EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/ MR Final FINAL REPORT OF A MISSION CARRIED OUT IN NEW ZEALAND FROM 1 TO 13 FEBRUARY 2007 IN ORDER TO EVALUATE THE OPERATION OF CONTROL SYSTEMS AND CERTIFICATION PROCEDURES FOR MILK AND PRODUCTS THEREOF AS WELL AS ANIMAL HEALTH CONDITIONS APPLICABLE TO IMPORTS INTO THE EUROPEAN COMMUNITY OF BOVINE SEMEN AND EMBRYOS UNDER THE AUSPICES OF THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND NEW ZEALAND ON SANITARY MEASURES APPLICABLE TO TRADE IN LIVE ANIMALS AND ANIMAL PRODUCTS Please note that factual errors in the draft report have been corrected. Clarifications provided by the New Zealand Authorities are given as endnotes, in bold, italic, type, to the relevant part of the report. 23/07/

2 TABLE OF CONTENTS ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT INTRODUCTION MISSION OBJECTIVES LEGAL BASIS FOR THE MISSION BACKGROUND Summary of previous mission findings Production and trade information Animal health information MAIN FINDINGS Competent Authority Legislation Control of the implementation of the legislation Certification CONCLUSIONS Competent Authority Legislation Control of the implementation of the legislation Certification Overall conclusion CLOSING MEETING RECOMMENDATIONS COMPETENT AUTHORITY RESPONSE TO RECOMMENDATIONS...30 ANNEX - LEGAL REFERENCES

3 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT APA ASD BNZ BVD/MD CA Campylobacter CCA CIG DG(SANCO) EBL EC ECT EU FDA FVO HACCP IBR/IPV ICR ICR MAF Mission NZ NZFSA NZFSA-VA OIE OV PAC PSP RA RMP RSP SCC SSC TB Trichomonas VA Animal Products Act 1999 (as amended) Animal Status Declaration Biosecurity NZ Bovine Viral Diarrhoea / Mucosal Disease Competent Authority Campylobacter fetus spp venerealis Central Competent Authority Compliance and Investigation Group (NZFSA) Health & Consumer Protection Directorate General (EC) Enzootic Bovine Leucosis European Commission Embryo Collection Teams European Union Farm Dairy Assessor Food and Veterinary Office Hazard Analysis of Critical Control Points Infectious Bovine Rhinotracheitis / Infectious Pustular Vulvovaginitis Importing Country Requirements Importing Country Requirements Ministry of Agriculture and Fisheries Audit under the VA New Zealand New Zealand Food Safety Authority NZFSA Verification Agency World Organisation for Animal Health Official Veterinarian Product Analysis Certificate Product Safety Programme Recognised Agency (formerly Third Party Agencies, TPA) Risk Management Programme Recognised Service Provider Semen Collection Centre Semen Storage Centre Bovine Tuberculosis Trichomonas foetus EC/NZ Veterinary Agreement (Council Decision 97/132/EC) 3

4 1. INTRODUCTION The mission took place in New Zealand (NZ) from 1 to 13 February The Commission team comprised 2 inspectors from the Food and Veterinary Office (FVO). The mission was announced to the NZ Central Competent Authorities (CCA) in a letter, dated 8 December 2006, from the FVO including an audit plan under the auspices of the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products set out in Council Decision 97/132/EC (the VA note that all legislation quoted are listed in the Annex to the report). The Commission team was accompanied during the review of dairy establishments and farms by a representative from the New Zealand Food Safety Authority s (NZFSA) Compliance & Investigation Group (CIG) and during the review of semen and embryo collection and storage establishments by a representative from Biosecurity NZ (BNZ). An opening meeting was held on 1 February 2007 with representatives from NZFSA and BNZ in Wellington. At this meeting, the Commission team confirmed the objectives and scope of the mission, confirmed the audit plan and schedule, confirmed the time, date and location of the closing meeting and responded to questions from the CCA concerning the review process. Additional information required for the satisfactory completion of the mission was requested. 2. MISSION OBJECTIVES The VA establishes the list of live animals or animal products for which equivalence of sanitary measures has been recognised for trade purposes. Trade in commodities for which equivalence has not been recognized may take place under the conditions required by the importing Party. Trade in commodities for which equivalence has been recognized may take place in accordance with the provisions of exporting Party standards and requirements (and application of special conditions, where applicable). The objective of the mission was to evaluate the enforcement of the measures and control systems put in place to fulfil the Importing or Exporting Party s requirements (including special conditions, where applicable), for the commodities included in the scope of the mission. The mission was part of the process to check the effectiveness of the controlling authority in delivering assurances of product safety that are equivalent to the EU system, and to propose appropriate action, if necessary. The scope of the mission was: To review the structure and operation of control systems in New Zealand s milk sector (milk and milk products). Legal provisions, documented control programmes, responsibilities, powers, operation and monitoring of controls, 4

5 approval procedures, certification were reviewed, with a particular emphasis on the certification and traceability systems and the operation of own checks. To review the structure and operation of control systems in New Zealand concerning the collection, storage and trade of bovine semen and embryos. In pursuit of the objectives, the following sites were visited: COMPETENT AUTHORITY VISITS Competent authority Central 2 NZFSA and BNZ Regional Local OTHER SITES VISITED Dairy establishments 2 Dairy farms 2 Independent coldstores (dairy) 1 Comments Certification offices 2 NZFSA-VA Airport office (semen & embryos) / NZFSA Central Certification Office (milk & milk products) Semen Collection Centres (SCCs) 2 Semen Storage Centres (SSCs) 2 One during the visit of an ECT Embryo Collection Teams (ECTs) 2 Laboratories 1 3. LEGAL BASIS FOR THE MISSION The mission was carried out, in principle, on the basis of the exporting Party s requirements, in accordance with the provisions of Art. 10 (1) of the VA. In addition, the special conditions established in Annex V of the VA apply. The sanitary measures applied for bovine embryos have been recognized as equivalent. However, for in-vitro derived embryos produced in New Zealand, the equivalence is in form of compliance with importing Party's requirements. The equivalence of the sanitary measures regarding animal health conditions applied to bovine semen from New Zealand is still under consideration. As a consequence, trade in this commodity occurs on the basis of compliance with the importing Party s requirement. For the sectors not yet evaluated or still being evaluated, the mission was carried out with a view to gathering information on standards in place in New Zealand, against current EC standards, including: Regulations of the European Parliament and of the Council (EC) No 852/2004, 853/2004, 854/2004 and 882/2004. Council Directives 88/407/EEC and 89/556/EEC, and Commission Decisions 2004/639/EC and 2006/168/EC. 5

6 4. BACKGROUND 4.1. Summary of previous mission findings This summary refers to previous findings relating to the objectives and scope of this present FVO mission. In November 2004, a mission was carried out in NZ (Report reference: DG(SANCO)/7197/ MR final) to evaluate the operation of controls over the production of fresh meat, meat products, minced meat, meat preparations, farmed game meat, wild game meat, milk and milk products under the auspices of the VA. This mission identified a number of deficiencies and the report included the following recommendations to the NZ authorities relating to milk and milk products: - To ensure that New Zealand regulatory requirements with regard to the dairy sector are uniformly applied. - To ensure that Third Party Agencies (TPAs) are operating as laid down in applicable New Zealand regulatory standards. - To implement effective supervision over TPA and EU approved dairy establishments in particular with regard to the follow up of nonconformances. - To review the operation of the databases which are used as tools for verification of the compliance status of products and operations in the framework of E-certification for dairy products. - To ensure that certification procedures and issuing of certificates for dairy products operates in compliance with Commission Decision 2004/438/EC. In response to the report, the NZ authorities provided assurances The FVO mission report has been published on the DG SANCO Internet website: ( The current mission was the first FVO mission undertaken in NZ on animal health conditions applicable to export of bovine semen and embryos to the EU Production and trade information Milk and milk products In 2003, 2004 and 2005 the following quantities of milk products were exported from NZ to the EU (sources: EUROSTAT): Butter (incl. fats / oil derived from milk 85,177 tonnes 84,177 tonnes 75,487 tonnes 6

7 Cheese 55,050 tonnes 29,047 tonnes 23,385 tonnes Milk and cream in solid forms 46,755 tonnes 2,196 tonnes 367 tonnes Fermented milk products 151 tonnes 296 tonnes 442 tonnes Whey products 149 tonnes 206 tonnes 283 tonnes Bovine semen and embryos NZ has approximately 9.6 million cattle, of which about 5 million are dairy cows (source: MAF, 2004). No data on the national production of doses of semen was available at the time of the mission. Data given by the CA showed that more than semen doses were exported to the EU in 2005, and less than up to October The same source stated that 63 bovine embryos were exported to the EU, and none in Animal health information Bovine tuberculosis (Mycobacterium bovis) is a notifiable disease in NZ, for which legislation and an eradication plan are in place. According to the CCA, the herd prevalence from June 2005 to June 2006 was 0.5 %. The last case of bovine brucellosis reported in NZ occurred in 1989 (source: World Animal Health Organisation (OIE)). Commission Decision 2004/751/EC (O.J. L 332, , p. 16) recognized New Zealand as free of Brucella abortus. Enzootic Bovine Leucosis (EBL) is not a reportable disease, but a voluntary control and eradication programme managed by the industry is in place. According to data provided by BNZ, the herd prevalence of EBL was 0.2% in 2004 and <0.2% in BVD/MD (Bovine Viral Diarrhoea / Mucosal Disease) and IBR/IPV (Infectious Bovine Rhinotracheitis / Infectious Pustular Vulvovaginitis) are not subject to national control programmes. Both diseases are present in the country, and the viruses are estimated to be widespread. Only the abortive sub-type of IBR/IPV is notifiable. Trichomonosis and bovine genital campylobacteriosis are not reportable diseases. The CCA indicate that a number of diseases affecting bovine animals have never occurred in NZ, including foot and mouth disease, rinderpest, blue tongue, Rift Valley fever, vesicular stomatitis and rabies. Anthrax was last reported in 1954 and bovine contagious pleuropneumonia in

8 5. MAIN FINDINGS 5.1. Competent Authority Milk and milk products The system in place was described in detail in the previous FVO mission report DG(SANCO)/7197/2004 and this section therefore will focus on changes made since this mission. During 2005 NZFSA underwent a restructuring process in order to move from a vertically or sector based structure to a more horizontal or functional structure. The NZFSA now comprise the following nine Directorates (Business Groups) under the leadership of the Executive Director: Communications and Infrastructure; Export Standards; Market Access. Science; Policy & Food Standards; Compliance and Investigation (CIG); Approvals & Agricultural Compounds and Veterinary Medicines; New Zealand Standards; NZFSA Verification Agency (NZFSA-VA); Responsibility for the dairy sector was moved from the previous "Dairy & Plant Products Business Group" to the Export Standards Group. However, despite these structural changes, no significant changes have been made regarding the operation of the CA controls over the dairy sector Bovine semen and embryos The CCA for the matters related to the scope of this mission is the Ministry of Agriculture and Forestry (MAF). Two main services of MAF have responsibilities: NZFSA has some responsibilities in the field of bovine semen and embryos to be exported to the EU. They provide via NZFSA-VA official assurance on behalf of BNZ that export standards are met (certification). Biosecurity-NZ (BNZ) is the CCA for the application of the export conditions for bovine semen and embryos. The Pre-Clearance Directorate (export group) is responsible for setting standards and monitoring the industry performance. The tasks related to the monitoring of the industry have been delegated since 1 March 2003 to a recognized agency (RA), which is a control body responsible for official controls. Recognition is granted by the CCA to the agency and each of its members acting as official veterinarians (OVs). This recognition is renewed each year following a documented request by the RA. 8

9 The nature of tasks delegated and the terms and conditions for delegation are detailed, documented and publicly available at They include provisions to ensure a quality system for operations, suitable expertise of the staff, and absence of conflict of interest. For this purpose, each individual is "accredited" by the CCA on a yearly basis. Information is made public at The control of these provisions was not always satisfactory, as: - The last notices granting recognition as a RA was issued more than three month after the previous recognition elapsed (RA Notice commencing 1 March 2006 was signed by BNZ on 12 June 2006); - The CCA requires the RA to be accredited as working according to the ISO standard not later than 6 months from the date of recognition, and to be assessed every year by an accreditation body. The mission team could not obtain any evidence of current accreditation, either from the RA or the CCA; - Recognition of OVs was granted by the CCA regardless of their expertise, contrary to their own procedure. These administrative deficiencies and lack of rigour in application of internal rules were also noted in the management by the CCA of approvals, either for the centres (see below), or the diagnostic laboratory (with an ante-dated approval certificate). The RA had a documented procedure to carry out its activities within the scope of the mission. It had sufficient staff to carry out its delegated role, and had appointed a general coordinator, in charge of supervision and training of the staff. The coordinator presented evidence of training and supervision, but this was not always correctly documented. A training map was organised by the coordinator according to his own evaluation of the acquired expertise of each OV. The evaluation of the expertise did not include a peer review of the supervision of the OVs on-site. Despite shared competence, no structured coordination was ensured between the BNZ and NZFSA in relation to the scope of the mission (for instance, the rules for control of export certificate forms are not harmonised between ruminant semen and embryos, and other animal products). The CCA explained that NZFSA acted as an executive agency, but was not subject to control by BNZ Legislation Milk and milk products Significant changes have been made to the legislation in the dairy sector since the last FVO mission in The dairy industry has been regulated under the Animal Products Act 1999 (as amended 2005) since 1 June 2005 when the Animal Products 9

10 Amendment Act and the Animal Products (Ancillary and Transitional Provisions) Amendment Act as well as new Animal Products (Dairy) Regulations 2005 entered into force. Regulated parties (farms, manufacturers, stores and transporters) are given a two year transitional period in which to have their Products Safety Programme (PSP) updated to a validated Risk Management Programme (RMP) in compliance with the Dairy RMP Specification. During the transitional period existing PSPs are deemed to be RMPs. At the time of the mission only 20% of the RMPs have been submitted to NZFSA for approval (deadline 1 June) a. The Dairy Standards were superseded from 1 June 2005 and were replaced by new Specifications and Notices under the Animal Products Act New Animal Products (Dairy) Approved Criteria have also been published in June 2005 under the Animal Products Act Bovine semen and embryos The Animal Product Act 1999 (APA) regulates general aspects for export of animal products, including bovine semen and embryos., Export of bovine semen and embryos is mainly administered by MAF BNZ. The collection, storage or trade of bovine semen or embryos at national level is not regulated. NZ semen standards and NZ embryo standards, referred to in the VA, are no longer in place. BNZ developed a set of guidance regarding the conditions applicable for collection and storage of ruminants semen and embryos for export ( These guides and standards are not legal documents or legal interpretation of the APA. These documents detail the organisation of approval and supervision of semen collection centres, semen storage centres, and embryo collection teams, as well as the process for certification for export. They explicitly refer to the requirements in European legislation for export to the EU, including for in vivo-derived embryos. Consequently, all the commodities included in the scope of this mission have been evaluated against EU standards. The guides give information which is not always accurate or kept up to-date (e.g. the position of the officer to be informed in case of a positive health test result no longer exists; links to internet pages were not working) Control of the implementation of the legislation Milk and milk products Equivalency has been agreed for milk and milk products for human consumption (Annex V, Section 3, point 8 of the VA) and the evaluation is therefore based on the exporting party requirements (APA). The system in place was described in detail in the mission report DG(SANCO)/7197/2004 and this section therefore will focus on changes made since this mission. 10

11 Recognised Service Providers Findings with regard to Recognised Service Providers (RSP) are based on observation of two dairy farm assessments conducted by the RSPs. Farm Dairy Assessors The annual assessment of all dairy farms by the 34 Farm Dairy Assessors (FDA) employed by 2 Recognised Service Providers was generally considered satisfactory with regard to structure, equipment and general hygiene. The following observations were made by the FVO team: - Some expired medicine and medicine stored at the wrong temperature was found in one farm. However, the assessors now include checks on the medicine store and treatment records in their assessment. - In one farm the treatment records were kept on computer and only printouts from a three month period were made available to the assessor b. - No routine checks were carried out for mastitis or other abnormalities in the individual cows in any of the farms visited. - The assessors did not check the hygiene during milking (e.g. visibly dirty udders not cleaned) Recognised Agencies There is now besides NZFSA-CIG only one Dairy Recognised Agency (RA), formerly Third Party Agencies (TPAs), to assess and verify the dairy sectors compliance with approved RMPs. Clear improvements were seen since the last FVO mission in the performance of the RA in relation to RMP verification in the dairy establishments. The reports were clearer with reference to the different parts of the RMP, agreed dates for correction of non-compliances and, in most cases timely follow-up and close-out (extension provided in some cases). The following observations were made: - Due to lack of Recognised Persons for Farm RMP evaluation/ verification the verification audits of Farm Dairy Assessors (FDA) was not carried out as required by NZFSA last year and it has now been agreed that NZFSA will carry out the verification this year. NZFSA require that all 34 FDAs should be included in a verification audit over a six year period (5-6 FDA per year) but only one FDA had been observed over the last months. - The RA did not include specific EU export requirements in all audit reports. - EU load-out checks had not been performed during the past 3 years in one coldstore exporting consignments monthly to the EU ( unchecked consignments). The NZFSA control system based on the monthly reporting from the RA had not picked up this discrepancy. 11

12 - Although the RA did not make any clear distinction between regulatory work and services agreed with the industry (e.g. traceability checks), no evidence was found of any conflict of interest Farms and milk-processing establishments visited The dairy plants generally operate to a high standard in good cooperation with the RA and NZFSA. The dairy industry (farms, transporters, manufacturers and stores) is still in a transitional period working under the former PSPs. The lack of updated RMPs makes it difficult to evaluate fully the performance of the RMP evaluation. However, some potential problem areas were identified: - Raw milk temperature is only measured at collection from the farm. Although the acceptable temperature is 7 C within 3 hours of milking higher temperatures are accepted in case of early collection (up to 18 C) and no chilling is performed during transport to the dairy plant. Milk was found in a storage silo at 10.3 C 8 hours after collection although the SOP included chilling at or below 9 C. - Raw milk is tested for inhibitors (penicillin) 7 times per month at farm level (covering 25% of collections). No further testing is performed at reception in the plant. The test results are not known until 2 days after collection. - If a positive reaction is found on an individual farm sample, a decision based on the calculated level in the storage silo (50% safety margin) is made on what corrective action is to be taken. If calculated level is under the MRL (0.003 IE/ml) no action is taken. In one case the detection above the MRL had affected a total of 559 tons of final product, which was excluded from export to EU. - Although the test method used for inhibitory substances has been modified to include inhibitory substances as well as penicillin it is clearly indicated in the method that: "some antibiotics are not detected by this test". - Milk from Tb reactor animals is not excluded from human consumption until the primary test has been confirmed by a secondary test. The NZ authorities consider the positive animal only to be testpositive after the first test and not a reactor animal. - No health marks or identification marks are used for dairy products. In the coldstore visited carton lids could easily be moved between cartons which make traceability less reliable Competent Authority operation and supervision No major changes since the last FVO mission in NZFSA-CIG has carried out an audit of the Recognised Agency (RA) during August The audit focused on interviews and reviews of records in four 12

13 RA offices and highlighted 5 key issues in relation to documented procedures and systems, technical competence and training of staff and review procedures. The audit report included recommendations to the RA, NZFSA New Zealand Standards and NZFSA Export Standards. The mission team found some of the lists of recognised persons published on the NZFSA website not being up-to-date at the time of the mission Bovine semen and embryos Approvals According to Commission Decision 92/452/EC, 4 embryo collection teams (ECTs) were approved at the time of the mission in NZ, but no Embryo Production Teams (EPTs). The Commission website recorded 8 semen collection centres (SCCs) and 3 semen storage centres (SSCs) approved. Approvals are granted on a 6-monthly basis by the CCA for SCCs, SSCs and ECTs, on the basis of a report of an inspection visit by an OV from the RA. No provisions are foreseen for approval of EPTs. Two levels of approvals can be granted for SCCs and ECTs: o General approval, meeting basic requirements for export; o EU approval, for centres meeting the EU requirements. The EU approval comes in addition to the general approval. The structure of approval numbers differs between general export approval numbers (NZSB--) and EU-approval numbers (NZAB--) for the SCCs. One system of numbering only is in place for approval numbers for ECTs (NZEB--). The list of approved centres and teams in NZ is available on the CCA website. According to national legislation, operators wishing to export must also be registered on an annual basis. Registration of exporters is managed by NZ- FSA. All sites visited were approved, and documentation regarding inspection visits and renewal of approvals was available. The mission team noted important shortcomings in the organisation of the system for approvals: - The operators have the possibility to refuse a 6-monthly inspection. Their approval is maintained, but their registration is considered as "lapsed", until they re-apply for an inspection. Semen or embryos collected until the registration expiry date are eligible for export if they are stored under approved conditions. BNZ could not present a record of such "lapsed registrations", and no public information is available regarding the periods during which the approved centres or team may have had their "registration" suspended. - Approvals refer to a physical address. The same approval number can be kept when the physical address is modified. In case of ECTs, this physical address does not refer to the address of the permanent laboratory facilities. 13

14 The management of the approvals presented also major shortcomings: - The inspection reports follow a standard pattern, but the scope of the inspections is not always clearly stated (against general or EU standards). The reports do not always give clear recommendations, and sometimes refer to other approval number structures ("NZSBOV--", "NZET--). This confusion led the CCA to issue EU-approvals on the basis of reports of inspection on general export requirements. - The same report may be issued for several approved centres. Approvals do not refer to a blueprint of the facilities included. The confusion is such that at one ECT visited by the mission team, the OV in charge of normal supervision realised at the end of the visit that the facilities were part of another ECT. - BNZ did not grant EU-approval for one of the SCCs on the EU list, from January 2005 to January The Commission was not informed of this withdrawal. The approval was re-granted in 2006 despite no indication in the inspection report stating that the centre complied with the EU requirements. - Approval of an ECT was given following an inspection report of which the scope was SSCs Infrastructure of semen collection and laboratories of embryo collection teams No animal housing was present at the SCCs visited. The bulls are kept on pastures. This is not in line with Annex A, Chapter I, 1, points (b) (i) and (d), to Directive 88/407/EEC on the conditions for approval of SCCs, nor is it according to guidance from BNZ. The isolation of the visited SCCs required by Annex A, Chapter I, 1, points (c) to Directive 88/407/EEC was insufficient. The SCCs visited based their isolation requirements on an indication in the BNZ guide, which stipulates that the isolation may be obtained by an empty space of 2 meters between isolated animals and animals of other health status. Other cattle were kept next to the SCCs visited, separated by a 2 to 3 meter double fence. In one SCC, a single fence separated a pasture from a public road. Bovine animals were also undergoing quarantine (and in one case prequarantine) in pastures within the SCCs visited, in places which had no specific approval by the CA granted for the purpose. This is not in line with Annex B, Chapter I, 1, a) to Directive 88/407/EEC. Isolation of these bovine animals within the SCCs could not be satisfactorily verified. The semen collection facilities were of a very good standard in one of the SCCs visited, and of a fair standard in the other (structure including a lot of wood, rough concrete floor). The processing room presented in one SCC had adequate infrastructure; in the other SCC, processing was split into two phases, with the second one taking place in a room of inadequate standard (cold room in a garage, with rough floor, rusty walls). 14

15 The infrastructure of the storage areas of the SCC and the SSC was not good, both on hygienic and isolation grounds: - The flooring of the rooms did not allow adequate hygiene to be maintained in two places visited (carpet on the floor, rough concrete); - In one SSC, the external door when closed was not insect-proof; - The premises used for storage of semen in both SCCs were not set aside for the purpose, and administrative activity was taking place in the storage rooms. In one of the SSCs, the storage room was a passage to reach either the permanent laboratory facilities of an ECT or the processing facilities of a SCC. The permanent processing facilities of the ECTs visited were of good quality and compliant. One of the ECTs also had a mobile laboratory, which did not present two separate sections, as required by Annex A, Chapter I, (e) to Directive 89/556/EEC. However, the team veterinarian explained that a procedure had been put in place in order avoid equipment and materials used in contact with donor animals from entering the mobile laboratory Animal health status of bulls in semen collection centres Conditions stated in Directive 88/407/EEC are applicable in EU approved SCCs. The CCA or RA have not established rules or guidance to implement these EU requirements in the national context, except for brucellosis. The system for identification and movement records of bovine animals in place in NZ does not ensure full traceability of animals, thus weakening the guarantees that can be obtained in regard with conditions of Annex B, Chapter I, 1, b) and c) of Directive 88/407/EEC, or Article 9), 1) a) and Annex B, 1, b) to Directive 89/556/EEC: - No identification is required for animals before 30 days of age; - Individual identification is required when older animals are moved from the holding of origin, but individual identification and movements are not recorded. The animal health conditions applied for bovine brucellosis and tuberculosis are not those required by Article 10, 3) to Directive 88/407/EC, or Article 9, 2 of Directive 89/556/EEC. They are not based on the standards of Annex A to Council Directive 64/432/EEC, and no similar conditions or derogations were laid down in accordance with the procedure foreseen in the abovementioned articles. The main variations from Directive 64/432/EEC identified by the mission team are: Tuberculosis (Tb): - Different set of tests authorised (caudal fold test as routine test, no skin measurement; gamma-interferon test used as confirmatory test); - Different age limits of animal tested, different frequency of tests; 15

16 - Different classification of herds, with a first clear status (C1) given 6 months after removal of last evidence of Tb infection; the classification is then increased each year (C2, C3, ). SCCs were accepting bovine animals coming from C1 herds. A publication from the service of the CCA responsible for Tb control indicates that C1 herds are not equivalent to the OIE status of officially-tuberculosis free herds. - History of movements of the bulls accepted into the SCC was limited, in particular for adult bulls. It was not possible to document the Tb status of all herds in which they had been from their birth, as required by Annex B, Chapter I, 1, (b) to Directive 88/407/EEC. - Pre-quarantine and routine Tb tests applied in SCCs were not in accordance with Annex B to Directive 64/432/EEC (caudal fold tests, with no skin measurement). They are performed by veterinarians authorized within the context of national control programme, but are not documented on an individual basis (as the report only indicates the number of animals tested, not their identification, unless they are reactors). One record sheet can include several approved places. Brucellosis: The CCA issued instructions to discontinue all brucellosis testing required by Annex B, Chapter I, 1, d) (ii) and Chapter II, 1, b) to Directive 88/407/EEC as from 01 October Serological tests for brucellosis were performed before that date in both SCCs visited. The CCA had notified the Commission of its decision. IBR/IPV: A major failure in the system was identified, where bovine animals giving seropositive IBR/IPV tests results are still maintained in EU-approved SCCs. This is contrary to Annex B, Chapter I, (d), (iv), and Chapter II, 1, (d), to Directive 2003/43/EC amending Directive 88/407/EEC, since its date of application (01/07/2004, with possible derogation until 31/12/2004). This point has never been raised in the 6-monthly inspection reports. The operators stated that the IBR/IPV-seropositive bulls in the SCCs were bulls which were authorised before entry in force of Directive 2003/43/EC. This was not always the case, as the mission team identified that a bull which gave a pre-quarantine IBR/IPV-serological positive test result was recently allowed into an EU-approved SCC. This has never been permitted under EU legislation since 1990 (Annex B, Chapter I, Art. 1, (d) (iv) and (e), (iv) to Directive 88/407/EEC before amendment, and Annex B, Chapter I, Art. 1, (d) (iv) and (e), (ii) to Directive 2003/43/EC). Pre-quarantine and quarantine tests: Bulls in both SCCs visited underwent pre-quarantine and quarantine health tests. In the first SCC visited, insufficient records were kept that could allow an effective control of the operations of the centre. The centre veterinarian 16

17 explained that the pre-quarantine and quarantine operations were held in the pastures of the centre itself, when all resident bulls are removed (but not the teaser animals). No quarantine period was defined; the end of quarantine was decided on an individual basis and could differ for each disease. The records were kept in such a way that they could not show that quarantine was lifted for all animals when no further seroconversion occurred for either disease. No express permission was issued by the centre veterinarian. Not all movements in and out of the centre were recorded. The second SCC visited hosted bovine animals without any identification. Deficiencies regarding the frequency of tests were noted (only one test for campylobacter and trichomonas in adult bulls; lack of BVD-MD tests during quarantine). No express permission of the centre veterinarian was given to release the bulls from the quarantine. Records showed semen collection and processing before reception of all quarantine test results. Evidence of request for semen testing for virus isolation of seropositive bulls was presented, in line with Annex B, Chapter I, 1), (f) to Directive 88/407/EEC. Regarding EBL, one SCC was receiving adult bulls and tested them according to Annex B, Chapter I, 1, (c) to Directive 88/407/EEC. The other SCC was applying the same conditions for younger bulls by testing their dam after removal of the offspring. The dam status was confirmed by DNA testing. Routine testing: Not all movements in and out of the centre were recorded. One SCC visited belonged to a company running several SCCs. Movements of bulls were not systematically recorded, and the traceability exercise performed with one bull failed to locate in which centre the bull was at a particular time. Both SCCs visited did not keep bulls more than one year, which were therefore not subject to routine tests. However, teaser animals, when staying on a permanent basis, were subject to annual testing in line with Annex B, Chapter II to Directive 88/407/EEC Action in case of positive results The national guide indicates that any unfavourable test result must be investigated under the advice of the CCA (although the position stated in the guide no longer exists). The mission team identified during the mission that one of the SCCs had its Tb status suspended following the identification of 2 reactor bulls (first and confirmation test) in a tested population of 508 bulls in the SCC. The 2 bulls were sent for slaughter, and, as no lesion was found in the post-mortem examination at the slaughterhouse, the status of the SCC was cleared. No documentation was available from the centre veterinarian, RA or CCA in order to ensure that provisions of Directive 88/407/EEC were complied with (both provisions in Annex B, Chapter I, 1, and Annex B, Chapter II, 3), as the centre may have hosted both bovine animals under routine testing and bovine animals under pre-quarantine testing). The Tb status of the centre 17

18 was restored without further testing of the other bulls, which is contrary to the provision in Annex A, I, 3A, b) to Directive 64/432/EEC Health checks applying to donor animals of embryos In the ECT visited, the control of animal health conditions applying to donor animals was documented. A declaration signed by the owner of the cow, and a statement by the veterinary practitioner of the herd of origin were available. As the donor cows are moved into a herd under the control of the ECT, further guarantee is given by the team veterinarian. However, the guarantees given by the declaration signed by the owner were not satisfactory, as they only bore a scanned signature and did not refer to any animal identification. In addition, the owner is required to sign a declaration for which he has no complete first-hand knowledge (as he guarantees the health situation of up to two different herds where the animals may have been hosted), in contradiction with the NZ guidance (official assurances programme for live animals and animal germ plasm). In addition, the declaration was issued before export of the embryos, up to more than one year after collection, meaning that the team veterinarian did not have, by his own knowledge, the guarantee that embryo he collected fulfilled the conditions for EU export. As the embryos were stored in a SSC, this point was not a shortcoming in relation to provisions of Annex A, Chapter II, 2, (e), (i) to Directive 88/407/EEC Collection and processing of semen Semen collection was performed in a hygienic way in the SCC where the mission team checked this aspect. The conditions and hygiene of processing in this SCC were not of the highest standard, with the use of towels on the worktop, and the lack of control of effective sterilisation of the equipment. The other SCC visited was not in operation. The hygienic conditions at the time of the visit were not good, with a large quantity of rotten organic liquid in an unplugged freezer in the processing room. Egg yolk was used in the processing of semen. In both cases, the operators were satisfied that the conditions of Annex A, Chapter II, 1), f), iv) to Directive 88/407/EEC were complied with, by knowing personally the farm from which these eggs came. No treatment or control was performed on the egg yolks. Antibiotics were added to the diluent only, thus not guaranteeing a minimal concentration in the final diluted semen which could ensure that the concentrations indicated in Annex C, 2 to Directive 88/407/EEC are always met. The other conditions of this article were met in one SCC (equilibration of more that 45 minutes at a temperature above 5 degrees), whereas the temperature condition was not met in the operation of the other SCC Embryo collection and processing In both ECTs, hygienic conditions for processing were adequate. At one ECT visited, the technician in charge explained the procedure for washing 18

19 embryos as stated in Annex A, Chapter II, 1, i) to Directive 89/556/EEC. However, dilution rates of successive washes were not measured, and the required 100-fold dilution could not be reached, as a 5 µl pipette was used to drop the embryos into a wash bath of about 0.2 ml (instead of 2 ml as stated initially by the technician). Products of animal origin (bovine albumin and porcine trypsin) used for the collection and processing of the embryos came exclusively from commercial companies. Evidence of absence of risk was not required by the team veterinarian for each batch of products he was receiving, but examples of certificates he had received from the manufacturing companies were available. The processing and storage activities were correctly documented at the ECT where these activities were checked Storage of semen and embryos Both SSCs visited were also storage rooms for adjacent SCCs, and an ECT in one case. Both SSCs had storage rooms where both EU and non-eu eligible semen and embryos were stored, thus not complying to the conditions set in Annex A, Chapter II, 2), (e), (i) to Directive 88/407/EEC. The operator of one SCC explained that dedicated areas were defined within the room, and operating procedures were in place, including dedicated instruments and transport trailers and containers for each area, with a specific colour code. This code was respected in the storage room, but not in the adjacent processing room for EU-eligible semen, where a transport trailer and container of the non-eu colour code was used. The containers storing EU-eligible semen contained also non-eligible semen, produced from IBR/IPV positive tested bulls after 31/12/2004. The second SSC had also non-eu semen and embryos stored in the same storage place. In addition, semen and embryos from other species, and animal tissues were also stored in the same room. The records of semen stored were checked in one SSC. These records were incomplete (incoming semen), unclear, difficult to analyse, and could be misleading as to the eligibility of semen for EU. In one SSC, the origin of one semen dose chosen at random could not be established, either by the labelling or by the records of movements either for semen (into the SSC). The movement records of the bull from the adjacent SCC could not guarantee either that the bull was in this SCC or not at the time of the collection. In one SSC, the training of personnel as required by Annex A, Chapter II, 2, (d) to Directive 88/407/EEC was checked, and was acknowledged to be insufficient. Manipulation of semen or embryo straws with bare hands was a common practice in all places visited but one. 19

20 Labelling of doses of semen and embryo containers None of the semen doses of bulls checked by the mission team had its EUapproval number (NZAB--), and sometimes the place of collection could not be established at all from the labelling. No differentiated system of labelling between EU-eligible and non EU-eligible semen or embryos was in place. The formats of labelling were not unified, and the date was indicated by a code for both SCCs visited. The date could therefore not be readily established by reading the straw, contrary to the provision in Annex A, Chapter II, 1) (f).(vii) to Directive 88/407/EEC. In one case, the code format could be guessed by an external reader, but in the other case, the date could only be determined by reference to the computerized database of the operator Laboratories In line with requirement of Annex B, Chapter I, 2) to Directive 88/407/EEC, the CCA has approved a number of laboratories to carry out the health tests. The names of the laboratories are publicly available, and all statutory tests checked by the mission team had been performed in approved laboratories. A documented procedure developed by the CCA defines the standard for approval of veterinary laboratories undertaking export testing. The laboratories must be accredited in accordance to ISO 17025, use methods prescribed in the OIE Manual, have an internal and external Quality Assurance Programme. The mission team noted the following during the visit of one the approved laboratories: - The laboratory had been approved by a letter from the CCA, which included a list of the tests and personnel covered; - The laboratory was accredited by the national authority for the accreditation of testing laboratories, and the scope of accreditation covered the tests related to Directive 88/407/EEC except campylobacter (identification), and trichomonas; - In addition to control of incoming samples, the laboratory had an input in the quality of the samples sent for analysis, by providing both advice and transport medium for the preputial washings for campylobacter and trichomonas analysis; - The laboratory successfully participated in regional ring-tests for serology (except for BVD antigen serology, which is not on offer by the organising party). These tests are part of an external quality assurance programme, and each test is subject to ring test at least once a year. However, the mission team also noted that: - Despite the accreditation, the document control system did not meet basic requirements of the ISO Operating procedures were not 20

21 under a standard format, did not bear any indication that their initial set-up, their reviews or changes were approved by authorised personnel and did not bear indications of date or version number in all pages. Composite versions were used. - Despite the approval, the persons in charge of the laboratory had not checked whether the tests were performed in accordance with the OIE Manual (controls, interpretation of results). The IBR/IPV tests were not performed with the appropriate controls of strong positive and weak positive which are indicated by the OIE manual. - Operating procedures are not always complied with, as reports of analysis for campylobacter were issued to SCCs 4 days after reception of samples, when the operating procedure states that 8 days are necessary for the carrying out the analysis. The laboratory offered all tests except brucellosis, and BVD/MD virus isolation from semen. This last test is performed in the national veterinary laboratory under the control of the CCA. This laboratory was not visited, but SOPs were made available. Procedures for both raw and extended semen are in place, and referred to OIE standards. It was noted that the procedure for testing raw semen included ultra-centrifugation, which is not a step foreseen in the OIE manual. The laboratory has not performed any validation of its methods for isolation of BVD virus in semen Supervision of semen collection and storage centres and embryo collection teams Supervision by the centre veterinarian All approved SCCs and SSCs must have a centre veterinarian, who is approved by the CCA. Both SCCs had a centre veterinarian, either employed by the SCC, or external. Detailed rules are given in the guidance on the minimum attendance of centre veterinarians. The supervision by the centre veterinarians was deficient in several aspects, not only for all deficiencies stated above in the report, but also: - Absence of supervision of storage of semen: a centre veterinarian of an integrated SSC/SCC stated that the supervision of the SSC was not part of his responsibilities; in another SCC, the status of incoming semen was not checked by the centre veterinarian; no guarantee from the centre veterinarian from the centre of origin was available (the EU status was stated only in a commercial document); - Inadequate supervision of entries. In no SCC visited was the express permission of the centre veterinarian sought for introduction of bovine animals into the centre. In one SCC, the conditions for authorised external visitors were not always applied, as the centre veterinarian did not check whether the mission team complied with the conditions stated in the internal procedure manual; and the mission team was not asked to record its visit in an entry book. 21

22 Team veterinarians of ECTs must also be approved. Evidence of effective supervision was noted, with internal audits and corrective actions taken in case of identification of non-compliance (error in record of identification of donor cows). Official supervision Inspections for the sites analysed by the mission team were always performed by the OVs twice per year, as required, and documented. The system for official supervision of the animal health status of the SCCs was not satisfactory: - The CCA guide states that this aspect must be checked by the OVs by taking three export certificates from the last six months, and check that animals whose semen was exported complied with the relevant rules. This system does not guarantee the animal health status of the SCCs, as all bovine animals in the SCC must be of the same status. The supervision does not ensure that the health status of the centre is maintained. - There is no alternative procedure in place in cases where no semen has been exported to the EU during the last six months, or in case the semen exported was not produced during the relevant period; the EUapproval of SCCs may therefore be renewed with no control that animal health conditions meet the relevant EU requirements. - The possibility for the SCCs to let their approval lapse, by refusing a 6-monthly visit, leave them the possibility to operate under approval for the last 6 months without any supervision. The performance of the supervision of the SCCs and SSCs by the OVs could not be checked on-site, as both OVs in charge of the centres visited were unavailable. The documentation of supervision by the OVs indicates an insufficient performance: - Although work manuals were present in places visited, the OVs failed to identify that they had parts which were outdated (legal reference), inaccurate (test regime), or incomplete (no map of site). - The 6-monthly reports of the SCCs and SSCs visited were superficial and did not report any non-compliances. - Operators may possess several approvals, and OVs may group inspections for several approvals when visiting one operator. As the definition of the area covered by each approval is not clear, confusion may arise. OVs may issue the same report for several approved entities, which does not demonstrate that each of the entities was subject to actual inspection. The coordinator of the RA stated that a detailed procedure for supervision of SCCs and ECTs was being developed at the moment, but not yet in use. 22