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CARDS TWINNING PROJECT BA05-IB-AG-01 ACTIVITY 3.1 “ANALYSIS & SUPPORT OF VETERINARY INSPECTIONS”

Report of Visit 3.3

20 July 2007 Version Final

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Visit 3.3: Assessment, Comparison and Support of Controls Within the Fields of Transmissible Spongiform Encephalopathies and Animal By-Products in Bosnia and Herzegovina with Reference to Best Practice in

the European Union (Regulations (EC) No. 999/2001 and 1774/2002)

EXECUTIVE SUMMARY A team of veterinary experts from Germany and the United Kingdom carried out an assessment of controls within the fields of transmissible spongiform encephalopathies (TSEs) and animal by-products in Bosnia and Herzegovina from 18 to 21 June 2007. The assessment was carried out with reference to EU requirements. The visit team concluded that national legislation on TSE controls should be harmonised with current EU requirements and that the implementation of national TSE legislation could be improved. A cattle identification programme is being implemented and a similar programme for small ruminants is planned. There is limited surveillance for BSE in cattle but there is effectively no surveillance programme for TSEs in small ruminants. Both TSE testing laboratories are designated as National Reference Laboratories for TSE although neither has the facilities to confirm TSE. Neither laboratory was accredited and only one has satisfactory containment facilities. Specified risk material is disposed of at official or unofficial burial sites. Although the national legislation prohibits the feeding of mammalian meat and bone meal to ruminants, there are no official controls to monitor compliance with this feed ban. The visit team provided a number of recommendations to the competent authorities and the laboratories with the aim of moving TSE controls in BiH towards those in the EU. ABBREVIATIONS The report contains the following abbreviations: AIA Animal Identification Agency BiH Bosnia and Herzegovina BSE Bovine spongiform encephalopathy CA Competent authority CCA Central competent authority CRL EU Community Reference Laboratory DB District of Brčko ELISA Enzyme-linked immunosorbant assay EU European Union FSA Food Safety Agency FBiH Federation of Bosnia and

Herzegovina FVO EU Food and Veterinary Office HACCP Hazard Analysis and Critical Control

Points


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IEC International Electrotechnical Commission

IHC Immunohistochemistry ISO International Organisation for

Standardisation LAVES Landesamt für Verbraucherschutz

und Lebensmittelsicherheit, Niedersachsen, Germany

MAWRMF Ministries of Agriculture, Water Resource Management and Forestry

MMBM Mammalian meat and bone meal MoFTER Ministry of Foreign Trade and

Economic Relations NRL National Reference Laboratory NRL-TSE National Reference Laboratory for

TSE OIE World Organisation for Animal Health RS Republika Srpska SRM Specified Risk Material SVO State Veterinary Office TSE Transmissible spongiform

encephalopathy UKAS United Kingdom Accreditation ServiceWRL World Reference Laboratory (of OIE) CONTENTS 1. Introduction 1.1. Objectives 1.2. Relevant EU Legislation 2. Main Findings 2.1. Background 2.2. Competent Authorities 2.2.1. Legislation 2.2.2. Veterinary Services 2.3. Epidemio-Surveillance 2.4. Laboratory Services 2.5. Eradication 2.6. Specified Risk Material (SRM) 2.7. Feed Controls 3. Conclusions 3.1 Competent Authorities 3.1.1 Legislation


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3.1.2. Veterinary Services 3.2. Epidemio-Surveillance 3.3. Laboratory Services 3.4. Eradication 3.5. Specified Risk Material (SRM) 3.6. Feed Controls 4. Final Meeting 5. Recommendations 5.1 Competent Authorities 5.1.1 Legislation 5.1.2. Veterinary Services 5.2. Epidemio-Surveillance 5.3. Laboratory Services 5.4. Eradication 5.5. Specified Risk Material (SRM) 5.6. Feed Controls Annex 1 – Officials Involved in the Visit Annex 2 – Questionnaire for BSE Status Recognition by OIE 1. INTRODUCTION The visit took place in Bosnia and Herzegovina (BiH) between 18 and 21 June 2007. The visit team consisted of two veterinary experts from Germany and one veterinary expert from the United Kingdom. 1.1. Objectives The objectives of the visit were: - to evaluate the competent authorities and veterinary services; the epidemio-surveillance programme; the laboratory capacity; and the national control and training programme in relation to the control and eradication of transmissible spongiform encephalopathies (TSEs) in BiH with reference to European Union (EU) requirements. - to provide recommendations to the Central Competent Authority (CCA) on improving the programme for the control and eradication of TSEs in BiH with reference to EU requirements. On 18 June 2007, the team held an opening meeting with the representatives from the State Veterinary Office (SVO) of BiH - the CCA - in Sarajevo. The expert from the United Kingdom provided the SVO with copies of DVDs on BSE and scrapie and copies of advisory leaflets on TSEs and cattle


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identification. The team visited the following sites accompanied by CCA representatives: Competent Authorities Central 1 State Veterinary Office, Sarajevo Regional 1 Republic Administration

Inspectorate in Banja Luka Laboratories National Reference (TSE)

2 The Veterinary Faculty, Sarajevo. The “Dr Vaso Butozan” Veterinary Institute, Banja Luka.

Abattoirs Cattle 1 M. I. Tulumović, Laktaśi Cattle, sheep and goats

1 Šišovic, Posušje

Official Burial Sites Sheep and cattle 1 Manjača near Banja Luka Annex 1 provides details of the officials involved in the visit. 1.2. Relevant EU Legislation

Regulation (EC) No.999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (as amended)

Regulation (EC) No.1774/2002 laying down health rules concerning

animal by-products not intended for human consumption (as amended)

[Regulation (EC) No. 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and welfare rules (as amended)]

2. MAIN FINDINGS 2.1. Background BiH has approximately 455 000 cattle, 729 000 sheep and 51 000 goats. In addition there are approximately 416 000 pigs and 3 million poultry. In 2000, the EU Food and Veterinary Office (FVO) reported1 that at least 60% of the population of BiH was involved in agriculture and rural based activities; 1 Final Report of a Mission carried out in Bosnia and Herzegovina from 6 to 20 November 2000 concerning evaluation of the veterinary services, general animal health situation, fresh meat and meat products. DG(SANCO)/1221/2000 http://ec.europa.eu/food/fvo/act_getPDF.cfm?PDF_ID=2265


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there were over 500 000 small scale, low income, privately owned family farms (representing over 95% of all production); and that average farm size was 2.9 hectares. 2.2. Competent Authorities The administrative structure of BiH was agreed by the 1995 Dayton Peace Accords. For administrative purposes, BiH is divided into two Entities – the Federation of BiH (FBiH) and the Republika Srpska (RS) – and the District of Brčko (DB) established in 1999. The FBiH is further divided into 10 Cantons. Under the Dayton Peace Accords, competence for the agricultural sector in BiH belongs to the Ministries of Agriculture, Water Resource Management and Forestry (MAWRMF) at Entity level, within which the Entities’ veterinary services are organized. The SVO operates under the Ministry of Foreign Trade and Economic Relations (MoFTER), which reports to the Council of Ministers for BiH. In 2004, BiH established a Food Safety Agency (FSA). The FSA provides scientific advice in the fields of the safety of food and animal feed to all the competent authorities 2.2.1. Legislation There has been national legislation in place laying down measures for the prevention, control and eradication of TSEs since 2003 (Official Gazette of BiH, No.31/03). This is based upon, but is not fully in accordance with, the provisions in Regulation (EC) No. 999/2001 as amended. The SVO advised that it was in the process of harmonising the national legislation with EU legislation. However, the existing legislation does not appear to be fully implemented or controlled, for example with regard to annual monitoring programmes or the ban on feeding mammalian meat and bone meal (MMBM) to ruminants. The existing legislation on TSE control does not appear to contain any enforcement powers in the case of non-compliance, but these may exist elsewhere. 2.2.2. Veterinary Services The veterinary service comprises the SVO as the CCA and the Entity and DB veterinary services as competent authorities (CAs). State Veterinary Office

The SVO was established in 2000 to coordinate the veterinary services at state level. The legal basis for the functioning of the SVO was adopted in


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2002. The SVO contains both animal health and public health units. The key functions of the SVO in relation to control of TSEs are as follows:

i. Proposing legislation on and coordinating the implementation of, uniform measures and procedures for the control of animal diseases

ii. Coordinating the operation of the network of diagnostic laboratories

iii. Proposing regulations on requirements for the registration of facilities,

as well as a common registration procedure iv. Managing the animal identification and movement control program

through the Animal Identification Agency (AIA).

v. Cooperating with international institutions. E.g. OIE, EU. vi. Representing BiH in international veterinary institutions.

vii. Harmonizing BiH legislation with EU legislation.

Entity Veterinary Services

The Entity veterinary services are defined in federal law. The process of harmonising Entity veterinary legislation with national veterinary legislation is underway.

In the FBiH, the veterinary services are organized at Federal, Cantonal and Municipal levels.

In RS, the veterinary services are organized at Republic and Municipal

levels. In both Entities the veterinary services form part of general inspectorates which are not dedicated to veterinary inspection. The veterinary services in RS have recently been privatized but this process is not yet complete in FBiH. The Entity veterinary services are responsible for the implementation of regulations adopted at national level. Entities develop their procedures under their own budgets. The SVO organizes regular meetings, workshops and training in order to improve both the communication at different levels and the implementation of the regulations. The audit of the Cantonal and Municipal veterinary services is carried out at Entity level, rather than at SVO level. On 19 June 2007, the team visited the Republic Administration for Inspection Activities – Inspectorate, in Banja Luka. The inspectorate has been in place for two years and contains nine other inspection functions in addition to veterinary services. The inspectorate seeks to standardise inspection procedures within the Entity. There are six departments in RS


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which will soon be electronically connected to support reporting and risk assessment systems. The departments will be linked to the animal identification database. Cattle identification should be complete by the end of 2007. An identification programme for small ruminants and pigs will start in 2008. The General Director of the Inspectorate advised that there was good cooperation with the Inspectorate in FBiH and they were linking information systems to support traceability. 2.3. Epidemio-Surveillance Based on information from the SVO and other competent authorities:

i. There is a central animal identification database in place. The AIA registers farms and updates birth, movement and death records on the database. The AIA also issues passports. Cattle identification should be complete by the end of 2007. An identification programme for small ruminants and pigs will start in 2008.

ii. There have not been any cases of BSE recorded in BiH although

testing is at a low level. Most cattle slaughtered for human consumption are below 24 months of age. Approximately 80% of slaughtered cattle are imported from neighbouring countries such as Croatia as well as Poland and Romania.

iii. Two years ago, the SVO organised training for veterinary inspectors on

TSEs. There have not been any suspect clinical cases of BSE reported. The legislation obliges an animal owner to report suspect cases of TSE to the veterinary inspectorate.

iv. BiH legislation prohibits the import of cattle from “areas” where there

have been BSE.

v. Brainstem samples from cattle slaughtered for human consumption over 30 months of age are collected and submitted by veterinary inspectors to one of the two National Reference Laboratories for TSE (NRLs-TSE). The results are returned to the veterinary inspector.

vi. Under the legislation, fallen stock should be tested for BSE but it is

unlikely that this is done.

vii. There is no TSE monitoring programme for small ruminants in BiH. On 19 June 2007, the team visited M. I. Tulumović Abattoir in Laktaśi near Banja Luka. This is a small, recently constructed abattoir which is not yet operating at full capacity. All the equipment is modern, the hygiene standards appeared to be high and there were entry restrictions for personnel. Currently there are few cattle slaughtered but the numbers are expected to increase. Last month an animal imported from Croatia was slaughtered.


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Ante mortem and post mortem inspection is carried out by a veterinary inspector, supported by an authorised veterinary surgeon contracted by the abattoir. The veterinary inspector advised that all cattle slaughtered in the plant have ear tags. After brainstem extraction from cattle over thirty months, the samples are submitted immediately to The “Dr Vaso Butozan“ Veterinary Institute in Banja Luka accompanied by documents requesting BSE testing. The sample pots and documents are labelled with the kill number and the ear tag number. After comparing the ear tag with the transport certificate, the ear tags are destroyed. There is an audit trail from the animal to the brain stem sample to the BSE test result back to the abattoir. The slaughter records appeared to be satisfactory. When the team visited the abattoir, there was no routine slaughtering in progress. However, one bull was slaughtered for demonstration purposes. The visit team was provided with protective clothing including boots. The animal was stunned with a captive bolt. The veterinary inspector did not use gloves when extracting the brainstem. The obex was visible. The brainstem was placed in a sample pot which was subsequently labelled. The abattoir had no contingency plan in the case of detecting a positive BSE case and would rely upon instructions from the SVO. On 20 June 2007, the team visited Šišovic Abattoir near Posušje. This is a family-run abattoir which has been operating for 25 years. Abattoir employees have been trained in HACCP and require biannual medical certificates. The abattoir owner also owned a private veterinary practice to support the abattoir operation. Most of the veterinary practice work is farm animal. There are few pets. The most common disease is parainfluenza although there has been brucellosis in the area. Most cattle are slaughtered below 30 months of age. The abattoir slaughters approximately 30 calves and 20 steers per day in addition to older cattle, sheep, goats and pigs. Sheep are generally sourced from selected farms, approved by the SVO for export. The abattoir advised that in BiH, most cattle are slaughtered in abattoirs and that the beef market is mainly veal and young beef. Sheep and goats are slaughtered in abattoirs and privately (home) slaughtered for domestic consumption/religious festivals. There is a culture of private (home) slaughter of pigs in the autumn. Ante-mortem inspection is carried out by a veterinary surgeon. Post-mortem inspection is carried out by a veterinary inspector. Fifty per cent of the cattle slaughtered are imported. Imports are controlled by the SVO. Generally it is only imported cattle which are over 30 months and


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which are sampled for BSE. The veterinary inspector takes most of the brainstem samples and the abattoir submits them to the Sarajevo laboratory. The abattoir owner pays for the testing. The results are returned the next day. All inspectors had sampling training three years ago. This was organised by the MoAWRMF. The veterinary inspector advised that 100% of the imported cattle have ear tags and that most of the indigenous cattle are tagged. The visit team saw imported cattle (from Croatia and Poland) arriving and in the lairage. There were also lambs and goats in the lairage. The visit team saw the inside of the abattoir which had recently been re-constructed to a satisfactory standard. It had HACCP and ISO:9001:2001 (UKAS) accreditation. Protective hair nets and coats were provided for the visit team. There was a disinfectant mat but dedicated boots were not provided for the visit team. The visit team did not see the slaughter operation. The visit team observed the brain stem sampling of a single head. Brain stem sampling was satisfactory and the obex was visible. The pot was labelled with the animal identity and the kill number. The visit team also saw half-carcases (sides) of bovines in the chiller. A label stuck to, rather than attached to, each side indicated the animal identity and the kill number. 2.4. Laboratory Services There are eight veterinary laboratories in BiH. These are registered at Entity level and authorised at State level. There are two National Reference Laboratories for TSE (NRLs-TSE) - The Faculty of Veterinary Medicine in Sarajevo and The “Dr Vaso Butozan” Veterinary Institute in Banja Luka - but none for Animal Proteins in Feed. On 18 June 2007, the team visited The Faculty of Veterinary Medicine in Sarajevo. This laboratory uses the Bio-Rad TeSeE (ELISA) test, approved as a rapid test in Article X of Regulation (EC) No.999/2001. Any positive sample would be submitted to the OIE WRL (and EU CRL) in Weybridge, UK for confirmation. The TSE laboratory has been in place since 2005. There have not been any clinical suspects although the main differential for BSE in cattle would be rabies. The laboratory has only received a few samples from fallen stock and private kills but there is no audit or response by the CCA. Most sampled animals are


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imported from Germany, Croatia and Poland. The CCA has not provided the laboratory with a contingency plan for the detection of BSE. The laboratory has been involved in training inspectors in brainstem sampling. Some 4000 bovine samples have been tested for TSE since December 2006. The maximum number of samples that have been tested per day is 100. It was not clear whether there was sufficient capacity to test all the cattle which should be tested. No small ruminants samples have been tested although the facilities are in place to do so. The laboratory advised that commercial slaughter of sheep and goats is unusual. There is commercial slaughter of lambs. Sheep are privately (home) slaughtered for religious festivals. The laboratory advised that the State provided limited funding to purchase testing kits. The Faculty pays the overheads. The owner pays for the sampling but it is expensive and the Faculty often has to negotiate the price with the owner. The laboratory does monitor sample quality but there is no standard sample grading protocol. Although the obex is not always provided, the samples are tested anyway. There is no communication of sample quality back to the abattoir. Samples arrive at the laboratory within hours of slaughter and the results are provided the same day if the samples are received by 9am. The laboratory is not accredited although it is trying to introduce accreditation. It advised that it did not have the support to introduce full traceability and bar-coding of samples. The team visited the testing laboratory. The brainstems were processed in one room on one side of a corridor. The samples were tested in another room on the other side of the corridor. No protective equipment was provided to the experts visiting the laboratory and the laboratory rooms did not meet OIE Hazard Group 3 containment standards. Sodium hydroxide is used for decontamination. Laboratory waste from BSE testing is disposed of to landfill sites. On 19 June 2007, the team visited The “Dr Vaso Butozan“ Veterinary Institute in Banja Luka. The Institute was established in 1934 and contains a TSE laboratory unit that has used the Prionics-Check Western Blot test for four years. The Prionics-Check Western Blot test is approved as a rapid test for BSE in Article X of Regulation (EC) No.999/2001. There was also some knowledge of histopathology and immunohistochemistry (IHC) for TSE diagnosis, but these methods are not employed routinely. Other laboratory units in the Institute have experience of ELISA testing for other diseases.


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According to the laboratory, the SVO determined the testing methods used in the two NRLs. Just over 500 bovine samples have been tested in 2007. The maximum capacity was estimated at 100 samples per day (200 per day with additional personnel). Samples are tested in batches of eight and the low level of sample submission means that some cattle are released into the food chain before the test results are released. Testing is carried out once or twice a week. Most tested cattle are imported from Croatia. The laboratory commented that cooperation between the inspectors and the laboratory was essential. There are a large number of small abattoirs with private veterinary inspectors authorised to check the meat. The laboratory was not clear exactly who was responsible for sample submission. According to the laboratory, the State covered the cost of the testing although it was unclear who covered the cost of sample submission. The laboratory advised that it could test fallen stock samples if it received samples. A few sheep submitted for post mortem examination have been sampled for TSE for academic interest, but this was not part of a TSE testing programme in small ruminants. No samples had tested positive. If any did, they would be sent to the OIE WRL in Bern, Switzerland for confirmation. The laboratory advised that it had documented procedures and that it was working towards accreditation. The laboratory monitors and provides feedback on sample quality, and this has improved. The CCA has not provided the laboratory with a contingency plan for the detection of BSE. The team visited the laboratory. Protective equipment was provided and there were “clean” and “dirty” areas separated by a changing room. The laboratory is dedicated to TSE testing. Chlorine is used for decontamination and the laboratory waste is disposed of to landfill. 2.5. Eradication Based on information from the SVO:

i. In 2006, BiH imported the offspring of a Slovenian BSE case (detected at an Austrian abattoir) from Croatia. The animal was traced but remains alive.

2.6. Specified Risk Material (SRM)


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A previous twinning visit in January 2007, to assess animal by-products disposal facilities in BiH noted that there were three processing (rendering plants) in BiH – Brčko, Gradiška and Visoko. The Brčko plant closed in 2001. The Gradiška plant appeared to be processing abattoir animal by-products irregularly: the frequency of processing was not determined but there was evidence of unprocessed animal by-products that had been stored for “a long time”. The Visoko plant was linked to a poultry slaughterhouse and processed only poultry animal by-products. The Brčko and the Gradiška plants required significant investment to enable them to meet EU requirements. The newer Visoko plant was able to meet EU requirements without further structural improvements. Based on information from the SVO:

i. There currently is no mammalian meat and bone meal production in BiH (although there is production of poultry meal at Visoko: the disposal route for the poultry meal was not investigated during the visit).

ii. SRM must be destroyed and abattoirs have contracts for the disposal

of SRM. On 19 June 2007, the team visited a Municipal Burial Site at Manjača near Banja Luka. The site was located in remote countryside several kilometres (≈3) down a rough track. There was no hard-standing area. The site was approximately 50-80 metres square and was fenced. There was a notice on the gate. (Figures 1 & 2). Figure 1: Municipal Burial Site at Manjača near Banja Luka


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Figure 2: Municipal Burial Site at Manjača near Banja Luka

The location of the site was determined by the RS authorities following an outbreak of Brucellosis mellitensis and Q Fever. These diseases together with Classical Swine Fever and Rabies have been the key notifiable diseases in BiH in the last decade. The location was agreed as an area where carcases of animals confirmed with disease could safely be disposed of. Some 2500 carcases had been disposed of at the sites – mostly sheep. There was apparently no ground water in the area. The Banja Luka authorities control the site, which is also used by surrounding municipalities. The municipal inspectorate maintains the documentation for carcases buried at the site. The local people did not support the location of the site. Diseased animals are brought to the site and euthanased with barbiturate. A sulphate disinfectant is applied to the carcases and the surrounding area and the carcases are buried 4 metres deep. The official advised that fallen stock (containing SRM) is routinely buried on farm. Before the war (1992-95), carcases were rendered and the mammalian meat and bone meal (MMBM) was used in feed. Abattoir waste (including SRM) is disposed of in different landfill sites. The abattoirs have contracts with landfill sites and there are commercial documents. On 19 June 2007, the team visited M. I. Tulumović Abattoir in Laktaśi near Banja Luka. There was no routine slaughtering in progress although one bull was slaughtered for demonstration purposes. The veterinary inspector explained that spinal cord was removed by suction but there was no


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categorisation of animal by-products. All animal by-products including the sediment from waste water disposal were disposed of to contracted landfill sites. On 20 June 2007, the team visited Šišovic Abattoir near Posušje. The visit team did not see the slaughter operation or the removal of SRM. The abattoir and the municipal authorities had constructed a burial pit for animal by-products including SRM. There was no sewage system and waste water and liquid by-products are disposed of to septic tanks and soak away. The abattoir advised that by 2008 waste water disposal would have to comply with environmental regulations. 2.7. Feed Controls Based on information from the SVO:

i. The legislation prohibits the feeding of mammalian protein to ruminants. There is no animal feed sampling and testing programme.

ii. The legislation only allows the import of fish meal and there is no

MMBM production in BiH. There is production of poultry meal at Visoko but the disposal route for the poultry meal was not investigated during the visit).

The Sarajevo laboratory provided anecdotal evidence of MMBM in animal feed although it had not carried out any testing of feed for the presence of prohibited animal proteins. At the Šišovic Abattoir near Posušje the small ruminants were fed cereal-based feed ingredients in the lairage. 3. CONCLUSIONS 3.1 Competent Authorities

i. The SVO does not audit the performance of the Entity veterinary services, some of which are privatised.

3.1.1 Legislation

i. The national legislation in BiH is not fully in accordance with the provisions in Regulation (EC) No.999/2001 as amended.

ii. The SVO intends to harmonise national legislation with EU

requirements. 3.1.2 Veterinary Services


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i. National veterinary policy is determined by the SVO.

ii. The Entity veterinary services are responsible for the delivery of veterinary services under their own budgets.

3.2. Epidemio-Surveillance

i. An animal identification database is in place for cattle but the implementation of cattle identification is not yet complete. A robust cattle traceability system is essential for the control and eradication of BSE and is a requirement of Regulation (EC) No. 1760/2000.

ii. An animal identification programme for small ruminants has not yet

been implemented, but is planned for 2008. iii. In terms of the requirements of Regulation (EC) No.999/2001:

Data from the Report for the Monitoring and Testing of Ruminants for the

Presence of TSE in the EU in 20052 may be used to determine the possible number of cattle eligible for BSE testing under EU requirements. However the actual number eligible for BSE testing varies considerably between countries depending upon their husbandry and slaughter practices (and in some cases, national monitoring policies which exceed EU requirements). Assuming that 50% of BiH’s reported cattle population of 455000 is adult (>24 months) one would expect:

o the number of “risk” cattle tested annually to be between 2139 and

21431 (mean = 7894) [0.94 - 9.42% ; Mean 3.47%].

o the number of “healthy slaughtered” cattle tested annually to be between 3458 and 71390 (mean = 45591) [1.52%-31.38% ; Mean 20.04%].

TSEs are notifiable diseases in BiH but no suspect clinical cases have

been reported. The SVO arranged TSE training for veterinary inspectors two years ago but there is probably scope for a wider education programme in accordance with Article 10.

There is surveillance of cattle over 30 months of age slaughtered for

human consumption in BiH, most of which are imported. The NRLs-TSE have tested approximately 4500 bovine samples for TSE in 2007. There does not appear to be any audit to ensure that all cattle over 30 months of age slaughtered for human consumption are tested. Some animals are released into the food chain before the results are received. In some cases the obex is not presented for testing, but carcases are released into the food chain.

2 Table B2 of http://ec.europa.eu/food/food/biosafety/bse/annual_report_tse2005_en.pdf


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Fallen bovines are not routinely tested. No active surveillance samples have tested positive for TSEs.

There is no TSE testing programme for small ruminants.

3.3. Laboratory Services

i. There are two TSE testing laboratories in BiH. Both are designated as NRLs-TSE although Regulation (EC) No.999/2001 only requires one NRL-TSE (or to use an NRL-TSE in another Member State or the CRL-TSE).

ii. There is no designated NRL for animal proteins in animal feed, as

required by Regulation (EC) No. 882/2004. iii. Both NRLs-TSE use EU-approved “rapid test”. (Sarajevo: Bio-Rad

TeSeE; Banja Luka: Prionics Check Western Blot). Neither NRL-TSE is able to carry out confirmation of suspected cases of TSE, as required by Annex X of Regulation (EC) No.999/2001.

iv. Both NRLs-TSE would rely on different OIE WRLs for the confirmation

of a suspected case of BSE.

v. Neither of the NRLs-TSE is accredited (e.g. ISO/IEC 17025) vi. One NRL-TSE (Sarajevo) did not have OIE Hazard Group 3

containment facilities. vii. Both NRLs-TSE have been involved in training veterinary inspectors in

TSE sampling. viii. Although brainstem sample quality is monitored, there is no standard

grading system and the laboratories do not always provide feedback to the sampler. Samples are tested regardless of whether the obex is present, which is not in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 20043 (or Annex X of Regulation (EC) No.999/2001). In one NRL-TSE (Banja Luka), the results of BSE testing are sometimes obtained after the carcases have been released into the food chain.

ix. It is not clear whether BiH does actually have sufficient capacity to test

all eligible animals for BSE (or other TSEs).

x. Laboratory waste is disposed of by burial. 3 http://www.oie.int/eng/normes/mmanual/A_00064.htm


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3.4. Eradication

i. Cattle identification and traceability systems are being implemented to support the identification and tracing of the offspring and cohorts of BSE cases.

ii. Based on the information provided by the SVO, in relation to a single

imported BSE offspring, it appears that such animals are not killed and disposed of as soon as possible. This is a requirement of Article 13 of Regulation (EC) No.999/2001

iii. Further work is necessary to support an eradication programme for

TSEs in small ruminants, in particular the development of an animal identification system.

iv. The visit team were not made aware of any approved incineration

facilities in BiH that could be used to dispose of the carcases of animals suspected of being infected with TSE or of animals killed in the context of TSE eradication measures (Articles 4(1)(a)(i), 4(1)(a)(ii), 4(2)(a) and 4(2)(b) of Regulation (EC) No.1774/2002).

3.5. Specified Risk Material (SRM)

i. It was not possible for the visit team to verify that SRM is satisfactorily removed from carcases intended for human consumption.

ii. There do not appear to be any approved incineration plants or

processing plants disposing of animal by-products in BiH.

iii. All official and unofficial disposal of animal by-products is by burial. Carcases of animals killed for disease eradication programmes are disposed of by deep burial in official sites. Animal by-products (including SRM) from abattoirs are disposed of in landfill sites. Fallen stock are routinely buried on farm.

iv. Without clear access to approved incineration or processing plants, the

deep burial of animal by-products appears to be the safest option of disposal. However this poses environmental, public and animal health concerns for the future e.g. contamination of groundwater and the accumulation of pathogens e.g. Anthrax.

v. Regulation (EC) No.1774/2002 requires the routine disposal of SRM by

incineration or processing and incineration (or landfill for pressure-processed non-TSE animal by-products only). Regulation (EC) No.1774/2002 only permits burial of SRM (other than for carcases of


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animals suspected of being infected with a TSE) under exceptional circumstances4. For example:

In remote areas5 - whole carcases containing SRM, Category 2 and

Category 3 (see Articles 7 and 9 of Regulation (EC) No. 811/2003)

During an outbreak of (former) OIE List A6 diseases where the competent authority rejects transport to the nearest incineration or processing plant because of health risks or capacity issues (see Articles 6 and 9 of Regulation (EC) No. 811/2003)

3.6. Feed Controls

i. National BiH legislation prohibits the feeding of mammalian protein to ruminants. This prohibition is not as extensive as the prohibition in Regulation (EC) No.999/2001 which is intended to minimise the risk of cross contamination.

ii. According to the SVO, the legislation allows the import of fish meal into

BiH. Under Regulation 999/2001, imported fish meal must be analysed for mammalian meat and bone meal by microscopy before it is released into circulation.

iii. There is no national sampling programme to monitor compliance with

the feed ban. iv. The extensive nature of agriculture in BiH suggests that forage feeds

(e.g. grass, hay) are likely to be the major feeds in use for ruminants and that the level of concentrate compound and feed ingredients (e.g. soya and cereals) used is likely to be low. However, at the Šišovic Abattoir near Posušje the small ruminants were fed cereal-based feed ingredients.

v. While SRM is buried, the risk of recycling ruminant proteins within BiH

is low. However the risk of recycling and the need for controls would be greater if SRM was processed to MMBM again.

vi. The trade in feed, particularly in feed ingredients, is global. Without

adequate controls, inadvertent import of contaminated animal feed remains a risk factor for the introduction of TSEs.

4. FINAL MEETING

4 http://ec.europa.eu/food/food/biosafety/animalbyproducts/guidance_note_en.pdf 5 Areas where the animal population is so small, and where facilities are so far away, that the arrangements necessary for collection and transport would be unacceptably onerous compared to local disposal. 6 Brucellosis and Q Fever were List B


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On 21 June 2007, the visit team held a final meeting at the Sarajevo Canton Trade Chamber in Sarajevo. This was attended by representatives of the SVO, CAs and NRLs-TSE. The visit team provided presentations on the implementation of TSE controls in the UK and the implementation of BSE monitoring and laboratory facilities in Germany. The visit team also provided a summary of its conclusions and recommendations after which there was a short discussion. 5. RECOMMENDATIONS 5.1 Competent Authorities

i. As a precursor to implementing EU level procedures, the CCA should

consider ensuring that the necessary controls and surveillance are in place to support an application for OIE “controlled” BSE risk status. The criteria are laid down in Chapter 2.3.13 of the OIE Terrestrial Animal Health Code (as amended)7. A copy of the questionnaire which forms the basis of an application to the OIE for categorisation of BSE risk status is provided as Annex 2 to this report for information.

ii. The CCA should consider ensuring that it is in a position to implement

official controls on food and feed law in accordance with Regulation (EC) No.882/2004.

5.1.1 Legislation

i. The CCA should continue to harmonise national legislation with the requirements of Regulation (EC) No.999/2001 as amended.

5.1.2 Veterinary Services

i. The veterinary services should continue to work together closely with the each other and with the SVO to implement national TSE legislation and controls uniformly, consistently and in accordance with the provisions in Regulation (EC) No.882/2004.

ii. The SVO and the veterinary services should work together to develop

a contingency plan for TSEs as required by Article 14 of Regulation (EC) No.999/2001 .

iii. The system of reporting information from the veterinary services to the

CCA should be improved. 4.2. Epidemio-Surveillance

7 http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm


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i. The CCA should consider whether further work is necessary to implement a national education programme in place in accordance with Article 11 of Regulation (EC) No.999/2001.

ii. The CCA should consider an assessment of the percentage of eligible

bovine animals tested for BSE. This would provide useful information on laboratory resources and the need for further enhancements to the active surveillance programme8.

iii. The CAs should ensure that there are clear protocols in place which

detail the responsibility for the collection of brain stem samples and their submission to TSE testing laboratories.

iv. The CAs should ensure that carcases from eligible9 cattle which are

not tested in accordance with the provisions of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2004 (i.e. where the obex is not available) do not enter the food chain.

v. The CAs should ensure that carcases from tested cattle do not enter

the food chain until a negative BSE test result is available. vi. The CCA should consider establishing a monitoring programme for

TSEs in small ruminants. Based on the reported populations and current EU requirements (Regulation (EC) No. 727/2007) this would be no more than 1500 fallen sheep and no more than 500 fallen goats per year.

5.3. Laboratory Services

i. The CCA should ensure that the NRLs-TSE receive sufficient resources to allow them to perform the functions required in Annex X of Regulation (EC) No.999/2001 .

ii. The two NRLs-TSE should collaborate closely to standardise

procedures. The use of the same testing method could produce useful efficiency savings.

iii. Both NRLs-TSE should consider depending upon the same OIE WRL

for confirmation of TSE, until sufficient facilities are available in BiH. iv. The NRLs-TSE should consider implementing quality management in

accordance with Part 1, Section 1.1.2 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2004 and aim for ISO/IEC

8 Under Article 6 of Regulation (EC) No.999/2001 (as amended) it will not be possible for a Member State to propose a reduced BSE monitoring programme until it has complied with current EU monitoring requirements for at least six years. 9 Healthy slaughtered over 30 months or Emergency slaughter/Sick at Ante Mortem over 24 months.


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17025 accreditation http://www.oie.int/eng/normes/mmanual/A_00012.htm

v. The NRLs-TSE should consider implementing Hazard Group 3 human

safety and laboratory containment facilities in accordance with Part 1, Section 1.1.6 and Appendix 1.1.6.1 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2004 http://www.oie.int/eng/normes/mmanual/A_00016.htm http://www.oie.int/eng/normes/mmanual/A_00017.htm

vi. The NRLs-TSE should record data on sample quality and provide feed

back to personnel involved in sampling. 5.4. Eradication

i. The CAs should continue to implement the animal identification programme.

ii. The CAs should contribute to, and be aware of, the contingency plan

for the control and eradication of TSEs (see also 5.1.2(ii).

iii. As part of the contingency plan, the CCA should consider the availability of suitable disposal facilities for animals killed in the context of TSE eradication. i.e. suitably approved incineration plants.

iv. The CAs should ensure that offspring10 and cohorts11 of BSE cases are

killed and disposed of as soon as possible. 5.5. Specified Risk Material (SRM)

i. A previous twinning visit in January 2007, to assess animal by-products disposal facilities in BiH, concluded that there should be an assessment of the volume of animal by-products produced in BiH. This should continue.

ii. The CAs should seek to ensure that burial of animal by-products is

carried out in accordance with the safeguards in Regulation (EC) No. 811/2003.

iii. The CAs should consider a framework to ensure that in the future,

SRM is disposed of in accordance with Regulation (EC) No.1774/2002. 5.6. Feed Controls

i. The CCA should continue to harmonise national legislation on the TSE-related feed ban with current EU requirements12.

10 Born within 2 years before, or any time after, the onset of clinical signs in the dam. 11 As defined in Regulation (EC) No.999/2001 as amended.


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ii. The CCA should consider carrying out an assessment of feed handling,

feed production, feed storage and feed use in BiH. This assessment would support the development of a risk-based national feed sampling programme13 to monitor compliance with the TSE-related feed ban (Regulation (EC) No. 882/2004).

iii. The CCA should consider developing laboratory expertise in

microscopy to detect animal proteins in feed (Commission Directive 2003/126/EC).

iv. The CCA should consider a microscopy sampling programme for

imported fish meal as per Annex IV of Regulation (EC) No.999/2001.

12 Under Article 6 of Regulation (EC) No.999/2001 (as amended) it will not be possible for a Member State to propose a reduced BSE monitoring programme until it has implemented the “total feed ban” for farmed animals for at least six years. 13 Commission Recommendation 2005/925/EC (under the previous Council Directive 95/53) provided a useful risk-based framework for a national feed sampling programme.


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ANNEX 1 – OFFICIALS INVOLVED IN THE VISIT 1. External Veterinary Experts Dr. Hans-Herbert Kornau – ex-CVO of Freie Hansestadt, Bremen, Germany Dr. Hans-Heinrich Fiedler – LAVES, Oldenburg, Germany Mr. Patrick Burke – Department for Environment, Food & Rural Affairs, United Kingdom 2. State Veterinary Office (SVO), BiH, Sarajevo (18/06/2007) DVM Slaviša Kreštalica - Secretary SVO DVM Sanin Tankovic - Assistant SVO Željko Kovač - Assistant SVO Dr. Karoline Schollmeyer - Resident Twinning Advisor (RTA) DVM Edin Lendo - RTA Assistant 3. The Faculty of Veterinary Medicine, Sarajevo (18/06/2007) Prof. Tarik Bajrovic -Head of Infectious Diseases Department, Veterinary Faculty DVM Lejla Velic - Veterinary Assistant, Veterinary Faculty DVM Sanin Tankovic - Assistant SVO Željko Kovač - Assistant SVO Dr. Karoline Schollmeyer - RTA DVM Edin Lendo - RTA Assistant 4. Republic of Srpska Inspectorate, Banja Luka (19/06/2007) Mr. Slavko Subotić - General Director, Republic Administration for Inspection Activities 5. The ”Dr Vaso Butozan” Veterinary Institute, Banja Luka (19/06/2007) Dr. Rudoljub Trkulja, DVM, MSc. PhD - Dept. Microbiology and Epidemiology DVM Babic Radovan - Veterinary Assistant, Veterinary Institute DVM Sanin Tankovic - Assistant SVO Željko Kovač - Assistant SVO DVM Edin Lendo - RTA Assistant 6. Municipal Burial Site at Manjača near Banja Luka (19/06/2007)14

DVM Sanin Tankovic –Assistant SVO DVM Edin Lendo - RTA Assistant Veterinary Inspector 14 Dr. Hans-Herbert Kornau & Mr. Patrick Burke only


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7. M. I. Tulumović, Laktaśi Abattoir near Banja Luka (19/06/2007)15 Mrs. Dobrila Aleša –Veterinary Inspector Mrs. Sniježana Čubrilović – Abattoir Authorised Veterinary Surgeon 8. Šišovic Abattoir near Posušje (20/06/2007) Petar Soldo - Veterinary Inspector DVM Sanin Tankovic - Assistant SVO Željko Kovač -Assistant SVO DVM Edin Lendo - RTA Assistant 9. Final Meeting at Trade Chamber of Canton Sarajevo (21/06/2007)

DVM Sanin Tankovic -Assistant SVO Željko Kovač -Assistant SVO Dr. Karoline Schollmeyer - RTA DVM Edin Lendo - RTA Assistant Representatives of the NRLs-TSE and the CAs 15 Dr. Hans-Heinrich Fiedler only


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ANNEX 2 – QUESTIONNAIRE FOR BSE STATUS RECOGNITION BY OIE

QUESTIONNAIRE FOR BSE-STATUS RECOGNITION

Revised version - 13 December 2005

GENERAL INTRODUCTION

Acceptance of this submission is based on the compliance of the Veterinary Service of the applicant country, zone or compartment with the provisions of Chapters 1.3.3 of the Terrestrial Code and the compliance of BSE diagnostic laboratories with the provisions of Chapter I.1.2 of the Terrestrial Manual. Documentary evidence should be provided to support this based on Chapter 1.3.4 of the Terrestrial Code.

The OIE Terrestrial Code Chapter on BSE, Article 2.3.13.2. prescribes the criteria to determine the BSE risk status of a the cattle population of a country, zone or compartment. This document is the means whereby a claim for negligible risk (Article 2.3.13.3.) or controlled risk (Article 2.3.13.4.) can be made to the OIE.

The document comprises the following:

Section 1 – Risk assessment (Article 2.3.13.2. § 1)

Section 2 – Other requirements of Article 2.3.13.2. §2-4

Ongoing awareness program

Compulsory notification and investigation

Diagnostic capability

Section 3 – Surveillance (Article 2.3.13.2 and Appendix 3.8.4.)

Section 4 – BSE history of the country, zone or compartment (2.3.13.3 and 2.3.13.4)

N.B. Where, during the completion of this questionnaire, the submitting Veterinary Service provides documentation regarding the legislation under which it is mandated, it should provide the content of any legal act described (in one of the three official languages of OIE), as well as the dates of official publication and implementation. Submitting countries are encouraged to follow the format and numbering used in this document.


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SECTION 1

RISK ASSESSMENT (2.3.13.2§1)

Introduction

The first step in determining the bovine spongiform encephalopathy (BSE) risk status of the cattle population of a country, zone or compartment is to conduct a risk assessment (reviewed annually), based on Section 1.3. of the Terrestrial Code, identifying all potential factors for BSE occurrence and their historic perspective.

Documentation guidelines

This section provides guidance on the data gathering and presentation of information required to support the risk release and exposure assessments in respect of:

Release assessment

(1) The potential for the release of the BSE agent through importation of meat-and-bone meal or greaves

(2) The potential for the release of the BSE agent through the importation of potentially infected live cattle

(3) The potential for the release of the BSE agent through the importation of potentially infected products of bovine origin

Exposure assessment

(1) The origin of bovine carcasses, by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of cattle feed production

(2) The potential for the exposure of cattle to the BSE agent through consumption of meat-and-bone meal or greaves of bovine origin

In each of the five areas of release and exposure assessment that follow, the contributor is guided in terms of the question, the rationale and the evidence required to support the country, zone or compartment status claim.

Release assessment

1.1. The potential for the release of the BSE agent through importation of meat-and-bone meal or greaves

Question to be answered Has meat-and-bone meal, greaves, or feedstuffs containing either, been imported within the past 8 years? If so, where from and in what quantities?

Rationale

Knowledge of the origin of meat-and-bone meal, greaves or feedstuffs containing either meat-and bone meal or greaves, is necessary to assess the risk of release of BSE agent. Meat-and-bone meal and greaves originating in countries of high BSE risk pose a higher release


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risk than that from low risk countries. Meat-and bone meal and greaves originating in countries of unknown BSE risk pose an unknown release risk.

This point is irrelevant if the exposure assessment outlined below in Article 3.8.5.5. indicates that meat-and bone meal or greaves has not been fed, either deliberately or accidentally, in the past 8 years. Nevertheless, documentation should be provided on the control systems (including relevant legislation) in place to ensure that meat-and-bone meal or greaves has not been fed to cattle.

Evidence required

1.1.1. Documentation to support claims that meat-and-bone meal, greaves or feedstuffs containing either meat and- bone meal or greaves have not been imported, OR

1.1.2. Documentation on annual volume, by country of origin, of meat-and-bone meal, greaves or feedstuffs containing them imported during the past 8 years.

1.1.3. Documentation describing the species composition of the imported meat-and-bone meal, greaves or feedstuffs containing them.

1.1.4. Documentation, from the Veterinary Service of the country of production, supporting why the rendering processes used to produce meat-and-bone meal, greaves or feedstuffs containing them would have inactivated, or significantly reduced the titre of BSE agent, should it be present.

1.2. The potential for the release of the BSE agent through the importation of potentially infected live cattle

Question to be answered Have live cattle been imported within the past 7 years?

Rational

The release risks are dependent on:

country, zone or compartment of origin and its BSE status, which will change as more data become available; this may result from the detection of clinical disease, or following active surveillance, or assessment of geographical BSE risk;

feeding and management of the imported cattle in the country, zone or compartment of origin;

use to which the commodity has been put as apart from representing risk of developing clinical disease, the slaughter, rendering and recycling in meat-and-bone meal of imported cattle represents a potential route of exposure of indigenous livestock even if meat-and-bone meal and greaves, or feedstuffs containing them, have not been imported;

dairy versus meat breeds, where there are differences in exposure in the country, zone or compartment of origin because feeding practices result in greater exposure of one category;

age at slaughter.

Evidence required:

1.2.1. Documentation including tables on the country, zone or compartment of origin of imports. This should identify the country, zone or compartment of origin of the cattle, the length of time they lived in that country, zone or compartment and of any other country in which they have resided during their lifetime.


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1.2.2. Documentation including tables describing origin and volume of imports.

1.2.3. Documentation demonstrating that risks are periodically reviewed in light of evolving knowledge on the BSE status of the country, zone or compartment of origin.

1.3. The potential for the release of the BSE agent through the importation of potentially infected products of bovine origin

Question to be answered What products of bovine origin have been imported within the past 7 years?

Rationale

The release risks are dependent on:

the origin of the cattle products and whether these products contain tissues known to contain BSE infectivity (Article 2.3.13.13.);

country, zone or compartment of origin and its BSE status, which will change as more data become available; this may result from the detection of clinical disease, or following active surveillance, or assessment of geographical BSE risk;

feeding and management of the cattle in the country, zone or compartment of origin;

use to which the commodity has been put as apart from representing risk of developing clinical disease, the slaughter, rendering and recycling in meat-and-bone meal of imported cattle represents a potential route of exposure of indigenous livestock even if meat-and-bone meal and greaves, or feedstuffs containing them, have not been imported;

dairy versus meat breeds, where there are differences in exposure in the country, zone or compartment of origin because feeding practices result in greater exposure of one category;

age at slaughter.

Evidence required:

1.3.1. Documentation on the country, zone or compartment of origin of imports. This should identify the country, zone or compartment of origin of cattle from which the products were derived, the length of time they lived in that country, zone or compartment and of any other country in which they have resided during their lifetime.

1.3.2. Documentation describing origin and volume of imports

1.3.3. Documentation demonstrating that risks are periodically reviewed in light of evolving knowledge on the BSE status of the country, zone or compartment of origin.

Exposure assessment

1.4. The origin of bovine carcasses, by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of cattle feed production

Question to be answered How have bovine carcasses, by-products and slaughterhouse waste been processed over the past 8 years?

Rationale


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The overall risk of BSE in the cattle population of a country, zone or compartment is proportional to the level of known or potential exposure to BSE infectivity and the potential for recycling and amplification of the infectivity through livestock feeding practices. For the risk assessment to conclude that the cattle population of a country, zone or compartment is of negligible or controlled BSE risk, it must have demonstrated that appropriate measures have been taken to manage any risks identified. If potentially infected cattle or contaminated materials are rendered, there is a risk that the resulting meat-and-bone meal could retain BSE infectivity. Where meat-and-bone meal is utilized in the production of any cattle feed, the risk of cross-contamination exists.

Evidence required:

1.4.1. Documentation describing the collection and disposal of fallen stock and materials condemned as unfit for human consumption.

1.4.2. Documentation including tables describing the fate of imported cattle, including their age at slaughter or death.

1.4.3. Documentation describing the definition and disposal of specified risk material, if any.

1.4.4. Documentation describing the rendering process and parameters used to produce meat-and-bone meal and greaves.

1.4.5. Documentation describing methods of animal feed production, including details of ingredients used, the extent of use of meat-and-bone meal in any livestock feed, and measures that prevent cross contamination of cattle feed with ingredients used in monogastric feed.

1.4.6. Documentation describing the end use of imported cattle products and the disposal of waste.

1.4.7. Documentation describing monitoring and enforcement of the above.

1.5. The potential for the exposure of cattle to the BSE agent through consumption of meat-and-bone meal or greaves of bovine origin

Question to be answered Has meat-and-bone meal or greaves of bovine origin been fed to cattle within the past 8 years (Articles 2.3.13.3. and 2.3.13.4. in the Terrestrial Code)?

Rationale

If cattle have not been fed products of bovine origin (other than milk or blood) potentially containing meat-and-bone meal or greaves of bovine origin within the past 8 years, meat-and-bone meal and greaves can be dismissed as a risk.

In the case of countries applying for negligible risk status, it will be required to demonstrate that the ruminant feed ban has been effective for at least 8 years following the birth of the youngest case.

Evidence required

1.5.1. Documentation describing the use of imported meat-and-bone meal and greaves, including the feeding of any animal species.

1.5.2 Documentation describing the use made of meat-and-bone meal and greaves produced from domestic cattle, including the feeding of any animal species.


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1.5.3 Documentation on the measures taken to control cross-contamination of cattle feedstuffs with the meat and-bone meal and greaves including the risk of cross-contamination during production, transport, storage and feeding.

1.5.4 Documentation, in the form of the following table, on the audit findings in rendering plants and feed mills processing bovine material, related to the prohibition of the feeding to ruminants of meat-and-bone meal and greaves.

Year

(information

should be

provided for

each of the 8

years for

effectiveness

is claimed)

Type of plant

(renderer or

feed mill)

Number of

plants

processing

bovine

material

(A)

Number of

plants in

(A)

inspected

Total number

of inspections

Total number

of plants in (A)

with

infractions

Year 1 Renderer

Feed mill

Year 2, etc. Renderer

Feed mill

1.5.5 Documentation, in the form of the following table, on each plant above with infractions, specifying the type of infraction and the method of resolution.

Year

(information

should be

provided for

each of the 8

years for

effectiveness

is claimed)

Type of plant

(renderer or

feed mill)

Plant ID Nature of

infraction

Method of

resolution

Follow up results

Year 1 Renderer ID 1

ID 2

ID 3, etc.

Feed mill ID 1

ID 2

ID 3, etc.

Year 2 Renderer ID 1

ID 2

ID 3, etc.

Feed mill ID 1


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ID 2

ID 3, etc.

1.5.6 Documentation explaining why, in light of the findings displayed in the preceding two tables, it is considered that there has been no significant exposure of cattle to the BSE agent through consumption of meat-and-bone meal or greaves of bovine origin.

1.5.7 Documentation of husbandry practices (multiple species farms) which could lend themselves to cross contamination of cattle feed with meat-and-bone meal and greaves destined to other species.


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SECTION 2

OTHER REQUIREMENTS (2.3.13.2 § 2-4)

2.1. Awareness program (Article 2.3.13.2 § 2) Questions to be answered Is there an awareness programme?

What is the target audience?

What is the curriculum and how long has it been in place?

Is there a contingency and/or preparedness plan that deals with BSE?

Rationale

An awareness program is essential to ensure detection and reporting of BSE, especially in countries of low prevalence and competing differential diagnoses.

Evidence required

2.1.1. Documentation indicating when the awareness program was instituted and its continuous application and geographical coverage.

2.1.2. Documentation on the number and occupation of persons who have participated in the awareness program (veterinarians, producers, workers at auctions, slaughterhouses, etc.)

2.1.3. Documentation of materials used in the awareness program (the manual, supportive documents, or other teaching materials).

2.1.4. Documentation on the contingency plan

2.2. Compulsory notification and investigation (Article 2.3.13.2 § 3) Questions to be answered What guidance is given to veterinarians, producers, workers at auctions, slaughterhouses,

etc.) in terms of the criteria that would initiate the investigation of an animal as a BSE suspect? Have these criteria evolved?

What were the date and content of the legal act making notification of BSE suspects compulsory?

What are the measures in place to stimulate notification, such as compensation payments or penalties for not notifying a suspect?

Rationale

The socio-economic implications associated with BSE require that there be incentives and/or obligations to notify and investigate suspect cases.


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Evidence required

2.2.1. Documentation on the date of official publication and implementation of compulsory notification. Including a brief description of incentives and penalties.

2.2.2. Documentation on the manual of procedures for investigation of suspect animals and follow-up of positive findings.

2.3. Examination in an approved laboratory of brain or other tissues collected within the framework of the aforementioned surveillance system (Article 2.3.13.2 § 5)

Questions to be answered

Are the diagnostic procedures and methods those described in Chapter 2.3.13 of the Manual?

Have these diagnostic procedures and methods been applied through the entire surveillance period?

Rationale

The OIE only recognizes for the purpose of this submission samples that have been tested in accordance with the Manual.

Evidence required

2.3.1. Documentation as to the approved laboratories where samples of cattle tissues from the country, zone or compartment are examined for BSE. (If this is located outside the country, information should be provided on the cooperation agreement).

2.3.2. Documentation of the diagnostic procedures and methods used.

2.3.3. Documentation that the diagnostic procedures and methods have been applied through the entire surveillance period.


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SECTION 3

BSE SURVEILLANCE AND MONITORING SYSTEM (2.3.13.2 § 4)


Does the BSE surveillance programme comply with the guidelines in Appendix 3.8.4. of the Terrestrial Code?

What were the results of the investigations?

Rationale

Chapter 2.3.13.2§.4 and Appendix 3.8.4 prescribe the number of cattle, by subpopulation, that need to be tested in order to ensure the detection of BSE at or above a minimal threshold prevalence.

Evidence required

3.1. Documentation that the samples collected are representative of the distribution of cattle population in the country, zone or compartment.

3.2. Documentation of the methods applied to assess the ages of animals sampled and the proportions for each method (individual identification, dentition, other methods to be specified)

3.3. Documentation of the means and procedures whereby samples were assigned to the cattle subpopulations described in 3.8.4.2., including the specific provisions applied to ensure that animals described as clinical met the conditions of 3.8.4.2§1.

3.4. Documentation of the number of animals meeting 3.8.4.2§1 as compared to the numbers of clinical samples submitted in previous years in accordance to the former provisions in the Code, and explanation of possible differences.

3.5. Documentation, based on the following table, of all clinically suspect cases notified complying with the definition in 3.8.4.2§1

Laboratory

identification number

Age Clinical signs Point of detection (farm, market

channels, slaughterhouse)

3.6. Documentation according to the following table, that the number of target points applicable to the country, zone or compartment and its BSE surveillance requirements (Type A or type B surveillance as a result of the risk assessment of section 1) are met as described in 3.8.4.2 and 3.8.4.4.


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SUMMARY TABLE FOR BSE SURVEILLANCE

Year: (complete a separate table for each year of surveillance)

Surveillance subpopulations

Routine slaughter Fallen stock Casualty slaughter

Clinical suspect

Samples Points Samples Points Samples Points Samples Points

>1 and

<2 years

≥2 and

<4 years

≥4 and

<7 years

≥7 and

<9 years

≥9 years

Subtotals

Total points


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SECTION 4

BSE HISTORY OF THE COUNTRY, ZONE OR COMPARTMENT (2.3.13.3 AND

2.3.13.4)


Has BSE occurred in the country, zone or compartment?

How has it been dealt with?

Rationale

The categorization of a country, zone or compartment in either negligible or controlled risk is dependent upon, the outcome of the risk assessment described in section 1, compliance with the provisions described in section 2, the results of surveillance described in section 3, and the history of BSE in the country, zone or compartment. This section provides the opportunity to describe the BSE history in the country, zone or compartment.

Evidence required

4.1. Documentation of whether a case of BSE has ever been diagnosed in the country, zone or compartment.

In the case of positive BSE findings:

4.2. Documentation on the origin of each BSE case in respect to the country, zone or compartment. Indicate the birth date and place of birth.

4.3. Documentation that:

the case(s) and all the progeny of female cases, born within 2 years prior to or after clinical onset of the disease, and

all cattle which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or

if the results of the investigation are inconclusive, all cattle born in the same herd as, and within 12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed.

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