EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) 2017-6118 FINAL REPORT OF AN AUDIT CARRIED OUT IN ROMANIA FROM 25 JANUARY 2017 TO 02 FEBRUARY 2017 IN ORDER TO EVALUATE THE IMPLEMENTATION OF THE PROGRAMME FOR THE SURVEILLANCE AND EMERGENCY PREPAREDNESS IN RELATION TO AFRICAN SWINE FEVER

Executive Summary This report describes the outcome of an audit in Romania, carried out from 25 January to 2 February 2017, as part of the published Directorate-General for Health and Food Safety audit programme. The objectives of the audit were to evaluate whether: the programme for surveillance of African swine fever (ASF) for the years 2015 and 2016 in domestic pigs and wild boars in Romania has been implemented effectively to achieve the objective of early detection of the disease; the measures in place to prevent the disease from spreading into the domestic pig population, if it appears in wild boars, are effective; emergency preparedness in the event of an outbreak of African swine fever in domestic pigs and cases of African swine fever in wild boar is effective. Overall, the report concludes that Romania does not yet apply many actions aimed at preventing ASF, e.g. wild boar population management and biosecurity in backyard holdings, and they will only apply them on confirmation of disease, with a consequential delay in results. Although hunters are aware of ASF, the poor passive surveillance programme on wild boars does not provide confidence that ASF would be detected at an early stage following introduction. This will delay the detection of the disease and thus the implementation of control measures, increasing the risk for further spread into domestic pigs, particularly into backyard holdings. The many backyard holdings with low level of biosecurity represent the most vulnerable point for introduction of infection in domestic pigs. In particular, backyard holdings with sows are likely to play a role in spreading the infection locally. Should the disease enter into backyard farms, the existing passive surveillance performed on them will probably detect the disease promptly in this sector. The authorities will face a challenge in tracing pigs and containing the disease in an outbreak scenario due to the absence of records on these backyard farms and the existence of unrecorded movements (e.g. piglets). The good biosecurity measures and the controls in place at commercial farms reduce the likelihood of introduction and spread of infection in these. However, continued delays in laboratory turnaround time and the lack of passive surveillance in industrial commercial holdings would likely delay early detection in domestic pigs and increase the risk of spread of infection in this sector. The competent authorities seem prepared to deal with outbreaks on backyard or small commercial holdings - which are the majority. For industrial commercial holdings, they will face problems in quickly depopulating them, due to their limited killing and disposal capabilities. The report contains recommendations aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. I

Table of Contents 1 Introduction...1 2 Objectives and scope...1 3 Legal Basis...2 4 Background...2 5 Findings and Conclusions...3 5.1 Preventive measures...3 5.1.1 Wild boar management and biosecurity...3 5.1.2 Biosecurity measures applied on pig holdings...6 5.2 Early detection...7 5.2.1 Training and awareness programmes...8 5.2.2 Surveillance in wild boar...8 5.2.3 Surveillance in pig holdings...10 5.2.5 Laboratory testing...11 5.3 Emergency preparedness for ASF...12 5.3.1 National plan and operations manual...13 5.3.3 Simulation exercises...14 5.4 Verification, supervision and expert group...15 5.4.1. Supervision by line management...15 5.4.2. Internal audits...15 5.4.3. Evaluation(s) by the expert group...16 6 Overall Conclusions...16 7 Closing Meeting...17 8 Recommendations...17 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ABPs ASF BIP CSVFSA CVET ELISA EU EURL IDAH IPT LDCC NDCC NRL NSVFSA PCR Explanation Animal by-products African swine fever Border Inspection Post County Sanitary Veterinary and Food Safety Authority Community Veterinary Emergency Team Enzyme-linked immunosorbent assay European Union European Union Reference Laboratory Institute for Diagnosis and Animal Health Immuno-peroxidase test Local disease control centre National disease control centre National Reference Laboratory National Sanitary Veterinary and Food Safety Authority Polymerase chain reaction III

1 INTRODUCTION This audit took place in Romania from 25 January to 2 February 2017 as part of the DG Health and Food Safety audit programme. The audit team comprised two auditors from the Commission services and one National Expert from a European Union (EU) Member State. At the opening meeting on 25 January 2017 the team confirmed the objectives and scope of the audit as well as the itinerary. The audit team was accompanied by representatives from the central competent authority throughout the audit. 2 OBJECTIVES AND SCOPE The objectives of the audit were to evaluate whether: the programme for surveillance of African swine fever (ASF) for the years 2015 and 2016 in domestic pigs and wild boars in Romania has been implemented effectively to achieve the objective of early detection of ASF; the measures in place to prevent the disease from spreading into the domestic pig population, if it appears in wild boars, are effective; emergency preparedness in the event of an outbreak of ASF in domestic pigs and cases of ASF in wild boar is effective. The scope of the audit included: The surveillance programme for the years 2015 and 2016. Preventive measures and contingency planning ( wild boar population management, biosecurity measures in hunting grounds, biosecurity measures on pig holdings, active and passive surveillance for ASF in domestic pigs and wild boars, ASF contingency plan and ASF operational manual); Competent authority processes (controls, supervision, verification and analyses of results, audits, use of expert groups, cooperation between authorities involved, coordination between Member States and neighbouring non-eu countries); Infrastructure (ASF laboratories, information technology systems for animal health management, pig traceability). 1

The audit team met/visited the following: Site visited/authority met Number Comments Central Competent Authority 2 Opening and closing meetings Regional Competent Authority 3 Iasi, Satu Mare, Maramures Pig holdings 6 2 - Industrial commercial 1 Commercial type A 3 - Backyard Hunter association / game collection centre Laboratory 1 NRL for ASF 2 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in agreement with the competent authority of the country, and in particular under: Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules; Article 20 of Council Directive 2002/60/EC laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever. Article 37 of Regulation of the European Parliament and of the Council (EU) No 2014/652 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC Other relevant legislation for this audit is mentioned in the Annex to this report. 4 BACKGROUND Since January 2014, ASF has spread in Estonia, Latvia, Lithuania and Poland. In response to this development, the Commission audited these Member States. In 2015, the Commission developed an ASF strategy 1 for the affected Member States and for those with a higher risk of introduction of the disease. This strategy aims to prevent further 2

spread of the disease and eventually lead to its eradication from the affected territories. The strategy was developed and updated taking into account the latest opinions from the European Food Safety Authority. To support this strategy, Member States at risk of introduction of ASF have been invited to develop surveillance and control programmes, cofunded by the Commission. Romania is considered to have a high risk of introduction of ASF from the bordering non-eu countries Ukraine and Moldova. In December 2016, ASF was confirmed in Ukraine less than 10 km from the Romanian border. Consequently, the audit focussed mainly on the eight at risk counties (Satu Mare, Maramures, Suceava, Botosani, Iasi, Vaslui, Galati and Tulcea). Since 2015, a programme for surveillance of ASF in Romania has been approved and subject to financial support from the European Commission. Grant Decision SANTE/VP/2015/RO/SI2.700828 (as amended) approves the programme for 2015 and Grant Decision SANTE/2016/RO/SI2.726025 approves the programme for 2016-2018. This was the first audit to evaluate the implementation of surveillance for early detection of ASF and emergency preparedness arrangements for dealing with cases/outbreaks of the disease in a non- affected Member State. Full details on competent authorities are available in the country profile at: http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=ro 5 FINDINGS AND CONCLUSIONS 5.1 PREVENTIVE MEASURES 5.1.1 Wild boar management and biosecurity Legal requirements Articles 15 of Directive 2002/60/EC; the approved national programme (based on ASF strategy for Eastern Part of the EU (SANTE/7113/2015-Rev 4) Findings 1. A total of 2,151 hunting grounds covering 220,468km² were recorded in Romania in 2016. During this period the total number of wild boar were estimated at 96,685 with a hunting quota of 37,733. 2. The Ministry of Water and Forestry is responsible for wildlife management activity. Their responsibilities include the drafting of contracts with hunting ground managers (outlining the tasks and responsibilities of hunting clubs), establishment of hunting quotas for wild boar and mapping of hunting grounds. The National Sanitary Veterinary and Food Safety Authority (NSVFSA) currently have no involvement with the establishment of hunting quotas. 1 SANTE/7113/2015 Rev 4 ASF Strategy for Eastern Part of the EU 3

3. The size of the hunting grounds reviewed ranged from around 7,600 hectares to 11,300 hectares. Approximately 10% of hunting grounds are managed by the state body, Romsilva. The remainder are run by private hunting managers who can be responsible for more than one hunting ground. 4. The hunting season for wild boar runs from 1 August through to 15 February of the following year. 5. Six out of the eight counties at risk have wild boar densities between 0.25 0.5 / km². The two remaining counties have wild boar densities between 0.5 0.75 / km² (see map below). The current ASF strategy for the eastern part of the EU considers a wild boar density of 0.5 wild boar / km² or lower as optimal to reduce the spread of ASF. 6. Wild boar densities are calculated on the total surface area of a county rather than the area of suitable biotype for wild boar (forest and agricultural land) within the county. Consequently, this does not reflect the true density. 7. Trends for national wild boar populations provided by competent authorities demonstrate a year on year increase in the wild boar population (see graph). EVOLUTION OF WILD BOARS POPULATION 2008-2015 8. A spring census of wild boar is performed by the hunters and sent to the Ministry of Water and Forestry representatives at county level. 9. County representatives of the Ministry of Water and Forestry record census results for each individual hunting ground. The audit team reviewed detailed records in one county visited showing actual and optimum wild boar densities (calculated by the Ministry of 4

Water and Forestry) by individual hunting ground and data relating to hunting quotas approved and actually achieved. In all 55 hunting grounds in one county, the actual number of wild boar exceeded the optimal number calculated for the particular biotype. For the period reviewed, 2015 and 2016, wild boar numbers were shown to increase. 10. National legislation (Decision No. 830 of 9 November 2016) approves the national programme for the surveillance, prevention and control of ASF in the country. Article 28 applies to wild boar populations and includes e.g. prohibiting feeding of wild boars and selective hunting of females aimed at achieving a wild boar density of < 0.5 / km². The competent authority confirmed that these measures will only be applied on confirmation of the first case of ASF. 11. Contracts between the Ministry of Water and Forestry and hunting ground managers require the obligatory feeding of a minimum quantity of food over the winter period. The audit team reviewed one contract: it required the feeding of a minimum 60 kg concentrate and 18kg vegetable matter per wild boar per hunting season. The hunting ground manager confirmed that these quantities could be exceeded and the hunters interviewed confirmed that the current practice of feeding wild boar over the winter period is to sustain them and to prevent them damaging agricultural ground. This practice does not take into account the ASF Strategy which recommends a ban on feeding in order to decrease wild boar density. 12. The competent authorities confirmed they had organised media campaigns to raise stakeholder (including hunter) awareness of ASF through television, newspaper and 5

national radio. Hunters met were aware of biosecurity recommendations regarding proper disposal of viscera in the field by e.g. deep burial ( though no official controls were in place to verify this), the requirement to sample all shot wild boar in the eight at risk counties for ASF and to report "found dead" wild boar. Authorities confirmed that found dead wild boar were transported in their entirety to laboratory for sampling and subsequently disposed as animal-by-products. 5.1.2 Biosecurity measures applied on pig holdings Legal requirements Articles 15 of Directive 2002/60/EC; the approved national programme for surveillance of ASF in Romania for 2015 and 2016 2018. Findings 13. The competent authority provided data for the number of holdings on December 2016 and indicated their classification: a) Non-professional holding - holding of animals organized for family use, registered in the National System of Identification and Registration of Animals and owned by private person (a "backyard" holding). Backyard holdings mainly keep fatteners but can also keep sows and piglets which they are allowed to sell b) Commercial holding - holding of animals, owned by approved private person, individual enterprises, family businesses or legal entities organized under the law, registered and approved by the Trade Register, registered in the National System of Identification and Registration of animals, which meets the norms of biosecurity and has sanitary- veterinary approval (commercial type A and industrial commercial holding). Backyard holdings Commercial type A holdings Industrial commercial holdings 583,711 3,101 3,86 14. National legislation requires industrial farms to have certain biosecurity measures in place, e.g. farm is fenced, disinfection of transport vehicles, restricted access for personnel entering production area requiring change of clothing and disinfection of footwear, requirement to clean and disinfect loading / unloading ramp after use and controls on animal-by-products. Two official controls are carried out each year on industrial farms which includes, inter alia, biosecurity standards. 15. The audit team visited three commercial farms. They fulfilled these biosecurity requirements e.g. curtilage fenced to a high standard, restricted access by transport vehicles (feed/live animal), single access point for staff who must sign a disclaimer stating that they do not keep pigs. 6

16. The NSVFSA Service Note of 24 April 2016 advised the County Sanitary Veterinary and Food Safety Authority to raise the awareness of ASF amongst non-commercial pig holdings and to recommend biosecurity measures for such holdings. An information note on biosecurity has been provided for non-commercial farms and competent authority confirmed that biosecurity advice is provided on non-commercial holdings during their annual census visit. The competent authority further confirmed that biosecurity rules on these holdings only becomes compulsory on confirmation of ASF (as outlined in chapter IV of Decision No. 830 of 9 November 2016).These compulsory requirements require type A farms to meet the same standards as industrial farms. For backyard farms, these compulsory requirements include no contact between other domestic pigs and wild boar or any product or by-product from wild boars. 17. To reduce the risk of spread of infection, the NSVFSA Service Note of 13 June 2016 instructed the closure of all 26 registered and approved pig markets in the eight at risk counties. 18. The NSVFSA Service Note of 20 January 2017 requested an update on how the counties enforced the closure of the markets. One county confirmed that markets which had previously sold pigs were multispecies and that it was only the pig part of the enterprise that had been closed. Markets are supervised by concessionary veterinarians who verify that no pigs are sold. The authorities consider that the trade in pigs which had previously occurred in markets now takes place directly between farms. Conclusions on Preventive Measures 19. The existing contracts between the Ministry of Water and Forestry and hunting ground managers are contributing to a year on year increase in the wild boar population with no evidence of arrangements in place between Ministry of Water and Forestry and the NSVFSA to reverse this trend. This increasing population will favour the spread of ASF and create difficulties in its elimination and control should the disease reach Romania. 20. The many backyard holdings (~ 600,000 containing around half the domestic pig population) with rudimentary biosecurity represent the most likely route for the introduction of the disease in the pig population. Backyard holdings with sows are likely to play a role in local spread of infection through the sale of piglets. 21. The likelihood of introduction and spread of infection in industrial farms is lower, due to the biosecurity measures and controls in place. 5.2 EARLY DETECTION Legal requirements Articles 4, 14, 15, and 18 of Directive 2002/60/EC, Commission Decision 2003/422/EC; Articles 4 to 10 and 12 of Regulation (EC) No 882/2004; the approved national programme (based on ASF strategy for Eastern Part of the EU (SANTE/7113/2015-Rev 4) 7

Findings 5.2.1 Training and awareness programmes 22. The audit team observed evidence of training and awareness programmes. One County Sanitary Veterinary and Food Safety Authority had organised ASF training for all free practice veterinarians on two occasions in 2015 and 2016. The same county provided Ministry of Water and Forestry guards and hunting ground managers with training in 2016. 23. The NSVFSA website has separate ASF fact sheets for free practice veterinarians, noncommercial pig keepers, hunters and information for display at Border Inspection Posts and border crossings. 5.2.2 Surveillance in wild boar 24. The current multi-annual programme (2016-2018) for the surveillance and control of ASF requires sampling and laboratory analysis of all wild boar found dead or sick and those killed in road traffic accidents from the entire territory of Romania (passive surveillance). In normal conditions it is expected that the minimum number of wild boar to be found in a given area is ~ 1% of wild boar population at risk. Based on this, the minimum number of wild boar sampled in the eight at risk counties in 2016 should have been ~170 (Total wild boar population was 17021). Additionally, in the eight at risk counties, the programme requires sampling and analysis (by polymerase chain reaction (PCR) and Enzyme-linked immunosorbent assay (ELISA)) for ASF in all hunted wild boar (active surveillance). The competent authority provided numbers of wild boar sampled under active and passive surveillance, in the eight at risk counties: County Active surveillance 2015 2016 Passive surveillance Active surveillance Passive surveillance Botosani 60 0 355 2 Galati 140 21 211 10 Iasi 306 0 414 3 Maramures 551 0 738 12 Satu Mare 580 0 848 3 Suceava 339 0 455 4 Vaslui 55 0 271 2 Tulcea 103 0 128 0 TOTAL 2,134 21 3,420 36 8

Passive surveillance 25. Finding dead wild boars is a challenge due to the large numbers of natural predators, cannibalism by the wild boar themselves and the tendency for dying wild boar to seek secluded areas where it is difficult to find them. Currently, there are no incentives encouraging hunters to overcome this challenge, on the contrary (a) hunters are expected to transport found dead wild boar to the nearest laboratory at their own expense and (b) hunters lose one animal from their hunting bag for each found dead wild boar reported. 26. The competent authority plans to incentivise reporting of found dead wild boar but cannot implement financial incentives until the budget is approved in line with National Decision 1156/2013 which lays down the budget for all animal disease control in Romania. They indicated this would take at least 60 days. 27. The authorities confirmed that the entire carcase of found dead wild boar must be submitted to a regional laboratory. Staff in regional laboratories despatch samples to the Institute for Diagnosis and Animal Health for ASF testing. 28. The audit team reviewed three individual test results from 2016 in Iasi County. The three passive surveillance samples, two of which were road kills, were taken during a very short timeframe (two weeks). 29. In 2015, Romania collected a low number of passive surveillance samples - all from one county. In 2016, the situation improved slightly with most at risk counties submitting samples. The numbers of samples submitted is well below the estimates for meaningful passive surveillance and early detection of disease. Active surveillance 30. Contracts between Ministry of Water and Forestry and hunting ground managers require hunters to be trained in sampling, packaging and despatch of ASF samples to regional laboratories. 31. The audit team visited two collection centres and observed identification of carcases with a unique identification number linking carcase to sampling and test result documentation, as required in national legislation. In one chiller, internal organs were held along with carcases which demonstrated good control of animal by-products. 32. Carcases are released on receipt of negative PCR test results. 33. The competent authority has biosecurity guidance for hunters which includes guidance on sampling. Hunters met were familiar with this guidance. 34. The authorities in Satu Mare County confirmed that at the end of the hunting season they correlate the number of shot wild boar to the number of samples taken. 9

5.2.3 Surveillance in pig holdings 35. The current multi-annual programme requires sampling and laboratory analysis of domestic pigs found sick or dead, from non-commercial holdings across the entire territory of Romania, where classical and ASF could not be ruled out (passive surveillance). This surveillance does not apply to commercial holdings. 36. There is currently no active surveillance in domestic pigs (i.e. screening of healthy animals for antibodies). 37. In two industrial commercial farms visited by the audit team, the private veterinarians providing a service had both submitted in 2016, pig carcases to regional laboratories for post mortem examination. In both cases the veterinarian had requested classical swine fever testing but not ASF testing. The authorities confirmed that samples submitted for classical swine fever testing were paid by the authorities but ASF analysis in commercial industrial farms had to be paid by farmer. In contrast, backyard holdings do not have to pay for ASF testing. 38. The competent authority confirmed there had been no official suspicion of ASF during 2015 and 2016. In one region visited, the decision to submit samples to NRL for ASF testing was taken by regional laboratory staff which contributed to passive surveillance in the region. 39. The competent authority provided results of passive surveillance in domestic pigs: County 2015 2016 Botosani 0 58 Galati 14 140 Iasi 23 24 Maramures 40 74 Satu Mare 0 103 Suceava 22 126 Vaslui 20 43 Tulcea 33 62 Total 152 630 40. Data provided by the competent authority confirmed that in the first six months of 2016, 117 domestic pigs were sampled in counties other than the eight at risk counties. In 2015, there was no requirement to sample outside the eight at risk counties. 41. The number of passive surveillance samples taken has increased between 2015 and 2016. In the counties visited, the audit team confirmed that the majority of these samples were from non-commercial holdings. 10

42. The competent authority confirmed that currently, there is no ante mortem or post mortem examination of pigs slaughtered for own, home consumption. 5.2.5 Laboratory testing 43. The Institute for Diagnosis and Animal Health is Romania's National reference Laboratory (NRL) for ASF. ASF tests for passive surveillance (wild boar and domestic pigs) are currently only performed in the NRL. OIE-real time PCR 2 is used for virus detection on all samples submitted for passive surveillance from across the territory of Romania. Additionally, the NRL exclusively perform ASF antibody detection on all samples submitted for active surveillance from all hunted wild boar in the eight at risk counties using an ELISA. 44. The results of the 2015 and 2016 Annual Inter-laboratory Comparison tests for ASF provided by EU Reference laboratory confirmed that the assay systems used by the NRL for detection of antibodies to ASF and detection of ASF virus in field samples are "fit for purpose." 45. A Community Veterinary Emergency Team (CVET) visited Romania in January 2016 and made a comprehensive assessment of the NRL capabilities for diagnosing ASF. The authorities advised that in response to CVET recommendation, they plan to introduce UPL- real time PCR 3 in 2017. 46. The NRL has established a framework agreement for supply of consumables, as recommended by CVET, which allows additional reagents to be purchased at short notice. They confirmed their current ASF diagnostic capacity as 200 PCR tests per week and 500 600 ELISA tests per day and indicated that, within a few days, this capacity could be increased by a factor of two-three times by reorganization of activity. 47. The NRL continue to develop an ASF diagnostic laboratory network at national level. OIE-real time PCR for active surveillance in wild boar, is currently performed in certain regional laboratories. Suceava and Satu Mare have the test accredited while Iasi, Braila and Tulcea have the method validated and have started the procedure for accreditation (notwithstanding, testing has already started). Laboratories in Arad, Prahova, Hunedoara and Maramures have been nominated to implement OIE-real time PCR but field samples are not currently tested in these sites. 48. The competent authorities provided documentation for the rejection of samples submitted to the NRL in 2016. A small number of samples were rejected mainly related to the submission of active surveillance samples from wild boar from counties not included in the eight at risk counties. 49. Only domestic pigs from non-commercial holdings, submitted to regional laboratories for classical swine fever passive surveillance, are routinely tested for ASF. When at 2 King et al, 2003 3 Fernandez-Pinero et al, 2013 11

regional level, a sample tests negative to classical swine fever, the samples are then sent to the NRL for ASF testing. The audit team reviewed laboratory reports in Iasi. The interval between initial submission of samples to the laboratory network and reporting of results was up to one month despite haemorrhagic lesions being identified at postmortem examination in regional laboratory. This does not meet the objectives of the approved programme for early detection of ASF. 50. The audit team reviewed the 2017 laboratory reports in Satu Mare for passive surveillance in domestic pigs. They showed delays in submission of samples from the regional laboratory to the NRL of up to two weeks. Results of ASF testing were available on the laboratory information management system within two days of receipt by the NRL, but it took another ten days before regional staff became aware of these results. 51. The competent authority issued a Service Note on 01/02/17 to remind SVFSA Directors that laboratory results are available on the laboratory information system. Conclusions on Early Detection 52. The current surveillance programme on wild boars, in particular the poor passive surveillance, does not provide confidence that ASF would be detected at an early stage following introduction. This will delay the detection of the disease and thus the implementation of control measures, increasing the risk for further spread into domestic pigs, particularly into backyard holdings. 53. The current system for reaching dead wild boars for testing is very inefficient for that, as it lacks incentives and poses burdens on hunters (by requiring them to deliver carcasses to the laboratory at their own cost and by reducing the hunting bag by the number of dead wild boars delivered to the laboratory). 54. Should the disease enter the domestic pig population, passive surveillance is more likely to detect it early in backyard holdings, while in commercial holdings, detection will be probably delayed due to the absence of passive surveillance. The existing long laboratory turnaround times hamper early detection and if they persist once the disease is detected, these will create difficulties in the containment of disease. 5.3 EMERGENCY PREPAREDNESS FOR ASF Legal requirements Articles 4, 5, 8, 21, 22, Annex VI of Dir. 2002/60, Dec. 2003/422, Dir.92/119 12

Findings 5.3.1 National plan and operations manual 55. The competent authority has a contingency plan for ASF (Edition IIIa, February 2016) as required by Article 21 of Directive 2002/60/EC and an instruction manual for ASF (version 2016) as required by Annex VI(e) of Directive 2002/60/EC. Both are available on NSVFSA website. 56. A chain of command has been set up as required by Annex VI(c) of Directive 2002/60/EC and is outlined in the Contingency Plan. The national disease control centre is led by the Minister of Interior and Administrative Reform who delegates the President of NSVFSA (the Chief Veterinary Officer) to implement the contingency plan and control the outbreak. At county level, the local disease control centre is led by the Prefect (who is the Ministry of Interior and Administrative representative). At local level, it is the Director of the County Veterinary Authority who proposes actions for disease control to the Prefect. 57. In one county visited, the instruction manual contained lists of personnel assigned to specific tasks. Certain practical aspects were missing e.g. the need to calculate killing rates or explanation of killing methods available. In one county office visited, staff were unsighted on using carbon dioxide and a sealed container as an option for killing piglets and were unaware of a central instruction issued in 2015 describing carbon dioxide as a possible killing method. 58. Romania keeps an up to date list of all pig holdings (including all backyard holdings) in its territory as required by Article 3 (1)(a) to Council Directive 2008/71/EC. 59. Competent authorities confirmed that the national database for animals, SNIIA, does not contain a complete record of geographic co-ordinates for all registered pig holdings as required by Article 1 (1)(d) to Commission Decision 2000/678/EC. 60. The database does not have a field where the competent authority could enter sanitary information, which is not in line with Article 1(e) to Commission Decision 2000/678/EC. Consequently, the database cannot be used for implementation and verification of ASF movement restrictions. 61. The establishment of protection and surveillance zones requires liaison between County and National veterinary authorities. If an outbreak is confirmed, the County veterinary authority send holding co-ordinates to the NSVFSA who provide a list of localities within the protection and surveillance zones. Localities are sub-divisions of circumscription areas and concessionary veterinarians are responsible for holdings within one or more circumscription areas. For each locality, the County veterinary authority have details on the industrial commercial, commercial type A and backyard pig holdings within the locality. If a locality is divided by the protection / surveillance zone determined by central competent authority, it is up to the County services to determine which holdings fall within the protection / surveillance zone. 13

62. In addition to approved rendering establishments, authorities have a contract with a commercial company to provide four mobile incinerators for carcase disposal. Rendering capacity has previously been identified by the central authority and the CVET as a limiting factor where depopulation is required on a farm with >10 000 pigs. The competent authority confirmed that situation remains the same. 63. There are no predetermined burial sites for disposal of carcases; the competent authorities confirmed these sites would be developed on a needs basis in consultation with the local prefecture when the moment arises. This is not in accordance with Annex IV(6) of Directive 92/119/EEC. 64. In non-professional and commercial type A holdings, pigs are identified by applying an ear tag printed with a unique identification number, which goes beyond EU legal requirements. These are applied by circumscription veterinarians who are responsible for updating the national database. Pigs from industrial commercial holdings are identified with a mark allocated to the farm and applied as a tattoo or printed on a plastic ear tag as required by Article 5(2) of Directive 2008/71/EC. 65. Circumscription veterinarians are responsible for issuing health certificates for the movement of all pigs within the country, which goes beyond EU requirements. If pigs are moved between counties, competent authorities advised consigning and consignee to contact County veterinary offices to seek approval for the movement. 66. None of the four backyard or commercial type A holdings visited by the audit team had an up-to-date register of movements, which is not in line with Article 4(1) of Directive 2008/71/EC this issue was previously identified in DG(SANCO)2014-7045. In contrast, the two industrial commercial farms visited had comprehensive records available showing e.g. movements, daily mortalities and the number and weight of dead pigs sent for rendering. 67. Circumscription veterinarians perform an annual census on all holdings which includes pigs. If the database has pigs recorded as being present on a holding but the animals are not in the farm when the annual census is done, the circumscription veterinarian moves these animals to a virtual holding named RO0000000000. The authorities confirmed that in 2016, the number of pigs that moved into virtual holding was 1,302,501. 5.3.3 Simulation exercises 68. The most recent simulation exercise was held in 2014 and prior to that, 2013.In 2014, participants included all County veterinary offices, the NRL, local Prefect and central competent authority's representatives. The objectives for simulation included collection, packaging and despatch of samples and epidemiological investigation. 14

Conclusions on emergency preparedness 69. The competent authority seems ready to deal with outbreaks on backyard holdings and small commercial holdings - which are the majority. However, for large industrial commercial holdings the limited killing and disposal capabilities will delay depopulation. 70. Although identification and movement controls for pigs go generally beyond EU legal requirements, the absence of records such as holding registers, geographic co-ordinates and field for sanitary information together with the large numbers of backyard pigs moving to a "virtual holding" (i.e. with an unknown destination) will significantly weaken the tracing of pigs and containment of disease in an outbreak scenario. 5.4 VERIFICATION, SUPERVISION AND EXPERT GROUP Legal requirements Articles 4 and 8 of Regulation No 882/2004; Directive 2002/60/EC (Articles 15, 16 and 22, Annex VI) Findings 5.4.1. Supervision by line management 71. The competent authority presented data on wild boar for the 2015 2016 hunting season for classical swine fever surveillance purposes. The authority advised that the previous data available was for the 2013 2014 hunting season. The data included, for each county, inter alia, number of hunting grounds, their total area, area of forest, hunting bag and an analysis of classical swine fever tests performed by age group of wild boar. Equivalent data was not available for ASF. 72. Official veterinarians check commercial industrial farms twice a year to verify, inter alia, compliance with legal requirements for biosecurity, pig identification, medicines use and animal-by-products controls. They use a standardised checklist for this purpose. 5.4.2. Internal audits 73. During September / October 2016 the NSVFSA Audit Directorate performed a series of audits in the eight at risk counties to evaluate the measures in place for surveillance and emergency preparedness for ASF. The reports reviewed by the audit team were comprehensive and identified areas of weakness e.g. delays in reporting laboratory results and lack of pre-determined burial sites following de-population. The reports included an action plan with recommendations and proposed follow up action by the County veterinary services. 15

5.4.3. Evaluation(s) by the expert group 74. The competent authority confirmed they had a scientific group established and could convene an ad hoc advisory council when required. Membership of the former included academia and Ministry of Water and Forestry representatives while the latter would include processors and traders. Conclusions on Verification, Supervision and Expert Group 75. The existing review mechanisms in place, if correctly followed-up, will enhance measures in place for surveillance and emergency preparedness for ASF e.g. recommendations of NSVFSA Audit Directorate. 6 OVERALL CONCLUSIONS Romania does not yet apply many actions aimed to prevent ASF, e.g. wild boar population management and biosecurity in backyard holdings, and they will only apply them on confirmation of disease, with a consequential delay in results. Although hunters are aware of ASF, the poor passive surveillance programme on wild boars does not provide confidence that ASF would be detected at an early stage following introduction. This will delay the detection of the disease and thus the implementation of control measures, increasing the risk for further spread into domestic pigs, particularly into backyard holdings. The many backyard holdings with low level of biosecurity represent the most vulnerable point for the introduction of infection in domestic pigs. In particular, backyard holdings with sows are likely to play a role in spreading the infection locally. Should the disease enter into backyard farms, the existing passive surveillance performed on them will probably detect the disease promptly in this sector. The authorities will face a challenge in tracing pigs and containing the disease in an outbreak scenario due to the absence of records on these backyard farms and the existence of unrecorded movements (e.g. piglets). The good biosecurity measures and the controls in place at commercial farms reduce the likelihood of introduction and spread of infection in these. However, continued delays in laboratory turnaround time and lack of passive surveillance in industrial commercial holdings would likely delay early detection in domestic pigs and increase the risk of spread of infection in this sector. The competent authorities seem prepared to deal with outbreaks on backyard or small commercial holdings - which are the majority. For industrial commercial holdings, they will face problems in quickly depopulating them, due to their limited killing and disposal capabilities. 16

7 CLOSING MEETING A closing meeting was held with the central competent authority on 2 February 2017 when the audit team presented the main findings and preliminary conclusions of the audit to the competent authority. During this meeting the competent authority provided certain clarifications and did not indicate any major disagreement with the findings and preliminary conclusions. 8 RECOMMENDATIONS No. Recommendation 1. To immediately start testing samples of dead pigs from industrial commercial pig holdings for ASF (which are submitted to laboratory under passive surveillance for classical swine fever) to ensure that passive surveillance covers the entire domestic pig population and meets the objectives of the approved programme i.e. monitoring and early detection of the presence of ASF virus in the susceptible population of domestic pigs. Approved programme for ASF (2016 2018). Recommendation based on conclusion No. 54. Associated finding Nos. 35, 37, 39 and 41. 2. Practical arrangements should be put in place to increase the number of dead wild boar reported in the eight at risk counties in order to meet the objectives of the approved programme i.e. monitoring and early detection of the presence of ASF virus in the susceptible population of wild boars. Approved programme for ASF (2016 2018). Recommendation based on conclusion No. 52. Associated finding Nos. 24, 25, 26, and 29. 3. The turnaround time for submitting, testing and reporting laboratory results for samples submitted under passive surveillance for ASF should be shortened to meet the objectives of the approved programme for early detection of ASF virus. This should include a mechanism for prioritising samples where ASF cannot be ruled out. Approved programme for ASF (2016 2018). Recommendation based on conclusion No. 54. Associated finding Nos. 49 and 50. 17

4. To enforce the requirement for an up-to-date register of movements (including the date, the origin or the destination, and the identification marks) to strengthen traceability in backyard and type A holdings. Article 4(1) of Directive 2008/71/EC; Articles 54 and 55 of Regulation (EC) No. 882/2004. Recommendation based on conclusion No. 70. Associated finding Nos. 66 and 67. 5. Collaboration between NSVFSA and the Ministry of Water & Forestry should be strengthened at central and county level to ensure wild boar populations are managed to reach (and maintain) a low wild boar density through e.g. implementation of a total feed ban and targeted hunting of females. SANTE/7113/2015-Rev 4 ASF Strategy for Eastern Part of the EU. Recommendation based on conclusion No. 19. Associated finding Nos. 5, 6, 7, 9 and 10. 6. Ensure that the national database for animals, SNIIA, contains all required information including the geographic co-ordinates of all registered pig holdings and a field where sanitary information can be recorded. Article 1 (1)(d) and 1(1)(e) to Commission Decision 2000/678/EC. Recommendation based on conclusion No. 70. Associated finding Nos. 59 and 60. 7. Ensure that, in cooperation with County Prefect, competent authorities have plans in place for the disposal of animals following depopulation when rendering is not an option. Annex IV(6) of Directive 92/119/EEC. Recommendation based on conclusion No. 69. Associated finding Nos. 62 and 63. The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2017-6118 18

ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 882/2004 - Article 45 (MS) OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 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 Dir. 64/432/EEC OJ 121, 29.7.1964, p. 1977-2012 Dir. 2008/71/EC OJ L 213, 8.8.2008, p. 31-36 Reg. 652/2014 OJ L 189, 27.06.2014, p. 1-32 Dec. 2000/678/EC OJ L 281, 7.11.2000, p. 16-17 Dec. 2003/422/EC OJ L 143, 11.6.2003, p. 35-49 Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-community trade in bovine animals and swine Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs (Codified version) Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC 2000/678/EC: Commission Decision of 23 October 2000 laying down detailed rules for registration of holdings in national databases for porcine animals as foreseen by Council Directive 64/432/EEC 2003/422/EC: Commission Decision of 26 May 2003 approving an African swine fever diagnostic manual

Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3 Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22 Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83 Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30 Dir. 2002/60/EC OJ L 192, 20.7.2002, p. 27-46 Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Dir. 92/119/EEC OJ L 62, 15.3.1993, p. 69-85 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs 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 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 Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever 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 Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease