Competent Authority response to the report recommendations received on 24 August 2016 ANNEX N Recommendation Action Proposed by the Competent Authority 1 Ensure that the database for porcine animals contains on each holding a data field to enter sanitary information (for example restrictions on movements, status or other relevant information in the context of EU or national programmes) as required by Article 1(e) of Commission Decision 2000/678/EC. Based on conclusion (41), and associated finding (22). VFSD has launched a project of integration of e-inspektor application, used by veterinary inspection as a document management system and Central farm register (which includes database for porcine animals) which will ensure all the movement restriction, as well as other relevant information is visible in the database of porcine animals as required by Article 1(e) of Commission Decision 2000/678/EC. Integration is planned to be fully operational by the January 2017. 2 Ensure that pigs can be traced back to the holding from which they came as required by Article 5(2) of Directive 2008/71/EC (i.e. they are marked with either an ear tag or tattoo making it possible to determine the holding from which they came). Based on conclusion (41), and associated finding (25). According to Article 5 of Directive 2008/71/EC, there are 3 general principles member states should ensure to be respected regarding the identification of pigs: (a) identification marks must be applied before animals leave the holding of birth; RoC ensured this principle is respected by stipulation of Article 12, paragraph 1 of the Ordinance on mandatory identification and registration of pigs (OG 51/2007): Pigs must be identified as soon as possible and in any case, before they are dispatched from the holding. Implementation of this principle is confirmed by the FVO audit as defined in finding 24. (b) no mark may be removed or replaced without the permission of the competent authority. RoC ensured this principle is respected by stipulation of Article 12, paragraph 10 of the Ordinance on mandatory identification and registration of pigs (OG 51/2007): None of the eartagg may be replaced or removed in contrary to the provisions of the Ordinance. The implementation of this stipulation is regularly checked by the official veterinarian and there was no evidence in FVO report this principle was disrespected. Date: 24 August 2016 Page: 1
Where a mark has become illegible or has been lost, a new mark shall be applied in accordance with this Article; (c) the keeper shall record any new mark in the register referred to in Article 4 in order to establish a link with the previous mark applied to the animal. RoC ensured this principle is respected by stipulation of Article 12, paragraph 8 of the Ordinance on mandatory identification and registration of pigs (OG 51/2007): When an eartagg or tattoo number has been lost or become not readable, pig shall be identified with the new eartagg with number of the holding where it s been noticed. and paragraph 9 of the same Article Keeper shall record retagging in on-the-farm register in a way to make connection with the number of previous holding visible. Regarding requirements of Article 5(2) of Directive 2008/71/EC, there is clear provision in the Ordinance on mandatory identification and registration of pigs (OG 51/2007) saying: Pigs must be identified as soon as possible and in any case, before they are dispatched from the holding None of the animals can leave the holding if it s not identified. Each consignment of animals is accompanied by a movement documents (and animal health certificate) in which all the eartaggs or tattoo numbers are mentioned and id number of holding from which they came as well. This is recorded in porcine database and in the register on the farm. In this way, it is possible to determine the holding from which pigs came and reference is enabled to both accompanying documents which mention such eartag or tattoo and to the list referred to in Article 3(1)(a). Therefore, movement of pigs is registered in database in such a way that the original or transit holding, centre or organisation can be traced. Date: 24 August 2016 Page: 2
3 Ensure that holdings with one single pig are registered as required under EU legislation (Article 3(1)(a) Directive 2008/71/EC). Based on conclusion (42), and associated finding (21). During the pre-accession period EC has implemented new methodology to ensure Croatia as a candidate country will be adequately prepared to join the EU. This new methodology included so-called benchmarks certain specific requirements which candidate country need to fulfil to open specific chapter. In the Chapter 12 Food safety, veterinary and phytosanitary policy, there were 4 benchmarks and one of those 4 was related to animal identification and registration: Croatia starts the implementation of an adequate system for identification and registration of pigs, caprine and ovine animals and demonstrates that appropriate measures have been taken in view to set up a compliant system for identification and registration of bovines and their movements. RoC invested a lot of financial, technical and human resources to fulfil this benchmark, which, in regards to porcine animals, meant to develop EU compliant legislative framework, to develop the database, procedures and forms, to provide trainings and to start registration of all farms. EC has verified fulfilment of this benchmark by reviewing the legislative framework and undertaking the peer review mission. Finally, by issuing document Opening benchmark assessment (MD 163/08) EC acknowledged Croatia met requirements: Croatia has adopted a range of implementing regulations in 2007 providing the legal basis for the establishment of a system for identification and registration of bovines, pigs, caprine and ovine animals in line with the relevant EU legislation. Concerning pigs, ovine and caprine animals implementation activities have started such as the entering of pig farms in the Farm Register (Aug. 2007), identification of pigs by tattoo (Nov. 2007), the use of new ear tags and record of first movements of pigs (Dec. 2007) Date: 24 August 2016 Page: 3
( Opening benchmark assessment (MD 163/08), page 5, in the attachment) The rule to exempt holdings with one pig was a part of that legislative framework (Ordinance on mandatory identification and registration of pigs (OG 51/2007)). Furthermore, in order to close the Chapter 12, Croatia had been constantly monitored by the EC with particular focus on the areas and issues highlighted in the EU Common Position(s) and one of those was: Achieve full compliance with the acquis and ensure its effective implementation regarding the identification and registration of animals. Again, it took a lot of administrative capacities and financial resources to achieve this goal which finally was acknowledged by EC by this stipulation: Commitment sufficiently met. Croatia has transposed the acquis in this area and effectively implements the acquis in this area, with the exception of Registration and issuing of passports for all horses which is in progress. (Monitoring table in the attachment, page 7) Following this assessment, Croatia considered the system for identification and registration of porcine animals fully compliant with the EU Acquis. On top of all the above mentioned, all the movements of one pig to those holdings (having not more than that one pig) are recorded in the database with the id number of the holding of departure, name of the new owner, his personal identification number, address, date of movement and movement document number, so Date: 24 August 2016 Page: 4
all those data can be listed in the porcine database and all of those movements are recorded in the register on the farm as well.. 4 Improve implementation of active surveillance in domestic pigs and wild boars by underperforming counties in order to achieve targets set out in the programme. Grant Decision Number SANTE/ 2016/HR/SI2.726011 (programme for 2016). Based on conclusions (77) and (102) and associated findings (48), (51), (86-88) and (91-93). 5 Improve robustness of surveillance in small-scale pig holdings in order to provide for early CSF warning in all segments of the pig population. Grant Decision Number SANTE/ 2016/HR/SI2.726011 (programme for 2016). Based on conclusion (77), and associated findings (59) and (60). In order to improve implementation of active surveillance in domestic pigs and wild boars in June 2016., 5 workshop were held across the country which were designated for veterinarians and veterinary inspectors. In total 393 people attended the workshops. In these workshops focus was on results of implementation on CSF programs. In addition, inspections will make an action plan, particularly for the control of the implementation of the CSF programs on the field. Components of surveillance program already include all type of holdings including the holding with one pig. In order to arise awareness among veterinarians and veterinary inspectors 5 workshop were held in June 2016, in total 393 people attended the workshops. According to the Aujeszky s disease (AD) control and eradication program, in 2015 were included small farms with 1-10 sows on territory of Karlovac, Sisak-Moslavina, Brod- Posavina and Vukovar-Srijem County. During visiting the farms authorised veterinarians and veterinary inspectors are obliged to follow regulation laid down in the Veterinary Act (OG8272013, 148/2013) as follows: Article 19 (1) Suspicion of an infectious or parasitic disease shall be considered to exist when in a herd, flock, yard, holding, or other location and premises where animals are temporarily or permanently held, the clinical characteristics of the disease, the epidemiologic circumstances or the course of laboratory tests indicate the occurrence of an infectious or parasitic disease, or when an animal dies suddenly without apparent cause, or when two or more cases of disease or death exhibiting equal or similar signs justify the suspicion of an infectious or parasitic disease. (2) Every veterinary worker shall report the existence of a Date: 24 August 2016 Page: 5
suspicion of an infectious or parasitic animal disease upon discovery to an authorised veterinary organisation or competent veterinary office. (3) An authorised veterinarian who suspects an infectious or parasitic disease has occurred shall set appropriate animal health protection measures for the holder until further measures are prescribed by the veterinary inspector. (4) Every veterinary worker shall undertake all necessary measures to ensure that his own actions do not influence the spreading of the causative agent. (5) The measures set in accordance with paragraph 3 of this Article shall be binding for the animal holder. Article 20 (1) Following the order of a veterinary inspector, veterinary organisations or veterinary practices shall: 1. establish whether a suspicion of an infectious or parasitic disease exists; 2. immediately implement appropriate measures to prevent the spreading of the infectious or parasitic disease, and the animal holder shall immediately implement such measures; 3. in the event of suspicion of an infectious or parasitic disease, appropriate diagnostic material shall be collected and delivered for examination to an official laboratory. (2) The costs of the implementation of measures referred to in paragraph 1 of this Article and the costs of laboratory tests shall be financed from the special item of the state budget for financing animal health protection measures. According to the AD program, in the case of detecting infected AD farms, competent veterinary inspector must perform an on farm check which must include a detail epidemiological investigation. In a case of suspicion of CSF, authorised veterinarian and veterinary inspector are obliged to follow procedure laid down in Date: 24 August 2016 Page: 6
6 Improve early warning system in wild boars by increasing the number of laboratory analysis carried out on wild boars found dead and road killed, in particular by raising awareness of the hunters and other relevant stakeholders on the need to report any feral pig found dead (including road kill). Any incentive should be coupled with an adequate information campaign. Grant Decision Number SANTE/ 2016/HR/SI2.726011 (programme for 2016). Based on conclusion (103), and associated finding (100). 7 Ensure that all confirmation virological tests used for CSF are within the scope of ISO 17025 accreditation. Article 12(2)(a) of Regulation (EC) No 882/2004. Based on conclusion (111), and associated finding (105). legislation for CSF and in Program for current year. In AD program for 2016, Class: 322-01/15-01/1084, Ref.No 525-10/0244-16-1 additional emphasis is placed for exclusion and suspicion for classical swine fever whenever it is required. In order to improve early warning system in Croatia for CSF, existing program is supplemented with the activity of active monitoring of dead domestic pigs that come from farms with less than 10 pigs in CSF program for 2016. is added Class: 322-01/15-01/1083, Ref.No:525-10/0244-16-3. In total 300 samples will be tested. Please see in attachment. Dopuna programa KSK_ testiranje uginulih domaćih svinja na KSK.pdfdopis_Dopuna programa KSK_testiranje uginulih domaćih svinja.pdf Communication to hunters will be intensified in order to keep them aware of their obligation to report to CA any wild boar found dead as well as the procedure to be followed in that case. Additionally information will be provided to the public including farmers. Written instructions on how to proceed with wild pigs found dead will again be submitted to all holders of hunting rights and additionally to the public. Communication with the competent authority for hunting is already more intensified in this regard. The National Reference Laboratory for CSF successfully participates in the inter-laboratory comparison testing (ILCT) organized by the EURL for CSF in Hannover since 1999. From the beginning of the recognition of NRL by the Ministry of Agriculture, the mission of the Laboratory was to update and implement all OIE recognized and recommended methods for CSF diagnosis. The Laboratory is accredited according to ISO 17025 from 2007 within the field of CSF diagnostics with two methods: enzyme linked immunosorbent assay (ELISA) for the detection of antibodies for CSF virus (SOP-Z-III-1-03, Rev 06 (2012.), OIE Manual of diagnostics tests and vaccines for terrestrial animals. Date: 24 August 2016 Page: 7
7th ed., 2012. Chapter 2.8.3. Classical swine fever) and ELISA for the detection of CSF virus antigens (SOP-Z-III-1-04, Rev 05 (2013.), OIE Manual of diagnostics tests and vaccines for terrestrial animals. 7th ed., 2012. Chapter 2.8.3. Classical swine fever) in whole blood, sera or tissue of swine. Apart from the accredited methods the Laboratory successfully participates in ILCT with these methods: Antibody ELISA (two protocols); Antigen ELISA; RT-PCR for the detection of pestiviruses; Three quantitative real time RT-PCR protocols; Virus isolation on SK-6 cell culture; VNT (using Alfort 187 and PK-15 cell culture); VNT (using genotype 2.3. and PK-15 cell culture); Immunofluorescent test; Antigen ELISA for BVDV Antibody ELISA for BVDV Sequence analyses (if appropriate). According to the trend (from 2010-2015) and sample collection as well as a result of validation and optimization of virological methods, NRL has started the process of accrediting a real time Syber Green PCR protocol (Viček et al., 1994) recognized and recommended by the EURL and used within the monitoring program for wild boar samples. We suppose that the accreditation will be finalized until mid 2017. This would be the second virological method to be accredited. All documents in regards to the protocols are registered and evidenced, as well as the maintenance of instruments used within the protocols. The work of the NRL is annually tested by ILCT, however, additional annual controls are made by the Internal Control System (ICS) recommended by ISO 17025 (internal experts annually control the process of testing); by ''blind probes'' that are given within routine work to control the technicians; by the Date: 24 August 2016 Page: 8
Croatian Accreditation Agency (CAA) and by visits of the Inspection Sector of the Ministry of Agriculture. The last ICS was made 30 of October 2015. No non-compliances were found. The last control made by CAA was done the 5th of June 2016. No non-compliances were found. The last visit and inspection done by the Ministry of Agriculture was done 06th of April 2016. No non-compliances were found. The NRL has three Ph.D. experts, two veterinarians and one molecular biologist, and two technical workers. All experts were educated for the diagnosis of CSF in EURL for CSF and other similar institutes. The Head of the NRL has a Master degree and PhD thesis with the topic of CSF that has been conducted in the EURL under the supervision of Dr. Irene Greiser Wilke. Date: 24 August 2016 Page: 9