIONS N. Recommendation 1. To complete the implementation of the new on-farm register 13

N. Recommendation 2. Take the necessary measures so that herds can be granted the status of officially free from bovine tuberculosis, bovine brucellosis and enzootic bovine leucosis. 3. To work towards finalising the contingency instructions for foot and mouth disease in particular and further develop instructions for other relevant cattle diseases such as bluetongue. 4. To work towards designation of a national reference laboratory for all relevant cattle diseases and implement national ring testing, in particular for the relevant tests for bovine brucellosis. 5. To ensure that laboratory results are reported accurately and individual animals are identified. The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/fvo/ap/ap_rs_2011-6225.pdf 14

ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Dir. 64/432/EEC OJ 121, 29.7.1964, p. 1977-2012 Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30 Dir. 2002/99/EC OJ L 18, 23.1.2003, p. 11-20 Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83 Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 1/2005 OJ L 3, 5.1.2005, p. 1-44 Reg. 206/2010 OJ L 73, 20.3.2010, p. 1 121 Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-community trade in bovine animals and swine Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption Regulation (EC) 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 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 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 Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements 15

Legal Reference Official Journal Title Reg. 605/2010 OJ L 175, 10.7.2010, p. 1-24 Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption 16