EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL FINAL REPORT OF A MISSION CARRIED OUT IN PORTUGAL FROM 15/01/01 TO 19/01/01

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/3166/2001 MR final FINAL REPORT OF A MISSION CARRIED OUT IN PORTUGAL FROM 15/01/01 TO 19/01/01 IN ORDER TO MONITOR THE PROGRESS OF THE Brucella melitensis ERADICATION PROGRAMME Please note that comments from the Portuguese authorities on factual errors have been included in bold, italic print in the body of the report. Comments providing additional information or expressing their view on particular issues are included as footnotes (in bold, italic print). 08/06/

2 TABLE OF CONTENTS 1. INTRODUCTION OBJECTIVES OF THE MISSION LEGAL BASIS FOR THE MISSION BACKGROUND Summary of previous mission results Response to recommendations of previous FVO report Eradication programme for MAIN FINDINGS Competent authority structure and responsibilities Farm Registration Animal Identification Movement controls Eradication programme Food safety controls CONCLUSIONS General Competent authority performance Animal identification and movement controls Eradication programme Food safety controls

3 7. CLOSING MEETING SUMMARY RECOMMENDATIONS To the competent authorities of Portugal To the Commission Services ADDENDUM

4 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT ADSs ALGV ALTJ BI BL BMEP BMF BMOF CCA DGV DIV DRA DSV EDM FVO GLP LNIV MS OPPs PISA PTE RBT RO TM Agrupamentos de Defensa sanitària (Co-operative structures now replaced by OPPs) Algarve Alentejo Beira Interior Beira Litoral Brucella melitensis eradication programme Brucella melitensis free (according to the definition of Council Directive 91/68/EEC). Brucella melitensis officially free (according to the definition of Council Directive 91/68/EEC) Central Competent Authority (ies) Direcção Geral de Veterinária (State veterinary services) Direcções Intervenção Veterinária (Local Veterinary Services) Direcção Regionais de Agricultura (Regional Agricultural Board) Direcções de Serviço de Veterinária (Regional Veterinary Services) Entre Douro e Minho Food and Veterinary Office Good Laboratory Practice Laboratorio Nacional de Investigação Veterinária (LNIV) Member State Organisação dos Produtores Pecuarios para a defesa sanitária dos ruminantes (Co-operative structures set up under official guidance responsible for a defined geographic area. The veterinarians associated are authorised for official duties through compulsory registration in the National Veterinary Council). Programa Informático de Saude Animal Portuguese Escudo Rose Bengal Test Ribatejo e Oeste Trás os Montes 4

5 1. INTRODUCTION The mission took place in Portugal from 15 to 19 January The mission team comprised 2 inspectors from the Food and Veterinary Office (FVO). The mission was undertaken as part of the FVO's planned mission programme The inspection team was accompanied throughout the mission by a representative from the central competent authority (Direcção Geral Veterinária - DGV). An opening meeting was held on 15 January 2001 with the Direcção Geral Veterinária. At this meeting, the objectives of, and itinerary for, the mission were confirmed by the inspection team, and additional information required for the satisfactory completion of the mission received. 2. OBJECTIVES OF THE MISSION The objective of the mission was to evaluate the progress of the Brucella melitensis eradication programme (BMEP) undertaken in A number of previous missions relating to the BMEP have been carried out in Portugal. This mission was the first of a series of missions to be undertaken in 2001 to all Member States where Community funded Brucella melitensis eradication programmes are in place. In pursuit of this objective, the following sites were visited: COMPETENT VISITS Competent authority AUTHORITY Comments Central 1 Regional 2 Local 2 ADSs Private farmer organisations which perform testing and control functions as part of the eradication programme. LABORATORY VISITS Central/reference 1 Regional 1 LIVE ANIMAL CONTROL SITES Farms 5 Vehicle disinfection facility 1 Comments Comments FOOD ESTABLISHMENTS PROCESSING Slaughterhouses 1 Milk processing premises 1 Comments 5

6 3. LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation and, in particular: Council Decision 90/242/EEC 1 of 21 May 1990 introducing a community financial measure for the eradication of brucellosis in sheep and goats. Commission Decision 98/139/EC 2 of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in Member States. Council Decision 90/638 3 of 27 November 1990 laying down Community criteria for the eradication and monitoring of certain animal diseases. Council Directive 91/68/EEC 4 of 28 January 1991 on animal health conditions governing intra-community trade in ovine and caprine animals. Council Decision 90/424/EEC 5 of 26 June 1990 on expenditure in the veterinary field 4. BACKGROUND 4.1. Summary of previous mission results Since 1953, Portugal has carried out campaigns of control of caprine/ovine brucellosis. The Community introduced financial measures for the eradication of brucellosis in sheep and goats in 1990 (Council Decision 90/242/EEC). A yearly programme is submitted to the Commission, which evaluates it for approval, and carries out inspection missions to check compliance with the programme. The previous mission took place in June 2000 and the report of this mission (DG(SANCO)/1095/2000 MR final) is available on the Health and Consumer Protection Directorate General internet site at The report of the previous mission made the following recommendations in respect of the action required of the competent authority in Portugal: 1. Consider the development and implementation of specific plans for regions or areas with high prevalence of the disease. 2. Enforce controls by the official services in respect of ADSs/OPPs, in particular those which do not currently accept the national policy. 3. Complete the transposition of Community legislation into national legislation, in particular Article 5(c) of Council Directive 92/102/EEC, and 1 Official Journal L 140, 01/06/1990 p Official Journal L 038, 12/02/1998 p Official Journal L 347, 12/12/1990 p Official Journal L 046, 19/02/1991 p Official Journal L 224, 18/08/1990, p

7 the requirements of Annex C to Council Directive 91/68/EEC, without undue delay. 4. An application should be made to the Commission services for a derogation from the provisions of Article 5(6) of Council Decision 90/242/EEC, for approval for testing vaccinated animals more than 30 months old. 5. Measures should be taken by the LNIV: to intensify control of laboratories certified to carry out serological tests for Brucella melitensis, to organise annual blind ring tests, to reduce the time for confirmatory CFT on samples coming from Algarve and to evaluate results of bacteriological tests with the aim of improving the eradication strategy. 6. National and Community legislation on milk from infected herds should be implemented in order to ensure that milk and milk products constitute no risk to human consumers. 7. An information campaign should be launched to target groups and consumers of potentially contaminated milk and milk products and the appropriate measures should be taken in the infected herds. 8. National legislation on the restriction of movements in the herds classified as infected should be implemented and sanctions applied as laid down in Decreto-Lei 338/ National legislation on cleaning and disinfection of vehicles used for transport of positive animals should be implemented Response to recommendations of previous FVO report During the current mission the action taken by the Portuguese authorities in response to these recommendations was assessed and the following is a summary of this action: Recommendation 1: Vaccination has been extended to cover particular regions and neighbouring parts of other regions. Within the Algarve region, no specific plans have been developed to accelerate eradication in areas of high incidence. Recommendation 2: While co-operation between OPPs and the official services has improved, there is still insufficient monitoring and checking of the activities of the OPPs. Recommendation 3: While instructions relating to the recording of the retagging of animals have been issued, this provision was not seen to have been implemented. The application of the CFT to negative RBT samples in herds where the prevalence of Brucella melitensis exceeds 5% has been implemented. Recommendation 4: An application has been made to the Commission for a derogation permitting the testing of vaccinated animals from the age of 36 months. Recommendation 5: Supervision of the regional laboratories by the LNIV has been enhanced and blind ring tests are being prepared. The Algarve laboratory now performs testing by CFT and the need for samples to be sent to the LNIV has been eliminated. 7

8 Recommendation 6: Instructions have been issued requiring notification of creameries of the status of supplying flocks. However, in one case seen during this mission, this provision had not been implemented. Recommendation 7: While various leaflets containing information on the disease in animals and humans are available, no information campaign has been initiated. Recommendation 8: Control of the movement of animals from infected flocks remains insufficient. Plans are in place to record details of individual animal identification numbers and this will improve the controls in this area. Recommendation 9: Cleaning and disinfection of vehicles was satisfactory at the slaughterhouse visited during this mission. The designation and approval of strategically located vehicle cleaning and disinfection facilities is in progress. In addition, and following the recommendations of a previous FVO mission, a non-compliance with Community legislation (Dir.91/68 Annex C) regarding the standardisation of the antigen used for the RBT has been rectified Eradication programme for 2000 The Portuguese programme for 2000 was approved by Commission Decision 2000/5/EC 6 of 30 November 1999 approving the programmes for the eradication and monitoring of animal diseases presented for the year 2000 by the Member States This programme details the control measures to be implemented, including those relating to animal identification, movement controls, classification of holdings, sampling frequency, laboratory testing, slaughter of positive animals, depopulation of severely infected flocks and compensation payments. 5. MAIN FINDINGS 5.1. Competent authority structure and responsibilities Services involved in the eradication programme Official services The central State veterinary services, Direcção Geral de Veterinária (DGV), forms part of the Ministry of Agriculture, Rural Development and Fisheries (Ministério da Agricultura, do Desenvolvimento Rural e das Pescas). It is organised on the basis of a central, pyramidal management system. Full details of the structure and activities of the Ministry can be found on their website at Within the DGV, and acting under the Director of Animal Health Services(Servicos de Saude Animal), a post of National Co-ordinator of the Brucella eradication programme was created in December OJ L 003, 06/01/2000 P

9 The official veterinary services are decentralised in Portugal and are included in the Regional Agricultural Boards (DRA, Direcção Regional de Agricultura), of which 7 are operative in mainland Portugal and one each in the Azores and Madeira. These regional veterinary services (DSV, Direcção de Serviços de Veterinaria) operate with local units (DIV, Divisõas de Intervenção Veterinària). In addition at local level, there are smaller administrative units or municipalities (the Concelhos). Each Concelho has at least one municipal veterinarian (Autoridade Sanitària Veterinària Concelhia); these are state veterinarians working for two different ministries (60% Ministry of Interior and 40% Ministry of Agriculture Rural Development and Fisheries). When the need arises, they can be deployed full time to work for the Ministry of Agriculture, Rural Development and Fisheries. DSVs depend for technical co-ordination on the DGV, but are administratively independent. The DIVs supervise the relevant activities regarding animal identification, herd registration, movement permits, eradication programmes and contingency plans. Non-official services Most of the practical aspects related to the eradication programme are implemented through co-operative structures set up under official guidance, the Organizações de Productores Pecuários (OPPs) (previously called the Agrupamentos de Defensa sanitària (ADSs)). These OPPs cover the entire territory of mainland Portugal. More than 90% of the farmers are associated with OPPs. In the Azores, this work is done by the official regional veterinary services, as no similar structures exist there. The veterinarians associated with the OPPs are authorised for official duties through compulsory registration in the National Veterinary Council. They are involved in health control linked to the eradication programmes, as well as to animal identification and registration for small and large ruminants. Some OPPs are also authorised to issue movement documentation. There is one veterinary co-ordinator per OPP assisted by several veterinarians. In case of emergencies, they can also be required by the DGV to assist at local level. In relation to the Brucella melitensis eradication scheme, OPPs are paid on the basis of the total animals eligible for sampling in their area. No additional payments are made where flocks are sampled more than once per year Independence The staff of the official services are independent of the industry. However, veterinarians employed by the official services at all levels are permitted to conduct private veterinary practice outside official working hours subject to authorisation from the Minister of Agriculture. As the OPPs are private farmer organisations, the veterinarians employed by them are, in effect, required to monitor the activities of their employers and to report irregularities to the official services. 9

10 Resources The annual budget allocated for veterinary measures is approved by the Ministry of Economic and Finances; 5 billion PTE ( ) was the budget for the year The total expenditure on Brucella melitensis eradication is approximately 8,000,000. Of this total, approximately 2,000,000 is provided from European Community funds. The EC contribution has been reduced in recent years Personnel Personnel resources at the DGV level consist of 145 veterinarians out of 451 total staff. At the regional level (DSV+ DIV), a total of 615 veterinarians are employed. At local level (Concelhos), about 250 veterinarians are working. In addition, there are a total of 119 private veterinary co-ordinators employed by the OPPs, who are further assisted by more than 400 private veterinarians. The Brucella eradication programme co-ordinator, operating at central level has the responsibility of monitoring the implementation of the programme throughout Portugal and of providing guidance to the DRAs. In carrying out these tasks, he may call on the part-time assistance of other staff within the DGV. In the DRAs, although there is a designated regional co-ordinator in all regions, this person usually has other additional responsibilities. Many of the tasks and responsibilities associated with the eradication programme may be split between a number of officials. This situation also applies in the DIVs. The mission team was informed that it is not always possible to complete all the necessary tasks (e.g. epidemiological investigations of infected flocks) due to manpower shortages. In the OPPs, the frequency of sampling of infected flocks and the checks of flock records were not performed as required due to a shortage of staff Recruitment and training Recruitment of staff is done at the respective central and regional levels. Planning for the total number of posts to be filled is made at central level and decided at ministerial level. Training is organised at the DGV level. There is a special division dealing with this aspect (Divisão de Formação, Informação e Documentação). In relation to the Brucella eradication programme, one training course is held per year. This course is attended by veterinarians working in the ADSs, is of two weeks duration, and covers all aspects of the work of these veterinarians. Attendance is not compulsory. The brucellosis eradication element of the course is approximately one day. There are approximately 20 places available per course so that a veterinarian working for an OPP can expect to attend one course every 10 years. 7 In their response to the draft report, the Portuguese authorities commented that the failure of the OPPs to carry out the prescribed number of inspections in infected herds is due to a failure to implement the approved programme, rather than a lack of staff. 10

11 An additional course covering informatics will be held in 2001 to improve the use of the national animal health database PISA. The DRAs also perform staff training and have a special department for this purpose Legal/enforcement powers Veterinary legislation has its basis in different national laws, which establish the role of the DGV, the DRA and the application of the measures in the veterinary field. While the DGV does not have direct authority over the activities of the DRAs, it may report to the Minister and request that he instruct the DRAs accordingly 8. In cases where flock owners do not co-operate with the programme (e.g. where they withhold reactor animals from slaughter), the official services may enforce the legislation through the courts. However, this is a lengthy and difficult process and only a small number of cases were initiated in New guidelines have been issued on the presentation of cases to the courts in order to increase the success rate of such cases Prioritisation of controls On a national basis, the National Co-ordinator is in a position to set control priorities in relation to the activities of the regional services. Instructions have been issued to the DSVs to increase inspections of infected herds. At regional level, and particularly in those regions where responsibility for implementation of the programme is unclear, controls are not prioritised Documentation of controls Technical reports on the eradication programmes are requested from the regions three times a year. The approval for the depopulation of infected flocks is given by the DGV on an ad hoc basis (the criteria used are set out in the legislation). The OPPs are required to submit, for approval, an annual programme of activities to the DGV Transposition of EC legislation EC legislation relating to all aspects of the eradication programme of Brucella melitensis has been transposed into national legislation. The principal legislation with the most recent amendments is listed below: Compulsory notification of disease (decree law 39209/1953), Animal identification and movement control (decree law 338/99), 8 9 In their response to the draft report, the Portuguese authorities have commented that, from a technical point of view, the DGV has direct authority over the activities of the DSVs of the DRAs. However, it does not have direct administrative authority. In their response to the draft report, the Portuguese authorities have commented that, if owners do not co-operate with the programme, the DSVs must impose the penalties provided for in the Decree-Law regulating the eradication programme. 11

12 All measures to combat brucellosis and health classification of holdings (decree law 244/2000), Health measures for marketing of raw milk and milk processing (decree law 533/93), With regard to slaughter of reactor animals/depopulation and compensation payments, further national legislation has been introduced (despacho conjunto 530/2000 and 371/2000). Rules concerning cleaning and disinfection of vehicles approved for animal transport are laid down in Decreto-Lei 338/99. Further clarification of the requirements is provided by Circular nº 133 of 10 August A more complete description of the Portuguese legislation in force is provided in FVO report DG(SANCO)/1095/2000 MR final Liaison with human health authorities The Department of Health informs the DGV of cases of brucellosis in humans on a monthly basis. The names and addresses of those affected are not given (the age, sex and municipality are provided). No information on whether these are the result of Brucella abortus or Brucella melitensis is provided. The DGV passes this information to the relevant region. Apart from this notification of human cases of brucellosis, there are no formal co-ordination mechanisms between the Ministries of Agriculture and Health. There are personal, informal contacts between staff in the two organisations. A number of the veterinarians encountered during the mission indicated that they suspected that there was significant under-diagnosis of the disease in humans due to a lack of awareness by medical practitioners Laboratory service (general) The Laboratorio Nacional de Investigação Veterinária (LNIV) of Benfica- Lisbon is the national reference laboratory. It is directly responsible to the Ministry of Agriculture, Rural Development and Fisheries. Each region has a state laboratory which performs serological testing. Some regional laboratories also perform bacteriology and parasitology. The regional laboratories are independent from the LNIV for their management. They are financed from the DRA s budget. In addition, there are some private laboratories, and laboratories belonging to the OPPs, at regional level. A total of 19 laboratories operate on the mainland with 5 on the islands. The LNIV is responsible for the accreditation of all the regional laboratories (state-owned and private) and for licensing them to participate in the eradication programmes. The LNIV organises audits of the regional laboratories and provides training for their technicians. The LNIV is responsible for supplying the regional laboratories with the reagents and necessary materials for standardisation of the diagnostic tests. Payments for performing official tests (e.g. brucellosis) are made through the DGV. 12

13 5.2. Farm Registration Description of the farming systems for sheep and goats In some regions of Portugal, the animal husbandry systems are not modernised with many small holdings with very basic animal housing facilities. A significant number of farmers own very small farms and in some cases do not own land. These farmers use rented grazing land, common grazing land or land that has been vacated by families moving to the cities and tourist areas to find employment. As a consequence there is direct and indirect contact between animals from different holdings. Fields contaminated with infected placentas and aborted foetuses may be grazed by animals from another holding. Many overnight pens and animal houses do not have impervious floors or smooth walls. In such circumstances, thorough and effective disinfection of infected premises is unachievable. Many of the breeds found in Portugal reach sexual maturity at an early age Description of herd registration system All persons wishing to receive a herd registration (marca) are entitled to do so by application to the DIV. While the location of the holding must be declared, there is no requirement for the applicant to specify the land on which the animals will be kept. Statistics for the last decade show significant variations in the numbers of registered holdings from year to year Operation of system One of the holdings visited possessed no land and used land belonging to other people in the area. This holding was infected and numerous reactors had been detected over a number of years. Some of the land used was also grazed by sheep and goats from other flocks. In one case a new registration had been granted to an owner, whose flock had been depopulated because of severe Brucella infection, almost immediately following depopulation. The flock owner had been allowed to purchase animals into this newly registered holding on the condition that the animals were held on separate land. In another case, and immediately following depopulation of a flock, a new registration number was granted to the wife of the flock owner who then kept newly purchased animals on the affected pasture. The flock owner subsequently repopulated his flock with animals from his wife s flock. This flock continues to yield Brucella melitensis reactors Animal Identification Description of system Two tags are used to identify sheep and goats: The right ear is used for tags inserted for zoo-technical reasons and for breeders associations. These tags bear the registration number of the holding where the animals were first tagged. 13

14 The left ear is used for official tags. These tags are supplied bearing a unique number. When applied to an animal, the registration number of the holding should be written on the tag using a special pen supplied by the tag manufacturer. Sheep and goats are tagged at the time that they are first blood sampled or vaccinated under the eradication scheme. Tags are supplied to the OPPs who have responsibility for their application. Additional identification, in the form of a tattoo or a green eartag in the left ear, is applied to vaccinated animals. This identification is composed of one digit referring to the year of vaccination, and 3 letters referring to the region, the concelho and month of vaccination. Animals in infected herds should also be additionally identified by a tattoo or other approved method. Official documentation states that this tattoo should be applied to the right ear. However, the mission team was informed that this was incorrect and that the tattoo should be applied to the left ear Operation of system Many animals were seen with official tags on which the holding registration number had not been inscribed. No remedial action had been initiated by the OPP when collecting blood samples from the flock. No records of the re-tagging of animals are kept, either by the flock owners or by the services (OPP) performing the tests on flocks. No register is kept by the OPPs to record which tags have been applied on which holdings. This information may be obtained through study of the blood sampling records but is not readily or easily available. Tags were not securely stored at one OPP office visited Movement controls Description of system Farm owners receive a flock passport for small ruminants (Passaporte de Rebanho). These passports should be kept on the farm but are generally held in the office of the OPP with which the farm is associated. All owners of sheep and goats must keep a herd registration book listing the total number of sheep and/or goats and the number of females which are over 12 months of age or have given birth. The movements of small ruminants entering and leaving the farm, the date of such movements and the place of origin and destination must be recorded in the farm registration book. According to Decreto-Lei 338/99, it is compulsory that farmers forward to DIV a declaration of the animals present in the farm (once a year, in December). In order to move animals legally between premises, flock owners are required to obtain a permit (guia). Three types of permit are used, depending on the destination of the animals: Movement to slaughter Sheep and goats being transported to an abattoir must be accompanied by a movement permit for immediate slaughter (guía de trânsito por abate imediato) 14

15 and a copy of the flock passport (passaporte de rebanho). The flock passport specifies the Brucella melitensis status of the flock. For sheep and goats over 6 months of age, the individual tags numbers of the animals moved should be given, either on the guía or on the copy of the flock passport. For herds classified as infected (category B2), permits are issued by the official services (DIV) or by an OPP which has signed an agreement (protocol) relating to the issue of permits. Guía de trânsito por abate imediato are in the form of self-carboning duplicates. One copy is retained by the issuing authority (DIV or OPP) while the original accompanies the animals. For BMF and BMOF flocks (categories B3 and B4), the flock owner may be authorised to issue a guía de trânsito por abate imediato for animals moving to slaughter. In such cases the owner is required to sign a protocol relating to the correct use of permits. Small numbers of permits are issued to the flock owners, who must account for their use before being allowed to obtain a fresh supply. Prior to issue, the permits are inscribed with the details of the flock to which they are issued. Movement to another farm or to a collection centre Sheep and goats transported to another farm or a collection centre situated in the same region must be accompanied by a movement permit (guía de trânsito) and a copy of the flock passport. The individual tag numbers of animals over 6 months of age should be recorded on the guía or on the copy of the flock passport. Guía de trânsito are in the form of self-carboning triplicates. One copy is retained by the issuing authority (DIV or OPP), the second is retained by the source flock owner and the original accompanies the animals. BMF and BMOF flocks may avail of a dispensation, similar to that for guía de trânsito por abate imediato, for the issue of guía de trânsito. Movement to a farm or to a collection centre in another region For BMF and BMOF flocks, the guía de trânsito is used. For flocks not of BMF of BMOF status, where the farm and/or the collection centre of destination is located outside the region, a health movement permit (guía sanitària de trânsito) is used. The Guía sanitària de trânsito may only be issued by a DIV Operation of system The various types of guía do not contain an indicator of the age of the animals being moved and it is not possible to determine from the guía whether the individual numbers of the animals should be specified (a previous version of the guía did require this information) In their response to the draft report, the Portuguese authorities have commented that, whenever the animals being moved have individual identification, this must be entered in the appropriate place in the movement permit. 15

16 In one case seen during the mission, animals of more than 6 months of age had been moved, yet the tag numbers of the animals were not recorded on the guía. Where a guía de trânsito por abate imediato is issued by a DIV or OPP, the copy of the permit is retained at the office and the only documentation available at farm level is the copy of the flock passport. In such cases insufficient information is available on-farm to enable a meaningful check of compliance. In one case, blank guía (with flock details inserted prior to issue) had been issued for use by a flock classified as B3. However, the flock owner had not signed the necessary protocol to avail of this facility. In a number of farms visited, the flock register had not been completed and the records were inaccurate. None of the problems seen during the mission had been identified by the OPPs when carrying out flock sampling and record checks Eradication programme No part of the Portuguese territory is declared Brucella melitensis officially free, according to the definition given in Council Directive 91/68/EEC. The Azores and Madeira are claimed to be free of the disease. The mission team was informed that data is being collated for submission to the European Commission to support this claim and to have the Azores and Madeira declared BMOF Disease statistics Progress of the B. melitensis situation for the period (2 trimesters): 1. Herd prevalence: YEAR Total HERDS Number of tested herds Positive herds % herd prevalence Once tested >1 tested TOTAL 1999 * , : 1 trimester , : 2 trimester ,29 * results for 1999 were presented differently and therefore some of the figures are not available; as from 2000, statistical data are presented in compliance with EC/2000/ Prevalence in small ruminants: YEAR Total animals Number of sampled animals Positive animals Once tested >1 tested TOTAL 1999 * : 1 trimester : 2 trimester * results for 1999 were presented differently and therefore some of the figures are not available; as from 2000, statistical data are presented in compliance with EC/2000/322. % prevalence 16

17 3. Evolution of B.melitensis by region YEAR 1999* ` trimester 2` trimester DRA Total Herds Posit. herds % herd prev. Herds tested once Posit. Herds % herd prev. Herds tested once Posit. herds EDM , TM , BL , BI , n.a n.a. n.a. RO , ALT , ALG , Total , * results for 1999 were presented differently to those for Informatics system / recording of information % herd prev. The Programa Informático de Saude Animal (PISA) is the national database for animal health. There is a communications network connecting all the sites where PISA is operated. However, the application itself is not networked. Each site runs its own version of the programme and versions differ slightly between sites depending on the type of office (OPP, DIV, DRA) and on the distribution of programme updates. The data entered at one location is not automatically available at other locations. Data is transferred between sites by means of floppy diskettes or by . Details of all registered holdings are held by the system (the addition of a new holding can only be performed by the official services). Data is entered by the DIV and is then distributed to other sites by or diskette. Flock tests are recorded by the OPPs when these are performed. Individual identification numbers of the animals tested are not recorded on the system in all regions. The system has recently been upgraded to hold individual animal identification numbers and their test results. It was stated that the recording of the individual animal identification numbers will be made compulsory in the second semester of When a flock test is completed, the list of animals sampled (and the relevant sample bottle numbers) are sent in paper form to the relevant laboratory. Serology results are recorded on these forms, which are then forwarded to the relevant DIV. At the DIV, the results (on a flock basis) and the resultant herd status are entered into the PISA system. This information is then forwarded to the relevant OPP by floppy diskette or by . For each holding, PISA stores a record of all tests carried out as well as data on flock treatments (vaccinations, anthelmintics) administered by the OPPs. PISA does not hold details of epidemiological studies of infected herds. Data of the relationships between herds (use of common pastures, transhumance) cannot 17

18 be recorded on the system in such a way that this information can be easily retrieved and utilised. The transfer of data by and diskette causes delays in the updating of information, and decisions made may not be based on up-to-date information. The lack of recording of individual tag numbers on the PISA system prevents the use of the system to trace individual animals or to verify herd movement records. In the regional and OPP offices visited, documentation was filed by document type and not by flock. As a consequence, retrieval of all relevant data for a particular flock was extremely difficult and time consuming. PISA produces summaries of the disease situation and these summaries are based on the model approved by the Commission Classification of holdings Holdings are attributed a flock health status for Brucella melitensis, based on test results, farm history and disease situation in the area. The BM eradication programme differentiates between 4 different health statuses. B1 Infected for the first time B2 Infected or non-free holding B3 Brucellosis free B4 Officially brucellosis free The classification and criteria used in the grading are laid down in Portuguese legislation (the legislative classification recognises three statuses: non-free, free and officially free). The definitions valid for B4 and B3 reflect the definitions for flocks officially free from B. melitensis (BMOF) and free from B. melitensis (BMF), as given in Council Directive 91/68/EEC. At the time of the previous mission (DG(SANCO)/1095/2000), classifications B2.1 and B2.2 were used for non-disease free holdings with current positive serology and non-disease free infected holdings without current positive serology holdings respectively. This distinction has been removed from the official classification system but remains in use at regional and local level. Newly registered farms are classified as B1. Two consecutive negative serologies of the whole flock are required in order to obtain a B2.2 classification. B2.1 flocks pass to a B2.2 status when two consecutive negative serologies with an interval of 3 to 6 months are obtained after slaughter of all reactor animals.. During the previous mission, many holdings eligible for classification as B4 (BMOF) were classified as B3 (BMF). The reason given was that the animal health status of the surrounding flocks and the possibility of common grazing was taken into consideration in determining the classification. In the intervening period, the number of BMOF flocks has increased. However, the mission team visited one farm which was classified as B3 (BMF) despite the fact that it had been free of Brucella for a number of years, had secure perimeters and operated a closed flock system. 18

19 Testing regime During 2000, a number of Circulares have been sent by the DGV to the DRAs to inform them about the application of the new legislation and the new strategy to be followed for the implementation of the BMEP. A new strategy for the BMEP was implemented during As part of this strategy, epidemiological units (individual flocks, villages where common grazing was practised) were to be identified. The testing regime, as defined in the eradication programme, is as follows: Holdings classified as B2: Serological tests must be performed on all animals over three months of age at 6 to 12 week intervals. A positive result to either RBT or CFT is considered as confirmation of infection. For epidemiological units with a prevalence greater than 5%, all RBT negative tests should be further tested using CFT. In practice all samples are tested by RBT and CFT. For epidemiological units with a prevalence less than 2 %, testing may be by RBT or CFT at the discretion of the regional authority. In practice samples are tested by RBT and all samples negative to RBT are further tested using CFT. For epidemiological units with a prevalence between 2 % and 5%, all samples must be testing using RBT. Further testing by means of CFT is discretionary. In practice samples are tested by RBT and all samples negative to RBT are further tested using CFT. When positive animals are slaughtered, the collection of bacteriological samples is mandatory. Vaccinated animals must be tested using RBT. All positives to the RBT should be further tested by CFT. Vaccinated animals must be more than 36 months of age before sampling. (Article 5(6) of Council Decision 90/242/EEC requires that testing of vaccinated animals commences at 18 months of age. Since the previous Brucella melitensis mission to Portugal, the Portuguese authorities have submitted a request for a derogation from this provision). Holdings classified as B3 or B4: Flocks should be tested once per year. Within such flocks the following animals should be sampled: 25% of all females of breeding age or in lactation. A minimum of 50 samples should be collected plus All animals purchased since the previous flock test plus All male animals. All samples should be tested using the RBT. Where seropositives are found, these should be slaughtered and bacteriological samples submitted for confirmation. 19

20 Additional movement controls Flocks classified as B2 are only permitted to sell animals for immediate slaughter. While the mission team did not see evidence of the inter-flock transfer of animals from restricted flocks, it was informed that this occurs and that it is difficult to verify that the restrictions have been complied with due to the lack of recording of individual animal numbers on the PISA system. Positive animals should be marked by means of a punch hole in the left ear Disinfection procedures - infected farms / transport vehicles A number of vehicle cleaning and disinfection facilities are being established throughout Portugal. These require approval from the regional authorities. When a vehicle is cleaned and disinfected at one of these facilities, a certificate of disinfection is issued to the driver. At the slaughterhouse visited, this system was in place and was operating correctly. In the Algarve region, 15 disinfection facilities have applied for approval and these applications are being processed. One vehicle cleaning and disinfection facility was visited. The facility was situated at a riding school and had only recently been approved. Pressurised water and cleaning chemicals were available. At the time of the visit the only vehicles that had utilised the facility were vehicles for the transport of horses Vaccination policy Vaccination has been re-introduced in some regions as a measure to accelerate the eradication process. Now, vaccination is performed in Beira Interior, Tras os Montes, Entre Douro e Minho and Beira Litoral. Vaccination of all young animals is done on farms in these regions with more than 5% disease prevalence Laboratory services Diagnostic tests used. Beside microbiological techniques, the following serological tests are used in the BM eradication programme: Rose Bengal Agglutination Test (RBT) Complement Fixation Test (CFT) The use of a modified Rose Bengal test is now in the process of validation at the LNIV. This test would increase the sensitivity. The possible use of this test in the eradication programme has been discussed with the other MS involved in the programme at a meeting in December Laboratories involved in the eradication programme. The LNIV has not yet licensed all regional laboratories despite the fact that they perform serological tests for the eradication programme. So far, all private laboratories (7) and 6 out of 12 public laboratories have been licensed. Of those that are not licensed, one laboratory has been closed (Setúbal, RO) while the 20

21 others continue to work. The mission team was assured by the LNIV that as long as they perform the serological tests correctly, the non-licensed laboratories could continue to work for the eradication programme while necessary structural improvements are made. All regional laboratories perform the RBT. Most of the regional laboratories (7 private laboratories and 5 out of the 12 public laboratories) are now using the CFT test. There is at least one laboratory in each region that can perform the CFT. Antigen production for both RBT and CFT used in Portugal is produced and controlled in the LNIV. No accreditation by an independent body for serological techniques has been granted to the central laboratory nor to the regional laboratories. A quality assurance project was started in 1998 and is progressing. In the central laboratory Good Laboratory Practice guidelines are being implemented. However, the anonymity of incoming samples was not respected both in the LNIV and in the regional public laboratory in Faro. Written procedures were seen in the central and regional laboratories visited. The LNIV has taken part in a ring test organised for all MSs by the CRL in Weybridge. Every year the regional laboratories are inspected by the LNIV. During these checks 50 samples are taken for re-testing at the LNIV and the results obtained in the regional laboratories and the LNIV compared. Within the next few months a blind ring-test will be organised by the LNIV for the regional labs. The LNIV organises training sessions for the staff in the regional laboratories. Refresher courses are organised for existing staff members at 2 yearly intervals and new staff receive induction training in the LNIV before commencing work in the regional laboratories. Bacteriology is carried out in the LNIV, in the laboratory of Oporto (a subdivision of LNIV), the public laboratory of Evora (the Evora laboratory is not licensed) and the Veterinary Laboratory on the island of Terceira in the Azores. Under the eradication programme, bacteriological analysis is done on organs from positive reactor animals and on material from abortions. In addition, testing of blood samples from slaughtered reactor animals has recently commenced. In the regional laboratory in Faro, both the RBT and CFT are carried out. The laboratory had recently (June 2000) started using CFT after receiving training in the LNIV. Management of incoming samples is done satisfactorily. Although incoming samples receive an internal serial number, names of herd-owners are recorded throughout the process of analyses. Written protocols for the serological tests were present. The ph of the antigen was not checked in the laboratory in Faro. CFT is routinely performed on all RB-negative samples from infected herds. Test results are normally available within one week following submission. While this laboratory appeared on the list of licensed laboratories, the mission team was informed by the head of the laboratory that the serology department had yet not been licensed by the LNIV Removal of positive animals / flocks Removal of positive animals 21

22 Following notification of results from the laboratory, the DIV arranges to remove positive animals. The relevant OPP and the flock owner are informed of the result of the test (but not of the identification numbers of the positive animals) and an appointment is made for the collection of the reactors. An official from the DIV accompanies the transport vehicle to the farm and supervises the loading of the animals to be removed. In two of the positive flocks visited during the mission, not all positive animals had been found at the time of removal for slaughter, and it must be assumed that these remained on the farm or were sold. In neither case were legal sanctions applied against the flock owner, nor was an investigation of the circumstances initiated or immediate re-sampling of the flock carried out. Information given to the mission team shows that the average time between detection of positive animals and the slaughter of those animals has been reduced to 30 days. However, a small number of cases were seen where there were considerable delays (the greatest being 11 weeks between results and slaughter). The eradication programme specifies a maximum period of 45 days between the time the flock owner is notified of the results of testing and the removal of the reactor animals. Removal of positive flocks (depopulation) The criteria for the depopulation of whole flocks are: The finding of positive bacteriological results and/or A herd prevalence of more than 15 % and/or The presence of positive males and/or. The absence of a favourable evolution of the disease. The decision to depopulate a flock originates from the DRA who must obtain the approval of the DGV before proceeding. During the mission, records were seen of a considerable number of flocks that had continually yielded positive animals over many years. No decision had been taken to depopulate these flocks. Some of these flocks used common grazing land and thus constituted a source of reinfection for other flocks Epidemiological studies of infected holdings The mission team was informed that epidemiological studies should be carried out on all infected holdings. In the Algarve, it was stated that it was not possible to conduct epidemiological studies of all infected herds due to staff shortages. The mission team did not see any evidence that thorough epidemiological studies were carried out or that these were used to develop strategies in relation to problem flocks and to problem areas. In particular the following are not performed: movement traces of animals purchased (to try to identify the source of disease), forward traces of animals sold (to identify other flocks that may have become infected), 22

23 investigations of grazing policy / use of common pasture /transhumance (to identify direct and indirect contact with other flocks). The number of abortions reported to the official services is extremely low. Most flock owners encountered during the mission were not aware of the need to report abortions Compensation system Compensation payments have been revised during Flock owners receive PTE15,000 per breeding female slaughtered for eradication purposes. An addition PTE3,000 per animal is paid when a flock has been depopulated. Compensation payments are administered by the IFADAP (Institute for the Financing and Support of Development in Agriculture and Fisheries). Following slaughter of the animals all documentation is sent to them for processing and payment. The average time between depopulation and payment of compensation has been reduced over a number of years and it was reported that farmer co-operation with the eradication programme has improved as a consequence. However, on the one farm visited where depopulation had taken place, the flock owner reported that he did not receive any payment until 4 months after the slaughter of his animals. In relation to premium payments, those farmers who do not fully co-operate with the system receive the same subventions as those who co-operate fully. The health status of the flocks has no bearing on the receipt of premium payments Food safety controls Milk and milk products Production of fresh cheese produced from raw milk is only authorised from BMOF and BMF flocks. On one milk production farm visited, the milk was delivered to a collection point. The eventual destination of the milk was not known, either to the flock owner or to the official services. While the flock in question was free of brucellosis, it was obvious that no mechanism existed for informing the processor of any infected flocks delivering milk to the collection point 11. The LNIV reported that they received very few samples of milk and milk products for bacteriological testing. In 2000, 55 samples of goats cheese and 6 samples of sheep milk were examined, of which 8 and 1 respectively were positive for Brucella melitensis. 11 In their response to the draft report, the Portuguese authorities have commented that, following the FVO mission in 2000, the DRAs were instructed to keep all industries regularly informed of free and officially free holdings. 23