EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2017) /05/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN ROMANIA ON 22 NOVEMBER 2016 IN ORDER TO EVALUATE THE UPGRADED FACILITIES OF THE INSPECTION CENTRE IC 2 IN THE BORDER INSPECTION POST AT HENRI COANDĂ BUCHAREST AIRPORT (FACILITIES FOR LIVE ANIMALS)

2 Executive Summary The report describes the outcome of an audit carried out by DG Health and Food Safety in Romania on 22 November 2016 in order to evaluate the suitability and readiness of the facilities proposed for the border inspection post (BIP) (inspection centre IC 2) at Henri Coandă Bucharest Airport. The competent authority applied for listing of the BIP (IC 2) for categories: registered equidae (E) and all species under the category other animals (O). Official veterinarians at the BIP have undergone training and demonstrated good knowledge of legislative requirements for the import of live animals. There is good cooperation between BIP staff and Customs supported by mutual access to the BIP database (TRACES) and Customs database (RCDPS) to ensure that all consignments of live animals from non-european Union (EU) countries will be subject to veterinary checks. Not all work instructions and procedures are yet in place, and some that have been finalised are insufficient. In particular, the competent authority has not documented how to address sampling to check compliance with the health requirements of the veterinary certificates, and there were no planned arrangements for handling of animals in cases where quarantine is required. This could affect the organisation of controls to be carried out at the BIP. At the time of the audit, the facilities had been renovated and were ready to use. Some shortcomings in the construction of the gates in the loading and unloading area for registered equidae (E) were noted. On the basis of the number of available rooms for other animals (O), the audit concluded that the BIP could accommodate cats, dogs, birds, aquaculture/fish, reptiles and amphibians, although non-compliances were noted in relation to the availability of appropriate cages for cats and dogs and vivariums. In view of the shortcomings identified, the report concludes that the lifting of the suspension of this BIP for categories E and O is premature. The report contains recommendations addressed to the Romanian competent authority, aimed at rectifying the shortcomings and/or further enhancing the official control system. I

3 Table of Contents 1 Introduction Objectives and scope Legal Basis Background Findings and Conclusions Organisation of the future controls BIP facilities and equipment Overall conclusions Closing meeting Recommendations...6 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ABP Approval categories BIP BTSF Customs EU IC IDAH NSVFSA RCDPS TRACES Explanation Animal by-products Categories of live animals for the receipt of which BIPs are approved in accordance with Commission Decision 2009/821/EC, as follows: E: registered equidae O: other animals (including zoo animals), (14): a limited number of species are permitted, as defined by the competent national authority. Border inspection post Better training for safer food National Customs authority European Union Inspection centre Institute for Diagnosis and Animal Health National Sanitary Veterinary and Food Safety Authority Romanian Customs Declaration Processing System Trade control and expert system III

5 1 INTRODUCTION This audit took place in Romania on 22 November 2016 and was carried out by one auditor from DG Health and Food Safety. The audit was performed at the request of the National Sanitary Veterinary and Food Safety Authority (NSVFSA) as an addition to the DG Health and Food Safety planned audit programme. During the audit, the auditor was accompanied by representatives from the NSVFSA. An opening meeting was held with the representatives from the central competent authorities, the border inspection post (BIP) and Customs. At this meeting, the auditor confirmed the objectives and the scope of the audit and gathered additional information required for the satisfactory completion of the audit. 2 OBJECTIVES AND SCOPE The objective of the audit was to assess the suitability and readiness of the facilities for live animals at the BIP at the Airport Bucharest Henri Coandă (inspection centre - IC 2), proposed by the NSVFSA, with the aim to provide a recommendation with respect to its listing in Commission Decision 2009/821/EC. The audit scope covered the facilities and equipment and the planned implementation of the import control system at the proposed BIP with respect to the requested approval. 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation and, in particular: 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 6(4) Council Directive 91/496/EEC; Article 4 of Commission Decision 2009/821/EC. A full list of the legal instruments referred to in this report is provided in Annex I and refers, where applicable, to the last amended version. 4 BACKGROUND The inspection centre (IC 2) at the BIP of Bucharest Henri Coandă Airport was approved for category E (registered equidae) and category O (other animals) in The competent authority temporarily suspended its approval in 2012 due to a flood and serious damage to the building and equipment. Accordingly, with Commission Implementing Decision 2012/197/EU, Annex I to Decision 2009/821 was amended. The IC 2 was visited during the audit DG(SANCO) where the structural damage was confirmed. The report is available at the following link: 1

6 The audit was performed at the request of the central competent authority with the objective of lifting the suspension of the inspection centre IC 2 at the BIP Henri Coandă Bucharest Airport for live animals, categories E and O. 5 FINDINGS AND CONCLUSIONS 5.1 ORGANISATION OF THE FUTURE CONTROLS Legal requirements Articles 4 and 6 of Regulation (EC) No 882/2004. Articles 3, 6, and 10 of, and Annex A to Directive 91/496/EEC. Articles 1, 3 and 5 of Commission Regulation (EC) No 282/2004. Annex II to Commission Decision 97/794/EC. Findings 1. The BIP (IC 2) is located within the Customs designated area of the point of entry into the EU, in accordance with the requirements laid down by Article 6(2)(a) and (b) of Directive 91/496/EEC. The facilities belong to NSVFSA. 2. A Protocol on the collaboration between the BIP and local Customs authority was signed in 2006 which stipulates that the BIP staff receive cargo manifests for imported goods and mutual access is ensured between the database of the BIP (TRACES) and Customs database (RCDPS), which is in line with Article 5 of Regulation (EC) No 282/ The competent authority informed the airport companies to bring products for inspection to the BIP in a letter, but live animals are not included in the text despite the fact that the checks of commercial movements of animals will be performed at the inspection centre. A phone number is available on the airport website for assistance, and when the questions concern animals, passengers are redirected to the BIP where the staff are on duty 24/7. 4. The BIP (IC 2) will be under the responsibility of NSVFSA and the staff on the spot carrying out official controls will comprise four full-time official veterinarians. Specific procedures (last updated in 2016) for performing the official controls are in place. The staff have undergone training for implementing the legislation, organised by NSVFSA which complies with the requirements of Article 6 of Regulation (EC) No 882/2004. Inspectors from the BIP participated in two training courses for import controls under the Better Training for Safer Food (BTSF) initiative (Vienna and Malaga) and afterwards organised internal training for the staff, and published the documents from the BTSF on the Intranet. Staff training is very well documented. 2

7 5. TRACES had been used at the BIP before its suspension in 2012 for pre-notification of the arrival of animals (including non-harmonised species) and for their traceability after completion of the veterinary checks by using the common veterinary entry document (CVED), as required by Articles 1 and 3 of Regulation (EC) No 282/2004. The last training on the use of TRACES was organised in December 2014 and all BIP staff attended it. Afterwards internal training at the BIP was carried out for new staff and when considered necessary. 6. BIP staff are responsible for conducting cleaning, disinfection and pest controls. However, a procedure for cleaning and disinfection operations was not available and the pest control programme is not detailed (in particular, it does not contain provisions for checks of the toxic bait stations and their reloading). 7. An acquisition procedure is ongoing to contract practitioner veterinarians for sampling, treatment and euthanasia of animals at the BIP. 8. A contract with a private company for transporting dead animals to an animal byproducts (ABP) processing plant has been concluded but it does not include the handling of manure. 9. On the basis of the interviews held with BIP staff, the audit team noted that there were no planned arrangements (nor any clear instructions) to handle animals at the BIP that are suffering from or suspected to be infected by a disease presenting a risk for public or animal health. It was therefore not envisaged how, in practice, the provisions of Article 10(1) and (2) of Directive 91/496/EEC would be applied, when necessary. 10. A sampling procedure to ensure risk-based testing of imported animals through the Airport Bucharest Henri Coandă in accordance with Part III of Annex II to Decision 97/794/EC had not been developed at the time of the audit although the staff was aware about these requirements. This is not in line with Article 8(1) of Regulation (EC) No 882/ The samples taken at the BIP will be analysed by the Institute for Diagnosis and Animal Health (IDAH), in accordance with point 6 of Annex A to Directive 91/496/EEC. 12. The BIP was evaluated by its staff before the audit of DG Health and Food Safety. Shortcomings were noted in relation to the heating, electrical, plumbing and ventilation systems, which have since been rectified. The audit plan for the BIP includes yearly audit by the coordination directorate at the central NSVFSA and an audit once every five years by the internal audit department which is in line with Article 4(6) of Regulation (EC) No 882/2004. Conclusions on the organisation and implementation of official controls 13. Official veterinarians at the BIP have undergone training and demonstrated good knowledge of the legislative requirements concerning the import of live animals, which 3

8 is an important prerequisite for performing the veterinary checks correctly. 14. There is good cooperation between BIP staff and Customs and mutual access to their respective databases, which contributes to ensuring that all consignments of live animals from non-eu countries will be subject to veterinary checks. 15. Some procedures and contracts were still under preparation at the time of the audit and were therefore not possible to evaluate. Some procedures were missing altogether and others were insufficient, e.g. procedures for cleaning, disinfection, pest control and sampling of the imported animals. Such gaps could affect the implementation of official controls if they are not resolved before the BIP is approved. 16. There were no planned arrangements for handling sick animals or those suspected of being sick, and also in respect to quarantine centres to which the animals could be sent. This could affect the correct implementation of the legislation for imported animals in particular when these animals are required to be quarantined. 5.2 BIP FACILITIES AND EQUIPMENT Legal requirements Articles 8 of Regulation (EC) No 882/2004. Articles 10 of, and Annex A to Directive 91/496/EEC. Findings 17. The layout and the construction of the BIP (IC 2) provide adequate space to perform veterinary checks of live animals. The premises for registered equidae (E) and for other animals (O) are fully separated. Internal communication between them can only be accomplished through a door in between the two veterinary offices. 18. Facilities for the loading and unloading of animals are available. The premises for equidae are not well protected against pests, with gaps underneath the gates and a gap in a wall as evidenced by the presence of a poisoned mouse near the horse boxes. 19. The surfaces are in general easy to clean and disinfect with a few exceptions: - the floor in the ABP room and a small part of the wall in the inspection room are not easy to clean; - in some of the premises for equidae the ceilings are very high, difficult to reach and super-structures are exposed; nonetheless they were visibly clean during the audit. 20. Windows that can be opened to the outside environment are fitted with insect-proof screens. 21. Adequate lighting, ventilation (natural in the premises for registered equidae and mechanical in the premises for other animals), water supply and sewage systems are ensured. 4

9 22. Offices, changing facilities and bathrooms (properly equipped) are available for the staff in the part for registered equidae and for other animals which is in compliance with point 4 of Annex A to Directive 91/496/EEC. 23. Proper rooms for storage of feed and bedding have been designated in line with point 8 of Annex A to Directive 91/496/EEC. The competent authority has arrangements in place for feeding, watering, and changing of bedding. 24. A cold storage room (lockable) with temperature control for ABP with two stainless steel containers is available in the immediate vicinity of the BIP (IC2) one for dead animals and the other for used bedding. 25. Equipment for sampling (fridge, syringes, seals, cool box etc.), to restrain animals (crush and muzzles) and microchip reader for pets (ISO 11784) are at the disposal of the official veterinarians. 26. In the unloading area for equidae a tap protruding from one of the walls could cause injuries to animals. 27. In the part of the building for other animals (O), the following rooms for housing animals with proper ceilings, walls and floors are available: one common room for cats and dogs (not taking into account the behaviour of these species when kept close to each other), a room for birds, a room for aquaculture and fish, and one for reptiles and amphibians. 28. Travel boxes (with the front doors missing) were placed in the room for cats and dogs. These are considered inappropriate for housing the animals longer than a few hours. 29. A terrarium with proper heating and aquariums were not available (only an air pump for aquariums was placed in the aquaculture/fish room), although these would be needed, when the animals are subjected to checks by BIP staff. Conclusions on BIP facilities and equipment 30. The facilities and equipment for registered equidae (E) have been renovated. A few shortcomings were noted in the construction of the gates in the loading and unloading area which undermine the pest-proofing of the building. 31. The competent authority applied for listing of the BIP (IC 2) for all species under the category other animals (O). Based on the expected flow of animals (6-8 consignments per month), the current number of rooms is considered sufficient to accommodate cats, dogs, birds, fish, reptiles and amphibians. However, appropriate cages for cats and dogs and vivariums are not available to protect/secure the animals (and their handlers) and to guarantee their wellbeing. 5

10 6 OVERALL CONCLUSIONS Official veterinarians at the BIP have undergone training and demonstrated good knowledge of legislative requirements for the import of live animals. There is good cooperation between BIP staff and Customs supported by mutual access to the BIP database (TRACES) and Customs database (RCDPS) to ensure that all consignments of live animals from non- European Union (EU) countries will be subject to veterinary checks. Not all work instructions and procedures are yet in place, and some that have been finalised are insufficient. In particular, the competent authority has not documented how to address sampling to check compliance with the health requirements of the veterinary certificates, and there were no planned arrangements for handling of animals in cases where quarantine is required. This could affect the organisation of controls to be carried out at the BIP. At the time of the audit, the facilities had been renovated and were ready to use. Few shortcomings in the construction of the gates in the loading and unloading area for registered equidae (E) were noted. On the basis of the number of available rooms for other animals (O), the audit concluded that the BIP could accommodate cats, dogs, birds, aquaculture/fish, reptiles and amphibians, although non-compliances were noted in relation to the availability of appropriate cages for cats and dogs and vivariums. In view of the shortcomings identified, the report concludes that the lifting of the suspension of this BIP for categories E and O is premature. 7 CLOSING MEETING A closing meeting was held on 22 November with representatives from the central and local competent authority. At this meeting, the main findings and the preliminary conclusions of the audit were presented by the auditor. The authorities did not express disagreement and clarified their interest in getting the BIP approved for categories: registered equidae (E), and other animals (O) (14) - cats, dogs, birds, aquaculture animals including all live fish, and reptiles. 8 RECOMMENDATIONS The competent authority is invited to provide details of the actions taken and planned aimed at addressing the recommendations set out below, including deadlines for their completion ('action plan'), within 25 working days of receipt of the draft audit report. No. Recommendation 1 To develop procedures for sampling of the imported animals in line with the requirements of Article 8(1) of Regulation (EC) No 882/2004, in order to comply with the requirements of Part III of Annex II to Commission Decision 6

11 No. Recommendation 97/794/EC. Recommendation based on conclusion 15. Associated finding To ensure that there are arrangements in place for handling animals in case of suspicion and sickness at the BIP (including arrangements for housing the animals in quarantine centres) for the species under the requested approval, in order to comply with the requirements of Article10(1) and (2) of Council Directive 91/496/EEC. Recommendation based on conclusion 16. Associated finding 9. 3 To ensure that appropriate equipment for each species is provided and deficiencies in the facilities are rectified following the requirements of point 2 of Annex A to Council Directive 91/496/EEC. Recommendation based on conclusion 30 and 31. Associated findings 18, 19 (first indent), 26, 28 and 29. The competent authority's response to the recommendations can be found at: 7

12 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , 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. 91/496/EEC OJ L 268, , p Dec. 2009/821/EC OJ L 296, , p.1 Reg. 282/2004 OJ L 49, , p Dec. 97/794/EC OJ L 323, , p Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2009/821/EC: Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces Commission Regulation (EC) No 282/2004 of 18 February 2004 introducing a document for the declaration of, and veterinary checks on, animals from third countries entering the Community 97/794/EC: Commission Decision of 12 November 1997 laying down certain detailed rules for the application of Council Directive 91/496/EEC as regards veterinary checks on live animals to be imported from third countries