Ref. Ares(2012)406656-04/04/2012 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2011-6127 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN NEW ZEALAND FROM 27 OCTOBER TO 08 NOVEMBER 2011 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF RAW MILK AND DAIRY PRODUCTS FOR HUMAN CONSUMPTION DESTINED FOR EXPORT TO THE EUROPEAN UNION, AS WELL AS CERTIFICATION PROCEDURES 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 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.
Executive Summary The report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in New Zealand from 27 October to 8 November 2011. The objectives of the audit were to evaluate the operation of controls over the production of milk and dairy products for human consumption destined for export to the European Union (EU), as well as certification procedures. It is concluded that the Central Competent Authority (CCA) of New Zealand had satisfactorily addressed most of the recommendations of the previous report DG(SANCO)/2008-7899-MR Final (hereafter referred to as report 2008-7899) on the same subject. However, although additional improvements in the certification system have been made, the system in place is not fully in line with Council Directive 96/93/EC. The New Zealand official controls system in place in the dairy sector is capable of delivering satisfactory assurances regarding the effective implementation of the provisions of the Agreement and EU requirements where relevant. The EU-OMAR requirements regarding microbiological testing no longer include all EU criteria as set in Regulation (EC) No 2073/2005. Reciprocal equivalence of microbiological criteria has been concluded between New Zealand and the European Union and publication of the amendment to the Agreement is pending. The New Zealand system of official controls provide adequate guarantees to ensure that the dairy establishments, dairy holdings and raw milk comply with the relevant New Zealand and EU- OMAR requirements. However, the instructions in place for the performance of assessments of dairy holdings by the industry are not up to date in relation to the verification of milking animal health and veterinary medicine prescriptions. Two recommendations have been made to the Competent Authority (CA) with a view to addressing the deficiencies identified during this audit. I
Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES...1 3 LEGAL BASIS...1 4 BACKGROUND...2 5 FINDINGS AND CONCLUSIONS...3 5.1 LEGISLATION AND COMPETENT AUTHORITIES...3 5.1.1 LEGISLATION...3 5.1.2 COMPETENT AUTHORITIES...4 5.2 HOLDING REGISTRATION, ANIMAL IDENTIFICATION...9 5.3 CONTROL OF MILK PRODUCTION HOLDINGS...10 5.4 CONTROL OF RAW MILK UPON COLLECTION...12 5.5 LISTING OF ESTABLISHMENTS...13 5.6 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL...14 5.6.1 GENERAL AND SPECIFIC HYGIENE REQUIREMENTS...14 5.6.2 HACCP-BASED SYSTEMS...15 5.6.3 MICROBIOLOGICAL TESTING...15 5.6.4 TRACEABILITY AND IDENTIFICATION MARKING...16 5.6.5 DOCUMENTATION OF OFFICIAL CONTROLS...16 5.7 OFFICIAL CONTROLS OF IMPORTS...16 5.8 LABORATORY SERVICES...17 5.8.1 LABORATORIES TESTING MICROBIOLOGICAL CRITERIA FOR FOODSTUFFS...17 5.8.2 LABORATORIES FOR THE CONTROL OF RAW MILK...17 5.9 OFFICIAL CERTIFICATION...18 8 OVERALL CONCLUSION...20 9 CLOSING MEETING...20 10 RECOMMENDATIONS...20 ANNEX 1 - LEGAL REFERENCES...22 II
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation Explanation AHB Animal Health Board APA 1999 Animal Products Act 1999 CCA(s) Central Competent Authority(ies) CEG Compliance and Enforcement Group CN/HS Commodity Codes DDG Deputy Director General DG Director General DG(SANCO) Health & Consumers Directorate General EC European Community(ies) EU European Union FBO(s) Food Business Operator(s) FVO Food and Veterinary Office HACCP Hazard Analysis of Critical Control Points ISO International Standards Organisation LIC Livestock Improvement Corporation MAF Ministry of Agriculture and Forestry NAIT National Animal Identification and Tracing NZ New Zealand NZCP New Zealand Code of Practice OMAR Overseas Market Access Requirement RA Recognised Agency RFID RMP RP SCC Radio Frequency Identification Risk Management Programme Recognised Person Somatic Cell Count III
SOR Summary of Records (Supporting documentation for certification) TPC Total Plate Count at 30 C IV
1 INTRODUCTION The audit took place in New Zealand from 27 October to 8 November 2011 as part of the planned audit programme of the FVO. The audit team comprised four auditors from the FVO. The audit team was accompanied by representatives from the (CCA), the Ministry of Agriculture and Forestry (MAF). The opening meeting was held on 27 October 2011. At this meeting the 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 The objectives of the audit were as follows: to evaluate the implementation, controls on and the enforcement of the sanitary measures in place aimed at ensuring fulfilment of the requirements applicable to exports of milk and dairy products for human consumption from New Zealand to the EU. These requirements are set out in the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products (hereafter referred to as the Agreement) approved by Council Decision 97/132/EC; and the follow-up action taken by the CA in response to the recommendations related to dairy products of report 2008-7899. In pursuit of these objectives, the following sites were visited: COMPETENT AUTHORITIES Competent Authorities Comments Central 4 Opening and final meeting. MAF certification office. One Recognised Agency headquarters FOOD PRODUCTION / PROCESSING / DISTRIBUTION ACTIVITIES Cold stores/dry stores 6 Three independent cold stores with associated dry stores facilities. Laboratories 3 One raw milk testing laboratory and two dairy product testing laboratories. Milk processing plants 7 In addition the audit team visited three headquarters offices of dairy companies. Dairy holdings 4 Three cow and one goat dairy holdings. 3 LEGAL BASIS The general provisions of EU legislation and, in particular: Article 10 of the Agreement; Article 46 of Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Other relevant EU legislation, which was taken into consideration during the audit and legal acts quoted in this report are provided in the Annex to this report. 1
N.B. Full legal references are provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the latest amended version. 4 BACKGROUND New Zealand is listed in columns A, B and C of Annex I to Regulation (EU) No 605/2010 authorising Member States' imports of raw milk and dairy products and indicating the type of heat treatment required for such commodities. The Agreement contains inter alia the list of animal products for which equivalence of sanitary measures has been established for trade purposes, and where equivalence of these measures has not yet been concluded upon. It also establishes which standards apply in trade. According to Point 8 of Annex V to the Agreement animal health sanitary measures as regards milk and milk products are recognised as Yes (1) equivalence agreed. Public health sanitary measures are recognised as Yes (1) for pasteurised milk and milk products and not pasteurised, thermised cheeses. Therefore, these commodities must comply with the New Zealand public health standards. Soft and hard raw milk cheeses are recognised as "E-still evaluating" and the EU standards apply. Nevertheless, according to the MAF only pasteurised products are exported from New Zealand into the EU. Moreover, currently there are no food business operators (FBOs) approved for the production of raw milk products in New Zealand. The Agreement does not currently recognise the microbiological testing of milk and dairy products, including test methods, standards for sampling and preparation and regulatory actions as equivalent. However, reciprocal equivalence of microbiological criteria has been concluded between New Zealand and the EU and publication of the amendment to the Agreement is pending. The certification procedure in the dairy sector is not recognised as equivalent. According to Commission Decision 2003/56/EC on health certificates for the importation of live animals and animal products from New Zealand, milk and dairy products must be accompanied by an official health certificate issued before the departure of the consignment, in accordance with the model prescribed by Commission Decision 438/2004/EC. Commission Decision 438/2004/EC has been repealed and the relevant legal requirements are now established in Regulation (EU) No 605/2010. The previous audit concerning the safety of dairy products in New Zealand was carried out from 31 January to 13 February 2008 the results of which are described in report 2008-7899. This report is accessible at: http://europa.eu.int/comm/food/fvo/ir_search_en.cfm The action plan received from the New Zealand authorities in response to the report's recommendations provided satisfactory guarantees in relation to recommendations 4 to 9 which concern milk and dairy products. The following quantities of milk and dairy products were imported from New Zealand into the EU (source: Eurostat). Year 2010 2009 2008 2007 EU imports from New Zealand (tonnes) 73 009 92 068 88 944 123 690 Since 2004 only one Rapid Alert System for Food and Feed notification regarding milk and milk products exported to the EU from New Zealand had been launched. According to the World Organisation for Animal Health Foot and Mouth disease and Rinderpest 2
have never been reported in New Zealand. Brucella abortus was last reported in 1989 and Brucella melitensis has never been reported. Moreover, Annex V of the Agreement recognises New Zealand as free from Brucella abortus and Brucella melitensis. The New Zealand Animal Health Board (AHB) Annual Report for 2010 reported a tuberculosis cattle herd prevalence of 0.13% in 30 June 2010. 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION AND COMPETENT AUTHORITIES 5.1.1 Legislation Legal requirements Point 1.2 of Annex VI to the Agreement stipulates that the audit process can include a study of the relevant Regulations. According to the Agreement, commodities for which equivalence has been established in level Yes (1) must comply with the relevant New Zealand animal and public health standards recognised as equivalent to those in the EU as prescribed in the Agreement, and specifically with the Food Act 1981 and Animal Products Act 1999 (hereafter APA 1999). Commodities for which equivalence of public health sanitary measures has not been established must comply with the EU standards. The current New Zealand regulatory system pertaining to milk and dairy products within the scope of this audit is based on the APA 1999 and associated statutory orders, regulations and standards. The APA 1999 governs the processing of dairy material, from harvesting at farm dairies through manufacture, storage and transportation to the point of retail sale and provides for the imposition of general export requirements, Overseas Market Access Requirements (OMARs), and for the MAF to issue official assurances. The APA 1999 also makes provisions for the promulgation of regulations, specifications and penalties for offences against the Act. The Animal Products (Dairy) Regulations 2005 are empowered under the APA 1999 and establish the food safety outcomes on dairy producers, manufacturers, transporters and store operators. The MAF administers the Regulations by approving specifications and Risk Management Programmes (RMPs) under the APA 1999, recognising inspection, testing and audit services, verifying compliance and certifying products. The dairy specifications interpret the regulatory requirements, and indicate the acceptable criteria for complying with the requirements and verifying compliance. The MAF also develop approved criteria documents and guidelines which seek to provide assistance to the New Zealand dairy industry on the implementation and compliance with the dairy specifications. The approved criteria and guidelines set out the criteria upon which a programme can be evaluated. They get legal status when they are issued on the basis of the APA 1999 or the specifications. In other cases they must be followed when referenced in the FBOs RMPs. Several templates have also been developed for dairy businesses requiring an RMP. These templates do not require independent evaluation and may be submitted directly to the MAF with an application for approval and registration. The EU-OMAR (sanitary and zoosanitary) requirements are based on the Agreement and where appropriate on other EU legislation. However, the audit team noted that the dairy 3
requirements outlined in the EU-OMAR had been updated in July 2011 and no longer include the process hygiene criteria and test methods for dairy products as prescribed by Regulation (EC) No 2073/2005. The EU-OMAR also allows for sample pooling which is not foreseen by Regulation (EC) No 2073/2005. The MAF stated that the EU-OMAR has been updated anticipating the adoption of the recommendation of the New Zealand Joint Management Committee recognising full equivalence of microbiological monitoring, tests and systems: including test methods, standards for sampling and preparation and regulatory actions, for the dairy sector. 5.1.2 Competent Authorities Legal requirements Point 4.2 of Annex VI to the Agreement specifies that the document review may consist of a review of the structures and powers of the auditee, and any relevant changes to food inspection and certification systems since the adoption of the Agreement or since the previous audit. Article 46 of Regulation (EC) No 882/2004 stipulates that EU controls in third countries shall verify compliance or equivalence of third country legislation and systems with EU feed and food law and EU animal health legislation. These controls shall have particular regard to points (a) to (e) of the aforementioned article. 5.1.2.1 Organisation of Competent Authorities Since July 2010 the New Zealand Food Safety Authority and Biosecurity New Zealand had been merged under the MAF. Subsequently MAF was merged with the Ministry of Fisheries in July 2011. Under the new structure the MAF Director General (DG) reports to the Minister of Food Safety, the Minister of Agriculture, Forestry and Biosecurity and the Minister of Fisheries. However, the organisation is still undergoing further re-structuring that will end with eight Deputy Director Generals (DDGs) heading different groups and reporting to the MAF DG. The MAF stated that this structure will be fully in place by March 2012. Three of these groups are relevant to the scope of the audit: DDG standards: responsible for standards, approvals, assurances, system audits, international communications and supervision of Recognised Agencies (RAs). The MAF stated that the Compliance and Enforcement Group (CEG) and the export and import food group will be placed under this DDG. The CEG currently has a dairy group formed by three specialists. DDG compliance and response: responsible for prosecution, enforcement actions, incursion, preparedness and response. DDG verification and systems: responsible for signing the certificates on behalf of the DDG Standards. Within the context of the Animal Products Act the DDG verification and systems does not undertake verification activities. In the framework of the APA 1999 and supported by the Animal Products (Dairy Recognised Agency and Recognised Persons Specifications) Notice 2011, Number 2 and the Animal Products (Dairy) Approved Criteria for the Recognition of Agencies and Persons the MAF recognises the competencies of RAs and Recognised Persons (RPs). There are currently three approved RAs acting as third party verification agents for the Government in the dairy sector. One of the three RAs is State owned enterprise with the other two being privately owned. The RAs must hold accreditation under the ISO standard 17020 and their functions include: 4
RMP evaluation and verification including (OMAR) requirements; Heat treatment evaluation and verification; Premises evaluation; Management of non conformances (exceptions) and product disposals;. Electronic verification of certificates for consignments for the EU. There is only one RA approved to carry out all these functions which is active in the largest part of the dairy industry. The RA employs RPs to carry out the tasks outlined above. The recognition is available in different areas such as RMP evaluation, RMP verification, heat treatment evaluation and premises evaluation and the competences required for the recognition of persons in these areas are outlined in Part 2 of The Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons. The RPs are also recognised in one or more specific product groups such as cream products, cheese, milk powder, farm dairy systems, etc. The farm dairy assessors verify the farm RMP compliance on behalf of the dairy companies. Some RAs provide farm dairy assessors to the dairy industry. The farm dairy assessors are not RPs under the APA 1999. At the time of the audit there were 45 farm dairy assessors working in the country. In accordance with the MAF specifications the RMP evaluation and verification activities are carried out by two distinct groups of RPs. The audit team noted that one RA verified the performance of its farm dairy assessors within the farm RMPs' verification. The RA stated that the farm dairy assessors and the RMP verifiers were placed in different sections of the company to avoid a conflict of interest. The procedures in place in the main RA were not updated with the changed instructions of the Animal Products (Official Assurance Specifications - Dairy Products) Notice 2011 regarding certification and did not include references to some of the check-lists used for the performance of the tasks of the RP in the dairy sector. 1 5.1.2.2 Competent Authorities powers, independence and authority for enforcement The APA 1999 provides extensive statutory powers to the MAF DG and the animal product officers. In addition, the MAF CEG group investigates breaches and can prosecute where appropriate. The Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons requires that any RA contracted to provide assessment services must have systems in place to ensure that the contractual criteria between the RA and their client allows full access to the relevant client records, facilities and personnel and includes a written authorisation to report relevant information to the MAF. These requirements must be specified in the RMP. Under the same approved criteria the RA must have procedures in place to prevent conflicts of interest. Also according to the Animal Products RMP specifications 2008 the RPs can request corrective actions within the RMP. However, the RPs do not have enforcement powers and when the RA becomes aware of a critical situation it has to immediately advise the MAF. 1 In their response to the draft report the CCA noted that the procedures will be updated as part of the annual review in March 2012. 5
The audit team noted that one recognised person had been employed before by the company that she was evaluating. The RA stated that they had a procedure in place to ensure that the RPs have a stand down period of two years before becoming involved in verification activities of companies that they had worked for. This procedure had been strengthened after an audit carried out by the CEG. The frequency of audits is increased due to non-compliances and this results in a financial penalty for the FBOs as they have to pay for every audit including the MAF audits. The audit team noted that the frequency of visits was increased in one dairy establishment due to unfavourable audit results. 5.1.2.3 Supervision The CEG carries out supervision of the RAs and the RPs in accordance with the Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons. The RAs, RPs and laboratories are assigned to three performance assessment categories according to specific criteria: Reduced assessment category: implies a full assessment every two years and a reduced assessment every alternative year; Standard/entry category: full assessment on an annual basis; Increased assessment: a full assessment is required at least every six months. The assessments are carried out by the CEG in order to evaluate defined parameters outlined in the approved criteria including knowledge of the OMAR requirements. The assessments have a component of on the job verification. In addition, the competence of the RP is assessed internally by the RA. The CEG also participates in the accreditation audits of the RAs under the ISO 17020 standard with the inclusion of one of its dairy experts in the accreditation body audit team. Also the CEG participates in laboratory accreditation audits and carries out laboratory audits at the request of the accreditation bodies and the MAF management. The performance of the farm dairy assessors is verified by the RA as part of the verification of the farm RMPs. During 2011 all four RAs have been audited by the CEG. The audit reports were available. In the RA visited the audit team verified the actions taken to address the non conformances and recommendations identified in the CEG report, which were satisfactory. The CEG also carried out an audit in 2011 of the farm dairy RMP operators and farm dairy assessors. The findings of the CEG audit reports were in line with the issues identified by the audit team and provided a valid picture of the activities audited. The RA visited had supervised the performance of 18 out of 45 farm dairy assessors during the last year. 5.1.2.4 Training of staff in performance of official controls Officials recruited to work in the dairy section of the CEG undergo the following training: induction training, on the job training with the CEG auditors which calibrate their performance highlighting 6
the individual training needs and, if necessary, technical training in the dairy industry. Before auditing on their own they will perform part audits with experienced colleagues and a full audit supervised by management. The training for RPs is catered for in order to fulfil the competence requirements outlined in Part 2 of the Animal Products (Dairy) Approved Criteria for Recognition of Agencies and Persons. The training for new RP includes: lead auditor training, training in the relevant dairy industry regulations and the MAF requirements, training in the RA compliance manual and dairy procedures. Also on the job training including an assessment is carried out by another RP. For established RPs ongoing training takes place. This training includes: annual peer review of technical and audit competencies, weekly calibration sessions, MAF workshops and an annual dairy training plan. The RA visited informed the audit team that the training of the dairy auditors to become RPs varied between three to nine months according to their individual experience and capacity. The audit team was presented with extensive individual training plans of RPs which included EU requirements. The RPs and officials met by the audit team had experience in the dairy industry and were familiar with the processes and requirements of the dairy sector. For the evaluation of heat treatment and premises the RP were trained specifically and held engineering degrees. The RPs could only carry out activities in the areas for which had been trained such as RMP evaluation, RMP verification, RMP verification of farms and RA approval of EU electronic certificates. 5.1.2.5 Resources The audit team observed that sufficient resources were available for the completion of the required official control tasks. 5.1.2.6 Organisation of control systems The control system regarding establishments approved to export dairy products to the EU is based on three levels of controls: Controls by the operators based on the implementation of compulsory RMP that include EU OMAR requirements; Evaluation and verification of the RMPs by the RA; Supervision of the RA and recognised persons by the MAF. The MAF also sets standards, and provides official assurances. The RA carries out the initial evaluation of the RMP and the evaluations when major changes to the RMP take place. The heat treatment procedures are also evaluated before approval by another RP approved to carry out this activity. After the assessment and registration of the RMP by the MAF (see section 5.6.2) the RA establishes the verification frequencies of dairy EU approved premises according to the requirements of the Animal Products (Export Verification Requirements) Notice 2009. The minimum frequencies of audits vary according to the activities: Dairy manufacturing premises: every three months; 7
Dairy stores: every six months; Transport: yearly. These minimum frequencies may be increased with a system of steps if the outcome of the audits is unacceptable. The maximum verification frequencies are once every two weeks which can be increased in exceptional cases by the MAF DG. After two satisfactory audits, or three in the case of step 1 or 2 rankings, the premises can be moved to a lower step of verification frequency. The audits are classified as announced and unannounced (with 48 hours notification) and are carried out with the help of check-lists/aide memoires. The audits are prepared in advance by the RA and include issues identified in previous visits. The results are entered in reports, and a copy is sent to the FBO. The audit consists of the verification of the correct implementation of different elements of the RMP including EU-OMAR requirements where appropriate. The elements verified in each audit include: Operator verification and management of corrective actions; Management of the processing environment; Critical control points; Management of product release, including supporting documentation for certification (Summary Of Records (SORs)), OMARs, reporting and management of non-conformances and product disposal; EU container load out if relevant. The elements verified annually include: Pest, pathogen, water and heat treatment plans; Product testing and specification management; Product traceability and labelling; Manufacturing systems, site services and utilities; Personnel training systems; Risk organism response plans; In the case of dairy stores there is also product acceptance and dispatch, premises and equipment hygiene, maintenance and calibration and control of security devices. The FBO has the obligation of reporting within 24 hours all non-conformances with the regulatory requirements. This is reported by the FBO to the RA that subsequently reports to the MAF the non-conformances which affect product. During RMP verification activities the RA verifies if all non conformances have been notified and if breaches are identified actions are taken. The RA also sends to the MAF a summary of the non conformances monthly. The audit system in place requires compliance verification of OMARs and SORs in general which can lead to EU-OMAR and EU-SORs not being evaluated regularly. One verification audit could take place up to a period of two to three days according to the complexity of the operations. 8
5.1.2.7 Documented control procedures The official control activities carried out by the MAF officials and by the RPs are based on procedures that include the use of check lists/aide memoires that highlight the different areas of the scope of the audit. There are individual audit plans drafted for the officials and the RPs including the frequencies and scope of the audits to be carried out in the different premises. At the end of the audit a report is drafted. This report includes non compliances and observations with deadlines for completion. As part of the documented procedures the RA must forward to the MAF the RMP verification reports, report non conformances and product disposals, has to notify the MAF of critical issues and failures to meet OMAR requirements, has to report non conformances to management and forward monthly RA performance/status reports. The planning and recording of the RA activities including reports is carried out in an electronic system. The follow up and closing of corrective actions was documented and when extensions to the deadlines were granted they were recorded and justified. The audit plans reviewed by the audit team were completed within the required time frames. Conclusions The New Zealand official control system in place in the dairy sector is capable of delivering satisfactory assurances regarding the effective implementation of the provisions of the Agreement and the EU-OMAR requirements. However, the EU-OMAR requirements regarding microbiological testing which are not yet recognised as equivalent in the Agreement no longer include the EU criteria as set in Regulation (EC) No 2073/2005. Nevertheless, reciprocal equivalence of microbiological criteria has been concluded between the EU and New Zealand and publication of the amendment to the Agreement is pending. In the EU approved establishments the procedures in place do not ensure that EU-OMAR and EU-SOR requirements are verified regularly. 5.2 HOLDING REGISTRATION, ANIMAL IDENTIFICATION Legal requirements As regards milk and milk products animal health sanitary measures are recognised by the Agreement as Yes (1)". The legal requirements regarding animal health sanitary measures are the New Zealand standard. Regarding public health sanitary measures, commodities for which recognition of equivalence is Yes (1) must comply with the relevant New Zealand public health standards in Food Act 1981 and APA 1999. The other commodities must comply with EU public health standards as prescribed in the Agreement. Point II.2 (a) of the Public Health attestation laid down in the relevant model health certificates drawn up in Part 2 of Annex II to Regulation (EU) No 605/2010 requires registration of milk production holdings in accordance with Regulation (EC) No 852/2004. On 1 July 1999, the AHB introduced the National Identification Programme for cattle and deer to facilitate the tracing of suspect and confirmed tuberculosis cases. The Programme must be operated in accordance with the Biosecurity (Animal Identification Systems) Regulations 1999 which 9
allow the utilisation of animal identification systems approved by the MAF DG. Currently there are two approved operational systems: one is operated by the AHB and the second is operated by Livestock Improvement Corporation (LIC) through their MINDA service and is used for the identification of dairy cattle. All cattle over 30 days old and older when first moved must be identified with approved primary and secondary identification devices, or if moving to slaughter with an approved primary identification device or an approved direct-to slaughter device. The AHB herd number and the unique animal identifier must be printed/stamped on each identification tag supplied. The AHB is now switching to the new National Animal Identification and Tracing (NAIT) system which will be fully implemented from 1 July 2012 and will require all cattle in New Zealand to be identified with NAIT approved radio frequency identification (RFID) tags. All cattle on the holdings visited were properly identified. On one farm visited all dairy cows were also identified with the new RFID tags. There is no legal requirement for the registration and identification of goats. The LIC operates its own independent database. With the introduction of the NAIT system the different databases will be interlinked. Within the RMP registration the MAF keeps a register of all the farms covered by the RMPs of the different FBOs. Conclusions The herd registration and animal identification systems were found in compliance with the New Zealand requirements. 5.3 CONTROL OF MILK PRODUCTION HOLDINGS Legal Requirements As regards milk and milk products animal health sanitary measures are recognised by the Agreement as Yes (1)". The legal requirements regarding animal health sanitary measures are the New Zealand standard. Regarding public health sanitary measures, commodities for which recognition of equivalence is Yes (1) must comply with the relevant New Zealand public health standards in Food Act 1981 and the APA 1999. The other commodities must comply with EU public health standards as prescribed in the Agreement. Point 13 of the APA 1999 request that the primary processors must operate under registered risk management programmes. Point II.2 (a) of the Public Health attestation laid down in the relevant model health certificates drawn up in Part 2 of Annex II to Regulation (EU) No 605/2010 requires controls of milk production holdings in accordance with Annex IV to Regulation (EC) No 854/2004. The DPC 2: Animal Products (Dairy) Approved Criteria for Farm Dairies sets up criteria for milk harvesting, storage of milk and milking animal health. The criteria in this document are to be used by the RAs when evaluating or verifying an RMP covering dairy activities at holding level. The NZCP1: Code of practice for the Design and Operation of Farm Dairies has been developed as a means of helping farm dairy FBOs to fulfil the requirements of a farm dairy RMPs. The farm RMP must provide details of the system for the assessment of dairy holdings to ensure 10
production of safe milk in compliance with regulatory requirements. This assessment is carried out by farm dairy assessors at least annually on behalf of the dairy companies. Non conformances are classified and follow up actions carried out according to the severity of these non conformances. Follow up visits are carried out to verify the correction of major non-compliances with minor noncompliances followed up at the next annual assessment. The RA verifies the farm RMP's compliance and farm dairy assessor's performance as part of the verification activities. The farm dairy assessors verify the compliance of the farm with the RMP in accordance with NZCP1 and DPC2 in the following areas: Premises, facilities and operation: with the evaluation of location, design and construction, maintenance, housekeeping and hygiene, cleaning, usage of premises and milk filtering and cooling. Milking animal health which includes the handling of sick and diseased animals, the use of veterinary medicines, the management of withheld milk and animal treatment records, and farm dairy water quality. Milk from declared tuberculosis reactors cannot be harvested for human consumption. All dairy holdings visited operated in line with the approved generic RMP prepared on the basis of DPC2 and the NZCP1. The RMPs were developed by the FBOs and covered all the farms supplying milk to the FBO. The NZCP2: New Zealand Dairy Industry Assessment of Farm Dairies Code of Practice has not been updated since 1991. As a consequence the routine veterinary visits prescribed by the DPC2 in order to evaluate milking animal health are not included in the dairy farm assessment protocols. In the holdings visited there was no documented evidence of the performance of these visits. In one holding visited the audit team noticed that the prescription of veterinary medicines was not properly documented as required by the NZCP1. This issue was identified by the farm dairy assessor during the audit. Non conformances regarding veterinary visits and veterinary prescriptions had been identified by the CEG in an audit carried out in the period March-July 2011 which covered 33 farms in 5 New Zealand major dairy farming areas. This audit report recommends the updating of the NZCP2. There is no requirement for farm dairy assessors to carry out farm assessments during milking. However, in one large dairy company the RMP in place required the performance of 5% of the farm dairy assessment during milking. In one holding visited dirty udders were washed prior to milking. However, the udders were not dried before applying the clusters contrary to the recommendations of the NZCP1. There is a plan at national level to detect subclinical cases of mastitis which includes special training programmes for veterinarians. Records of the farm dairy assessments were present on all farms visited. Reports were prepared on the basis of check-lists which are part of the RMP. The farm dairy assessors met by the audit team were competent and familiar with the requirements of the DPC2 and the NZCP1. The dairy holdings visited were subject to regular tuberculin skin test according to New Zealand standards. These standards do not require the testing of goat herds. Conclusions 11
On farm controls carried out by the farm dairy assessors and the verification RMP activities performed by the RA were generally satisfactory. However, the instructions in place for the performance of assessments of dairy holdings by the industry are not up to date in relation to the verification of milking animal health and veterinary medicine prescriptions. 5.4 CONTROL OF RAW MILK UPON COLLECTION Legal Requirements Commodities for which recognition of equivalence for public health sanitary measures is Yes (1) must comply with the relevant New Zealand public health standards established in Food Act 1981 and APA 1999. The other commodities must comply with EU public health standards as prescribed in the Agreement. Point II.2 (a) of the Public Health attestation laid down in the relevant model health certificates drawn up in Part 2 of Annex II to Regulation (EU) No 605/2010 establish requirements for the raw milk from which dairy products are manufactured. The DPC2 sets the New Zealand requirements for raw milk upon collection. Milk must be cooled to 7 C or below within 3 hours of the completion of milking. When milk collection takes place less than 3 hours after the completion of milking the temperatures should be in a range of between 18 C and 7 C, calculated linearly. The following criteria apply also for raw milk upon collection: Somatic Cell count (SCC): Three tests per month with a limit of 400 000 cells/ml. Total Plate Count (TPC): Three tests per month with a limit of 100 000 cfu/ml. This criteria also applies for milk from goats and sheep. Inhibitory substances: Three tests per month with a limit of 0.003 IU penicillin or equivalent/ml. This criteria also applies for milk from goats and sheep. In addition the EU-OMAR specifies that rolling geometric averages for SCC of <400 000 for a period of three months and TPC of <100 000 for a period of two months have to be respected for raw milk from cows. The FBO controls the criteria of raw milk as part of the farm RMP. The RA verifies the systems in place to ensure compliance with the raw milk criteria regarding SCC and TPC as part of the verification activities of the farm RMP. The verification activities of the compliance with the inhibitory substances requirements can be carried out during the RA verification of the transport or manufacturing RMPs depending on which level this responsibility rests. Milk temperatures are recorded automatically by the trucks at milk collection. The audit team noted that temperature requirements were followed at holding level. The goat milk processing establishment included more stringent requirements in their RMP such as temperature of milk at collection and testing of inhibitory substances for each holding at each delivery. All the required samples were collected in accordance with the DPC2. The tests were done with the appropriate frequency and the farmers were informed about the results. Moreover, SCC tests are performed on a daily basis for each holding. The MAF stated that national average for SCC is 216 000 cells/ml and for TPC is less than 20 000 cfu/ml for raw milk from cows. 12
The dairy companies RMPs operate a system of demerits that comes into place already below the requirements for SCC and TPC as described in the EU-OMAR. The RMPs also included procedures to help farmers addressing issues such as TPC and SCC before the EU- OMAR limits are breached. These procedures also included the suspension of collections if the EU-OMAR limits were not respected and the issue was not corrected within a month. The audit team was presented with evidence of the system in place including suspension of collection of farmers that did not comply with the EU-OMAR requirements for SCC and TPC. A rapid test for the presence of inhibitory substances is carried out on each milk load delivered to the dairy establishments as part of the RMP. In case of a positive result the load is rejected. In one establishment visited the manager in charge of the milk intake was not aware that the internal procedure for testing for inhibitory substances had recently been changed. There is a procedure in place to deal with reports of positive results for inhibitory substances at farm level when the rapid test performed at the milk load was negative. The MAF stated that this procedure is in place due to the fact that the inhibitory substances test farm results are available after the product has been processed. When this situation occurs the FBO calculates the estimated concentration of the substance in the final product 2. If the estimated final result in the product is below 0.003 IU penicillin or equivalent the product is declared fit for human consumption 3. Nevertheless, the procedures in place in the establishments visited did not allow for knowingly diluting milk that was positive for the presence of inhibitory substances. In case of positive results for inhibitory substances the collection of milk is immediately suspended until the farmer can demonstrate that the milk is free of these substances. Moreover, most of the export companies require that every delivery from this farm will be tested for a period of one year by the Milk Test New Zealand laboratory. There is an obligation to inform the farmer of the results of the raw milk tests and milk temperatures at collection. Conclusions The official controls carried out over raw milk upon collection were found to be generally satisfactory to ensure compliance with the New Zealand and EU-OMAR requirements. 5.5 LISTING OF ESTABLISHMENTS Legal requirements Article 12 of Regulation (EC) No 854/2004 requires that products of animal origin may be imported into the EU only if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up, kept up-to-date and communicated to the Commission. Point 27.B of the Agreement concerning "premises listings" sets as a required Action "lists to be maintained by the competent authority of the exporting country and be made readily accessible in the public domain". 2 In their response to the draft report the CCA noted that the procedures for the EU requirement applies to raw milk at the start of manufacture. 3 In their response to the draft report the CCA noted that the procedures for the EU requirement is that the concentration in the raw milk does not exceed 0.003 IU/ml penicillin equivalent if the inhibitory is not a betalactam, and does not exceed 0.006 IU/ml penicillin equivalent if the inhibitor is shown to be a beta-lactam. 13
In response to recommendation 6 of report 2008-7899 to complete the outstanding EU listing audits in historically listed EU export dairy establishments the CCA stated that all the outstanding historical EU listing audits had been carried out. EU listing audits in the dairy sector are carried out by the CEG and based on the procedure Special Audit Rev 2 using a check-list that contains the specific New Zealand and EU-OMAR requirements. When major changes take place in the establishment the CEG carries out another EU listing audit in order to evaluate compliance. Establishments are not included by the MAF in the EU list until the deficiencies highlighted during the EU listing audit are corrected. The audit team noticed that all the establishments visited had been audited by the CEG for the purpose of EU listing and generally complied with the New Zealand and EU-OMAR requirements for the dairy sector (see section 5.6) The audit team noticed that the CEG do not forward the EU listing reports to the RP in charge of verification activities in the establishment. Therefore, the RP may not be aware of the recommendations and corrective actions involved in the approval process. Conclusions Recommendation 6 of report 2008-7899 had been addressed and the procedures in place for EU listing are capable of ensuring that the EU listed dairy establishments comply with the New Zealand and EU-OMAR requirements. 5.6 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL Legal requirements Article 12.2 of Regulation (EC) No 854/2004 lays down that the CA of the third country of origin has to guarantee that establishments placed on the list of establishments from which imports of specified products of animal origin to the EU are permitted, together with any establishments handling raw material of animal origin used in the manufacture of the milk products, comply with relevant EU requirements, in particular those of Regulation (EC) No 853/2004 or with requirements that were determined to be equivalent and that an official inspection service supervises the establishments and has real powers to stop the establishments from exporting to the EU in the event that the establishments fail to meet the relevant requirements. Commodities for which recognition of equivalence for public health sanitary measures is Yes (1) must comply with the relevant New Zealand public health standards in Food Act 1981 and Animal Products Act (1999). The other commodities must comply with EU public health standards as prescribed in the Agreement. In addition, the requirements for certification conditions for the introduction into the EU of milk and dary products laid down in the Public Health Attestation of the relevant model health certificates drawn up in Part 2 of Annex II to Regulation (EU) No 605/2010. 5.6.1 General and specific hygiene requirements The DPC 3: Animal Products (Dairy): approved Criteria for the Manufacturing of Dairy Material Product outlines the criteria to be used by the RA when evaluating or verifying an RMP covering dairy processing activities. The assessment of general and specific hygiene requirements including the premises and their maintenance is performed by the RA as part of the verification of the RMP. 14
There is no legal requirement for the temperature at acceptance and storage of milk at establishments prior to processing. It is normal practise not to refrigerate milk at arrival and during storage in establishments. The audit team noticed that in the establishments visited the milk received was up to 11.5 degrees. In one establishment the RA had not identified the risk of cross contamination due to the use of a powder cleaning system during the production. In the same establishment, although no further processing step other than dry blending occurred, the FBO extended the durability of the composite product to a longer period than that of one of the ingredients used without supporting evidence of shelf life studies. In the other 12 premises visited the audit team observed only minor issues which had not been identified by the CA. The establishments and stores visited were in compliance with the New Zealand requirements. In all establishments visited the official controls had been carried out according to the established frequencies. Non-compliances were followed by action plans with set deadlines. Follow-up of non compliances was regularly carried out. The follow-up was based on documentary evidence provided by the FBO to the RA, subsequently verified on the spot at the next scheduled or unscheduled visit. 5.6.2 HACCP-based systems Under the APA 1999 all the FBOs must implement an RMP. An RMP is an assurance programme designed by each FBO to manage known biological, chemical or physical hazards. The programme must include the application of Hazard Analysis Critical Control Point (HACCP) principles, identifying the system of control, and demonstrating that they are effective. The FBO must develop and confirm the validity of the RMP, which must then be evaluated by the RA. When the evaluation of a RMP is completed, the evaluation report and the RMP are forwarded to the MAF. The MAF then assesses the application prior to deciding on registration of the RMP. After registration the operation of the programme must be verified on an ongoing basis by the RA. The DPC1 prescribes the requirements of dairy HACCP plans. This document describes how HACCP plans must be developed and implemented, as well as the criteria to be used by the RA when evaluating or verifying an RMP covering dairy processing activities. The heat treatment evaluation is done in accordance with the criteria outlined in the DPC3: Animal Products (Dairy): Approved Criteria for the Manufacturing of Dairy Material and Product which include heat treatment requirements and equivalences including pasteurisation temperature times of 72 o C during 15 seconds or 63 o C during 20 minutes as described in the EU-OMAR. Verifications of RMP were satisfactorily carried out at the establishments visited, according to the procedures and the set frequency. 5.6.3 Microbiological testing Microbiological testing was performed according to the latest updated version of EU-OMAR requirements (Version 23 of September 2011). This was verified by the RA as part the RMP verification. However, issues were identified by the audit team regarding the EU-OMAR dairy microbiological requirements (see section 5.1.1). 15