com-report-uae

EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

FINAL REPORT OF A MISSION

CARRIED OUT IN

THE UNITED ARAB EMIRATES

FROM 25 JANUARY TO 02 FEBRUARY 2011

IN ORDER TO EVALUATE THE ANIMAL HEALTH CONTROLS IN PLACE ON CAMEL MILK BASED PRODUCTS INTENDED 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 a footnote.

DG(SANCO) 2011-6205 - MR FINAL

Ref. Ares(2011)584078 - 30/05/2011

Executive Summary

This report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in the United Arab Emirates (UAE) from 25 January to 2 February 2011.

The overall objective of the audit was to assess animal health controls in place on the camel population in the UAE in relation to the production of milk and milk-based products intended for export to the European Union (EU). It was organised following a request from this country to be authorised to export these commodities to the EU under conditions set out for countries, listed in column C of Annex I to Commission Regulation (EU) No 605/2010, where there is a threat of foot-and-mouth disease (FMD).

The main outcome of the audit was that, in spite of the condition of the relevant camel farm, which is generally in compliance with the national rules in force, and in spite of the initiative undertaken by a local CA regarding identification and registration of animals, the UAE CCA is currently not in a position to provide the required guarantees concerning animal health in their country. This is a result of a number of weaknesses found during this audit in the field of animal health legislation, CA structures and performance, including laboratories, animal health controls and import controls, combined with the current animal health situation. Therefore, UAE OVs are currently not in a position to sign the relevant health certificate for the export of camel milk and products derived from such milk, as provided for in Regulation (EU) No 605/2010.

In light of the findings and conclusions, recommendations have been made to the CA to address the deficiencies identified.

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Table of Contents 1 INTRODUCTION ........................................................................................................................1 2 OBJECTIVES ...........................................................................................................................1 3 LEGAL BASIS ..........................................................................................................................2 4 BACKGROUND ..........................................................................................................................2

4.1 LEGAL CONTEXT ............................................................................................................................2 4.2 PRODUCTION FIGURES .....................................................................................................................2

5 FINDINGS AND CONCLUSIONS ...................................................................................................4 5.1 LEGISLATION .................................................................................................................................4

5.1.1 LEGAL REFERENCES ................................................................................................................4 5.1.2 FINDINGS .............................................................................................................................4 5.1.3 CONCLUSION .........................................................................................................................5

5.2 COMPETENT AUTHORITIES ................................................................................................................5 5.2.1 LEGAL REFERENCES ................................................................................................................5 5.2.2 FINDINGS .............................................................................................................................5 5.2.3 CONCLUSIONS ........................................................................................................................7

5.3 LABORATORIES ..............................................................................................................................8 5.3.1 LEGAL REFERENCES ................................................................................................................8 5.3.2 FINDINGS .............................................................................................................................8 5.3.3 CONCLUSIONS ........................................................................................................................9

5.4 ANIMAL HEALTH SITUATION AND CONTROLS .......................................................................................9 5.4.1 LEGAL REFERENCES ................................................................................................................9 5.4.2 FINDINGS ...........................................................................................................................12 5.4.3 CONCLUSIONS ......................................................................................................................14

5.5 FARMS .......................................................................................................................................14 5.5.1 LEGAL REFERENCES ..............................................................................................................14 5.5.2 FINDINGS ...........................................................................................................................15 5.5.3 CONCLUSIONS ......................................................................................................................15

5.6 IDENTIFICATION AND REGISTRATION OF ANIMALS / ANIMAL MOVEMENTS / MARKETS ............................15 5.6.1 LEGAL REFERENCES ..............................................................................................................15 5.6.2 FINDINGS ...........................................................................................................................16 5.6.3 CONCLUSION .......................................................................................................................16

5.7 IMPORT CONTROLS .......................................................................................................................17 5.7.1 LEGAL REFERENCES ..............................................................................................................17 5.7.2 FINDINGS ...........................................................................................................................17 5.7.3 CONCLUSIONS ......................................................................................................................18

5.8 INTERNATIONAL VETERINARY CERTIFICATION ...................................................................................18 5.8.1 LEGAL REFERENCES ..............................................................................................................18 5.8.2 FINDINGS AND CONCLUSION ....................................................................................................18

6 OVERALL CONCLUSIONS .........................................................................................................19 7 CLOSING MEETING ................................................................................................................19 8 RECOMMENDATIONS ...............................................................................................................19ANNEX 1 - LEGAL REFERENCES .................................................................................................21

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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation ExplanationADFCA Abu Dhabi Food Control AuthorityAWD Department of Animal WealthBIP Border Inspection PostCA Competent AuthorityCCA Central Competent AuthorityCFT Complement fixation testEU European UnionELISA Enzyme-linked immuno-sorbent assayFMD Foot-and-mouth diseaseFVO Food and Veterinary OfficeHACCP Hazard Analysis Critical Control PointISO International Standardisation OrganisationLFD Lateral flow devicesMOEW Ministry of Environment and Water (CCA)MS Member States of the European UnionNSP Non-structural proteinsOIE World Organisation for Animal Health (Office international des épizooties)OV Official VeterinarianRB Rose BengalSAT Serum agglutination testTerrestrial Code Terrestrial Animal Health Code of the OIETerrestrial Manual Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the

OIEUAE United Arab Emirates

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1 INTRODUCTION

This audit took place in the United Arab Emirates (UAE), from 25 January to 2 February 2011. It was undertaken following an application from the UAE to be approved for imports of certain camel milk products into the European Union (EU). It was the first audit undertaken in this country on this subject. It was combined with an audit on the food safety aspects related to this application, audit DG(SANCO) 2011-6123 and undertaken in accordance with the approved Food and Veterinary Office (FVO) audit programme.

The FVO team comprised two inspectors from the FVO. The team was accompanied throughout the audit by representatives of the Ministry of Environment and Water (MOEW), being the Central Competent Authority (CCA).

An opening meeting was held on 25 January 2011 with representatives of the CAs from central and local levels. At this meeting, the FVO team confirmed the scope of, and the itinerary for, the audit and received additional information from the representatives of the CAs.

2 OBJECTIVES

The objectives of the audit were:

• To assess the animal health controls in place on the camel population in the UAE in relation to the production of camel milk-based products intended for export to the EU;

• To assess the animal health aspects of the veterinary certification conditions in place for camel milk-based products intended for export to the EU in order to verify that they are in compliance with or at least equivalent to those laid down in the relevant EU legislation.

In pursuit of these objectives, the following meetings were held and sites visited:

Site N CommentCA visitsCentral 4 Opening and closing meeting, clarification meeting and

visit to MOEW Customer serviceRegional 1 Regional MOEW Office in Al DhaidLocal 3 Municipal Veterinary Services in Dubai and in Al Ain

(Abu Dhabi)Laboratory visitsOfficial laboratories 3 Central laboratory from MOEW and 2 municipal animal

health laboratories – in addition the laboratory at a border inspection post (BIP) was briefly visited as well

Private laboratories 1Live animal premisesFarms 2 1 dairy cattle, 1 camel farm

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Markets/assembly centres 2Other sitesBorder inspection posts (BIPs) 2 1 serving both a combined land crossing point and a

seaport and 1 in an airport

3 LEGAL BASIS

The audit was carried out under the general provisions of the EU legislation and, in particular:

• Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council, and

• Article 10 of Council Directive 2002/99/EC.

Full legal references are provided in the Annex to this report. Legal acts and international standards quoted in this report refer, where applicable, to the last amended version.

4 BACKGROUND

4.1 LEGAL CONTEXT

Directive 2002/99/EC lays down the general animal health conditions for trade in, and imports of, animal products. In accordance with Article 7, Member States (MSs) shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements applicable to the production, processing and distribution of such products within the Union or if they offer equivalent animal health guarantees. Article 8 of this Directive lays down the conditions for listing third countries from which such imports are allowed under certain conditions.

In accordance with the same Article, Commission Regulation (EU) No 605/2010 draws up a list of third countries from which MS shall authorise imports of milk and milk-based products. Consignments of these commodities from these third countries shall be accompanied by, and comply with, conditions laid down in a health certificate drawn up in accordance with the relevant model included in Part 2 of Annex II to the said Regulation. This Regulation laid down for the first time the model to be used for species other than cows, buffaloes, ewes and goats.

At the moment, the UAE is not authorised to export milk or milk-based products to the EU as it is not included in the above mentioned list.

According to Article 4, Paragraph 2 of the same Regulation, dairy products from other species must have undergone one of the treatments specified in this Article if they are imported from a listed country considered at risk of FMD.

The UAE is not recognised by the World Organisation for Animal Health (OIE) as having an FMD free status as outbreaks are reported from time to time.

4.2 PRODUCTION FIGURES

At the opening meeting; the CCA provided the following livestock figures:

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Table: Livestock population (Source MOEW)

Note: Reg = Administrative region - These regions refer to the administrative organisation of the country and do not correspond to the borders of individual Emirates

No precise figures were available regarding the number of livestock holdings, but according to the CCA, the large majority of animals are kept in so-called Eizabs, i.e. holdings in villages, where animals are kept for the domestic consumption at the owner's household, and only a few commercial farms exist in the country, mainly for dairy cows and dairy camels as well as poultry.

The camel farm interested in export for which the CCA introduced an application for EU approval has approximatively 2500 animals of different ages, from which some 20 to 25% are lactating females. The milk production varies strongly from month to month, with a monthly average of approx 1000 hectolitres. From this production, eight tonnes of milk powder have been exported to one of the Member States spread over several consignments in the last few years.

In view of insufficient national production, large numbers of animals are imported, mainly from Middle East countries and for slaughter. The following import figures were provided by MOEW at the opening meeting. No figures were available regarding imports of camels, but according to the same source, definitive imports are rather exceptional. On the other hand, for the purpose of camel racing and beauty competitions temporary imports do take place regularly, from neighbouring countries.

Table: Imports of farm animals (Source MOEW)

SpeciesNumbers per Year

2008 2009Cattle 23 603 7338 Sheep 1 171 358 774 527 Goats 1 318 789 858 799

In September 2010, the FVO received a request from the UAE CCA to be visited in relation to exports of heat treated camel milk to the EU. This request was accompanied by a number of documents about the organisation of the CCA and some of the relevant UAE legislation, translated into English.

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Species Eastern reg Northern reg Central reg Western reg Total

Sheep 54.016 57.115 171.649 851.174 1.133.954

Goats 385.051 254.366 244.298 909.981 1.793.696

Cattle 6.922 5.888 19.219 33.150 65.179

Camels 798 11.936 62.825 322.548 398.107

Total 446.787 329.305 497.991 2,116.853 3.390.936

5 FINDINGS AND CONCLUSIONS

5.1 LEGISLATION

5.1.1 Legal References

Article 8 of Directive 2002/99/EC provides for the establishment of lists of third countries or regions of third countries from which imports of specified products of animal origin are permitted and requires the Commission to take particular account of, amongst others, the legislation of the third country concerned when drawing up or updating those lists;

To appear in such lists, the CA of the third country should provide appropriate guarantees as regards compliance or equivalence with EU animal health rules.

5.1.2 Findings

In the UAE, legislation at federal level consists of Laws, Decrees (or By-Laws) and Ministerial Resolutions. A similar hierarchy exists for legislation at Emirate level.

According to the information received, there is currently no federal animal health law in place. A draft has been prepared and has been going through the preparation and adoption process for some time. The FVO team was not allowed to see a copy of the draft as it had not yet been approved by the Minister.

However, Law No (10) 2002 on practising the veterinary profession, deals with some animal health issues, such as disease notification, licensing of veterinary clinics and laboratories, as well as farms. Federal Law No (6) 1979 regarding Veterinary Quarantine and, more specifically, Ministerial Decree No (460) 2001 concerning the Executive By-Law on the Veterinary Quarantine in the Cooperation Council for the Arab States of the Gulf, lay down the rules and criteria for imports, exports and transit of animals and products thereof. Implementation rules for these legal framework texts are laid down in some ministerial resolutions and circulars, such as Ministerial Resolution No (191) 2009 concerning the Control of Camel Movement and Transit.

The FVO team received a number of recently adopted ministerial resolutions covering various subjects such as biosecurity on commercial farms, notification of animal diseases, and technical conditions for commercial cattle farms and for commercial camel farms.

Ministerial Resolution (193) 2010 deals with the notification of animal diseases and health procedures in food producing animals. It covers, amongst others, FMD, rinderpest, brucellosis and tuberculosis. In addition, it provides in its Article (8), for the main measures to be taken in the event of an outbreak, such as movement bans, treating sick animals, and starting vaccination in the neighbouring zones.

Apart from this general resolution, there are no specific federal rules regarding control of epizootic diseases nor regarding identification and registration of animals, but the recently adopted Abu Dhabi Regulation No (4) 2010 has installed a comprehensive system for identification and registration of cattle, camels, sheep and goats. While this regulation entered into force in December 2010, its practical implementation has not been completed yet (see section 5.7). In addition, federal Ministerial Resolutions (615) 2009 and (191) 2010 require, albeit implicitly, the farm owners to provide for the identification of their animals and the registration of their herd details. However,

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these resolutions apply only to commercial cattle farms and commercial milking camel farms respectively.

5.1.3 Conclusion

Various legal acts exist in relation to animal health, but there is no general animal health law. No legislation is in place at federal level on official animal identification, although some ministerial resolutions foresee, indirectly, that animals in commercial farms have to be identified.

Some additional legislation has been adopted at individual Emirate level, such as that on identification and registration of animals in Abu Dhabi.

5.2 COMPETENT AUTHORITIES

5.2.1 Legal references

Article 8 of Directive 2002/99/EC provides for the establishment of lists of third countries or regions of third countries from which imports of specified products of animal origin are permitted and requires the Commission to take particular account of the following aspects of CA performance when drawing up or updating those lists:

• the organisation of the competent veterinary authority and its inspection services in the third country;

• the powers of these services;• the supervision to which they are subject;• the means at their disposal, including staff capacity, to apply their legislation effectively.

To appear in such lists, the CA of the third country should provide appropriate guarantees as regards compliance or equivalence with the EU animal health rules.

Regulation (EU) No 605/2010 draws up a list of third countries from which MS shall authorise imports of milk and milk-based products. This Regulation also lays down the animal and public health veterinary certification requirements for the importation into the EU of the said commodities. On the animal health attestation contained in the models of health certificates included in Part 2 of Annex II to the said Regulation, official veterinarians (OV) are required to certify that the milk or milk-based products have been obtained from animals which are under the control of the official veterinary services.

Article 46 of Regulation (EC) No 882/2004 requires the Commission experts, when carrying out official controls in third countries, to pay particular attention to, amongst other things, the existence and operation of documented control procedures and control systems based on priorities. In addition, Article 48 of the same Regulation requires, as one of the conditions for listing third countries for imports into the EU, the existence of adequate official controls.

5.2.2 Findings

Veterinary services in the UAE exist at different levels. Various CAs have responsibilities regarding animal health and their interaction and distribution of duties is not clearly defined.

At federal level, the Department of Animal Wealth (AWD) of the Ministry of Environment and

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Water (MOEW) is the CCA and is responsible for animal health legislation, as well as for imports and exports and international contacts.

At local level (i.e. Emirate or municipal level), state (or municipal) veterinary services exist. Apart from their own animal health work, they also provide assistance to the MOEW, e.g. for practical issues at border crossing points. In addition, for one of the markets visited, the relevant municipality had a veterinary service different from the veterinary service in the relevant Emirate CA.

In the MOEW, separate services exist for Internal and External Audits, the latter one apparently competent for auditing local services. Regional offices of MOEW are responsible for veterinary activities, in particular in regions where the local CA does not carry out this kind of activity.

Practical work in the field is done by veterinary clinics which are either under the responsibility and supervision of the federal or of the local CA.

1) Organisation:

There were no documents available to demonstrate a clear distribution of responsibilities between the federal and local levels. Apart from minutes of two meetings with individual Emirates veterinary services, one in December 2008 with the Abu Dhabi and Dubai CA regarding information on the FMD virus strains to be used in the coming vaccination campaigns, and another one with the Abu Dhabi CA in October 2010 regarding various subjects, such as the laboratory functioning, the sero-surveillance to be carried out and co-ordination between MOEW and the local CA, the FVO team did not see any evidence of a comprehensive co-ordination of activities of the various levels. Supervision of the local services by the MOEW does not take place. However, the team was informed that the MOEW Department for External Audits will carry out audits on the local services in the future, but no details have been provided regarding the start of this exercise. A possible role of another Department in MOEW, the Office of Municipalities Affairs Coordination was not discussed.

No comprehensive maps were available to show the location of federal and state veterinary clinics. However, in the Regional Office visited of the MOEW, a map was available, indicating the sites under their responsibility, such as the federal veterinary clinics and the border inspection post (BIP).

2) Resources:

In the two Emirates where local veterinary services were visited, as well as in the Regional MOEW Office visited, there was no indication of a shortage of manpower and offices and other facilities were generally well equipped. The Dubai CA use hand-held computers to carry out site inspections (in commercial farms and food producing establishments) enabling the relevant inspector to provide the owner of the premises inspected with a print-out of the non-compliances and the score as well as indicating the amount of the fine imposed when applicable. A similar system was used in Abu Dhabi CA.

The Al Ain Veterinary Hospital (under the Al Ain Municipality Branch of Abu Dhabi Food Control Authority - ADFCA) has a number of specially equipped vehicles for mobile anti-tick spraying campaigns.

Also at the BIP for live animals visited, staff provisions (both from MOEW Regional Office and from the relevant Municipal Veterinary Service) appeared to match the needs.

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Training files were seen in one of the local CA and were well documented. In spite of the fact that few or no procedures exist, the inspectors met were generally aware of their tasks. In the CCA, no training files were seen.

3) Documentation:

Various degrees of documented systems were in place, from adequate (such as these in the MOEW Regional Office Customer Service, responsible for issuing import permits and establishment licences), to basic, with a lack of clear procedures for some of the activities. MOEW's intranet gives information regarding legislation.

As mentioned above, in one State Veterinary Service (in Dubai Municipality), checklists were available on hand-held computers with evidence of the non-compliance report being issued to the inspected farms. In that CA, a line management was in place for the approval of the inspection reports. Apart from the print-outs of the non-compliance reports, inspectors completed an inspection card available in the farm, allowing an easy overview of the dates of the inspections and the main items inspected.

Almost no standard operating procedures were in place.

As far as reporting is concerned, forms and modalities differed between the various CAs visited. Either individual monthly activity reports of the veterinary clinics or overview reports for all clinics under a certain office were forwarded, generally by email, to the relevant head offices.

4) Transparency – communication – information to the public:

Although in general the CA representatives were cooperative and open, there were some difficulties in a few instances regarding access to files and openness of discussions. With a few exceptions, these could be solved by the intervention of the relevant hierarchy.

In particular, the head inspector at a border inspection post for food and products of animal and plant origin refused to show the FVO team documentation regarding exports of camel milk which had taken place through this post. He claimed that access to such documentation could only be provided if his hierarchy, as well as the company concerned had formally authorised him to do so and that such authorisation could not be obtained at short notice during the FVO visit.

As far as communication is concerned, officials make wide use of email and mobile phones for keeping in touch with their colleagues and/or respective headquarters. For importers, MOEW's website contains a list of the different import bans and restrictions in place.

Regarding information to the public, at various sites the FVO team saw examples of leaflets provided to the farmers for increasing awareness for animal health issues, as well as information to veterinarians.

5.2.3 Conclusions

The complex CA structures with unclear integration and coordination between the different levels make it rather difficult to understand in each case which CA is the relevant one for providing animal health guarantees for farms or herds in a particular part of the territory. In addition, the lack of a well documented system and a lack of openness towards the FVO team noted during some visits

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reduce the transparency of the system.

5.3 LABORATORIES


Article 8 of Directive 2002/99/EC provides for the establishment of lists of third countries or regions of third countries from which imports of specified products of animal origin are permitted and requires the Commission to take particular account of the following aspect of CA performance when drawing up or updating those lists:

(b) the means at their disposal, including staff capacity, to apply their legislation effectively.

Article 46 of Regulation (EC) No 882/2004 requests the Commission experts, when carrying out official controls in third countries, to pay particular attention to, amongst other things::

(d) the resources including diagnostic facilities available to CA

5.3.2 Findings

Laboratories in the UAE active in animal health exist at the different levels.

The MOEW Department of Laboratories under the Executive Director for technical affairs has a network of four laboratories dealing with animal health. One of them, the Veterinary Laboratory of the Sharjah Central Laboratory is referred to by the CCA as the national reference laboratory for animal health. The other three MOEW veterinary laboratories are part of the quarantine facilities located at major entry points for imported live animals (port, airport and land border posts) while, in addition, MOEW has laboratory facilities in its four regional offices, as well as a laboratory in Al Ain, dealing with residues and pesticides. The large majority of samples tested within this network are from imported animals.

The Municipalities of Dubai and Al Ain have their own animal health laboratories, both visited by the team. According to information received, similar laboratories exist in other Municipalities of the Emirate of Abu Dhabi. Municipal laboratories mainly carry out tests in the context of surveillance for certain diseases and for diagnosis in case of clinical disease.

A number of private laboratories are also active in the field of animal health, one of them being an OIE reference laboratory for camel pox and glanders. Such laboratories are not subject to any official controls apart from the fact that they need to be licensed by MOEW. They are entitled to carry out testing of samples, submitted to them by farm owners, for animal diseases including those subject to legal requirements or official surveillance programmes.

As far as the national reference laboratory is concerned, no evidence of the designation of the laboratory concerned has been shown to the FVO team. In addition, this laboratory did not organise any inter-laboratory proficiency testing with other official laboratories in the UAE, nor did it participate itself in any such testing schemes organised by international reference laboratories abroad or by accreditation organisations. According to information provided to the FVO team, the laboratory receives samples for confirmation from other laboratories. However, in one of the municipal laboratories visited, the FVO team was told that Sharjah laboratory sent some samples to them for confirmation.

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Of all laboratories visited, only one at municipal level was accredited and had a quality system in place. This laboratory also underwent inter-laboratory proficiency testing regarding brucellosis testing with a national reference laboratory in one of the MSs.

The private laboratory visited worked to high standards but lacked accreditation. Surveillance samples taken on the camel farm proposed for export of milk or milk products to the EU were tested only in this laboratory and results were sent directly to the farm. However, the laboratory is not approved by the CA for official controls.

Generally, the tests used for FMD and brucellosis in all laboratories visited were those of the OIE diagnostic manual11: in particular a commercial Enzyme Linked Immuno-Sorbent Assay (ELISA) test is used for the detection of antibodies against the non-structural proteins (NSP) antigens of FMD virus. When the number of samples was low, a rapid test (Lateral flow devices - LFD) was used for this purpose in the Sharjah laboratory. For brucellosis, the Rose Bengal (RB) test and a commercial ELISA for the detection of the antibodies against Brucella sp were used and, for confirmation purposes in some laboratories, the complement fixation text (CFT).

However, weaknesses seen in most laboratories visited concerned the lack of use of control samples other than those provided by the kit manufacturer, i. e. no international reference material is used during the performance of the ELISA tests to verify whether false positives and false negatives can be excluded. Another weakness noted in all laboratories but one was the absence of inter-laboratory proficiency testing.

In addition, none of the tests had been validated for camels.

Documentation in the different laboratories visited was of different standards, but in several no detailed test protocols, registers or work sheets were available.

5.3.3 Conclusions

Serious weaknesses in several of the official laboratories visited undermine the reliability and transparency of their work. These weaknesses concern mainly the lack of accreditation and even of a quality control system, the lack of organisation of national, and participation in international, inter-laboratory proficiency testing and the lack of use of international reference material for providing negative and positive controls. Interpretation of test results is jeopardised by the fact that the OIE recommended diagnostic methods are not validated for testing camel samples.

Results provided by the private laboratory concerning testing for diseases for which certain legal requirements exist, such as FMD or brucellosis, cannot be considered as official controls.

Finally, the lack of CA supervision on laboratories and the limited collaboration between the laboratories provide insufficient confidence that a comprehensive laboratory network is dealing with animal health issues in the UAE.

5.4 ANIMAL HEALTH SITUATION AND CONTROLS


Article 7 of Directive 2002/99/EC requires that products of animal origin intended for human

1 http://www.oie.int/fileadmin/Home/eng/Health_s tandards/tahm/2.01.05_FMD.pdf

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http://www.oie.int/fileadmin/Home/eng/Health_s%20tandards/tahm/2.01.05_FMD.pdf

consumption that are introduced from third countries must comply with the animal health requirements of Chapter 1 of the said Directive, applicable to all stages of the production, processing and distribution of such products in the Union, or offer equivalent animal health guarantees thereto.

Article 8 of the same Directive provides for the establishment of lists of third countries or regions of third countries from which imports of specified products of animal origin are permitted and requires the Commission to take particular account, amongst others, of the following aspects of CA performance when drawing up or updating those lists:

(g) the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;

(h) the regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases in its territory, particularly the notifiable diseases listed by the World Organisation for Animal Health (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases listed in the Aquatic Animal Health Code of the OIE;

(i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries.

On the animal health attestation contained in model 'Milk-HTC' of health certificates included in Annex II to Regulation (EU) No 605/2010, OVs are required to certify that the milk or milk-based products have been obtained from animals which

(i) were under the control of the veterinary services,

(ii) belong to holdings which were not under restrictions due to FMD and rinderpest, and,

(iii) were subject to regular veterinary inspections to ensure compliance with animal health requirements of Regulation (EC) No 853/2004.

The animal health conditions of Regulation (EC) No 853/2004 referred to above (Annex III, Section IX, Chapter I) are, in particular, as follows:

1. Raw milk and colostrum must come from animals:

(a) that do not show any symptoms of infectious diseases communicable to humans through milk and colostrum;

(b) that are in a good general state of health, present no sign of disease that might result in the contamination of milk and colostrum and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder;

(c) that do not have any udder wound likely to affect the milk and colostrum;

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2 (a) In particular, as regards brucellosis, raw milk and colostrum must come from:

….

(iii) females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the competent authority has approved.

(b) As regards tuberculosis, raw milk and colostrum must come from:

….

(ii)females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the competent authority has approved.

3. However, raw milk from animals that does not meet the requirements of point 2 may be used with the authorisation of the competent authority:

….

(c) in the case of females of other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, but belong to a herd where brucellosis or tuberculosis has been detected after the checks referred to in point 2(a)(iii) or 2(b) (ii), if treated to ensure its safety.

The Report of the second meeting of the OIE ad hoc group on diseases of camelids2 mentions the diseases of relevance for the different species of camelidae. FMD and rinderpest are not in the list for the dromedary camels, while brucellosis caused by B. melitensis is mentioned as known to produce significant diseases. Other diseases for which the relevant species is mentioned as known to be a potential pathogen carrier, are Q fever and tuberculosis (TB).

In the Terrestrial Animal Health Code of the OIE (hereafter: the Terrestrial Code)3, the age of testing the animals for brucellosis is equal to or more than 12 months and 6 months for brucellosis in cattle and in sheep and goats respectively; and for TB equal to or more than six weeks in cattle .

In addition, OIE standards apply regarding diagnosis of FMD as laid down in chapter 2.1.5 of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE (hereafter: the Terrestrial manual)4

A similar approach was followed in relation to diagnosis of brucellosis and bovine tuberculosis; in addition to applicable EU standards, the FVO team assessed the situation against OIE standards in that regard as laid down in chapters 2.4.3 and 2.4.7, respectively, of the Terrestrial manual.

There are no specific requirements for Q fever, either in EU law or in the Terrestrial Code.

2 http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/A_Diseases_Camelids_May10.pdf 3 http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/ 4 http://www.oie.int/international-standard-setting/terrestrial-manual/access-online/

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http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/

http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/

http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/A_Diseases_Camelids_May10.pdf

5.4.2 Findings

5.4.2.1 Foot-and-mouth disease (FMD)

Intensive vaccination campaigns against FMD are carried out three times annually by the official services using inactivated vaccines in cattle and sheep and goats. Although vaccination is strongly recommended, it is not compulsory. Vaccines used are laid down in a list approved by MOEW and are imported from international producers (Turkey, France, Russia). Camels are not vaccinated. There is no monitoring of the efficacy of the vaccination.

The last outbreak notified to the OIE occurred in wild animals kept in a zoo in 2009. According to MOEW figures, there were 10 sheep clinically suspected in 2010, but the results of the confirmatory tests were negative.

However, the FVO team saw evidence in a private laboratory that a further clinical outbreak occurred in another game enclosure in March 2010 and that the virus was isolated and confirmed in the World Reference Laboratory (Pirbright). Similarly, the data of the same laboratory showed that in December 2010, sero-positive wild animals (oryxes) were found in another fenced area, with antibodies indicating virus circulation.

Some active serological surveillance is carried out in cattle and small ruminants aiming to detecting infected animals with negative results in recent years. In this context, according to MOEW figures, 3969 and 1024 samples were tested in 2009 and 2010 respectively, all with negative result. This surveillance did not cover camels.

As explained in Section 5.1, Ministerial Resolution (193) 2010 deals with the notification of animal diseases and health procedures in food producing animals. It covers, amongst others, FMD, rinderpest, Q fever, brucellosis and tuberculosis and provides in its Article (8), for the main measures to be taken in the event of an outbreak, such as movement bans, treating sick animals, and starting vaccination in the neighbouring zones. These are not specific for any particular disease and are not very precise, as no details are provided such as how long measures remain in place, or how big the vaccination zone has to be. There is also no provision for any compensation of owners for their losses, but this is less relevant as infected animals are not killed and destroyed.

In addition, no operational contingency plan exists for FMD at federal level. However, at the final meeting, the FVO team received a document, which the CCA representatives described as the federal contingency plan for FMD. This document did not bear any date nor heading, making it impossible to perceive it as an approved plan with a certain legal value. It describes basically the elements which have to be taken into account to draft a contingency plan for epizootic diseases in general, such as the need to conceive a strategy and to designate an official responsible for the issue. A second document, provided to the team at the same meeting, prescribes the main features of FMD, including disease symptoms, but does not provide any concrete indication or description of action which should be taken in the event of an outbreak.

At local level, the CA of Dubai Municipality, provided a generic plan to the FVO team which covered possible strategies to control epizootic diseases but this plan did not clearly prescribe specific measures to be taken in the event of certain diseases. A more specific plan was available for avian influenza. From discussions with officials it appeared that in the event of a clinical outbreak, animals would be treated and emergency vaccination applied in a zone around the outbreak, combined with a stand-still.

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The CA and the farm veterinarians have explained that FMD monitoring in camels is not relevant as this species would be less susceptible, or even not susceptible at all, to FMD virus infection, which is in line with the above-mentioned OIE report on diseases of camelids.

5.4.2.2 Rinderpest

According to information provided by the CCA, the UAE has been free from rinderpest since 1995. However, there is limited relevance of the rinderpest situation as, according to the technical information available at the OIE, camelidae are “dead-end hosts and do not transmit the virus”5 the disease is also not listed in the above-mentioned OIE report on diseases of camelids.

According to information received at the MOEW laboratory, 3475 samples had been tested in 2010 for this disease, all with negative result.

5.4.2.3 Q Fever

According to information received at the opening meeting, Q fever has never been reported in the country.

5.4.2.4 Brucellosis controls

Brucellosis testing is carried out as an annual survey in commercial farms, as well as in private family holdings in susceptible animals, including camels. For the latter species, some difficulties were experienced concerning doubtful testing results. Blood samples are generally taken by the farm's own veterinarians and often tested in private laboratories. Also, in one of the markets visited where cattle and camels were sampled, such private laboratories were used for the testing of the samples.

In the framework of the surveillance programme in 2009, 6018 were tested (with 18 testing positive but no camels were positive). In 2010, the figure was 900 (70 camels, 450 cattle, 205 sheep and 175 goats, from which 2 tested positive (1 goat and 1 sheep).

According to the information received, B. melitensis cases occur in different species but apart from culling the positive animals, no clear policy is followed regarding the rest of the herd. No evidence has been seen that a herd status is attributed confirming freedom of the disease. In view of the absence of a reliable identification system and of harmonised movement controls, such status would only make sense for commercial farms with a strict regime of testing and isolation of newly purchased animals. This was the case in the cattle farm visited, where records were available demonstrating the results of the annual testing. All animals of two years of age or above were included in the sampling, as well as newly introduced animals sampled during the isolation period on the farm. No records were available on the testing of the four breeding bulls on this farm. In addition, milk ring testing took place on bulk milk on a monthly basis, in the framework of the company's own check programme.

In the camel farm concerned, although a large percentage of newly purchased camels reacted positively to the test, no clinical signs were ever recorded which were attributed to brucellosis, according to information received. Aborted foetuses were routinely investigated micro-biologically, but isolation of Brucella had not been reported since the farm was established in 2006.

5 http://www.oie.int/animal-health-in-the-world/technical-disease-cards/

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http://www.oie.int/animal-health-in-the-world/technical-disease-cards/

However, the above mentioned Ministerial Resolution (193) 2010 could allow the CA to impose measures if the zone where the outbreak is found is declared an “infested zone”.

5.4.2.5 Bovine tuberculosis (TB) controls

Similarly, programmes for TB testing of cattle are in place. Reactors are culled but no information was available on the post-mortems carried out on such animals.

In the commercial cattle farm visited it was explained that intra-dermal tuberculin testing was done annually by the Municipal CA. Only animals of two years or older are tested, except for newly introduced animals which undergo the test during the isolation period on the farm. Reactors were allegedly never recorded in this farm.

As camels appear not to provide reliable results with intra-dermal tuberculin testing, no such testing takes place. It was claimed by the farm veterinarian that TB is not a significant risk in camels, which is not in line with the above-mentioned OIE report on diseases of camelids.

5.4.3 Conclusions

The animal health situation in the UAE is not completely clear as only limited information on disease outbreaks was available and indications were seen that not all outbreaks were necessarily notified. In addition, the UAE approach to animal disease control is different from that applied within the EU as no clearly defined control measures are in place for FMD and as control measures for zoonotic herd diseases, such as brucellosis or TB are not considered to be equivalent to the requirements of EU legislation.

Therefore, and in view of the above mentioned findings, the CA cannot provide equivalent guarantees regarding animal health, in particular on the following points:

• Clinical outbreaks of FMD are apparently quite rare in farmed animals, which could be explained by a frequently organised vaccination campaign – even though its efficacy is not monitored. Nevertheless, the sub-clinical presence of FMD virus cannot be excluded. Moreover, there is no clear policy regarding measures to be implemented in the event FMD infected animals are found. In addition, weaknesses found in FMD notification undermine the reliability of the CA.

• In addition, the monitoring programmes for brucellosis and TB do not cover all animals which would be eligible for testing within the EU. In the absence of a clear eradication programme for these diseases, it is difficult to provide guarantees equivalent to the EU rules.

The FVO team was not in a position to investigate the claim that camels would not be susceptible to FMD and that bovine TB is a low risk for the species.

5.5 FARMS


As explained in section 5.4.1, OVs are required to certify on the animal health attestation contained in model 'Milk-HTC' of health certificates included in Annex II to Regulation (EU) No 605/2010, that the milk or milk-based products have been obtained from animals which

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(i) were under the control of the veterinary services,

(ii) belong to holdings which were not under restrictions due to FMD and rinderpest, and,

(iii) were subject to regular veterinary inspections to ensure compliance with animal health requirements of Regulation (EC) No 853/2004.

5.5.2 Findings

Commercial cattle and camel farms are the subject of specific technical requirements in the federal legislation6 including the designation of a licensed farm veterinarian, own checks in the format of a HACCP7 system, biosecurity, isolation of animals before their introduction, identification and registration of the animals kept, vaccination and testing programmes. Such farms must be licensed.

The FVO team saw evidence of the inspection reports on both farms. In one of the municipalities visited, print-outs of the scoring results after each inspection were seen.

Both farms visited were operating in accordance with good farming practices and records regarding health care (treatments, vaccinations, sampling) and production were kept in good order. A HACCP system was in place and had been verified during some of the CA inspections. The technical requirements of the federal legislation were largely met on the two farms visited, although the FVO team observed some minor deficiencies not reported upon by the CA inspectors during their regular (approx monthly) visits: as an example, in both farms, certain requirements regarding fences were not completely observed.

The camel farm's licensing was seriously delayed because of a problem to license the foreign farm veterinarians. In spite of the fact that it had been operating since 2006 and supplying milk for export for several years, the licence was only granted in January 2011.

5.5.3 Conclusions

The specific requirements for commercial farms in place can assist the CA in providing additional guarantees for the safety of their products, provided that they keep being properly implemented and enforced.

5.6 IDENTIFICATION AND REGISTRATION OF ANIMALS / ANIMAL MOVEMENTS / MARKETS



(b) the organisation of the competent veterinary authority and its inspection services in the third country; the powers of these services; the supervision to which they are subject; the

6 In particular Ministerial Resolutions (615) 2009 and No. (192) 2010, on the Technical and Health Conditions of Cattle farms and Camel Farms respectively, as well as No (185) and (186) of 2010 on Quality and Safety of Animal Farm Production and on Bio-security for Farm Animals respectively

7 Hazard Analysis Critical Control Point

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means at their disposal, including staff capacity, to apply their legislation effectively.

....


5.6.2 Findings

Apart from a pilot project in one of the Emirates which has reached its final stage of implementation and includes herd registers, no legal requirement exists to identify farm animals in the UAE. However, in commercial farms, the owners are obliged to identify and record their animals. The FVO team noted in the two commercial farms visited that this rule was well respected.

For animal movements, no legislation is in place. In the absence of any animal identification for non commercial farms, it would be virtually impossible to conceive a reliable movement control system. However, some movements were seen, such as sheep and goats arriving at a market from a BIP quarantine located in a different Emirate, for which a clear identification of the animals and a movement document issued by the Municipality vet services were available.

In one of the markets visited, a reasonably well organised system of controls at arrival was in place and documents were generally providing information regarding the vaccination status of cattle and the sampling status of cattle and camels. However, the fact that there was no clear link between the documents relating to the origin of the animals and the register of the animals checked, which was in the form of loose sheets, made traceability rather cumbersome.

Some animals seen at the same market had already received identification marks in accordance with the above mentioned pilot project.

At the other market visited, used mainly for slaughter animals, the OV stated that he carried out only a clinical check on each consignment and that most of the animals were not traceable. No records of these checks were kept, but inspection records from the supervisory OV showed that some supervision took place. The fact that the market was emptied daily and animals which had not be sold for slaughter went back to the traders' premises can be considered a potential risk for spreading infectious diseases, in particular as most of the animals in this market had been imported previously.

5.6.3 Conclusion

There is no system equivalent to that in the EU in place for identification and registration of animals as only commercial farms have to identify their animals.

The current pilot project developed in one Emirate offers valuable possibilities and it will be interesting to see the development and a possible extension of the system to the whole country. However, an assessment of the system was not possible as it is not yet fully implemented.

Therefore, and combined with the absence of a clear and generally applicable animal movement control system, it is virtually impossible for the CA to provide full traceability of animals introduced into given farms.

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5.7 IMPORT CONTROLS



….


5.7.2 Findings

A system is in place for limiting the risk of introducing animal diseases through the import of animals and their products. While this is a federal competence, in particular regarding the issuing of import permits and export certificates for live animals, some BIPs are under the Municipal Veterinary services, like the BIP in one of the ports in Dubai.

At the MOEW Regional Customer Office, the FVO team learnt about the procedures in place for issuing import permits. In spite of legal restrictions, import permits have been issued for live animals from FMD infected countries, in particular in Africa and the Middle East. The team saw an import permit issued on the day of the visit, for imports of camels from an African country which is not FMD free according to OIE data, in spite of the provisions of Ministerial Resolution No (191) 2009 concerning the Control of Camel Movement and Transit which bans imports of camels from countries which are not FMD free.

In the case of another African country with an unfavourable animal health situation, it was explained that imports were only granted for consignments from a certain quarantine station in that country. For live animals, other than slaughter animals, import licences are only granted to licensed holdings, which are inspected yearly to check, amongst other things, whether their capacity is sufficient to house the imported animals.

The BIP visited with a quarantine premises attached was in a good state of maintenance and hygiene and generally well documented. However, certain weaknesses were noted, in particular the fact that the facilities were used both for imports and exports (export certification is done by the OV at the BIP), that the sampling of three animals per consignment on heterogeneously composed consignments is unlikely to be statistically relevant and that regularly infected animals (brucellosis and/or FMD) are regularly discovered leading to the destruction of the positive animals only and the return of the other animals to the country of origin.

Animals are often not identified at all when being imported and do not systematically receive an identification when leaving the quarantine facility (used for holding the animals during the time needed for testing in the laboratory on site). In addition, different documents/procedures are used when releasing the animals after a favourable test, such as a release document issued by the relevant Municipal services assisting the MOEW (but without any stamp) or a manifest issued and stamped by the customs services, while at the market in Dubai, no document was apparently available for

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animals imported through the local BIP.

For imports of animal products, one BIP was visited, which appeared to work in accordance with certain procedures and using a well documented system for random sampling of consignments in relation to risk. Physical checks mainly concerned quality and integrity of packaging, and compliance of labelling. Imports of animal products are only from approved countries according to information provided from MOEW, explaining that country lists were comparable to EU third country lists. MOEW documents regarding temporary import restrictions from certain countries were available. Generally they did not concern animal health issues (apart from restrictions imposed as a result of the bovine spongiform encephalopathy situation in the country of origin), but were linked to food safety issues.

The inspector in this BIP, from Dubai Municipality claimed not to be entitled to provide answers to specific questions regarding the export of camel milk products from the relevant company (see more details in section 5.2.2).

5.7.3 Conclusions

The CCA have put a great effort into organising systematic import controls for live animals and animal products. However, serious weaknesses exist in the import system, in particular for live animals. These weaknesses increase the likelihood that infectious diseases might enter the territory from abroad.

5.8 INTERNATIONAL VETERINARY CERTIFICATION

5.8.1 Legal References

Annex II to Regulation (EU) No 605/2010 contains the models of health certificates that lay down the animal and public health veterinary certification requirements for the importation into the Union of milk and milk-based products. In particular, it notes on its Part 1 that:

• The original of the certificate must be completed and signed by a representative of the CA responsible for verifying and certifying that the milk or milk-based products meet the requirements of Regulation (EC) No 853/2004;

• The CA of the exporting country shall ensure that the principles of certification equivalent to those laid down in Directive 96/93/EC are followed.

5.8.2 Findings and conclusion

The FVO team was not able to check whether the principles of good certification were adhered to as they did not receive the requested information in the BIP visited (see section 5.2.2). However, the FVO team dealing with the food safety aspects of camel milk exports did check this issue in the certification office they visited. Findings and conclusions will therefore be reported upon in report (DG)SANCO 2011-6123.

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6 OVERALL CONCLUSIONS

In spite of the condition of the relevant camel farm, which is generally in compliance with the national rules in force, and in spite of the initiative undertaken by a local CA regarding identification and registration of animals, the UAE CCA is currently not in a position to provide the required guarantees concerning animal health in their country. This is a result of a number of weaknesses found during this audit in the field of animal health legislation, CA structures and performance, including laboratories, animal health controls and import controls, combined with the current animal health situation.

Therefore, UAE OVs are currently not in a position to sign the relevant health certificate for the export of camel milk and products derived from such milk, as provided for in Regulation (EU) No 605/2010.

7 CLOSING MEETING

A closing meeting was held on 2 February 2011 with representatives of the CCA and some local CA during which the FVO team presented its main findings and initial conclusions. The CCA acknowledged the findings presented and asked for clarification of certain issues.

8 RECOMMENDATIONS

The CCA of the UAE. is invited to submit an action plan describing the actions taken or planned in response to the recommendations of the report and setting out a timetable for their completion. This information should be presented to the Commission within 25 working days of receipt of this report.

N°. Recommendation

1. The CCA should consider to adopt the necessary missing legislation regarding animal health without delay. In particular, they should consider the accelerated adoption of the animal health law and the adoption of specific and detailed rules for disease controls, applicable in the whole territory, in line with the requirements of Article 8, Paragraph 1, a) of Directive 2002/99/EC.

2. The CCA should consider to improve the organisation and functioning of their services at different levels, in line with Article 8, Paragraph 1, b) of Directive 2002/99/EC. This should in particular cover an improvement of the coordination between the different levels of the CA and increased transparency.

3. The CCA should ensure that laboratories involved in the official control apply the principles of internationally recognised quality assurance techniques, such as ISO/IEC

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N°. Recommendation

17025 or equivalent, and use internationally recognised quality assurance programmes /standards, where available, for standardising test methodologies and testing proficiency to ensure the reliability of analytical results.

4. The CCA should consider to improve disease notification and control systems, in line with Article 8, Paragraph 1, h) of Directive 2002/99/EC.

5. In order to be able to provide reliable guarantees on the origin of animals used for the production of camel milk for export, in line with the requirements on good certification principles of Directive 96/93/EC, the CCA should consider:to extend the animal identification and registration system which has been put in place by one of the Emirates, but only when an assessment of its implementation in practice has been conducted by all relevant authorities,organise a system of movement controls for live animals, in particular but not exclusively in the event of disease outbreaks.

6. The CCA should consider reinforcing import conditions and controls in line with Article 8, Paragraph 1, i) of Directive 2002/99/EC

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

http://ec.europa.eu/food/fvo/ap/ap_ae_2011-6205.pdf

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http://ec.europa.eu/food/fvo/ap/ap_ae_2011-6205.pdf

ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Dir. 64/432/EEC OJ 121, 29.7.1964, p. 1977-2012

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30

Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products

Dir. 2002/99/EC OJ L 18, 23.1.2003, p. 11-20

Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption

Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin


Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption


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

Reg. 605/2010 OJ L 175, 10.7.2010, p. 1-24

Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption

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com-report-uae

Documents

animal health controls

export of camel milk

production of milk

relevant health certificate

milkbased products

european union eu

camel population

uae cca