EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2015) /11/2015 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Directorate F - Food and Veterinary Office DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN AUSTRALIA FROM 05 MARCH 2015 TO 16 MARCH 2015 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION AND CERTIFICATION PROCEDURES OF FRESH BOVINE MEAT DESTINED FOR EXPORT TO THE EUROPEAN UNION, AS WELL AS TO VERIFY THE APPLICATION OF THE PROVISIONS RELATING TO THE CERTIFICATION OF AUTHENTICITY FOR HIGH QUALITY BEEF QUOTAS 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 an audit carried out by the Food and Veterinary Office (FVO) in Australia from 5 to 16 March The objective of the audit was to evaluate the operation of controls over the production of fresh meat destined for export to the European Union (EU), as well as certification procedures. The official control system in Australia is capable of ensuring satisfactory assurances regarding compliance with, or equivalence to, EU requirements in line with Article 46.1(h) of Regulation (EC) No 882/2004. Further strengthening of the following components of the audit system will improve the rigour of the controls of the official control system: Documentation of Department of Agriculture official controls, especially regarding the follow up of certain observations identified during the Area Technical Manager s audits carried out under the new audit programme. Verification of EU eligible cattle identities present in the EU Cattle Accreditation Scheme holdings during AUS-MEAT audits in conjunction with the improvement of auditor access to National Livestock Identification System database information regarding the presence of EU active identities on the holdings. The official controls are capable of ensuring, that the requirements in relation to the listing of establishments, general and specific requirements, Hazard Analysis Critical Control Points, microbiological testing, food chain information, identification marking and ante-mortem inspection included in model certificate BOV in Part 2 of Annex II to Regulation (EU) No 206/2010, are met. The Competent Authority (CA) had addressed recommendation No 2 of audit report and the post-mortem inspection is performed by government Food Safety Meat Assessors or by Australian Government Authorised Officers (AAO) employed by an independent AAO employer. However, some post-mortem procedures are not carried out in line with Chapter I of Section IV of Annex I to Regulation (EC) No 854/2004. The CA has formally requested Directorate-General for Health and Food Safety DG(SANTE) to evaluate the equivalence of the Australian and EU post-mortem inspection. The official controls did not ensure that labelling of meat destined for export to the EU was always in line with the requirements of Article 13 of Regulation (EC) No 1760/2000. Animal welfare at the time of slaughter was generally in line with the requirements of Regulation (EC) No 1099/2009. The CA had introduced measures to address recommendation No 3 of audit report regarding certification. Weaknesses were identified in the supporting documentation provided for the validation of request for EU certified consignments. A number of recommendations have been made to the CA with a view to addressing the deficiencies identified during this audit I

3 TABLE OF CONTENTS 1. Introduction Objectives of the audit Legal Basis for the audit Background Findings and Conclusions COMPETENT AUTHORITIES Holding registration and animal identification Listing of establishments Official controls at establishment level General and specific hygiene requirements HACCP-based systems Microbiological criteria for foodstuffs Traceability, labelling and identification marking Food Chain Information (FCI) Ante-mortem and post-mortem inspection Animal welfare at the time of slaughter or killing Official certification Overall Conclusions Closing Meeting Recommendations...14 Annex 1 - Legal References II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AAO(s) AAs ABP ATM CA(s) CAR CCA(s) CCP(s) COM DA DG(SANTE) EU EUCAS EUVD EX-DOC FBO(s) FSMA(s) FVO HACCP HGPs Explanation Australian Government Authorised Officer(s) Approved Arrangements Animal By-Product Area Technical Manager Competent Authority(ies) Corrective Action Report Central Competent Authority(ies) Critical Control Point(s) European Commission Department of Agriculture Directorate General for Health & Food Safety European Union European Union Cattle Accreditation Scheme EU Vendor Declaration An electronic certification system administered by the DA Food Business Operator(s) Food Safety Meat Assessors Food and Veterinary Office Hazard Analysis and Critical Control Point Hormonal Growth Promotants Hygiene Package Regulations (EC) No 852/2004, No 853/2004 and No 854/2004 IAE MEVS MICOR NCI NFAS NLIS Independent AAO Employer Meat Establishment Verification System Schedule Manual of Importing Country Requirements Non Conformance Incident National Feedlot Accreditation Scheme National Livestock Identification System III

5 OIE OPV OV(s) PICs RFID(s) RFP(s) SOP World Organisation of Animal Health On-Plant Veterinarian Official Veterinarian(s) Property Identification Code(s) Radio Frequency Identification Device(s) Request for Permit(s) Standard Operating Procedure IV

6 1. INTRODUCTION The audit took place in Australia from 5 to 16 March 2015 as part of the planned audit programme of the Food and Veterinary Office (FVO). The audit team comprised two auditors from the FVO, one auditor from the Directorate-General for Agriculture and Rural Development and one expert from an European Union (EU) country. The audit team was accompanied during the audit by representatives from the Central Competent Authority (CCA), the Department of Agriculture (DA). The opening meeting was held on 5 March 2015 with the CCA in Canberra. At this meeting the FVO audit team confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested 2. OBJECTIVES OF THE AUDIT The objective of the audit was to evaluate whether the official control system put in place by the competent authority (CA) can guarantee that the conditions of production of bovine meat destined for export to the European Union (EU) are in line with the requirements laid down in EU legislation. In addition, the audit team assessed the follow-up actions taken by the CA in response to recommendations of the previous audit DG(SANCO) (hereafter referred to as audit report ). The audit team in particular: Reviewed the systems for certification of animals and meat in relation to the requirements of Council Directive 96/93/EC; Reviewed the system for the control and recording of animal movements, including those controls necessary for certification in accordance with the requirements of Commission Regulation (EU) No 206/2010; Assessed the controls in place over the production of fresh bovine meat including those controls necessary for certification in accordance with the requirements of Commission Regulation (EU) No 206/2010; In particular, controls over fresh bovine meat in the framework of Regulations (EC) No 178/2002, No 852/2004, No 853/2004, No 854/2004 and No 206/2010 were subject to this evaluation. In pursuit of these objectives, the audit itinerary included the following: COMPETENT AUTHORITIES Comments Central 1 Opening and final meeting Competent Regional 2 authorities At three slaughterhouses, holdings and saleyard Local 6 visited FOOD PRODUCTION / PROCESSING / DISTRIBUTION ACTIVITIES Slaughterhouses 3 Cutting premises 3 Attached to the slaughterhouses visited Cold stores 3 Attached to the slaughterhouses visited 1

7 Holdings 3 Feedlots Saleyards 1 3. LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and, in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. N.B. Full EU legal references are provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the latest amended version. 4. BACKGROUND According to the Australian livestock industry the cattle population in Australia is approximately According to the CA the quantities of beef exported to the EU during 2013 and 2014 were and tonnes respectively. Australia is a member of the World Organisation of Animal Health (OIE) and is recognised by the OIE as free from foot and mouth disease, rinderpest and contagious bovine pleuropneumonia; and is recognised as negligible risk for Bovine spongiform encephalopathy. EU Member States are authorised to import bovine meat from Australia if the requirements of Model "BOV" certificate of part 2 of Annex II to Regulation (EU) No 206/2010 are satisfied. The previous audit concerning the safety of fresh meat in Australia was carried out from 12 to 24 October 2012, the results of which are described in audit report This report is accessible at: The action plan received from the Australian authorities provided satisfactory guarantees in response to all of the report's recommendations. 5. FINDINGS AND CONCLUSIONS 5.1. COMPETENT AUTHORITIES Legal requirements Article 46.1 of Regulation (EC) No 882/2004. Audit findings 1. The organisation and control systems in place in Australia are described in detail in previous FVO audit reports. 2. In order to address recommendation No 2 of audit report Australian Government Authorised Officers (AAOs) employed by FBOs, can no longer 2

8 perform post-mortem inspection of cattle slaughtered for the EU. The post-mortem inspection of cattle intended for the production of fresh meat destined to be exported to the EU must be performed by DA employed Food Safety Meat Assessors (FSMAs) or AAOs employed by an Independent AAO Employer (IAE). In both cases, the DA defines the duties and the standards of the personnel and the official On-Plant Veterinarian (OPV) must verify the outcome of the inspection. The AAOs are responsible to the DA for the performance of their functions. At the time of the FVO audit, the post-mortem inspection in 17 out of the 23 EU listed slaughterhouses was performed by DA employed FSMAs while in the remaining slaughterhouses IAE employed AAOs performed these duties. So far, five IAEs had received DA approval. In addition to other conditions the scheme requires that the IAE holds ISO 17020:2012 accreditation. Meat Notice 3/2014 outlines the necessary requirements for a slaughterhouse wanting to source AAOs through an IAE. 3. In one of the slaughterhouses visited, the post-mortem inspection was performed by FSMAs. In the other two slaughterhouses IAE employed AAOs were performing post-mortem inspection with FSMAs carrying out final carcass inspection. All AAOs were approved by the DA and held the required qualifications. In order to ensure availability of enough AAOs for the performance of post-mortem inspection for the EU, the IAEs provided extra AAOs to the slaughterhouses and, in accordance with the rules in place, these AAOs also performed other tasks on the slaughter line such as trimming. 4. The DA has delegated the audits of EU Cattle Accreditation Scheme (EUCAS) farms, feedlots and saleyards to AUS-MEAT Limited, which is a non-profit industry owned company. A Memorandum of Understanding confirms the arrangements between the DA and AUS-MEAT. 5. In slaughterhouses with associated activities, there is a permanent presence of an OPV who performs official controls at different frequencies described in the Meat Establishment Verification System Schedule (MEVS). The MEVS links the different control items to the relevant Work Instructions and Standard Operating Procedures, which are available to the OPV in an on-line library. The OPV must record the outcome of the controls in a standard verification form. The Area Technical Manager (ATM) must perform bi-monthly audits which include the supervision of the OPV performance. These audits are performed using a checklist that covers different topics such as sanitation, Hazard Analysis Critical Control Points (HACCP), good hygiene practices, pest control and animal welfare. The DA was in the process of implementing a new Export Meat Systems Audit Programme. Within this new programme the ATMs carry out an audit every six months and bimonthly OPV supervision controls. The new bi-annual audit must be performed by two ATMs over 2.5 days with the support of a more comprehensive check-list that covers more areas of control including specific EU requirements. According to the non-compliances identified, the audit frequency can be increased up to monthly audits. New OPV verification forms had also been issued under the audit management system. 3

9 6. Weekly meetings between the OPV and the FBO must take place to discuss issues identified and related corrective actions taken. The OPV must forward weekly and monthly reports to the ATM highlighting the issues identified during the controls. The ATMs report to three Field Operations Managers. In stand-alone establishments, the official controls are performed quarterly by Food Safety Assessors. 7. The FVO audit team noted that the official controls were performed at the required frequencies. In addition to the OPVs controls the FSMAs also performed controls such as pre-operational checks. Examples of OPV controls over electronic FBO records such as the temperatures of chillers were available as the FBO system kept a record of the OPV logs. 8. In one slaughterhouse visited, the items listed on the verification form used were in some cases difficult to link to the MEVS. As a consequence the OPV could not explain to the FVO audit team the control frequency of some controls performed and the areas covered. Nevertheless, in the other two slaughterhouses visited where the new Export System Audit Programme was already implemented the updated verification forms introduced clearly linked the control items to the MEVS. 9. Examples of Corrective Action Requests (CAR) and Non Conformance Incident (NCI) reports including their follow up, issued after the identification of significant non-conformances, were available. For less significant observations, follow up records were available in the weekly meetings documentation. However, the documentation available was not adequate to demonstrate the follow up of all the corrective actions carried out by the FBO in order to address the shortcomings not leading to CARs or NCIs identified by the ATM audits performed under the Export System Audit Programme. 10. In one slaughterhouse where the OPV took over his duties two weeks before the FVO audit team s visit, the records relating to key official controls such as load out checks and audits related to certification procedures and ante-mortem inspection were not available. In addition, in another slaughterhouse two supervision controls were not recorded in the system at the time of the FVO audit. 11. The computer system used for the electronic documentation of the official controls was not user friendly. As a consequence it was cumbersome for the officials to retrieve some data Conclusions on Competent Authorities 12. The official control system in Australia is capable of providing satisfactory assurances regarding compliance with, or equivalence to, EU requirements in line with Article 46.1(h) of Regulation (EC) No 882/2004. The full implementation of the new Export System Audit Programme will improve the quality of the official controls. However, the controls could be enhanced to include better documentation and follow up of observations identified during the ATM audits carried out under 4

10 the Export Meat Systems Audit Programme. 13. The CA had addressed recommendation No 2 of audit report and the post-mortem inspection is performed by Government FSMAs or by AAOs employed by an IAE Holding registration and animal identification Legal requirements Point II.2 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Point II.1.7 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Audit findings 14. Each holding is identified with a unique Property Identification Code (PIC) issued by the relevant State or Territory authority (the State authorities). 15. To ensure Hormonal Growth Promotants (HGPs) freedom, cattle slaughtered for the EU must be sourced from the EUCAS approved farms, feedlots and/or saleyards. These three locations and the EU approved abattoirs constitute the EUCAS pathway. 16. The EUCAS main components are: The farms, feedlots and saleyards must be accredited by the DA. In the case of saleyards and feedlots, the accreditation process includes an on-site joint audit by the DA and AUS-MEAT while the farm accreditation is performed only on the basis of documentary checks. Cattle moved outside the EUCAS pathway lose EU eligibility. The cattle movements must take place with an EU vendor declaration (EUVD). Segregation of EUCAS cattle from non-eu cattle at feedlot, saleyard and abattoir. All cattle on farms must be within EUCAS except house cows and breeding stock sourced outside EUCAS which, in both cases, are not EU eligible. There are 37 feedlots and 42 saleyards approved within the EUCAS and these must be audited at least once a year. The EUCAS farms must be audited at random and on a targeted basis. 300 out of approximately EUCAS farms were audited during AUS-MEAT performs the EUCAS audits at farms, feedlots and saleyards. The EUCAS audits in feedlots are carried out by AUS- MEAT in parallel with the National Feedlot Accreditation Scheme (NFAS) and High Quality Beef audits. 17. All cattle must be identified with a Radio Frequency Identification Device (RFID) and movements must be recorded in a central database as required by the National 5

11 Livestock Identification System (NLIS). The State authorities are responsible for issuing RFIDs and to follow up issues related to the NLIS. Managers of the EUCAS properties have to fulfil specific cattle movement notification and verification requirements. In addition, the EUCAS farms must identify all cattle with an NLIS tag at the latest at the time of weaning. 18. In the three feedlots and in the saleyard visited, the EUCAS audits were performed annually by AUS-MEAT in accordance with the procedures in place. At all visits the FVO audit team verified the identities of cattle belonging to EU lots. All cattle selected were registered in the NLIS database as EU eligible and were covered by EUVDs. 19. See footnote The information available to AUS-MEAT regarding the number of cattle present on the holding includes active and inactive cattle identities. For example, in one of the feedlots visited the information available to AUS-MEAT auditor indicated that EU eligible cattle were present while in reality were present. The observed difference in the cattle numbers is due to the formatting of the information. The NLIS system holds more accurate information regarding the presence of EU eligible cattle but cannot be accessed by AUS-MEAT. 21. All replacement tags issued to a holding become active identities immediately. In feedlot and saleyards these new active identities are initially given non-eu status and, in order to be activated as EU eligible, they need to be linked to a pre-existing EU eligible identity. 22. In the saleyard visited, the operator could not locate around 400 new tags issued. In addition, over 40 damaged new tags which should have been removed from the system were active and were on visible display in one open office. Only three out of the four deceased cattle verified by the FVO audit team were removed from the system. AUS-MEAT auditor stated that the issues noted by the FVO audit team were not present during the last EUCAS audit. 23. EU eligibility status was removed in the database when issues arose that compromised the EU eligibility of cattle. 24. In the three feedlots and in the saleyard visited, the EU eligible cattle were clearly segregated from non-eu cattle. 25. The EUCAS farms and feedlots must perform an annual reconciliation of the cattle identities present on the holding against the identities registered in the NLIS database. According to the CA this reconciliation can be carried out reading all the NLIS devices on the cattle in the holding or through the management tags. 26. In the three feedlots visited, the total number of cattle identities active in the database was greater than the actual number of cattle. In some cases the differences 1 In their response to the draft report the Australian CA provided clarifications and the report was amended accordingly. As a result this paragraph has been deleted. 6

12 amounted to approximately identities out of These discrepancies were mainly observed in the non-eu cattle and were mainly due to: Replacement tags being issued that were active in the system without being used. Lost tags due to lost animals and animals losing tags. When non EU eligible cattle are re-tagged with NLIS replacement tags, there is no obligation to link the new tag number with the previous one. The uploading of NLIS identities of slaughtered cattle may take up to 48 hours and the movements of cattle from saleyards are uploaded to the database at the moment of sale while the physical movement of animals may take several days. In the feedlots visited, the feedlot operators could do a close reconciliation between the EU cattle in the NLIS database and the EU cattle present in the feedlot. 27. In the three feedlots visited, the management of veterinary medicine withdrawal periods was done using a computer system that, when relevant, blocked the identity of the animal to be moved to slaughter. In addition, the use of HGPs also blocked the animal identities from being EU eligible. HGPs are only allowed in the form of implants as the adding of HGPs to feed is prohibited in Australia. 28. Examples of co-ordination between the State authorities and AUS-MEAT used for the performance of the EUCAS targeted audits were available. Conclusions on holding registration and animal identification 29. The system for holding registration and cattle identification in place in Australia can provide sufficient guarantees to support the statements of Points II.1.7 and II.2 of the model certificate in Part 2 of Annex II to Regulation (EU) No 206/2010. However, further strengthening of AUS-MEAT controls regarding the verification of EU eligible cattle identities present in the holding and the improvement of access of AUS-MEAT auditors to the NLIS database information regarding the presence of EU active identities on the holding could improve the rigour of the controls Listing of establishments Legal requirements Article 12 of Regulation (EC) No 854/2004. Audit findings 30. The system for listing establishments for export to the EU remains as described in previous FVO audit reports. The CA has to approve and stamp the Approved Arrangements (AAs) of the establishment which must include all areas of activity. 7

13 31. The DA has produced the Manual of Importing Country Requirements (MICOR) where the EU requirements are listed. In practice, the FBOs use the MICOR for the drafting of the AAs. 32. In the establishments visited where this issue was evaluated the AAs contained the relevant EU requirements including the segregation of EU and non-eu product. Conclusion on listing of establishments 33. The EU listing procedures for the establishments subject to the audit were satisfactory Official controls at establishment level General and specific hygiene requirements Legal requirements Article 12 of Regulation (EC) No 854/2004. Point II.1.2 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Audit findings 34. The CA must evaluate compliance with the general and specific requirements as part of the regular audits performed by the ATMs and the controls performed by the OPVs and FSMAs. Examples of non-conformances in relation to general and specific requirements identified by the OPVs, FSMAs and ATMs and related follow up actions were noted by the FVO audit team. 35. In the establishments visited, only minor maintenance issues such as floor damage and rust in some areas not identified by the official controls were noted by the FVO audit team. The operational hygiene and the overall carcass hygiene were satisfactory in all slaughterhouses visited. The FVO audit team noted that all three FBOs visited performed carcass dressing to a high standard. All cattle were washed before slaughter. After carcasses were declared fit for human consumption they were subject to hot water washing (i.e. 82 o C for seconds) and, in some cases, spray chilling was performed in the carcass chillers. Potable water was used for both practices. According to the AAs in place, carcasses could be boned after the carcass surface temperature was lower than 7 o C. Heads were subject to washing before post-mortem inspection HACCP-based systems Legal requirements Point II.1.1 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/

14 Audit findings 36. The FBO s HACCP based procedures must initially be endorsed by the ATM. The implementation of these procedures by the FBOs is evaluated as part of the ATM s audits with the use of an audit check-list/aide memoire. In addition, the OPV must evaluate weekly the implementation of the CCPs. 37. In the three slaughterhouses visited, a zero tolerance CCP for carcass contamination for faeces, ingesta and milk was implemented. For every slaughter shift the OPV must verify the hygiene of 11 carcass sides as required by the procedures Microbiological criteria for foodstuffs Legal requirements Point II.1.6 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Point II.1.10 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Audit findings 38. Meat Notices 2003/6 and 2007/12 establish the basis for the microbiological testing of carcasses for total viable counts (TVCs), Escherichia coli and Salmonella. Microbiology sampling is subject to regular official controls. 39. In the establishments where this issue was evaluated by the FVO audit team the microbiological testing was performed in line with the Australian requirements and the results were trended accordingly Traceability, labelling and identification marking Legal requirements Point II.1.5 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Articles 13 and 15 of Regulation (EC) No 1760/2000 and Regulation (EC) No 1825/2000 set out specific labelling requirements for beef meat. Audit findings 40. The official controls included traceability exercises and within the certification procedures the FBO must present information regarding the traceability of the EU eligible loads to the OPV (see section 5.5). 41. Prior to slaughter, the feedlots send the slaughterhouse a list of the identities of cattle sent for slaughter. A cross-check of the EU eligibility of the listed cattle takes place before slaughter. Where cattle originated from EUCAS farms, the verification of the EU eligibility takes place after reading the RFID tags at the slaughterhouse. 9

15 The FVO audit team noted that in some slaughterhouses the RFID tag reading took place after slaughter. This procedure made it cumbersome to segregate non-eu eligible cattle at that stage. 42. Labelling controls including identification marking are performed by both AUS- MEAT and the DA. In the three establishments visited identification marking evaluated by the FVO audit team was satisfactory. However, in one establishment official controls did not identify that the label applied to cartons containing beef to be exported to the EU, did not meet the requirements of Article 13 of Regulation (EC) No 1760/2000 as the indication did not read: slaughtered in (name of the third country) (approval number) and cutting in : (name of the third country) (approval number) Food Chain Information (FCI) 43. Cattle slaughtered with the intention of producing beef to be exported to the EU must be accompanied by an EUVD. The EUVD is signed by the holding manager and, among other issues, include declarations regarding compliance with withholding periods following veterinary treatments and freedom of HGP treatment during the life of the animals. 44. The official controls included the evaluation of the EUVD which is verified as part of the ante-mortem procedures and at holding and saleyard audits. The FVO audit team verified that EU eligible cattle were accompanied by the relevant EUVD at slaughterhouses, saleyard and feedlots. The EUVD numbers evaluated were recorded in the NLIS system linking the declaration to the identities of cattle moved and the locations between which these movements took place Ante-mortem and post-mortem inspection Legal requirements Point II.1.4 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Audit findings 45. According to the Australian requirements all cattle slaughtered for the EU must be subject to ante- and post-mortem inspection in accordance with the EU requirements. In the slaughterhouses visited ante-mortem inspection of EU eligible cattle was performed by the OPV according to the procedures and recorded on antemortem cards. In one slaughterhouse the ante-mortem inspection cards available only covered the kills for the last two weeks. The DA stated that the OPV can dispose of the ante-mortem cards if a reference to the ante-mortem evaluation is included on the kill sheets. However, no reference to the ante-mortem evaluation was available on the kill sheets presented. 46. SOPs numbers 3.06 and describe the post-mortem procedures. In response to recommendation No 2 of audit report the Australian CA modified the 10

16 arrangements in place regarding the employment of AAOs performing post-mortem inspection (see chapter 5.1). 47. The FVO audit team noted that before de-hiding all EU eligible carcasses were palpated for the presence of HGP implants and triangular ear punches. 48. Contrary to the requirements of Regulation (EC) No 854/2004 the post-mortem inspection procedures only included one cut of the external masseter muscles and did not include the incision of the prescribed lymph nodes (e.g. retropharyngiales, mandibulares, parotidei and mediastinsales). The Australian CA has formally requested DG(SANTE) to evaluate the equivalence of the Australian and the EU post-mortem inspection based on Australia s low prevalence of Cysticercus bovis and alternative inspection procedures; and Australia s freedom from bovine tuberculosis Animal welfare at the time of slaughter or killing Legal requirements Point II.3 of the model certificates in Part 2 of Annex II to the Regulation (EU) No 206/2010. Audit findings 49. In the slaughterhouses visited, cattle were slaughtered under religious rites but with prior stunning using the concussion method. In all slaughterhouses visited, procedures were in place to evaluate the effectiveness of the stunning procedure. 50. The FVO audit team observed that cattle were handled and slaughtered satisfactorily. However, in one slaughterhouse the oesophagus was fully exposed and ligated immediately after sticking In the slaughterhouses visited when cattle had to stay over periods of 12 hours they were moved to outside paddocks and fed hay. Conclusions on official controls at establishment level 52. The official controls are capable of ensuring, that the general and specific requirements, HACCP, microbiological testing, food chain information (FCI), identification marking and ante-mortem inspection included in model certificate BOV in Part 2 of Annex II to Regulation (EU) No 206/2010, are met. 53. The post-mortem procedures in relation to masseter muscle cuts and lymph node incisions are not in line with Chapter I of Section IV of Annex I to Regulation (EC) No 854/2004, as a consequence the post-mortem inspection carried out in Australia do not ensure that the relevant requirements of model certificate BOV in part 2 of Annex II to Regulation (EU) No 206/2010, are met. The Australian CA has formally 2 In their response to the draft audit report the Australian CA noted that an investigation regarding this issue has taken place establishing that dressing activities in this slaughterhouse commence between 125 and 140 seconds after sticking. 11

17 requested DG(SANTE) to evaluate the equivalence of the Australian and the EU post-mortem inspection procedures based on Australia s low prevalence of Cysticercus bovis and alternative inspection procedures; and Australia s freedom from bovine tuberculosis. 54. The official controls did not, in one establishment visited, ensure that the labelling of meat destined for export to the EU was in line with the requirements of Article 13 of Regulation (EC) No 1760/ Animal welfare at time of slaughter was generally in line with the requirements of Regulation (EC) No 1099/ Official certification Legal requirements Council Directive 96/93/EC. Annex V of Regulation (EU) No 206/2010. Annex VI of Regulation (EC) No 854/2004. Audit findings 56. To address recommendation No 3 of audit report the CA committed to validate the Requests for Permits (RFPs) and countersign the Meat Transfer Certificates (MTCs) used to issue the final EU export certificate. In addition, weekly monitoring of in/out EU loads and monthly traceability audits of RFPs and MTCs by DA staff were implemented. Meat notice 1/2014 on EU product integrity and certification requirements contains details of the revised certification procedures. In addition, specific work instructions to CA staff regarding certification related issues such as verification of certification integrity and RFP validation for the EU is available. According to these procedures the FBO's personnel conducting RFPs validation including load out inspection, signing MTCs and RFPs must be approved for that purpose and designated in the establishment s AAs. Also, at least twice a year, the FBO must perform trace back and forward product identified in a health certificate including EU certificates as appropriate. In the establishments visited, where these requirements were evaluated, they were implemented satisfactorily. 57. The DA's RFP validators and MTC counter signatories must review all supporting documentation. In the slaughterhouses visited the OPVs demonstrated how they validated the RFPs using supporting documentation and recorded the validation in the EXDOC system in order to get the final EU certificate issued at a central office. Also demonstrations of the EU weekly load out checks were performed. In all three cases fresh meat was exported directly from the establishments to the EU. Work Instruction specifies that, as part of RFP validation for the EU, on plant staff must check relevant records such as final kill sheets and production summaries. In one of the three establishments visited, the supporting documentation associated with the validation of RFPs established clearly the EU eligibility status of the 12

18 certified beef. However, in the other two, the documentation presented to the OPV supporting the traceability of the consignment for RFP validation, was inadequate: In one slaughterhouse, the RFP validator (OPV) did not identify that the amount of cuts in the production summary report exceeded the maximum possible cuts available from the EU eligible cattle processed. At the request of the FVO audit team the FBO investigated and clarified the reason for the discrepancies. This was a regular occurrence that was not identified by RFP validator. In addition, only two weeks of documented evidence of EU load out checks were available and monthly verification of RFPs was not documented. In this slaughterhouse, only a limited traceability exercise was recently documented by the OPV as part of the official controls. In another slaughterhouse, the traceability system was very sophisticated and could trace an individual cut to a particular carcass. However, the documentation provided to support the RFP validation was insufficient to establish the EU eligibility of the load as a whole. 58. Nevertheless, in all establishments visited, the FVO audit team carried out successful full traceability exercises of consignments certified for the EU. These exercises identified that only EU eligible beef was certified as part of the EU consignments evaluated. 59. In cold stores the weekly load out verifications does not take place. The CA informed the FVO audit team they are experiencing technical difficulties with the system in place which require that the supporting documentation for RFP validation includes photographic evidence of the load outs. The CA stated that a new technological solution is on trial. Independent cold stores were not visited during this audit. Conclusions on official certification 60. In establishments with permanent OPV presence the CA has introduced measures to address recommendation No 3 of audit report The implementation of the RFP validation procedures is undermined by weaknesses in the supporting documentation accepted by the RFP validators in order to certify EU consignments. 6. OVERALL CONCLUSIONS The official control system in Australia is capable of ensuring satisfactory assurances regarding compliance with, or equivalence to, EU requirements in line with Article 46.1(h) of Regulation (EC) No 882/2004. Further strengthening of the following components of the audit system will improve the rigour of the controls of the official control system: Documentation of DA official controls, especially regarding the follow up of certain observations identified during the ATM s audits carried out under the new audit programme. Verification of EU eligible cattle identities present in the EUCAS holdings during 13

19 AUS-MEAT audits in conjunction with the improvement of auditor access to National Livestock Identification System database information regarding the presence of EU active identities on the holdings. The official controls are capable of ensuring, that the requirements in relation to the listing of establishments, general and specific requirements, HACCP, microbiological testing, food chain information, identification marking and ante-mortem inspection included in model certificate BOV in Part 2 of Annex II to Regulation (EU) No 206/2010, are met. The CA had addressed recommendation No 2 of audit report and the postmortem inspection is performed by government FSMAs or by AAOs employed by an independent AAO employer. However, some post-mortem procedures are not carried out in line with Chapter I of Section IV of Annex I to Regulation (EC) No 854/2004. The CA has formally requested DG(SANTE) to evaluate the equivalence of the Australian and EU post-mortem inspection. The official controls did not ensure that labelling of meat destined for export to the EU was always in line with the requirements of Article 13 of Regulation (EC) No 1760/2000. Animal welfare at the time of slaughter was generally in line with the requirements of Regulation (EC) No 1099/2009. The CA had introduced measures to address recommendation No 3 of audit report regarding certification. Weaknesses were identified in the supporting documentation provided for the validation of request for EU certified consignments. 7. CLOSING MEETING A closing meeting was held on 16 March 2015 with the CCA, the DA. At this meeting the FVO audit team presented the findings and preliminary conclusions of the audit and advised the CCA of the relevant time limits for production of the report and their response. The representatives of the CCA acknowledged the findings and conclusions presented by the FVO audit team. In addition, information on action already taken and planned in order to address particular findings in the establishments visited was provided. 8. RECOMMENDATIONS An action plan describing the action taken or planned in response to the recommendations of this report and setting out a time table to correct the deficiencies found should be presented to the Commission within 25 working days of receipt of the report. No. 1 Recommendation To ensure that documentation on the follow up of all non-compliances identified during Area Technical Manager s audits and documentation of the On-Plant Veterinarian s controls are available to support the certification of 14

20 the requirements of Model "BOV" certificate of part 2 of Annex II to Regulation (EU) No 206/2010. Recommendation based on conclusion No 12 Associated findings No 9 and No To strengthen AUS-MEAT controls regarding the verification of European Union (EU) eligible cattle identities present in EU Cattle Accreditation Scheme holdings and to improve the access of the auditors to the National Livestock Identification System database information regarding the presence of EU active identities on the holdings in order to ensure that the requirements of Model "BOV" certificate of part 2 of Annex II to Regulation (EU) No 206/2010 are met. Recommendation based on conclusion No 29 Associated findings No 19 and No 20. To ensure that the post-mortem procedures are carried out in line with Chapter I of Section IV of Annex I to Regulation (EC) No 854/2004. Recommendation based on conclusion No 53 Associated finding No 48. Review the official controls over labelling in order to ensure that all establishments comply with the requirements of point 5 of Article 13 of Regulation (EC) No 1760/2000. Recommendation based on conclusion No 54 Associated finding No 42. To ensure that the Request For Permit validation is only carried out when adequate supporting documentation is available in order to guarantee that the requirements of Model "BOV" certificate of part 2 of Annex II to Regulation (EU) No 206/2010 are met. Recommendation based on conclusion No 60 Associated finding No 57. The competent authority's response to the recommendations can be found at: 15

21 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 1760/2000 OJ L 204, , p Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 Reg. 1825/2000 OJ L 216, , p Reg. 178/2002 OJ L 31, , p Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Reg. 854/2004 OJ L 139, , p. 206, Corrected and re-published in OJ L 226, , p. 83 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Commission Regulation (EC) No 1825/2000 of 25 August 2000 laying down detailed rules for the application of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

22 Reg. 2073/2005 OJ L 338, , p Reg. 2074/2005 OJ L 338, , p Reg. 2075/2005 OJ L 338, , p Reg. 1099/2009 OJ L 303, , p Reg. 206/2010 OJ L 73, , p Reg. 931/2011 OJ L 242, , p. 2-3 Reg. 101/2013 OJ L 34, , p. 1-3 Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific rules on official controls for Trichinella in meat Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011 on the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin Commission Regulation (EU) No 101/2013 of 4 February 2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases

23 Reg. 1079/2013 OJ L 292, , p Dir. 96/22/EC OJ L 125, , p. 3-9 Dir. 96/23/EC OJ L 125, , p Dir. 96/93/EC OJ L 13, , p Dir. 98/83/EC OJ L 330, , p Commission Regulation (EU) No 1079/2013 of 31 October 2013 laying down transitional measures for the application of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of betaagonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption