EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO) 2009-8352 - MR FINAL

FINAL REPORT OF A MISSION

CARRIED OUT IN

AZERBAIJAN

FROM 12 TO 19 OCTOBER 2009

IN ORDER TO EVALUATE THE ANIMAL HEALTH CONTROLS IN PLACE FOR EQUIDAE DESTINED FOR EXPORT TO THE EUROPEAN UNION

In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected;any clarification appears in the form of an endnote. Executive Summary

Objective and context of the mission: Following the request of the Competent Authorities of Azerbaijan, the objective of the mission was to evaluate the animal health situation and controls in place for equidae, in view of proposing the country to be listed for authorisation of export of equidae to the European Union.

Overall conclusion: The significant shortcomings in the organisation and implementation of the import controls of live equidae make the health status of the country unreliable. Evidence for absence of some diseases in the country is insufficient, and part of the national territory is not under official control. In addition, the incomplete legal framework for notification of diseases, and the weaknesses in the control system for identification, registration, movement control and certification of equidae fail to provide guarantees equivalent to those laid down in EU legislation.

Recommendations :

Recommendations were made to the Competent Authorities of Azerbaijan to address the shortcomings described in this report, which need to be addressed before authorising imports of equidae can be considered.

I Table of Contents

1 INTRODUCTION ...... 1 2 OBJECTIVES OF THE MISSION ...... 1 3 LEGAL BASIS FOR THE MISSION ...... 1 4 BACKGROUND ...... 2 5 FINDINGS AND CONCLUSIONS ...... 2 5.1 NATIONAL LEGISLATION ...... 2 5.1.1 LEGAL REQUIREMENTS ...... 2 5.1.2 FINDINGS ...... 2 5.1.3 CONCLUSIONS ...... 3 THE NATIONAL LEGISLATION IN PLACE DOES NOT PROVIDE FOR HEALTH GUARANTEES EQUIVALENT TO THOSE LAID DOWN IN EU LEGISLATION FOR COMPULSORILY NOTIFIABLE DISEASES. SOME DISEASES OF EQUIDAE, THE STATUS OF WHICH IS RELEVANT FOR EXPORT TO THE EU, LACK LEGAL BASIS FOR THEIR CONTROL...... 3 5.2 COMPETENT AUTHORITIES ...... 3 5.2.1 LEGAL REQUIREMENTS ...... 3 5.2.2 FINDINGS ...... 3 5.2.3 CONCLUSIONS ...... 5 5.3 LABORATORY SERVICES ...... 6 5.3.1 LEGAL REQUIREMENTS ...... 6 5.3.2 FINDINGS ...... 6 5.3.3 CONCLUSIONS ...... 7 5.4 REGISTRATION OF HOLDINGS, ANIMAL IDENTIFICATION AND MOVEMENT CONTROLS ...... 7 5.4.1 LEGAL REQUIREMENTS ...... 7 5.4.2 FINDINGS ...... 8 5.4.3 CONCLUSIONS ...... 9 5.5 ANIMAL HEALTH CONTROLS ...... 9 5.5.1 LEGAL REQUIREMENTS ...... 9 5.5.2 FINDINGS ...... 10 5.5.3 CONCLUSIONS ...... 12 5.6 CERTIFICATION PROCEDURE ...... 13 5.6.1 LEGAL REQUIREMENTS ...... 13 5.6.2 FINDINGS ...... 13 5.6.3 CONCLUSIONS ...... 14 5.7 CONTROLS OVER VETERINARY MEDICINAL PRODUCTS ...... 14 5.7.1 LEGAL REQUIREMENTS ...... 14 5.7.2 FINDINGS ...... 14 5.7.3 CONCLUSIONS ...... 15 6 OVERALL CONCLUSIONS ...... 15 7 CLOSING MEETING ...... 15 8 RECOMMENDATIONS ...... 15 ANNEX 1 - LEGAL REFERENCES ...... 17

II ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation AHS African Horse Sickness BIP Border Inspection Post CA Competent Authority CCA Central Competent Authority CEM Contagious Equine Metritis CFt Complement Fixation Test DG(SANCO) Directorate General for Health and Consumers EE Equine encephalomyelitis EIA Equine Infectious Anaemia EU European Union EVA Equine Viral Arteritis FVO Food and Veterinary Office LVS Local Veterinary Station OV Official Veterinarian OIE World Organisation for Animal Health PVP Private veterinary practitioner Rayon Regional administrative unit of Azerbaijan (the national territory consists of 60 rayons ) SVS State Veterinary Service RVL (Central) Republican Veterinary Laboratory VMP Veterinary Medicinal Products VS Vesicular Stomatitis

III 1 INTRODUCTION

The mission took place in the Republic of Azerbaijan from 12 to 19 October 2009. The mission was undertaken at the request of the competent authorities (CA) of Azerbaijan, as part of the Food and Veterinary Office (FVO)’s planned mission programme. The mission team comprised two inspectors from the FVO and was accompanied at each location visited by representatives from the Central Competent Authority (CCA), the State Veterinary Service (SVS) of the Ministry of Agriculture of the Republic of Azerbaijan . An opening meeting was held on 12 October 2009 with representatives of the CCA. At this meeting the inspection team confirmed the objectives and itinerary of the mission. Additional information required for the satisfactory completion of the mission was requested.

2 OBJECTIVES OF THE MISSION

The objective of the mission was to evaluate the animal health situation and controls in place for equidae, in view of proposing the territory identified by the CA to be listed for authorisation of export of equidae to the European Union (EU). In pursuit of this objective, the following sites were visited: VISITS COMMENTS Competent Authorities Central 2 State Veterinary Service, Ministry of Agriculture Provincial (rayons and 4 Baku, Ganja, Goyghol and Tovuz cities) Local 1 Local veterinary station in Tovuz Laboratories Central 1 Central veterinary laboratory Provincial 2 Tovuz and Goyghol regional veterinary laboratories Equestrian organisation 1 Issuing passports for thoroughbreds and Arabian horses Holdings 4 Baku and Ganja

3 LEGAL BASIS FOR THE MISSION

The mission was carried out under the general provisions of Community legislation and, in particular: • Article 46 of 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; • Article 17 of Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae; • Article 17 of Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in, and import into the Community, of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Council Directive 90/425/EEC.

1 Legal acts quoted in this report refer, where applicable, to the last amended version, and can be accessed at the following internet site: http://eur-lex.europa.eu/en/index.htm .

4 BACKGROUND

The Republic of Azerbaijan is not on the list of third Countries from which Member States may authorise imports of live equidae (Commission Decision 2004/211/EC). In their letter of 20 April 2009 to the Commission services, the CA of Azerbaijan requested acknowledgement of the health situation of equidae in order to be entitled to export live equidae to the EU. The CA did not specify a territory or a category of equidae. This was the first FVO mission to Azerbaijan on animal health controls. Azerbaijan is a country of about 87,000 km 2 , including the landblock exclave of the Nakhichevan autonomous Republic. It counts about 70,000 horses and 50,000 donkeys ( source: SVS ), and 2.5 million cattle, 8 million sheep and goats, 20 million poultry ( source: OIE – 2008 ). According to the World Animal Health Organisation (OIE), Azerbaijan has never identified any occurrence of equine disease. The only diseases affecting equidae which have been reported by Azerbaijan are anthrax and rabies, which are endemic.

5 FINDINGS AND CONCLUSIONS

5.1 NATIONAL LEGISLATION

5.1.1 Legal requirements

Article 12(2)(b) of Directive 90/426/EEC states that particular account shall be taken of the legislation of the third country in relation to animal health and welfare, in drawing up or amending the list of countries from which importation of equidae into the Community may be authorised. Health certificates for equidae to be introduced into the Community require that African horse sickness (AHS), dourine, glanders, equine encephalomyelitis (EE) of all types, equine infectious anaemia (EIA), vesicular stomatitis (VS), rabies and anthrax, be compulsorily notifiable in the country of origin (Commission Decisions 92/260/EEC, 93/197/EEC, 93/195/EEC and 93/196/EEC). 5.1.2 Findings

In the past two years the CA have issued several pieces of legislation related to animal health. The CA also indicated that there is a political will to approach EU standards. The mission team was provided with translations in English of several legal acts. Additionally, other pieces of legislation in Azeri were orally translated during the mission. Among these legal acts, the following are of particular relevance to this mission: • Law on Veterinary Medicine of 31.5.2005, which is a framework law determining the legal and organisational basis for all veterinary activities, including those of the SVS. • Presidential Decree No 316 of 22 November 2005 providing implementing measures for the Law on Veterinary Medicine. • List of especially dangerous diseases for which prevention and control programmes are funded by the State, approved by Resolution No 65 of 7.3.2006. • Procedure for quarantine of animals imported from other countries, approved by Decision No 11 of 23.1.2007.

2 • Rules on the organisation of controls on the import and export of animals and products of animal origin, approved by Resolution No 66 of 21.4.2009. • Rules concerning the approval, registration, import, storage, transport, sale and use of Veterinary Medicine Preparations, approved under Resolution No 66 of 16.4.2007. • Regulation on animal identification approved under Resolution No 19 of 30.01.2007. • Law on Horse Breeding of 27.2.2007, including provisions for identification and registration of horses. Observations: A comprehensive check of national legislation was not carried out. However, during the evaluation of the control system for animal health and certification, the following legal aspects were noted: • The Law on Veterinary Medicine of 31.5.2005 requires owners of animals to report to the SVS any suspicious case of mass disease or mortality. However, the national legislation does not provide any list of compulsorily notifiable diseases. • Anthrax, rabies, AHS, contagious equine metritis (CEM), EE, glanders and strangles are the diseases of equidae listed as especially dangerous diseases in Resolution No 65 of 7.3.2006, for which prevention, diagnosis and eradication can be funded by the State. Vesicular stomatitis (VS), dourine and equine infectious anaemia (EIA) are not included in the list. • Copies of national legislation were only available at the central level. The CA indicated that it was not necessary to keep copies of the legislation at the rayons or cities offices. 5.1.3 Conclusions

The national legislation in place does not provide for health guarantees equivalent to those laid down in EU legislation for compulsorily notifiable diseases. Some diseases of equidae, the status of which is relevant for export to the EU, lack legal basis for their control.

5.2 COMPETENT AUTHORITIES

5.2.1 Legal requirements

Article 12 (2) (c) of Directive 90/426/EEC requires that account be taken of the organisation of the competent veterinary authority and its inspection service, their powers, the supervision to which they are subject, and the means at their disposal (including staff and laboratory capacity) to apply national legislation effectively, in drawing up or amending the list of countries from which importation of equidae into the Community may be authorised. 5.2.2 Findings

Organisation of the CA The SVS is the CA in charge of animal health. It is subordinated and reports directly to the Ministry of Agriculture. It has a separate budget from the Ministry of Agriculture. The SVS consists of eight Departments, of which the following ones are of major importance in the scope of the mission: • The Department for Epidemiological control, treatment and prophylaxis of especially dangerous diseases; • The Department for inspection over veterinary control; The structure of the SVS is pyramidal with territorial veterinary administrations distributed in

3 rayons (departments) and cities. Rayons are sub-divided into local veterinary stations (LVS) and the major cities are sub-divided into districts. Each LVS is staffed by one official veterinarian (OV) and one veterinary technician. SVS inspectors have legal powers to initiate and follow-up prosecutions. They can impose fines on the basis of Article 125 of the Code of Administrative Infringements. Whereas the SVS remains in charge of defining and controlling the animal health conditions for import of animals and products of animal origin, it has no power to control consignments at borders: this authority lies with the Ministry of Customs, which has its own staff of veterinary inspectors. The "Republican Scientific Production Unit", within the Ministry of Agriculture but not related to the SVS, is the CA in charge of identification and registration of equidae. Observations: • The territory of the Nakhichevan autonomous Republic is not under the authority of the SVS; it has its own veterinary organisation, which collaborates with the SVS of the Republic of Azerbaijan. This region has no borders with Azerbaijan but only with Armenia and Iran, and movements of animals take place via Iran. • 11 rayons in the South-West of the country (Nagorno Karabakh and adjacent area, representing around 14% of the national territory), are de facto not under control of the SVS, as they are partially or totally under foreign military occupation. Staff from the veterinary offices of these rayons have been displaced to nearby districts. • Certain areas close to the border with Armenia are difficult to access for security reasons. As stated by the CA, no activities are performed in the daytime. • The mission team could not meet representatives of the CA in charge of controls at the borders, and did not receive any information on the organisation of this CA. A visit was scheduled and agreed in advance to the Border inspection post (BIP) of Baku airport, but access to the BIP was eventually denied at the last moment. The SVS is unaware of the controls performed at the BIPs, and no system is in place to inform the BIPs of the veterinary requirements for import of animals or products of animal origin. The SVS was not aware of all consignments of horses imported in 2009 through BIPs. • All rayon and city offices visited were equipped with telephones, fax-machines, computers and programmes. Staff working at the LVS do not have any office, neither are they provided with any equipment. They use their own mobile phones. • The CA in charge of registered equidae indicated that they lack the necessary resources to perform their tasks. Staff The Head and the two Deputy Heads of the SVS are directly appointed by the Minister of Agriculture. The remaining 32 staff of the SVS at central level are appointed by the Head of the SVS. The SVS indicated that they have more than 3,000 staff, including nearly 2,500 OVs. OVs are recruited on the basis of an interview, and are required to have between one and five years of practical experience. The SVS explained that training in the field of animal health is regularly provided, with the contribution of foreign and international agencies. The last training sessions included: • Initial measures to be taken in case of disease outbreaks (3-day training sessions, organised between 2008 and 2009 for 560 veterinary staff, by The United States Defense Threat

4 Reduction Agency). • Epidemiological surveillance training and simulation exercises were organised in 2009, with the contribution of the World Bank and the Food and Agricultural Organisation of the United Nations. • Specific training on avian influenza was organised in September 2009 by the United States Agency for International Development. Observations: • No specific training has been organised so far on equine diseases listed in national legislation as "particularly dangerous diseases" or on those diseases for which surveillance is performed. • Official tasks, such as vaccination against anthrax, or mallein test for glanders, may be performed by private veterinary practitioners (PVPs). The terms for delegation, implementation or reporting of these official tasks are not defined. • The CA in charge of identification of registered equidae indicated that they do not have any trained official for this task. Prioritisation and documentation of controls A yearly prophylactic plan is issued by the CCA, indicating for each species the number of vaccinations and tests to be performed per territorial unit. The plan is based on the number of animals reported by the Central Statistics Office to the SVS. Each LVS must report its activities within this plan, and territorial units submit monthly reports on the advancement of the implementation of the plan. Official controls do not need to be documented, and supervision of the field activities is left to the discretion of the rayons and cities. The CCA performs documentary supervision of the territorial offices. Observations: • Instructions or guidance are not issued. The SVS indicated that staff have sufficient knowledge to perform their tasks, which are described in national legislation. • Monthly reports, detailing the number of vaccinations and tests performed and the owners of the animals, were available in the rayons but not at the city offices visited. • One city office presented a report of supervision visits performed in early 2008 to the districts. It listed deficiencies and requested corrective actions to be taken; no evidence of follow-up was available. 5.2.3 Conclusions

In the parts of the national territory to which it has access, the SVS has sufficient resources and legal powers to perform its tasks, with the exception of controls of imports. The organisation of official controls of imports suffers from the lack of coordination and cooperation with the CA in charge of controls at the borders. The resources for the CA in charge of identification and registration of equidae are insufficient. The lack of specific training, guidance and instructions, the unavailability of legislative documents at operational level, and the weaknesses in documenting the official controls and supervision , bring the reliability of official animal health controls in equidae into question.

5 5.3 LABORATORY SERVICES

5.3.1 Legal requirements

Article 12 (2) (a) of Directive 90/426/EEC requires that particular account should be taken of the health status of equidae and other domestic animals and wildlife, and the environmental situation. Article 12 (2) (c) of Directive 90/426/EEC requires that particular account should be taken of the laboratory capacity of the third country. Article 12 (1) 3rd paragraph of Directive 90/426/EC specifies that relevant international standards should be used to evaluate how the CA applies and implements animal health provisions, in particular the principle of regionalisation, and the sanitary requirements for importation from other third countries. The relevant international standards for animal health are drawn up by the World organisation for animal health (OIE), recognised as a reference organisation by the World Trade Organisation. The OIE manual of diagnostic tests and vaccines for terrestrial animals (OIE manual) indicates the standards of quality management programmes enabling laboratories to demonstrate that they operate a viable quality system, including validation of diagnostic assays (Chapters 1.1.3. and 1.1.4. of the 2009 edition of the OIE manual). The OIE manual provides detailed descriptions of laboratory tests that can be used in a variety of applications for individual diseases, including diagnosis, disease control, surveillance, epidemiological studies and screening for international movement. Only those tests that are suitable for international movement testing are included in the OIE list of Prescribed and Alternative Tests. Health certificates for equidae to be imported or temporarily admitted into the EU require that they are tested for some diseases, including in any case EIA, dourine, glanders, and possibly equine viral arteritis (EVA), CEM, AHS, VS, Eastern and Western EE, and equine encephalosis (health certificates of Decisions 92/260/EEC, 93/197/EEC and 93/196/EEC). 5.3.2 Findings

The veterinary laboratory network in Azerbaijan consists of one central republican veterinary laboratory (RVL) in Baku, 12 regional veterinary laboratories (plus one in Nakhichevan) and 47 diagnostic rooms. The RVL is staffed by 66 veterinarians and 39 technical assistants, and a further 194 veterinarians and 217 assistants work in the regional laboratories. Diagnosis of diseases of equidae is carried out at the RVL only. The range of diagnostic tests for equidae available at the RVL includes tests for EIA, glanders and dourine, and chlamidiosis. Rabies diagnosis is also performed only at the RVL. The range of tests performed by regional laboratories includes toxicological, serological and bacteriological tests, including anthrax. Observations: • The RVL had adequate and new infrastructure and equipment. One of the regional laboratories visited had basic equipment and inadequate infrastructure. The other one had been recently refurbished. The CCA indicated that a project is under way to equip 5 regional laboratories to perform more diagnostic tests. • Staff at central level received regular training, and some of them participated in training on laboratory diagnosis in foreign laboratories (Italy, Egypt, Ukraine, Croatia). Staff at regional laboratories also received induction training, and a five-year programme on serology was under-way.

6 • The RVL indicated that accreditation was in progress for its equipment. However, the standards applied for the accreditation could not be explained.. • Most reagents came from foreign laboratories or manufacturing companies, although some were produced locally (i.e. sensitised red blood cells for CFT). Problems in supply of reagents resulted in the impossibility of the RVL to perform tests for dourine and glanders in 2009; reagents had just been received at the time of the visit of the mission team. • The RVL indicated that instruments and equipment are calibrated every year by the specialists of the State Committee for Standardization, Metrology and Patents, but there was no documented evidence. • No external or internal proficiency testing of the diagnostic tests performed for equine diseases was in place. Information on the validation of the diagnostic assays in use was not available. • Staff performed tests according to manufacturers' leaflets or publications, but not according to Standard Operating Procedures, and working protocols were not kept. It was not possible to check the procedures and protocols applied. • The complement fixation test for glanders was performed according to a procedure detailed in a publication, which presented some variations from the procedure prescribed by the OIE manual, with reduced incubation times and without final centrifugation. • Tests for AHS, CEM and EE could not be performed in the country, and no agreement was in place with external laboratories. 5.3.3 Conclusions

The official laboratory service, although sufficient as regards infrastructures, staff and resources, lacks a reliable quality system and presents operational shortcomings , thus weakening confidence in the results. A limited range of equine diseases can currently be officially investigated in Azerbaijan.

5.4 REGISTRATION OF HOLDINGS, ANIMAL IDENTIFICATION AND MOVEMENT CONTROLS

5.4.1 Legal requirements

Article 12 (2) (d) of Directive 90/426/EEC requires that assurances which the CA can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community be considered for drawing up or amending the list of countries from which importation of equidae into the Community may be authorised. Article 14 of Directive 90/426/EEC requires that equidae remain without interruption in the part of the territory approved, for a period to be determined. This period is three months for import (Commission Decision 93/197/EEC), 40 days for temporary admission (Commission Decisions 92/260/EEC), or the period of temporary stay (Decision 93/195/EEC).

Article 16 (1) of Directive 90/426/EEC requires the imported equidae to be identified by the required means of identification adapted to their category. Article 2 (c) of Directive 90/426/EEC defines the terms of equidae for breeding and production, equidae for slaughter, and registered equidae. Imports of equidae into the Community and their requirements may be restricted to registered horses (Commission Decisions 92/260/EEC, 93/195/EEC, 93/197/EEC), or be open to other categories of equidae (Commission Decisions 93/197/EEC for equidae for breeding and production

7 from some countries, 93/196/EEC for equidae for slaughter). According to Article 4, second indent of Council Directive 94/28/EC, and Article 1, third indent of Commission Decision 96/510/EC, the identification document accompanying imported registered equidae must be conform to the passport whose format is laid down in Commission Regulation (EC) No 504/2008. Article 3 (1) of Council Directive 94/28/EC requires that the CA of the third country approves the bodies identifying registered equidae to be exported to the EU. Article 4 (6) of Commission Regulation (EC) No 504/2008 requires the CA of the third country to guarantee that these bodies issue identification documents as laid down in the Regulation, and that updated lists of such issuing bodies are communicated to the Commission. 5.4.2 Findings

Resolution No 19 of 30.01.2007 requires that all equidae are identified with a tattoo applied inside the ears within four months from birth. According to the same Resolution, all holdings must be registered. The "Horse Breeding Law" of 27.2.2007 defines the Ministry of Agriculture as the CA for issuing identification documents of registered horses, and for keeping the stud books. It foresees the possibility to delegate the registration activities to third parties. The CCA indicated that registered horses were divided into several categories: native breeds (Dilbaz and Karabakh horses), thoroughbred, Arabian, Akhal-Teke and sport horses. In practice, the Ministry of Agriculture directly looks after identification and registration of the native breeds, and the registration of other horses is under the responsibility of delegated bodies. The CA explained that owners must apply to the local OV before any movement of animals, providing the relevant documentation concerning official vaccinations and tests. For movements within the territory of the rayon animals are accompanied by the receipt of the application, whereas for all movements to other rayons the territorial office issues a movement certificate ("form 1"). This document indicates the health status of the animals and of the holding. Owners are not required to keep a record of movements for their animals. Observations: • The system for identification of equidae by tattoo was not in place at the time of the mission. In general, equidae are not identified; some owners identify their equidae by branding or with a microchip. • The specimen of the identification document issued by the Ministry of Agriculture for native horses contains the horse description, the pedigree and the records of the results of trials and competitions. However, it does not include fields to enter data of the owner, official controls, vaccinations, tests or medicine records. • The format of the identification document for native breeds has been changed three times since the adoption of the horse breeding law. A register of identification documents issued was kept by the CCA, but contained only data related to two horses; many more identification documents were issued. As stated above, the CA indicated that they lack funding and have no trained personnel in horse identification. • The body in charge of registration of the Arabian horses, thoroughbreds and Akhal-Teke, has received a formal agreement from the CCA to keep studbooks for the first two breeds. It has also been approved by the International Stud-Book Committee for thoroughbreds, and the World Arabian Horses Association. Horse passports were issued by this body for the first two breeds; they conformed to the international format, but lacked the sections concerning

8 the results of tests and the control of the identification of the horse. The Ministry of Agriculture did not delegate or supervise the identification of these horses. • The operator that was indicated by the CA as in charge of registration of sport horses indicated that it does not issue identification documents. • Holdings with only one horse are recorded by the municipalities for statistical purposes but not registered by the SVS. • In Baku, six holdings with 231 breeding horses in total had been registered. In addition, 169 equidae (draft horses or local breeds) were accounted for at the local office. • One holding, keeping both registered and non-registered horses, was located on the administrative border between Baku city and a nearby rayon ; it had not been registered by either office and was not under effective official control from the SVS. • The field OVs met had no access to instructions or guidance on movement controls. No legal basis could be provided to the mission team1. • In several instances the movement documents were not issued. For example, in Baku the CA indicated that only one movement document was issued in 2009, for two horses exported. This CA had not been informed that horses had actually been moved between two holdings, one of which was located in a different rayon, and that horses kept in holdings under this jurisdiction had been abroad for competitions. The mission team could not visit a market. The CA in charge of official supervision of the market in Ganja indicated that they checked that all animals coming from other rayons were accompanied by the “form 1”. However, the the CA of Tovuz indicated that animals were regularly sent to the market in Ganja, but that they were not issuing any “form 1” for these animals, as this form was only necessary in case of movement for summer grazing. 5.4.3 Conclusions

The non application of the legal requirements on compulsory identification of all horses, and incomplete implementation of those for holding registration, affects the overall effective official supervision of the equidae at national level. Similarly, the system for movement controls is insufficient and poorly organised, implemented, and controlled, to allow any basic traceability of equidae within the country. The implementation or control of the system in place for the identification of registered horses by the CA in charge is not reliable. The identification documents issued by the CA lack many essential features, and would not allow such horses to be considered as registered in accordance with Regulation (EC) No 504/2008.

5.5 ANIMAL HEALTH CONTROLS

5.5.1 Legal requirements

Article 12 (2) (a) of Directive 90/426/EEC requires that particular account should be taken of the health status of equidae and other domestic animals and wildlife, and the environmental situation. Article 12 (2) (e) of Directive 90/426/EEC requires that particular account should be taken of the regularity and rapidity of the information supplied by the third country relating to the existence of

1 In their response to the draft report, the CA of Azerbaijan stated that newly prepared guidance on movement controls is now available.

9 infectious diseases of equidae in its territory. Article 12 (2) (f) of Directive 90/426/EEC requires that particular account should be taken of the guarantees given by the third country to inform directly the Commission and Member States of occurrence of diseases, animal health status, proposed changes in the national sanitary rules (in particular for importation of equidae) and, at regular intervals, of the animal health status of its territory concerning equidae;

Article 12 (2) (i) of Directive 90/426/EEC requires that particular account should be taken of the rules on the prevention and control of infectious diseases in force in the third country and their implementation, including rules on importation of equidae from other third countries. Article 17 (3) of Directive 92/65/EEC indicates that semen, ova and embryos may only come from third countries able to provide guarantees equivalent to those contained in Annex D to the Directive (conditions related to the approval of collection centres, admission of donors males (including negative tests for EIA, EVA and CEM), health conditions of donor females, collection, storage and transport of semen or embryos). The health requirements for import of semen, ova and embryos are further detailed in Commission Decisions 96/539/EC and 96/540/EC. Article 13 of Directive 90/426/EEC requires that imported equidae come from a country, or, if decided so by the Commission, from part of a country which is free from AHS, and has been free from VEE for at least 2 years, and from dourine and glanders from at least 6 months. Article 14 of the same Directive requires that equidae come from holdings placed under veterinary supervision. Article 15 of the same Directive requires either that the country be free from VS and EVA for at least 6 months, or that the animals be tested. According to Article 15, a) of Directive 90/426/EEC, imported equidae must also comply to specific animal health requirements. These requirements are detailed in the various decisions and certificates, and include, in addition to the previous requirements, the absence of diseases in the holding of origin (6 months for EE, VS, EIA until the infected animals are removed and two further clear tests performed three months apart on the remaining animals, one month for rabies, 15 days for anthrax), as laid down in Article 4 (5) (a) of Directive 90/426/EEC. Certification for permanent imports also requires a statement on the absence of suspicion of CEM. In addition to individual testing (see section 5.3), certification is required on the possible vaccination against some diseases (i.e. AHS, EVA, as in relevant certificates in Decisions 93/197/EEC, 93/196/EEC and 92/260/EEC). 5.5.2 Findings

5.5.2.1 Surveillance and internal control

According to national legislation, owners of animals have the obligation to report to OVs any suspicious case of disease or death of animals. OVs must report the pathological cases, and may take samples and send them to the regional laboratory, where generic microbiological, serological and toxicological tests can be performed. In case of absence of diagnosis, the regional laboratory sends the samples to the RVL, where generic virological investigation, through inoculation of embryonated eggs, can be performed. An electronic animal health database funded by the United States of America Defense Threat Reduction Agency, is under development. A second database on similar topic, funded by the World Bank, is being tested in six rayons, with reports received by the CCA.

10 In addition to passive surveillance, the CA applies a targeted programme of active surveillance in horses for glanders, by the use of the mallein test. This mallein test is primarily performed on registered horses and at borders. Donkeys are not tested. In addition, the annual official programme of the SVS foresees the official vaccination of all equidae (and other species) against anthrax. According to the CA, no positive reaction to the mallein test has been recorded for the last 50 years.

Some operators implement their own disease surveillance and control programmes with their PVPs, including additional vaccinations (equine influenza, EVA, anthrax, tetanus, leptospirosis, rhinopneumonia) and testing (for glanders, brucellosis, dourine, EIA, EVA, chlamidiosis). These tests were performed either at the RVL or in a foreign laboratory. Observations: • No training, instructions, legislation regarding the surveillance of diseases of equidae have been provided to the OVs in the rayons or in the field. At the LVS visited, the local OV could not indicate what would make him suspect cases of glanders, but indicated that he would report all diseased or dead animals; • According to the RVL, in the past seven years, a total of two suspicious cases of deaths in horses were reported and subject to laboratory analyses. In both cases the cause of death was determined to be due to intoxication. • No guidelines or instructions have been developed for the mallein testing programme (selection of holdings and animals to be tested, protocol for mallein test). • In 2008, the plan was to test 50% of the horse population. In this year, less than 2% of the horse population was tested, due to problems of supply of mallein. In one rayon, the regional veterinary officer indicated that supply of mallein was chronically deficient, with absence of such supply in 15 of the last 18 years. • At the city office of Baku and in two out of three holdings visited, documentation concerning tests and official vaccinations was not available. • The reports of vaccination of equidae against anthrax indicate that 100% of the target population was vaccinated in 2008. However, this target represents 90% of the total population. • Concerning other possible surveillance, the RVL indicated that a serological survey was performed in 2006 on 247 horses, for EIA, glanders and dourine, but no detail of the survey was available. The RVL also tested 85 samples for dourine, 34 for glanders and 49 for EIA in 2007, and 17 samples for dourine and 25 samples for EIA in 2008. These tests were performed at the request of owners; all results were negative. Tests performed in foreign laboratories or their results need not to be notified to the CA. • AHS, CEM, EE, strangles and glanders are the equine diseases officially declared as “specially dangerous animal diseases”, for which prevention, diagnosis and eradication can be funded by the State budget. However, apart from glanders, they are not subject to any specific surveillance and, at least for the first three, cannot be currently investigated. • There is currently no animal health legislation applied to the collection, storage, transport, or use of semen, ova or embryos of equidae.

11 5.5.2.2 Import controls

Procedures for import controls on live animals are described in Resolutions No 11 of 23.01.2007 and No 66 of 21.4.2009. An application must be made by the importer to the Import-Export Department of the SVS before importation of live animals. Before granting the authorisation, this Department verifies the health situation of the country of origin, consulting the weekly bulletin of OIE. In case of favourable opinion, the SVS delivers to the operator a standard model of health certificate, in Azeri and in English, which has been developed for all imports of horses. This standard model of health certificate requires, in addition to health statements, that the horses be tested for CEM, EIA, glanders and dourine, and to be vaccinated against anthrax. Although the SVS is not aware of the kind of checks performed at the BIPs by the CA in charge, they indicated that there are no facilities to check animals. Imported animals must be quarantined for 30 days in the holding of destination, where they are checked by the local OV. During the quarantine horses must be subjected to laboratory testing against a number of diseases (for horses: surra, piroplasmosis, rhinopneumonia, CEM, EIA, VS, glanders, EVA, etc) and to the official vaccinations. Observations: • The criteria used to approve countries from which horses may be imported are not laid down. Whereas the OIE weekly bulletins indicate significant health events reported, they do not reflect the health status of the countries. • The standard model of health certificate does not require certification on the residency of the animals, and does not contain elements regarding AHS. • The mission team reviewed the health certificates concerning horses imported from various countries. Three out of four did not correspond to the standard model of health certificate. Two certificates did not indicate any testing of the imported animals, and one did not certify any animal health aspect. • The flow of information between the SVS and the CA at the borders is not defined. In several instances the SVS was not aware of horses imported into the territory, or re-imported after participation in events in third countries. The SVS could not present evidence of transmission of information to the CA at the border following approval for specific import consignments. In one case, the application and the authorisation for the import of a consignment of breeding horses had been made six days after the arrival of the animals at destination. • The notification of imported consignments of horses to the territorial CA of destination was not documented. No legislation or any instruction was available at the cities or rayons on the controls to be performed for imported horses. • The list of diseases for which laboratory tests must be performed during the quarantine is kept open, with no indication on what additional tests could be decided, or by whom. Most of the required tests cannot be performed at the RVL. • No evidence of the official controls performed or of the quarantine imposed was available either at the offices or at holdings visited. • Although the CCA affirmed that no authorisation for the import of horse semen has been granted, semen imported from EU Countries was stored in one of the holdings visited.

12 5.5.3 Conclusions

The very scarce evidence of organisation and reports from passive surveillance, the absence of active surveillance in equidae other than horses and for glanders, affect confidence in the health status of the country, in particular for diseases which are not of epizootic proportions. More precisely, these points, together with the lack of official status or surveillance for dourine makes it unlikely that occurrence of this disease in the country would be officially identified. The limited and poorly organised, implemented and controlled active surveillance of glanders, provides insufficient guarantees of the absence of glanders in the whole country. The rules for import of equidae from other countries are insufficiently defined, and, for most of them, not applied or checked. The system of official checks at import cannot guarantee that animal health conditions of imported equidae are respected. As a consequence, the import system presents major deficiencies which could affect the animal health status of the population of equidae in Azerbaijan.

5.6 CERTIFICATION PROCEDURE

5.6.1 Legal requirements

Articles 13, 14, and 15 of Directive 90/426/EEC lay down the requirements regarding the health status of the country of origin, the residency requirements of the equidae to be imported, and further animal health requirements. Article 16 lays down identification and certification requirements. The animal health conditions and veterinary certification for temporary admission of registered horses are detailed in Decision 92/260/EEC, whereas for import of registered equidae and equidae for breeding and production, they are detailed in Decision 93/197/EEC. All equidae must be clinically examined by the OV on the day the certificate is signed. Council Directive 96/93/EC establishes the rules, principles and controls on the certification of animals and animal products. Rules and principles applied by third-country certifying officers are expected to provide guarantees at least equivalent to those laid down in this Directive; the OIE Terrestrial Code (chapter 5.2) lays down certification procedure requirements similar to those established in this Directive. 5.6.2 Findings

Procedures for the export of animals are described in a regulation approved by Resolution No 66 of 21.4.2009. The OV at the rayon or city office, upon receipt of an application from the operator (who must also deliver the animal health requirements of the country of destination), inspects the animals to be exported according to the requirements, and issues a veterinary health certificate which must be of a protected format, and stamped. Certificates are valid for ten days and copies of these documents must be kept at the rayon or city office. The SVS indicated that their procedures also foresee the issuance of internal movement documents (“form 1”), for movement up to the border. Observations: • The OVs signing certificates have no access to copies of current legislation; instructions or guidance have not been developed; • At the offices visited the only documentation available on export of horses was in relation to one consignment of two horses exported. Copies of the certificates or supporting documentation were not available at the city office, with the exception of the internal

13 movement document. There was no documented evidence of the quarantine and of the serological tests declared, or of any official visit to the holding. • Copies of the health certificates and of the results of the tests for the same consignment were made available to the mission team by the operator. The health certificates were not of a protected format, and were not stamped. The samples for laboratory testing had been taken by a PVP on a date which did not correspond to the one referred to in the internal movement document. 5.6.3 Conclusions

The certification system and its application do not meet basic requirements for certification, as laid down in Council Directive 96/93/EC (no evidence that certifying officers were informed as to the rules to be followed for drawing up and issuing certificates, and to the extent of enquiries to be performed; indications that certifying officers certified unverified data. Additionally, the lack of a system for traceability, vaccinations and tests of animals does not provide sufficient guarantees on the health status of the animals certified. Finally, the lack of knowledge of what happens with the consignments at the exit border represents a further weakness in the system, the extent of which the mission team was not able to evaluate.

5.7 CONTROLS OVER VETERINARY MEDICINAL PRODUCTS

5.7.1 Legal requirements

Commission Decision 2004/211/EEC lists the countries from which MS may import equidae for slaughter. In addition, all equidae, if not expressly indicated in Section IX of their passport, as established by Article 20 of Regulation (EC) No 504/2008, are regarded as food-producing animals. Article 11 of Council Directive 96/22/EEC indicates that third countries authorising stilbenes or thyrostatic substances, for food-producing animals, may not be on the list of countries from which MS may import such animals; MS must also prohibit the importation of farm animals to which beta agonists, or substances having oestrogenic, androgenic or gestagenic action have been administered, unless these substances meet specific conditions of approval and formulation, and the product is administered and recorded by a veterinarian. Article 29 of Council Directive 96/23/EEC indicates that the retention on the lists of third countries from which MS are authorised to import certain animals (including equidae) shall be subject to submission of a residue monitoring plan. 5.7.2 Findings

According to national legislation (Regulation No 66 of 16.04.2007), VMP may be produced or imported only if they are registered by the SVS, and approved by the Scientific Institute for Control on Veterinary Preparations of the SVS. A public register of such authorised VMPs is kept at the Ministry of Agriculture. The SVS indicated that no stilbene, tyrostatic substance, or any use of hormones or growth promoters have been authorised in the country. Horses are not considered as food-producing animals in Azerbaijan; there is no obligation to record treatments administered to animals. No residue monitoring plan is in place for equidae. Observations : • The authorisation and registration of VMPs is not indicated on the labels or packaging of the

14 VMPs, making it difficult to check whether used products have been duly approved. • In one of the holdings visited, a synthetic hormonal preparation, derivative of stilbene (s inestrol) was used in mares. The SVS indicated that it was a product authorised in human medicine, and subsequently could be used by PVPs in horses. • In some horses holdings visited, records of treatments were kept in a register, but nowhere was there the possibility to record them on individual documents. 5.7.3 Conclusions

The absence of a residue monitoring plan, the insufficient controls on the authorisation and administration of drugs to equidae, and the possible legal use of stilbene derivatives in horses preclude equidae from this country to enter the EU food chain.

6 OVERALL CONCLUSIONS

The significant shortcomings in the organisation and implementation of the import controls of live equidae make the health status of the country unreliable. Evidence for absence of some diseases in the country is insufficient, and part of the national territory is not under official control. In addition, the incomplete legal framework for notification of diseases, and the weaknesses in the control system for identification, registration, movement control and certification of equidae fail to provide guarantees equivalent to those laid down in EU legislation.

7 CLOSING MEETING

A closing meeting was held on 19 October 2009 with the CCA and representatives from the CA of the cities and rayons visited. At this meeting the main findings and conclusions of the mission were presented by the mission team to the national authorities. In their initial response, the representatives of the CCA acknowledged the findings and conclusions presented, and provided further clarification on some of the issues discussed.

8 RECOMMENDATIONS

The Competent Authorities of Azerbaijan are invited to present an action plan describing the action taken or planned in response to the recommendations of this report and setting out a time table, and a description of the actions taken to correct the deficiencies identified, within 25 working days of receipt of the report. N°. Recommendation

1. To provide guarantees that the Competent Authorities are adequately organised and submitted to supervision, and have effective powers and means at their disposal to apply national legislation on the whole territory submitted for authorisation for import of equidae, in line with Article 12 (2) (c) of Directive 90/426/EEC;

2. To provide guarantees that the rules on importation of equidae or products from equidae from other third countries (point assessed according to Article 12(2)(i) of Directive 90/426/EEC), are adequately defined and applied, in order to prevent and

15 N°. Recommendation

control relevant infectious or contagious animal diseases;

3. To provide guarantees that diseases listed in point III(a) of health certificates of Decisions 92/260/EEC and 93/197/EEC and point III(a) of health certificate in Annex II to Decision 93/195/EEC are compulsory notifiable in Azerbaijan;

4. To substantiate the claim that the territory submitted for approval is free from the diseases as required by Article 13, and possibly 15(b) of Directive 90/426/EEC. (e.g. by adequate surveillance programmes and surveys, including when appropriate laboratory investigations).

5. To provide guarantees that registered horses to be exported to the EU are identified with an identification document conforming to Annex I to Regulation (EC) No 504/2008, as required by Commission Decision 96/510/EC, with relevant information in the required health and control sections.

6. To ensure that rules, principles and controls on certification are equivalent to those of Council Directive 96/93/EC (e.g. consider developing a procedure covering all aspects to be certified for export of equidae to the EU, and in particular a procedure describing the nature and extent of tests and enquiries to be performed to certify all points listed in the animal health certificates).

7. To consider the possibility to limit the scope of the request for authorisation both in term of geographical terms (regionalisation, as provided for in Article 13 (2) (a) of Directive 90/426/EEC) and of categories of equidae and movements (Columns 6 to 10 of Annex I to Commission Decision 2004/211/EC), in order to facilitate the design and implementation of relevant actions and control system addressing the findings, conclusions and recommendations of the present report.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/ap/ap_az_2009-8352.pdf

16 ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Dir. 90/426/EEC OJ L 224, 18.8.1990, Council Directive 90/426/EEC of 26 June 1990 on p. 42-54 animal health conditions governing the movement and import from third countries of equidae

Dir. 92/65/EEC OJ L 268, 14.9.1992, Council Directive 92/65/EEC of 13 July 1992 p. 54-72 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC

Dir. 94/28/EC OJ L 178, 12.7.1994, Council Directive 94/28/EC of 23 June 1994 laying p. 66-68 down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species

Dir. 96/22/EC OJ L 125, 23.5.1996, Council Directive 96/22/EC of 29 April 1996 p. 3-9 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

Dir. 96/23/EC OJ L 125, 23.5.1996, Council Directive 96/23/EC of 29 April 1996 on p. 10-32 measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

Dir. 96/93/EC OJ L 13, 16.1.1997, p. Council Directive 96/93/EC of 17 December 1996 28-30 on the certification of animals and animal products

Reg. 882/2004 OJ L 165, 30.4.2004, Regulation (EC) No 882/2004 of the European p. 1, Corrected and Parliament and of the Council of 29 April 2004 on re-published in OJ L official controls performed to ensure the 191, 28.5.2004, p. 1 verification of compliance with feed and food law, animal health and animal welfare rules

17 Legal Reference Official Journal Title

Reg. 504/2008 OJ L 149, 7.6.2008, p. Commission Regulation (EC) No 504/2008 of 6 3-32 June 2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae

Dec. 92/260/EEC OJ L 130, 15.5.1992, 92/260/EEC: Commission Decision of 10 April p. 67-83 1992 on animal health conditions and veterinary certification for temporary admission of registered horses

Dec. 93/195/EEC OJ L 86, 6.4.1993, p. 93/195/EEC: Commission Decision of 2 February 1-6 1993 on animal health conditions and veterinary certification for the re-entry of registered horses for racing, competition and cultural events after temporary export

Dec. 93/196/EEC OJ L 86, 6.4.1993, p. 93/196/EEC: Commission Decision of 5 February 7-15 1993 on animal health conditions and veterinary certification for imports of equidae for slaughter

Dec. 93/197/EEC OJ L 86, 6.4.1993, p. 93/197/EEC: Commission Decision of 5 February 16-34 1993 on animal health conditions and veterinary certification for imports of registered equidae and equidae for breeding and production

Dec. 2000/68/EC OJ L 23, 28.1.2000, p. 2000/68/EC: Commission Decision of 22 72-75 December 1999 amending Commission Decision 93/623/EEC and establishing the identification of equidae for breeding and production

Dec. 2004/211/EC OJ L 73, 11.3.2004, p. 2004/211/EC: Commission Decision of 6 January 1-10 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species, and amending Decisions 93/195/EEC and 94/63/EC

18