EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF A MISSION CARRIED OUT IN THE UNITED KINGDOM FROM 19 TO 29 JANUARY 2010 IN ORDER TO EVALUATE MEASURES CONCERNING BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

2 Executive Summary This report describes the outcome of a Food and Veterinary Office specific audit carried out between 19 to 29 January 2010, which formed part of the general audit 2009 of the United Kingdom conducted under the provisions of Regulation (EC) No 882/2004. As part of the general audit, the objective of this specific audit was to evaluate that official controls are carried out in conformity with the multi-annual national control plan drawn up in accordance within Article 41 of Regulation (EC) No 882/2004. The specific audit evaluated the implementation of certain protective measures against Bovine Spongiform Encephalopathy (BSE). Overall, the report concludes that active surveillance was satisfactory and that some progress has been made as regards the quality of samples for BSE testing. Passive surveillance was appropriately carried out and measures related to suspect animals and following confirmation of BSE were implemented in line with Community requirements. The arrangements in place for collection and handling of specified risk material were mainly satisfactory, although there were some weaknesses in commercial documentation. In Great Britain, the identification of users of fish meal and feed containing fish meal has significantly progressed but the registration and authorisation process of such users was far from being completed. Some important steps have been taken to improve the risk prioritisation of inspections, but it remains affected by an incomplete knowledge of some key feed operators. In Northern Ireland, the identification of users of feed containing fish meal was still on-going. The priorities set for inspections in the national control programme were not complied with, resulting in very few visits to on-farm mixers and mixed species farms, including those using fish meal or feed containing fish meal; moreover, the prioritisation of feed ban controls did not take account of the significant use of bulk feather meal as organic fertilisers on farms. The large majority of the said farms were therefore not visited despite several incidents concerning cross-contamination of feed with feather meal that occurred in the recent past. In addition, limited enforcement actions and sanctions had been taken following a number of breaches of feed ban rules. The report makes a number of recommendations addressed to the United Kingdom competent authorities aimed at rectifying the shortcoming identified and further enhancing the implementing and control measures in place. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES OF THE MISSION LEGAL BASIS FOR THE MISSION BACKGROUND FINDINGS AND CONCLUSIONS BSE SITUATION BSE EPIDEMIO-SURVEILLANCE IDENTIFICATION AND REGISTRATION OF BOVINE ANIMALS PASSIVE SURVEILLANCE ACTIVE SURVEILLANCE ANIMALS BORN BEFORE 1 AUGUST MEASURES FOLLOWING SUSPICION/CONFIRMATION OF BSE SPECIFIED RISK MATERIAL REQUIREMENTS OFFICIAL CONTROLS FEED BAN REQUIREMENTS ALONG THE CHAIN OFFICIAL CONTROLS LABORATORY NETWORK SAMPLING AND LABORATORY TESTING FOR BSE TESTING FOR THE DETERMINATION OF CONSTITUENTS OF ANIMAL ORIGIN ACTIONS TAKEN IN CASE OF NON-COMPLIANCE OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...21 ANNEX 1 - LEGAL REFERENCES...23 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT ABP Action plan AH AHO AHDO AHRO APHIS BSE CA CCA CRL CTS DARD DEFRA Feed ban HACCP MHS NFA NRL OCDS OF/SI OV Report 8316/2006 Animal by-products Actions announced/undertaken as submitted to the Commission services by the CCA in response to the recommendations made in mission reports 8316/2006 Animal Health Animal Health Office Animal Health Divisional Office Animal Health Regional Office Animal and Public Health Information System Bovine spongiform encephalopathy Competent authority Central competent authorities, DEFRA, Food Standard Agency, DARD and the Scottish Government Community Reference Laboratory Cattle Tracing System Department of Agriculture and Rural Development Department for Environment, Food and Rural Affairs Prohibition of feeding products derived from animals to farmed animals and exception applicable to this ban Hazard Analysis and Critical Control Points Meat Hygiene Service National feed audit National reference laboratory Older Cattle Disposal Scheme Organic fertilisers and soil improvers Official veterinarian Report on a mission carried out in the United Kingdom from 20 to 29 November 2006 concerning protective measures against BSE III

5 Report 7742/2008 RMOP SRM UKAS VLA Report on a mission carried out in the United Kingdom from 17 to 26 November 2008 concerning the implementation of health rules on certain ABP Required Method of Operation Specified risk material United Kingdom Accreditation Service Veterinary Laboratories Agency IV

6 1 INTRODUCTION The specific audit took place in the United Kingdom from 19 to 29 January The audit team comprised three inspectors from the Food and Veterinary Office. The specific audit was undertaken as part of the general audit 2009 of the United Kingdom carried out under the provisions of Regulation (EC) No 882/2004 of the European Parliament and of the Council. Representatives from the central competent authorities (CCA) of the countries visited, namely the Department for Environment Food and Rural Affairs (DEFRA) in England, the Scottish Government in Scotland and the Department of Agriculture and Rural Development (DARD) in Northern Ireland, accompanied the audit team for the duration of the audit. Representatives of the Food Standard Agency and of the Meat Hygiene Service (MHS) were also present during some onthe-spot visits. An opening meeting was held on 19 January 2010 with all CCA. At this meeting, the objectives of, and itinerary for, the specific audit were confirmed by the audit team and the control systems were described by the CCA. 2 OBJECTIVES OF THE MISSION As part of the general audit, the objective of this mission was to verify that official controls are carried out in conformity with the United Kingdom multi-annual national control plan drawn up in accordance with Article 41 of Regulation (EC) No 882/2004. For this purpose, the mission evaluated specifically the measures put in place to give effect to Regulation (EC) No 999/2001 of the European Parliament and of the Council. In terms of scope, the mission focused on active and passive bovine spongiform encephalopathy (BSE) epidemio-surveillance in bovine animals, removal and handling of specified risk material (SRM), and the prohibition of feeding products derived from animals to farmed animals and exceptions applicable to this ban (hereafter: feed ban). The evaluation also followed up on the actions taken and planned by the CCA in response to recommendations made in previous FVO missions which addressed the above issues. In pursuit of the above objectives the following meetings/visits took place: 1

7 COMPETENT AUTHORITY VISITS Comments Competent authority Central Regional Opening meetings in Great Britain and Northern Ireland and a closing (de-briefing) meeting Meeting in one AHRO in England, one AHO in England and one AHDO in Scotland Food processing establishments Slaughterhouses Other visits Feed mill 2 1 Two high throughput establishments for cattle with two attached cutting plants Producing feed containing derogated products derived from animals Mobile mixer 1 Using derogated products derived from animals and producing feed for ruminants and non-ruminants On-farm mixers 2 Using derogated products derived from animals and producing feed for ruminants and non-ruminants ABP intermediate plant 2 Collection centre for fallen stock and SRM where sampling for BSE takes place Processing plant 2 Category 1 processing plants collecting SRM and also performing collection and sampling of fallen stock Storage plant for OF/SI 1 Storing bulk feather meal used as OF/SI on farms 3 LEGAL BASIS FOR THE MISSION The specific audit was carried out under the general provisions of Community legislation and, in particular: Art. 21 of Regulation (EC) No 999/2001; Art. 45 of Regulation (EC) No 882/2004; Other legislation was considered during this mission, in particular: Regulation (EC) No 1774/2002 of the European Parliament and of the Council. A full list of the legal instruments referred to in this report is provided in the Annex and refers, where applicable, to the last amended version. 4 BACKGROUND The previous mission concerning BSE in the United Kingdom was carried out from 20 to 29 2

8 November 2006, the results of which are described in report DG(SANCO)/8316/2006 MR Final (hereafter: report 8316/2006). In addition, a mission concerning the implementation of health rules on certain animal by-products (ABP) was carried out from 17 to 26 November 2008, the results of which are described in report (DG(SANCO)/ MR Final (hereafter: report 7742/2008) also gives background information relevant to the current specific audit. These reports are accessible at: In response to report 8316/2006, the CCA provided the FVO with the actions planned and/or undertaken to address the recommendations contained in the report (hereafter: action plan). Where appropriate, relevant recommendations set out in report 8316/2006 are indicated under the appropriate section headings in section 5 below. The corresponding actions as announced in the action plan are outlined thereafter. This was the first FVO mission carried out on this subject in the United Kingdom, since the entry into force of the following pieces of legislation: Commission Decision No 2007/411 on the prohibition of placing on the market of products derived from animals born and reared within the United Kingdom before 1 August 1996 and exempting these animals from certain control and eradication measures laid down in Regulation (EC) No 999/2001; Commission Decision No 2009/719 of 28 September 2009 authorising certain Member States to revise their annual BSE monitoring programmes and increasing the age testing limits from 24 and 30 to 48 months. 5 FINDINGS AND CONCLUSIONS 5.1 BSE SITUATION The number of BSE positive cases in Great Britain and Northern Ireland is shown in the table below (data as of 31 December 2009; information provided by the DEFRA). Great Britain Northern Ireland Passive surveillance Active surveillance Passive surveillance Active surveillance The last BSE positive case identified by passive surveillance in a herd without previous BSE cases occurred in In 2009, six BSE positive cases were animals born before 1 August

9 5.2 BSE EPIDEMIO-SURVEILLANCE Identification and registration of bovine animals Legal requirements Regulation (EC) No 1760/2000 of the European Parliament and of the Council establishes a system for the identification and registration of bovine animals. The said identification and registration system is essential for BSE monitoring and eradication as required by Artt. 6, 12 and 13 of Regulation (EC) No 999/2001. Findings The organisation and functioning of the systems in place for the identification, registration and movements of cattle in the United Kingdom are described in report 8316/2006. The mission team noted that: Ιn Great Britain, the Cattle Tracing System (CTS) database contained all information necessary for ensuring traceability of animals. It was confirmed that CTS used in conjunction with the Offspring and Cohort Cull (OCC) System, could allow for identification of cohort and offspring and tracing of all bovine animals related to positive BSE cases. In Northern Ireland, the Animal and Public Health Information System (APHIS) allowed for effective BSE monitoring, surveillance and eradication. APHIS could also be used for the identification and traceability of cohorts and offspring in case of suspicion or eradication, implementation of movement restrictions, and controls on cattle imported or traded to Northern Ireland. In the farm visited in Great Britain, the format of the register kept was not in line with the template provided by the CCA; however, it contained all required data, including dates, places and reasons for movements of animals. In all the slaughterhouses and sampling sites visited, all animals present were correctly identified; they were accompanied with passports or movement documents (fallen stock) which allowed for their identification and history of movement. Official controls on animal identification and registration were carried out on a regular basis. Breaches identified in this respect were recorded and farmers were called to rectify shortcomings. Persistent offenders were traced and targeted for follow-up inspections as well as prioritised for future inspections. Conclusions The systems in place for the identification and registration of bovine animals and recording of their movements can efficiently support the implementation of the BSE control measures required by Artt. 6, 12 and 13 of Regulation (EC) No 999/ Passive surveillance Legal requirements Art. 10 of Regulation (EC) No 999/2001 requires competent authorities (CAs) to organise training in, among others, clinical signs and epidemiology of BSE. Art. 11 of the said Regulation sets out the requirements for the notification of suspect cases. 4

10 Findings In 2009, one BSE positive case was detected by passive surveillance in the United Kingdom (two in 2008 and seven in 2007). There is a visible declining trend in slaughtered suspects in which BSE has been confirmed (seven out of 70 in 2007, two out of 40 in 2008 and none out of 21 in 2009). None of those positive cases have been confirmed in Northern Ireland. DEFRA has continued to organise awareness actions addressed to farmers (individually and through their organisations), local authorities and private veterinary practitioners. In 2009, an updated advisory booklet on BSE (available on DEFRA s web page) was sent to livestock farmers and their organisations. The mission team noted that: DEFRA s letters mandating a regular spread of information concerning BSE together with materials distributed to farmers or local authorities were present in all Animal Health Offices (AHO) visited. This was also observed during on farm visits, both in Great Britain and Northern Ireland. In one of the slaughterhouses visited, a BSE suspect was notified in 2008; records reflecting the measures taken for that case were presented to the mission team and it could be confirmed that this case had been appropriately dealt with. In one of the AHOs visited, a clinical suspect of BSE had been notified. The appropriateness of the actions taken by Animal Health (AH) could be confirmed. According to CAs, there is no reluctance to notifying suspects as the compensations paid for animals slaughtered as suspects, cohort and offspring, are recognised as strong financial incentive by farmers. This was confirmed by the farmers met during the mission. Conclusions Arrangements in place for providing training and information on BSE, its clinical signs and epidemiology satisfied the provisions of Art. 10 of Regulation (EC) No 999/2001. The requirement laid down in Art. 11 to the said Regulation for the notification of suspect cases were satisfactorily complied with Active surveillance Legal requirements Art. 6 of Regulation (EC) No 999/2001 requires that Member States carry out a BSE monitoring programme in accordance with its Annex III. Findings The relevant recommendations of report 8316/2006 concerned the sampling of all eligible cattle slaughtered for human consumption, the appropriateness of ante- mortem examination records, the quality of samples taken from fallen cattle and the effectiveness of measures to prevent all cohorts and offspring born after 1 August 1996 from being slaughtered for human consumption. In this 5

11 respect, the action plan provided by the CCA indicated that amendments would be introduced in procedures and that farmers would be reminded of their obligations. According to DARD, several changes have been introduced in procedures concerning the extraction and entry of data from and onto APHIS. The Required Method of Operations (RMOPs) in all slaughterhouses were reviewed and amended to require post slaughter identification checks. These are designed to ensure the correct identification of all animals prior to BSE sampling. According to MHS, staff were reminded to follow instructions concerning recording of ear tag numbers in ante-mortem registers as well as to make sure that food operators submit the BSE samples with proper codes allowing identification of different sub-categories of animals under active surveillance (healthy slaughtered, found sick at ante-mortem, emergency slaughtered) to be identified and recorded. In the United Kingdom, all cattle keepers have been contacted and reminded of their legal obligation to notify all fallen stock within 24 hours of the animals death. Operators involved in collection of fallen cattle had also been reminded of their legal requirements to collect and sample these animals if they met age requirements. The CCAs in Great Britain continued the policy which had been implemented in the past and which provides for immediate passports seizure and movement restriction of animals identified as cohorts and offspring when BSE suspect case is notified and their culling without delay when the BSE positive result is confirmed. In Northern Ireland, restricted animals received special status in APHIS, which allows their identification at slaughterhouses if in the meantime they were delivered for slaughter. In 2009, 11 BSE positive cases were detected by active surveillance in the United Kingdom (35 in 2008 and 60 in 2007). A breakdown of theses cases is shown in the table below (data provided by the CCA as of 31 December 2009): Active surveillance Year Great Britain Northern Ireland In Great Britain, on 12 January 2009, the Government-funded service for collection and disposal of fallen cattle requiring a BSE test ended. Since then farmers have a statutory obligation to deliver fallen cattle requiring BSE testing to a sampling site approved by the CA. Similar arrangements entered into force in Northern Ireland in November Data concerning fallen stock notified, sampled and tested between 2007 and 2009 are presented in the table below: 6

12 Notified Sampled Tested Great Britain 2008 > 24m 221, , , > 48m 139, , ,183 Northern Ireland 2008 > 24m 39,429 37,841 37, > 48m 24,093 23,512 23,512 The mission team noted that: In all slaughterhouses visited, relevant RMOPs had been reviewed and regularly updated; further training had been given both to official veterinarians (OVs) and slaughterhouses staff with regards to sampling of animals. Ιn the slaughterhouse visited in Great Britain, the ante-mortem inspection records allowed for cross reference to individual animals. The sub-populations of animals found sick at antemortem or emergency slaughtered were reflected when samples were taken and sent for examination. According to the OV met in the slaughterhouse visited in Northern Ireland, animals with clinical signs consistent with BSE would be rejected at ante-mortem inspection, and animals with localized lesions such as distal limb lameness were not recorded as sick at ante-mortem and therefore considered as healthy slaughtered. On the spot checks detected one animal which should have been recorded as sick at ante-mortem but which was recorded as healthy slaughtered. All ante-mortem information was recorded on APHIS and this triggered the BSE testing category on the sample label; however, timing of data entry could result in the default printing of the label as healthy slaughtered. In both slaughterhouses visited, bovine animals older than 48 months were properly identified as eligible for monitoring and sampled for BSE. Additional verification concerning the age and country of origin was in place to avoid mistakes when animals from Member States not eligible for the over 48 months rule were slaughtered. Effective traceability systems allowing for link between samples and detained carcases as well as all other parts of slaughtered animals waiting for examination results were in place. According to the data provided by the Veterinary Laboratories Agency (VLA), in 2008 and 2009, there were, respectively, 85 and 17 bovine animals slaughtered for human consumption eligible for testing, for which tests results were non-negative and further testing was not possible due to sample shortage in Great Britain. According to the CCA, all carcases yielding such test results have been handled correctly and disposed of as Category 1 by incineration. In one of the slaughterhouses visited, in 2009, one cow was sampled incorrectly, therefore there was no examination result for this sample. Documentary evidence of the detaining and proper disposal of the whole carcass, its related part, blood and hide were seen by the mission team. In Northern Ireland, there was one case in 2009 where a bovine animal eligible for testing was slaughtered for human consumption and not tested. According to the CCA, this was due to a human error by the manufacturer of a replacement tag. When this error was identified, the meat from this animal had already been placed on the market. Following that case, an additional document verification procedure was put in place in the lairage for animals of all ages as an obligatory check. In all sampling sites visited, sampling of fallen bovine animals was performed by trained 7

13 Conclusions staff, without delay and in accordance with procedures delivered by the CAs. According to the operators met, samples were taken from all animals collected even those with significant brain destruction or in putrefied state. Additional samples of ear tissues were collected and stored for identification purpose in case of positive results as well as for routine traceability exercise by the CA. Evidence of such actions were seen by the mission team. The previous recommendations on active surveillance have been addressed and the requirements laid down by Art. 6 of Regulation (EC) No 999/2001 were largely complied with, although in Northern Ireland there were a few cases where monitoring records did not reflect the subpopulations set out in point I.A.4 of Chapter B of Annex III to the said Regulation Animals born before 1 August 1996 Legal requirements Decision 2007/411/EC prohibits the placing on the market of products derived from animals born and reared within the United Kingdom before 1 August 1996 and exempts these animals from certain control and eradication measures laid down in Regulation (EC) No 999/2001. Findings The Older Cattle Disposal Scheme (OCDS) was an exceptional market support measure providing for disposal of and compensation for cattle born before 1 August It started on 23 January 2006 and ended on 31 December Several campaigns were directed to bovine keepers, food operators and fallen stock collectors to make them aware of their duties concerning animals born before 1 August According to the CCA, there are still around 66,000 such animals in Great Britain and 5,800 in Northern Ireland. The number of these animals has significantly decreased in Great Britain between 2008 and 2009 since cattle keepers had become aware that OCDS, which had supported financially collection and disposal of such animals, would stop. Although the OCDS ended on 31 December 2008, cattle keepers in NI could still avail of the free collection and disposal service for these older fallen cattle until November Both CTS and APHIS holds information about animals born before 1 August 1996 and, in both databases, a special status is applied to distinguish them from other animals. According to the Rural Payment Agency, collection, processing and use of hides harvested from animals born before 1 August 1996 have finished together with the OCDS. All hides kept previously on stock under official controls of the Rural Payment Agency have been either processed or destroyed. Representatives from the Rural Payment Agency confirmed that the last hide store was emptied in 15 May 2009, the last OCDS hide was processed on 9 October 2009 and the last OCDS tannery had been cleaned down and signed off by the CA on 21 October Under the OCDS, 391,128 hides were harvested out of which 375,970 were salvaged; the remaining ones were destroyed by incineration due to non-negative results or poor quality. The mission team noted that: According to the CCA, animals born before 1 August 1996 and any products derived from them were disposed of in accordance with Regulation (EC) No 1774/2002 and these animals 8

14 Conclusions were sampled and classified as fallen stock. In one of the slaughterhouses visited, in 2008, two bovine animals were presented for slaughter and identified by slaughterhouse staff as born before 1 August In both cases animals were killed in lairage and disposed of as fallen stock. Samples were taken accordingly. There is a satisfactory supervision system in place which is able to prevent the placing on the market of animals born or reared in the United Kingdom before 1 August 1996, or products derived from these animals, as required by Decision 2007/411/EC. 5.3 MEASURES FOLLOWING SUSPICION/CONFIRMATION OF BSE Legal requirements Artt. 12 and 13 of Regulation (EC) No 999/2001 establish, respectively, the measures to be taken with respect to suspect animals and following confirmation of BSE. Moreover, points I.6.4 to I.6.6 of Chapter A of Annex III to the said Regulation set out the measures to be taken following a positive or inconclusive result found following a rapid test. Findings According to the CAs met, notifications of BSE suspect triggered appropriate verification procedures by AH; suspected animals were put under movement restrictions and the identification of their offspring and cohorts was immediately launched. Suspicions which were not ruled out resulted in epidemiological investigations and in the application of movement restrictions to all animals considered as offspring and cohorts. Following the confirmation of BSE, measures including culling of cohorts and offspring of affected cases were put in place The mission team noted that: In the AH offices visited, several records of recent BSE positive cases were examined by the mission team. In all cases documented evidence of compliance with the measures following suspicion and confirmation of BSE were seen. In one of the slaughterhouses visited, a positive BSE case had been identified in the past in a group of healthy slaughtered animals. It was confirmed that all parts of the carcase of the positive case, the one carcase before and the two carcases after the positive case were disposed of as Category 1 ABP. Conclusions Measures taken following suspicion and confirmation of BSE were in accordance with the requirements laid down by Regulation (EC) No 999/ SPECIFIED RISK MATERIAL Requirements Legal requirements Art. 8 of Regulation (EC) No 999/2001 sets out that SRM shall be removed and disposed of in 9

15 accordance with its Annex V; these requirements are further detailed in points 1 to 10 of this Annex. Art. 7 of Regulation (EC) No 1774/2002 required that ABP (which includes SRM) are collected, transported and identified in accordance with its Annex II. Findings The relevant recommendation of report 8316/2006 concerned commercial documents and disposal of SRM at farm level. In response to this recommendation, the CCA undertook to remind operators of their obligations and take enforcement actions when required. Following the increase in the age above which vertebral column is categorised as SRM, butchers are no longer permitted to remove SRM bovine vertebral columns. The mission team noted that: Harvesting of head meat from bovine animals aged over 12 months was carried out by one of the slaughterhouse visited. This was taking place in a separate area dedicated for this activity. Head meat was collected from heads which were still hanging on slaughter line hooks, in a manner preventing its contamination by central nervous system tissues. On-farm slaughtering of bovine animals, although legally authorised, is subject to stringent requirements (ante- and post-mortem examination including BSE testing for cattle over 48 months, staining of SRM and disposal of ABP) which, in practice, makes this activity very rare. This was confirmed during visits to processing plants collecting fallen stock where operators clearly stated that they were not collecting any remains of animals which could be the sign that on-farm slaughtering was taking place. Ιn the slaughterhouses visited, the removal, collection and staining of SRM were performed in accordance with EU requirements. Labels with a blue stripe were used to distinguish carcasses of bovine animals below 30 months from those over 30 months from which removal of vertebral column was required at a later stage. In all the slaughterhouses visited, SRM was disposed of as Category 1 ABP and sent to approved ABP plants. However, at the time of the visit to the slaughterhouse in England, there were five vehicles on site used to transport animal by-products. Three vehicles were in use and two were empty. One vehicle was in the boning hall disposal bay and contained Category 3 material. It was labelled Category 3 with a temporary paper label which was not strictly compliant with Regulation (EC) No 1774/2002 in that it did not contain the words not for human consumption. Two vehicles were in the back yard, contained SRM and were correctly labelled Category 1 for disposal only. Two vehicles were in the front yard, were empty and unlabelled. According to the MHS inspector met, these were awaiting Category 3 material. In one Category 1 intermediate plant visited in England, most of the commercial documentation used for collection of SRM from places where fallen stock was used for feeding dogs (final users of ABP) was not containing the information required by Annex II to Regulation (EC) No 1774/2002. In particular, there was no information on the quantity of material collected. In Scotland, an inspection of a Category 1 intermediate plant had just found that this operator had not been using any commercial document for consignments of SRM dispatched from its site. Although not within the scope of this mission: 10

16 Conclusions In the Category 1 processing plants visited, processed products derived from Category 1 ABP, including SRM, were not marked with GTH as required by Regulation (EC) No 1774/2002. As already mentioned in report 7742/2008, this requirement is not yet transposed into domestic legislation and the CCA confirmed that it is not enforced across the United Kingdom. In the Category 1 processing plant visited in England, processed fat derived from Category 1 ABP, including SRM, was partly combusted on site and partly sent to a biofuel plant and an incineration plant in another Member State. This processed fat was not subject to method 1 nor checked for insoluble impurities. The required temperature of 1,100 C was not reached during the combustion process. As already mentioned in report 7742/2008, Commission Regulation (EC) No 92/2005 is not yet transposed into domestic legislation and is therefore not enforced across the United Kingdom. However, according to DARD, Category 1 fat destined for combustion is always processed to Method 1 and checked for insoluble impurities. This was confirmed in the Category 1 processing plant visited in Northern Ireland. The requirements for collection and removal of SRM set out by Art. 8 of Regulation (EC) No 999/2001 were largely complied with. However, the traceability of SRM was affected by weaknesses in commercial documentation and the identification of means of transport, which were not entirely in line with the requirement laid down in Art. 7 of Regulation (EC) No 1774/ Official controls Legal requirements Art. 8 of Regulation (EC) No 999/2001 sets out that SRM shall be removed and disposed of in accordance with its Annex V; in particular, point 11 requires CAs to carry frequent official controls to verify the correct application of this Annex. Art. 7 of Regulation (EC) No 1774/2002 required that ABP (which includes SRM) are collected, transported and identified in accordance with its Annex II; in particular, Chapter VIII of this Annex requires that CA must take the necessary measure to control the collection, transport and disposal of ABP. Findings The relevant recommendation of report 8316/2006 concerned the frequency of official controls on SRM. In response to this recommendation, the CCA undertook to review, where necessary, the frequency of inspections. The organisation of controls performed on SRM is described in report 8316/2006. Since the last mission on BSE in the United Kingdom, official controls in cutting plants approved to remove bovine vertebral column classified as SRM have moved to a risk-based approach and they are now similar to those in other approved cutting plants. The frequency of official controls mainly depends on the operator's record of compliance and reliability of own controls. The mission team noted that: 11

17 In the slaughterhouses visited, regular checks were in place in order to verify the correct staining and identification of SRM before its collection by ABP operators. In addition, forward tracings and reconciliation tests between estimated amount of SRM and quantities effectively disposed of were carried out on a regular basis. In a Category 1 intermediate plant in Scotland, although several inspections had been carried out in this established, the inspector confirmed that no attention had been paid to commercial documents. In was only after several months. In the Category 1 intermediate and processing plants visited, there was evidence that official controls had been carried out on a regular basis. However, the shortcomings identified by the mission team in relation to commercial documents in the Category 1 intermediate plant and in the slaughterhouse visited in England (see 5.5.1) were not mentioned in the inspection reports examined. Although not within the scope of this mission: Conclusions In one Category 1 processing plant visited, verification that the transport arrangements used for bulk Category 1 processed fat were appropriate to avoid cross-contamination of other products was not carried out during official controls Shortcomings were identified in the approval procedure of Category 1 intermediate plants collecting SRM. In England, a Category 1 intermediate plant visited had been approved while the application received by AH did not contain a HACCP plan nor any written procedures explaining how the site should be operated. During the visit to this plant, an incomplete HACCP plan was presented to the mission team. In Scotland, a Category 1 intermediate plant had been approved, but it HACCP plan did not contain any reference to the Category of ABP handled (the same HACCP plan had been used for the approval of this plant as a Category 3 intermediate plant a few months before). Validation of Category 1 processing plants visited (which were processing SRM) had been carried out. However, in one of them (Northern Ireland), which had been validated by DARD, the raw material process rate was not identified as a critical control point and there were no arrangements in place to ensure that it would not exceed its maximum permitted value (the value at which the plant was validated and the residence time calculated). However, according to DARD, the validation of this plant was carried out at the maximum material process rate achievable and therefore, it was very unlikely that it could be exceeded under normal operating conditions. Frequent official controls were carried out to verify the correct implementation of Annex V to Regulation (EC) No 999/2001 throughout the chain, and these were satisfactory at slaughterhouse level; however, official controls at ABP intermediate and processing plants paid insufficient attention to the verification of compliance with the requirements of Annex II to Regulation (EC) No 1774/2002 concerning the identification and transport of ABP including SRM. 12

18 5.5 FEED BAN Requirements along the chain Legal requirements Art. 7 of Regulation (EC) No 999/2001 prohibits the feeding to farmed animals of products derived from animals in accordance with the conditions laid down in its Annex IV, which establishes a number of derogations from the said prohibition and specific conditions for the application of such derogations. Findings The relevant recommendation of report 8316/2006 concerned the authorisation of establishments using fish meal for the production of feed, the use of feed containing fish meal on mixed species farms and the labelling of feed containing fish meal. In response to this recommendation, the CCA undertook to take all necessary actions in the following National Feed Audit (NFA) programmes. Since the last mission, the procedure in place for authorising and registering users of fish meal or other derogated products derived from animals, which is described in detail in report 8316/2006, has been simplified. In Great Britain, authorisations to produce feed containing derogated products derived from animals have replaced registrations as in both cases the requirements to comply with were deemed very similar. Official permission to store or use complete feed containing derogated products derived from animals on premises with ruminants present is granted following a satisfactory official inspection. According to DARD and DEFRA, there is no evidence of use of dicalcium or tricalcium phosphate of animal origin in the United Kingdom. Concerning the use of blood and blood products, both the CCAs declared their use is very limited, and one industry assurance scheme in the UK includes a voluntary ban on the feeding of blood products to pigs. Commission Regulation (EC) No 956/2008 has not yet been transposed into BSE domestic legislation, which therefore does not provide for a derogation in relation to the use of fish meal to unweaned farmed animals of the ruminant species. Consultations are on-going or about to be launched by the different CCA in order to amend the different domestic legislations. A few samples on milk replacers have been taken in Great Britain but were tested negative for the presence of fish meal. According to DEFRA, little interest has been expressed by the feed industry and farmers associations as regards the use of fish meal in milk replacers. The mission team noted that: Lists of authorised users of fish meal were being kept by AH and DARD. However, in Northern Ireland, the activities indicated on the list of users did not always reflect the actual activities carried out by the operators. In Great Britain, important progress has been made in the identification, authorisation and permitting process of users of fish meal and feed containing fish meal. AH achieved such progress by requesting feed mills to provide the lists of purchasers of fish meal and feed containing fish meal. As a result of this exercise, around 10,000 purchasers were identified. The central operations delivery team of AH, which has taken over the authorisation and permissions database, had already contacted around 5,200 of these premises and 393 had 13

19 been sent to AHROs and AHDOs for inspections, resulting in 329 of them being authorised or permitted. However, the identification process is still incomplete as one half of the purchasers identified (around 5,000) has still to be contacted. The tracing exercise carried out centrally by AH focused on farms purchasing fish meal and feed containing fish meal. According to AH, intermediaries or feed stores present on the lists obtained and possibly supplying such feed to other farms or feed operators have not yet been contacted. In some of the AHOs and AHDOs visited, AH staff requested updates of lists of purchasers of feed containing fish meal from local feed business operators. In some cases, such lists (which contained significant proportions of new purchasers) have been sent to AH central operations delivery team (further delaying their authorisation or permission) while in other cases they have been dealt with at local level. AH staff inspecting ABP plants, in particular those handling fish meal, have been requested to forward to the NFA lead veterinary officer any relevant information allowing the identification of users. However, importers, brokers or storage plants have not yet been requested to provide list of purchasers of fish meal and it could be confirmed that a limited feed back has been received from AH staff performing ABP inspections; for instance, not all plants involved in bulk storage of fish meal were known by the NFA lead veterinary officer. In Northern Ireland, DARD had recently obtained lists of purchasers of feed containing fish meal from feed mills. Around 70 farms keeping ruminants and non-ruminants and buying such feed have been identified and are in the process of being registered. All authorised users of fish meal visited were also producing ruminant feed. Adequate arrangements, including physical separation and dedication of equipments or means of transports, were in place to avoid cross-contamination of ruminant feed except in one onfarm mixer visited, where there was an incomplete physical separation between the storage of bulk feed material used for ruminant feed and the area where feed containing fish meal was manufactured. Labelling requirements for fish meal and feed containing fish meal were complied with and in most cases a warning sentence was printed on the bags. In one on-farm mixer visited, bags of fish meal were not properly labelled but this had been identified by AH which had taken immediate corrective actions. On a number of consignments of imported fish meal checked during the mission, it was verified that microscopy testing had been carried before they were released for free circulation. Conclusions Legal and administrative arrangements are in place in order to ensure that the use of products derived from animals is subject to the requirements of Art. 7 of Regulation (EC) No 999/2001 and there is a good level of compliance amongst the feed operators using derogated products derived from animals. However, even if the authorisation and permission process of such users has made important progress since the last FVO mission, it is still far from being completed. As a consequence, it can not be yet ensured that the use of derogated products derived from animals is always carried out in accordance with the conditions established in Annex IV to Regulation (EC) 14

20 No 999/ Official controls Legal requirements Art. 7 of Regulation (EC) No 999/2001 prohibits the feeding to farmed animals of products derived from animals in accordance with the conditions laid down in its Annex IV, whose point F requires CAs to carry out documentary and physical checks throughout the feedingstuffs production and distribution chain in order to control compliance with the provisions of the said Regulation Art. 3 of Regulation (EC) No 882/2004 requires that official controls are carried out regularly, on a risk basis and with appropriate frequency, taking account of identified risks, operators' past records, the reliability of own check and any information that might indicate non-compliance. Findings The relevant recommendation of report 8316/2006 concerned the prioritisation, implementation and documentation of official controls on the feed ban. In response to this recommendation, the CCA undertook to review the risks prioritisation of the NFA programme and to amend existing procedures. In Great Britain, following the last FVO mission on BSE, changes were made to the design of the NFA programme and risks were reviewed. In particular, a higher risk weighting was attributed to feed mills producing ruminant feed or using bakery co-products as well as to mobile mixers. The NFA programme now includes a portal programme which foresees inspections and sampling at entry points of feed on the basis of the type of bulk feed material and the total annual tonnage imported or traded from other Member States. Part of the NFA programme consists of the annual livestock farm programme which focuses on ruminant on-farm mixers, mixed species farms, users of organic fertilisers and soil improvers (OF/SI), hobby farms and other farms identified as having welfare problems. The Northern Ireland Livestock Feed Sampling Plan has not significantly evolved since the last FVO mission on BSE. It covers inspections and sampling to on-farm mixers and other livestock farms, feed mills, hauliers, intermediate stores, ports and entry points. The mission team noted that: Instructions have been issued by DARD and AH in order to ensure consistency of official controls performed as part of the verification of the feed ban. All AH and DARD staff met had an up to date knowledge of these instructions and, in most cases, were following them when carrying out inspections and sampling. In Great Britain, most of the risk criteria contained in Commission Recommendation 2005/925/EC have been incorporated into the NFA programme. However, the weighting allocated to home mixers using derogated products derived from animals and keeping nonruminants only was very low. In practical terms, this resulted in such operators being almost excluded from the scope of official controls performed by AH after they had been inspected once for authorisation. 15

21 In Great Britain, AH had still an incomplete knowledge of certain key feed operators such as feed mills, intermediaries or stores of feed which were therefore not included in the programme of inspection and sampling. Moreover, in England, in the AHO and AHRO visited neither local authorities nor AH could confirm what were the actual activities of certain feed operators or, for instance, whether they were storing bulk feed (although such operators are to be inspected under the NFA programme). In Great Britain, inspections and sampling were usually following the prioritisation foreseen in the NFA programme. There was a well balanced distribution between samples taken on feed material, ruminant and non-ruminant feed. In Great Britain, farms using OF/SI were subject to an increased frequency of inspections due to the possible risks of cross-contamination with feed. According to the CCA, the use of OF/SI is very limited and consists in liquid products which are soil injected. However, in England, the AHO and AHRO visited had not liaised with the Environmental Agency in order to verify if such users had been identified. In addition, most of NFA inspectors met stated that they were not visiting on-farm fertilisers stores (although this is required under the NFA programme). In Northern Ireland, the Livestock Feed Sampling Plan follows the prioritisation foreseen by Recommendation 2005/925/EC. However, other important criteria such as the use of coproducts from the food industry or the use of OF/SI were not taken into account in this programme; yet, bulk feather meal is traditionally used as OF/SI on farms. In Northern Ireland, inspections were not following the risk prioritisation set out in the Livestock Feed Sampling Plan. In 2009, around 80% of farm inspections were carried out in farms which were not considered as high priority operators. As a consequence, a very limited number of home mixers, home mixers using derogated products derived from animals and farm keeping ruminants and non-ruminants were visited. In addition, mixed species farms using feed containing fish meal have not yet been subject to feed ban inspections as they were in the process of being identified. In Northern Ireland, samples were spread over the different categories of feed operators mentioned in the Livestock Feed Sampling Plan with around 70% of all samples taken at feed mills. However, the distribution of samples between feed materials, ruminant feed and non-ruminant feed could not be provided by DARD. In the United Kingdom, transporters of bulk processed animal proteins (e.g. feather meal) are subject to registration under domestic legislation. In 2006, AH staff in charge of inspections to ABP plants were asked to identify such hauliers and to feed back this information to the NFA lead veterinary officer. In all AH offices visited in Great Britain, there was a satisfactory knowledge of transporters involved in the transport of bulk processed animal proteins. A register of such operators was kept centrally by AH and inspections had been carried out at some of these operators. In Northern Ireland, a few hauliers have been registered but no inspections were conducted on hauliers in 2008 and 2009 although this was required under Livestock Feed Sampling Plan. In addition, during inspections at farms to which hauliers were delivering bulk processed animal proteins there was not a proactive approach in place in order to identify them or verify that they met the requirements of Annex IV to Regulation (EC) No 999/2001. During one visit to a farm 16