VERIFICATION 2005 STATEMENT OF POLICY

Transcription

1 VERIFICATION 2005 STATEMENT OF POLICY This statement specifies the policy NZFSA will apply in regard to the performing of verification under the Animal Products Act for animal materials and products other than dairy, live animals and germplasm. This statement contains: the NZFSA requirements in respect of the performance of verification activities for animal product businesses whether they supply the domestic market, the export market, or both; and the standard initial verification frequencies that will apply to an animal product business, the performance measures around changing verification frequencies and the ceiling frequencies that apply to certain industries; and specific provisions allowing for variation of the standard verification frequencies, changes and ceilings for certain business situations. Signed at Wellington this 31 st day of March 2005 Tony Zohrab Director (Animal Products) New Zealand Food Safety Authority (Acting under delegated authority)

2 1 Application 2 Commencement 3 Interpretation 4 Application 5 General 6 Premises shutdown 7 Dormancy 8 Closure Contents Part 1 Application and Definitions Part 2 General Export Verification Requirements 9 Veterinary accountability Part 3 General Verification Requirements for Premises with Fulltime Verification Agency Supervision 10 Application 11 Verification responsibilities of the accountable veterinarian 12 Performance levels 13 Performing verification 14 Regulatory market access reviews 15 Capacity building responsibilities of the accountable veterinarian 16 Accountable veterinarian meetings 17 Reporting responsibilities of accountable veterinarians 18 Right of appeal 19 Shutdown and Dormancy Part 4 General Verification Requirements for Circuit Premises 20 Application 21 Key responsibilities of verifiers 22 Start-up meeting for new businesses 23 Performing verification 24 Unscheduled verification 25 Premises shutdown 26 Dormancy 27 Reporting responsibilities of verifiers 28 Follow-up action 29 Consequences of an unacceptable outcome 30 Right of appeal Part 5 Specific Clarifications of the Verification Requirements for Circuit Premises

3 31 Application 32 Verification requirements for fishing vessels 33 Verification frequencies for multi-business, multi-site, or multi-risk management programme situations 34 Verification frequencies for emerging businesses 35 Application Part 6 Allowances for Accelerated Performance Specific 36 Accelerated performance for domestic market only businesses with a step 7 ceiling 37 Accelerated performance for the transfer of businesses from the Food Act regime where official assurances are being provided 38 Accelerated performance for certain domestic businesses taking export opportunities 39 Accelerated performance for businesses requiring official assurances but not requiring a risk management programme 40 Application 41 Class one 42 Class two 43 Class three 44 Class four 45 Class five 46 Class six Part 7 Requirements for specific classes of supervision 47 Alternative classes 48 Interpretation of class supervision clauses Schedule 1 Verification frequency for circuit premises Schedule 2 Initial verification frequencies and ceilings Schedule 3 Change in verification frequency Schedule 4 Verification frequency for fishing vessels

4 Part 1 Application and Definitions 1 Application (1) Subject to clause (2), this statement of policy applies to: all animal product businesses, licensed or approved under the Meat Act 1981 and all those that are listed, or registered, or have registered risk management programmes under the Animal Products Act 1999; and regulated control schemes made under the Animal Products Act 1999 where that scheme specifically provides that the verification set out in this Statement of Policy applies; and recognised verifying agencies, verifiers, and providers of ante-mortem and/or post-mortem examination as appropriate. (2) This statement of policy does not apply to: dairy processors; and animal product businesses processing, storing or handling germplasm and live animals for export. 2 Commencement (1) This statement of policy applies from 1 April (2) The Verification 2005 Statement of Policy signed on 17 February 2005 is withdrawn. 3 Interpretation (1) In this Statement of Policy, unless the context otherwise requires accountable veterinarian is the official veterinarian with overall technical accountability for the recognized verification agency s activities provided at the particular animal product business Act means the Animal Products Act 1999 Agency Technical Manager is the Verification Agency manager with overall technical accountability for the agency Animal Products Group means the Animal Products Group of the NZFSA, MAF business means an animal product business as described in section 4(1) of the Act ceiling means the maximum verification step achievable, as set out in schedule 2 of these specifications circuit premises means an animal product business that does not have a fulltime verifier, and are verified on a periodic basis closure means the permanent cessation of all operations of an animal product business country listing means the requirement of an importing country to establish and maintain a list of premises or places that can process or store animal material or animal product intended for export to that country and this requirement will be notified as an overseas market access requirement by NZFSA deficiency means any departure from a regulatory requirement which is reasonably likely to result in exposure of humans or animals to an unacceptable level of hazard; or jeopardize overseas market access; or threaten the integrity of the official assurance system; or

5 (d) (e) (f) where there is significant repetitive or collection of departures from regulatory requirements even though these would be unlikely to trigger the impacts listed in to Director-General means the Chief Executive of MAF dormancy (dormant) means a shut-down where no level of activity is present and where there is no intended date for restarting processing, and includes an animal product business with a suspended risk management programme emerging business includes animal product businesses that are involved with novel animal materials and products, and processes irrespective of the length of time that particular business has been established export certificate is the form of an official assurance determined by the Director- General pursuant to section 62 of the Act fishing vessel means any vessel registered under the Fisheries Act 1996 that is operating a registered risk management programme MAF means the Ministry of Agriculture and Forestry Meat Act means the Meat Act 1981 monthly verification activity means all the functions, inspections and activities performed by the verifier that contribute towards the verification report monthly verification period means that the period between these audit reports is a calendar month New Zealand fishery means all New Zealand fisheries waters as defined in the Fisheries Act 1996 NZFSA means the New Zealand Food Safety Authority which is a semiautonomous agency of MAF official veterinarian means a person that has an appropriate veterinary qualification, is registered with the Veterinary Council of New Zealand, is employed under the State Sector Act 1988, is an official assurance verifier, and is appointed as an Animal Products Officer overseas market access requirements means the overseas market access requirements notified or made available under section 60 of the Animal Products Act 1999 operator means the owner or other person in control of an animal product businesses operator verification process includes operator verification procedures as well as the corrective actions set out in a registered risk management programme including procedures to deal with unforeseen circumstances, and in all other circumstances involves the operator verification activities to be undertaken; and corrective action to restore control; and any actions to be undertaken when corrective actions are not effective; and management of product disposition; and preventive actions; and follow-up actions to ensure control is maintained recognised verifying agency means an agency recognised under section 103 of the Act to perform verification regulatory market access review means a review that is undertaken, when required by this policy statement or by notice, by an appropriately qualified verifier, covering the regulatory requirements and verification as they are applied by an operator and verifier respectively. In the case of the NZFSA Verification

6 Agency, a market access review is conducted by an Agency Team Leader or unit coordinator regulatory requirement means any requirement of the Meat Act 1981 and associated regulations; or the Animal Products Act 1999, associated regulations and notices that apply, and the registered risk management programme(s); and the official assurances programme if applicable, and any applicable overseas market access requirements in accordance with section 60 of the Act and general requirements for animal product or material exports in accordance with section 59A of the Act shut down occurs where, due to maintenance or the seasonal unavailability of animal material or product, an animal product business temporarily ceases all or some of its functions team leader means a manager employed by the Verification Agency, with technical accountability for Verification Agency personnel, within a defined geographical area ungulate means hoofed animal and includes pigs, sheep, cattle, goats, deer and horses unit co-ordinator means a Verification Agency employee with the title unit coordinator who is to assist the Agency Team Leader in meeting their technical accountabilities within a defined geographic area verifier means a person recognised under section 103 of the Act to undertake verification. (2) Any term or expression that is defined in the Animal Products Act 1999, Animal Products (Ancillary and Transitional Provisions) Act 1999, or regulations made under those Acts and used, but not defined, in this Statement of Policy has the same meaning as in those Acts or regulations. Part 2 General Export Verification Requirements 4 Application This Part applies to all animal product businesses listed, approved, licensed or registered under the Animal Products Act 1999, or the Meat Act 1981 intending to export animal material or animal product with an official assurance. 5 General (1) Where an animal product business is involved with export product and overseas market access requirements or general requirements for export (including supervision, examination, surveillance, frequencies of review, audit, and dormancy) apply, such export notices are in addition to this Statement of Policy, and where there is a contradiction with this Statement of Policy, the requirements stated by notice take precedence. (2) Where the verifier does not hold confidence in the eligibility of any animal material or product for export from New Zealand to an intended market(s), then the verifier must take actions, as appropriate, to ensure that only animal materials and animal products that have met all appropriate regulatory requirements are exported, such actions may include: the suspension of the issuing eligibility documents and export certificates to affected market(s); and increasing the verification frequency and/or intensity.

7 6 Premises shutdown (1) An animal product business which has country listings must, during a period of shutdown, ensure that the animal product business is maintained in a manner that will permit processing to commence at short notice for those countries. (2) Sub-clause (1) does not apply to parts of an animal product business that are subject to substantial alteration or maintenance work. (3) An animal product business that is in shut-down must meet the minimum verification requirements for any activities that continue to function. 7 Dormancy (1) An animal product business with country listings must receive a regulatory market access review to confirm that the animal product business complies with specifications and any overseas market access requirements for the listed country, prior to processing recommencing. (2) Where an animal product business is in an extended period of dormancy, country listings for that animal product business may be removed at the discretion of the Director (Animal Products), NZFSA. 8 Closure To maintain eligibility of any animal material or animal product for an official assurance, the operator must transfer all applicable animal material and animal product to another, appropriately licensed, registered and/or listed animal product business, prior to closure. 9 Veterinary accountability (1) A veterinarian must be held technically accountable for the proper application of the functions prescribed in the Animal Products Act 1999, for all animal materials and products derived from: fish, ungulates, ostriches and emus that are exported with an official assurance to the European Union, the United States, China and any other country where, as notified by way of overseas market access requirements, the requirements of the European Union, United States or China are required; and ungulates, ostriches and emus for human consumption, regardless of the intended market. (2) A line of veterinary technical accountability must exist from the recognised agency performing the verification of the applicable animal product business, through to the Director (Animal Products) in accordance with a memorandum of understanding between the Animal Products Group and every applicable recognised agency. Part 3 General Verification Requirements for Premises with Fulltime Verification Agency Supervision 10 Application (1) This Part applies to animal product businesses that are subject to fulltime supervision by an official veterinarian. (2) The verification and supervision functions in this Part are restricted to verifiers employed by the NZFSA Verification Agency. 11 Verification responsibilities of the accountable veterinarian The accountable veterinarian must perform verification on a monthly verification period; and

8 (d) (e) negotiate the method for the monthly verification activity with the operator so as to determine what is most appropriate for the particular site; structure monthly verification activity in line with standard verification practices and protocols; and ensure the monthly verification activity adequately covers all periods of operation, including night shifts; and determine an outcome after each monthly verification activity and accordingly assign a performance level. Note: Clause 11 refers to verification method. Examples include a method of incremental daily activity, or a method involving a single discrete verification activity within the period. 12 Performance levels (1) Performance levels are as follows: Performance Levels Level 6 Level of Verification Intensity Decreasing verifier involvement Level 5 Level 4 Level 3 Level 2 Level 1 Increasing verifier involvement (2) New premises commence on level 1. (3) When a premises receives an acceptable outcome from a monthly verification, then the performance level is to be increased by 1 level to the maximum of level 6. (4) When a premises receives an unacceptable outcome from a monthly verification, then the performance level is to be reduced by 1 level to the minimum of level 1. (5) If the accountable veterinarian considers that the performance level of an animal products business should change contrary to the changes specified in subclauses (3) and (4), then such a change must be authorised by the Agency Technical Manager. Note 1: Level 1 to 3 performance is typically indicated when the operator verification programme is not effective by the verifier frequently being directly involved with process control decisions. Performance is a sign that there is high risk to business and market access continuity. Therefore the operator can expect to receive more intensive verification in order to ensure that regulatory requirements are being met. Note 2: Level 4 to 6 performance is typically indicated when there is an effective operator verification programme and as a consequence verifier intervention is infrequent and more oriented to technical guidance and leadership. Overall there is low risk to business and market access continuity. External verification reinforces good practices and contributes to technical capacity building.

9 13 Performing verification (1) Monthly verification activity is to focus on an assessment of the operator s verification activities, including monitoring and corrective actions; and any records relating to those activities. (2) The objective of the monthly verification activity is to make a determination as to whether the operator is consistently complying to a satisfactory level with regulatory requirements. (3) The official veterinarian is not restricted by sub-clause 1, and may extend the scope of the monthly verification activity to include any areas of investigation considered necessary to provide confidence in compliance with regulatory requirements. (4) The premises performance level determines the depth of verification activity and the interventions applied regarding non-compliances, with the most intensive verification applying at level 1 and the least intensive verification involvement applying at level 6. (5) When a premises is on a performance level of 4 and above, any Verification Agency interventions beyond routine processing matters must be authorised by the Agency Technical Manager. (6) When a premises is assigned down to a performance level of 1 or 2 following an unacceptable outcome, the operator is required to provide a management plan and the accountable veterinarian has discretion to apply interventions in consultation with their Verification Agency s Team Leader. (7) The accountable veterinarian must assign one of the following outcomes on the completion of the monthly verification activity An acceptable outcome, where the accountable veterinarian is satisfied (i) that the operator is substantially complying with regulatory requirements; and (ii) where there have been any departures from requirements, that the operator s corrective actions have been, or are being, applied appropriately and are effective. An unacceptable outcome, where the accountable veterinarian has determined that the operator is not in substantial compliance with regulatory requirements. Note: An operator is considered to be not in substantial compliance where the operator verification process repeatedly fails to identify deficiencies; or the operator verification process is implemented in a manner that is ineffective because deficiencies are not effectively managed or there are numerous non-compliances that individually do not constitute a deficiency, but collectively indicate a trend towards loss of control; or the required records are absent or are incomplete or have been altered, to a degree that prevents the accountable veterinarian having confidence in the system being verified; or (d) the operator is not in substantial compliance with their duties as an operator. 14 Regulatory market access reviews (1) The monthly verification activity is to be supplemented by an independent regulatory market access review. (2) Market access reviews must be of sufficient depth and breadth to confirm an acceptable level of compliance. (3) Market access reviews must include a reality check of the animal product business and assess the accountable veterinarian s monthly report and verification activities.

10 15 Capacity building responsibilities of the accountable veterinarian (1) Accountable veterinarians must work with companies in a pro-active manner by providing assistance as part of the mandated cost-recovery programme, including: providing training, calibration and correlation for activities such as certification, and good hygienic practice; and constructively critiquing company systems; and providing technical advice by participating in the company management team, including involvement with company technical meetings; and (d) contributing to the compliance programme; and (e) participating in NZFSA approved off-premises programmes; and (f) assisting with commercial auditors; and (g) participating in supply-chain verification programmes. (2) Assisting in a pro-active manner does not include those activities relating to the final decision making by the operator, including: assuming accountability for company compliance; or acting in the capacity as a quality assurance manager; or acting as an advocate between industry and NZFSA; or (d) assuming ownership for writing company systems; or (e) providing commercial services for non-mandatory activities. 16 Accountable veterinarian meetings (1) Prior to commencing verification of a new business the Verification Agency must ensure that each of the following points relevant to the business are discussed between the accountable veterinarian and the operator (and conveyed by a means suitable for future reference by the operator) in a start-up meeting Verification Agency and verifier responsibilities; and the duties of the recognised verifying agency and verifiers; and the rights of verifiers and the powers of animal product officers and official assessors; and (d) the operator s responsibilities and duties in relation to verification performed in accordance with this Statement of Policy; and (e) an overview of the regulatory framework, including verification (regulatory overview and external reviews), official assurance programme, overseas market access requirements, general requirement for export and country listings, as applicable; and (f) the appeal process in relation to verification. (2) The accountable veterinarian is responsible for conducting weekly meetings with the operators management team, to advise on technical issues and negotiate action plans for non-compliances. During periods of shutdown or dormancy, the meeting frequency may be altered in agreement with the operator. Note to sub-clause 1: A new business is new because it has either commenced operations for the first time or because it has had a risk management programme registered for the first time or become subject to a regulated control scheme (that links to this Statement of Policy) for the first time. 17 Reporting responsibilities of accountable veterinarians On completion of the monthly verification period, including completion of any follow-up activities, the accountable veterinarian must provide to the Verification Agency and operator, a written report by the first working day of the following month which covers any deficiencies and the follow up actions to be undertaken by the verifier to confirm that the operator has addressed each deficiency; and a summary of the monthly verification activity including verification of the risk management programme, any regulatory market access reviews that occurred

11 (d) within the month, mandated frequencies and any other matters requested by the Agency Technical Manager; and the outcome of the monthly verification activity; and the performance level assigned and any consequences. 18 Right of appeal An operator who is dissatisfied with a decision made by an official veterinarian can seek a review of that decision in accordance with any published procedure by the NZFSA. 19 Shutdown and Dormancy Animal product businesses that are in a state of shutdown or dormancy may assume the general verification requirements for circuit premises, in accordance with Part 4. Part 4 General Verification Requirements for Circuit Premises 20 Application This Part applies to all circuit premises. 21 Key responsibilities of verifiers (1) Different verifiers of the same recognised agency may verify an animal product business on separate occasions if regular dialogue, including meetings and joint visits, is maintained between those official assurance verifiers. (2) The verifier must structure verification activities in line with standard verification practices and protocols (verifiers are to include an unscheduled visit in accordance with the requirements of this Statement of Policy); and schedule verification to adequately cover all periods of operation, including night shifts; and not take over any tasks which are the responsibility of the operator to perform; and (d) determine an outcome after each verification and accordingly assign a verification frequency, as set out in schedule 1, to each animal product business verified. 22 Start-up meeting for new businesses (d) (e) Prior to commencing verification of a new business the recognised verifying agency must ensure that each of the following points relevant to the business are discussed (and conveyed by a means suitable for future reference by the operator) in a start-up meeting with the operator recognised verifying agency and verifier responsibilities; and the duties of the recognised verifying agency and verifiers; and the rights of verifiers and the powers of animal product officers and official assessors; and the operator s responsibilities and duties in relation to verification performed in accordance with this Statement of Policy; and an overview of the regulatory framework, including verification (regulatory overview, external reviews), official assurance programme, overseas market

12 (f) access requirements, general requirements for export and country listings, as applicable; and the appeal process in relation to verification. Note 1: A new business is new because it has either commenced operations for the first time or because it has had a risk management programme registered for the first time or become subject to a regulated control scheme (that links to this Statement of Policy) for the first time. Note 2: The initial verification frequencies and ceilings are set out in schedule 2 of this Statement of Policy. Despite schedule 2, where a business licensed or approved under the Meat Act is registering a risk management programme, the initial verification frequency will be the same verification frequency that business was subject to under the Meat Act. Where a premises licensed or approved under the Meat Act is currently on a weekly visit then they will remain on that frequency until three consecutive acceptable outcomes have been achieved in order to move to step one of this Statement of Policy (2-weekly visits). 23 Performing verification (1) At the commencement of verification, the verifier must advise the operator being verified of the scope of verification, which must include as a minimum; an assessment of the operator s verification activities, including monitoring and corrective actions; and an assessment of any records relating to those activities; and a physical check of the business during the verification visit. (2) Despite advising the scope, the verifier is not restricted to the planned scope during the verification visit should it be justified to expand the areas of investigation. (3) The objective of verification is to make a determination as to whether the operator is consistently meeting the regulatory requirements relevant to their business. (4) The verifier must assign one of the following outcomes on the completion of a verification visit An acceptable outcome, where the verifier is satisfied (i) that the operator is substantially complying with regulatory requirements; and (ii) where there have been any departures from requirements, that the operator s corrective actions have been, or are being applied appropriately and are effective. An unacceptable outcome, where the verifier has determined that the operator is not in substantial compliance with regulatory requirements. Note 1: An operator is considered to be not in substantial compliance where the operator verification process repeatedly fails to identify deficiencies; or the operator verification process is implemented in a manner that is ineffective because deficiencies are not effectively managed or there are numerous noncompliances that individually do not constitute a deficiency, but collectively indicate a trend towards loss of control; or the required records are absent or are incomplete or have been altered, to a degree that prevents the verifier having confidence in the system being verified; or (d) the operator is not in substantial compliance with their duties as an operator. Note 2: The outcome of any verification activity imposed by overseas markets which has occurred within the review period (if this is applicable to the business), or the issuing of any corrective action requests, should contribute to the report

13 and collective findings, but are not of themselves reasons for the verifier to assign an unacceptable outcome. 24 Unscheduled verification (1) The verifier must perform unscheduled verification visits at circuit businesses, including fishing vessels. (2) An unscheduled verification visit may occur when the verifier has reason to believe that the operator is not meeting regulatory requirements, and, with the exception of fishing vessels, is to additionally occur routinely 1 visit out of every 5 visits where the operator is on steps 1 to 5; or once every 2 years where the operator is on steps 6 or 7. (3) The verifier will use their professional judgment when determining the scope of the verification for an unscheduled visit. (4) 1 out of 2 unscheduled verification visits should be unannounced. 25 Premises shutdown (1) During periods of shutdown, the verification frequency may be reassessed by the verifier, in consultation with the Agency Technical Manager, and a suitable frequency applied during this period. (2) An animal product business that is in shut-down must meet the minimum verification requirements for any activities that continue to function. 26 Dormancy (1) When an animal product business is in dormancy, the verification frequency may be reassessed by the verifier, in consultation with the Agency Technical Manager, and a suitable frequency applied during this period. (2) An operator may elect to maintain a dormant animal product business in a state of shut-down. 27 Reporting responsibilities of verifiers (1) On completion of a verification visit the verifier must inform the operator verbally of (i) any deficiencies found during the verification visit; and (ii) the likely outcome of the verification visit; and (iii) the consequential change to the verification frequency, if any in accordance with schedule 3; and (iv) when the next verification will be undertaken (this does not prevent the verifier from making an unscheduled verification visit in accordance with clause 24 of this Statement of Policy). advise the Director (Animal Products), NZFSA, as soon as practicable if an unacceptable outcome is achieved. Notwithstanding, in the case of the NZFSA Verification Agency, the Agency Technical Manager is to be notified in place of the Director (Animal Products). (2) On completion of a verification visit, including completion of any follow-up activities, the verifier is to provide to the recognised verifying agency and operator a written report within 5 working days which specifies the outcome of the verification visit and any change to the verification frequency in accordance with schedule 3; and

14 any deficiencies and the follow up actions to be undertaken by the verifier to confirm that the operator has addressed each deficiency; and when the next verification visit will be undertaken (this does not prevent the verifier from making an unscheduled verification visit in accordance with clause 24 of this Statement of Policy). 28 Follow-up action (1) The verifier must confirm with the operator that any follow-up actions have been addressed within an agreed period of time. (2) The verifier may perform follow-up actions, which may be unscheduled, at their discretion and in line with standard verification practices and protocols to confirm that the operator has undertaken any corrective and preventative actions in the manner and timeframe agreed. (3) As part of the follow-up action, the verifier may request that documented evidence of the corrective and preventive actions are supplied. 29 Consequences of an unacceptable outcome (1) Where an animal product business is assigned an unacceptable outcome on step 1, despite the verification frequencies set out in schedule 1 of this Statement of Policy, the recognised verification agency s technical manager must determine, in consultation with the Director (Animal Products), a modified verification frequency for the business. The frequency must allow the verifier the opportunity to verify any enhancements of the systems, processes and controls of the business effectively such that the verifier has confidence that the operator will produce animal product that is fit for intended purpose and meets any applicable overseas market access requirements. (2) An unacceptable outcome on step 1 or 2 will require the operator to prepare a written corrective action management plan that must be provided to the verifier for their agreement within 5 working days from the day the operator receives written notification enabling the corrective action management plan to be prepared. (3) The written corrective action management plan must include a description of the investigation process covering what will be done to identify the root cause of the deficiency; and the anticipated specific actions that will be taken to resolve the root cause and how these actions are expected to prevent recurrence of the deficiency; and the anticipated time frames for implementation of the specific actions. (d) how, in the interim, continued processing will produce product fit for its intended purpose, including meeting any overseas market access requirements of intended markets. Note: Where an operator is appealing an unacceptable outcome, the operator is not required to prepare the written corrective action management plan until the decision of the appeal is notified to the operator and that decision upholds the requirement to prepare a written corrective action management plan. Despite this, the operator should still actively address any deficiencies identified even when the outcome of the appeal is pending. 30 Right of appeal (1) An operator who is dissatisfied with a decision made by a verifier can seek a review of that decision in accordance with any published procedure by the NZFSA.

15 (2) An operator seeking a review of a verification frequency given by a verifier must operate according to the frequency given by the verifier until a decision from the appeal process is given. Part 5 Specific Clarifications of the Verification Requirements for Circuit Premises 31 Application This Part applies to the following circuit premises: fishing vessels; and multi-business, multi-site, or multi-risk management programme situations; and emerging businesses. 32 Verification requirements for fishing vessels (1) Fishing vessels must be subject to a verification visit: after the first voyage following registration of the risk management programme; or when re-entering the New Zealand fishery, and in such a situation the vessel will commence verification on step1 of schedule 4; or prior to the vessel leaving the New Zealand fishery. (2) Fishing vessels will be subject to the application of schedule 4. (3) Fishing vessel operators must keep a record of all visits to port for each fishing vessel and these records must be available on demand for verification. (4) Each visit to port must be notified to the contracted recognised verification agency 24 hours in advance, except in the case of an emergency port visit, and the recognised verification agency must advise promptly within the 24 hour period whether a routine verification is to be conducted. (5) When a verification visit is to be conducted, fish must not be unloaded from the vessel until the verifier has given approval to unload. (6) Fishing vessels must not return to sea following a verification visit until the verifier has cleared the vessel to recommence fishing and this clearance has been recorded in the verification report. (7) Where a fishing vessel has not been subject to a verification visit within 6 months then that fishing vessel s risk management programme may be suspended or withdrawn as appropriate. 33 Verification frequencies for multi-business, multi-site, or multi-risk management programme situations (1) Where more than one risk management programme applies to a business site, or where the business site has a premises license or approval under the Meat Act as well as a risk management programme(s), then the business operator and the recognised verification agency may agree that the site may be verified as a whole, and when this is the case, the most frequent verification frequency will be applicable to the whole site. (2) Where a risk management programme applies to more than one business site, then each business site will be subject to this Statement of Policy in accordance with any direction provided by the Director (Animal Products), and the verification frequency can vary between the individual sites.

16 (3) Where a business is under a multi-business risk management programme, then each business entity will be subject to this Statement of Policy in accordance with any direction provided by the Director (Animal Products), and the verification frequency may vary between the individual businesses. Note: The Animal Products Act contains the concept that each risk management programme is subject to verification in its own right. Clause 14(1) allows for a multi-rmp site to be verified as a whole. 34 Verification frequencies for emerging businesses (1) Where an animal product business is an emerging business and the application of the verification frequencies determined from schedules 1 and 2 are not considered appropriate by the verifier, then the verifier can advise the operator to make a written request to the applicable recognised verification agency s technical manager for a dispensation to be made on a case-by-case basis. (2) The application will be considered by the recognised verification agency s technical manager in conjunction with the Director (Animal Products), and a ruling will be made on what verification arrangement will be applied. (3) This ruling will be notified to the operator and will be final, not subject to appeal. (4) In all cases where an altered verification arrangement is applied, it will be subject to the requirement that the operator must provide its recognised verification agency with written advice of any change in the processing profile that would mean that the animal product business was no longer an emerging business. (5) This accelerated performance arrangement does not override any specific requirements of relevant overseas market access requirements. Part 6 Allowances for Accelerated Performance Specific 35 Application (d) This Part puts in place criteria that allow for accelerated progression in the following circuit premises: where the business supplies product only to the domestic market; and businesses transferring from the Food Act regime where official assurances are being provided; and businesses expanding from supplying product only to the domestic market to export; and businesses requiring official assurances for export but not requiring a risk management programme. 36 Accelerated performance for domestic market only businesses with a step 7 ceiling Despite the requirements set out in schedule 3, businesses that have a ceiling of step 7 or 8 (these are all businesses that supply product only to the domestic market) may be reassigned immediately to the ceiling step as a result of an acceptable outcome.

17 37 Accelerated performance for the transfer of businesses from the Food Act regime where official assurances are being provided (1) Where a business has formerly been regulated under the Food Act regime and official assurances continue to be provided under the Animal Products Act, and where an initial verification of the risk management programme results in an acceptable outcome, then the verification frequency may be re-assigned to the verification frequency applied for enabling official assurances prior to risk management programme registration despite the requirements set out in schedule 3. (2) The application of sub-clause 1 will be limited to where the process operation is materially unaltered from that which occurred under the Food Act regime. (3) This accelerated performance arrangement does not override the verification ceilings established by schedule 2. (4) This accelerated performance arrangement can only be applied with the consent of the recognised verification agency s technical manager. Note: For clarity, this clause may apply to primary processors that require official assurances directly or are supplying animal product to secondary processors that require official assurances, or where a secondary processor is themselves supplying another secondary processor that requires official assurances. 38 Accelerated performance for certain domestic businesses taking export opportunities (1) This accelerated performance provision applies to the following categories of animal product businesses as defined in Schedule 2: All other processors of animal product for human consumption. ; and All other processors of animal product for animal consumption. (2) Where businesses in these categories have been domestic businesses and have begun to export, they will be subject to an export step 1 verification visit, and where the initial export verification of the risk management programme results in an acceptable outcome, then the verification frequency may be re-assigned to any step up to the export verification ceiling frequency despite the change in verification frequency requirements set out in schedule 3. (3) In determining the verification frequency in accordance with clause 2, the verifier should consider: The outcome of the initial or any subsequent verification visit; and Any known history of regulatory compliance; and The adequacy and suitability of the systems and programmes in place to give the verifier confidence in the business ongoing food safety performance. (4) This accelerated performance arrangement does not override the verification ceilings established by schedule 2 nor any specific, relevant, overseas market access requirements, including where a country requires and initial listing inspection visit. (5) This accelerated performance arrangement can only be applied with the consent of the technical manager of the recognised agency. 39 Accelerated performance for businesses requiring official assurances but not requiring a risk management programme (1) Animal product businesses that are export businesses subject to official assurances issued in accordance with the Animal Products Act 1999 that are not

18 required to have a registered risk management, may have a verification frequency re-assigned to any step up to the export verification ceiling frequency, despite the change in verification frequency requirements set out in schedule 3. (2) This accelerated performance arrangement does not override any specific requirements of relevant overseas market access requirements. (3) This accelerated performance arrangement can only be applied with the consent of the recognised verification agency s technical manager. Part 7 Requirements for specific classes of supervision 40 Application (1) This Part describes classes of supervision that apply to operators that slaughter and dress ungulates, emus and ostriches for human consumption, where the application is notified by way of an overseas market access requirement. (2) Unless otherwise notified, this Part applies only for the period when the animal product business is processing product for the country that has the overseas market access requirement triggering application. 41 Class one (d) (e) Class one supervision requires: full time, continuous on-site presence by an official veterinarian; and an official veterinarian must carry out ante-mortem examination; and preliminary tasks associated with ante-mortem examination, including the identification of defective (suspect) animals, may be conducted by either a nonveterinary official assessor or an animal products officer; and post-mortem examination must be performed by an official assessor or animal product officer under the direct supervision of an official veterinarian; and final disposition for all suspect animals is to be determined by the official veterinarian. 42 Class two Class two supervision requires: ante-mortem and post-mortem inspection must be carried out by an official assessor or animal products officer, under the supervision of an official veterinarian; and final disposition for all suspect animals is to be determined by the official veterinarian; and full time, continuous on-site presence by an official veterinarian at all times when slaughtering is in progress except where a good level of compliance has been consistently demonstrated, and in this case supervision may take the form of: (i) a daily onsite overview visit by the official veterinarian; and (ii) direct supervision of the animal product business, whilst slaughtering is in progress, by an animal products officer acceptable to the accountable veterinarian; and (iii) the official veterinarian must be available at all times to be recalled to the animal product business if required; and (iv) the official veterinarian must make decisions regarding the suitability for processing of any suspect animals; and (v) visits by the official veterinarian must occur at random times during the slaughter period.

19 43 Class three Class three supervision requires: ante-mortem and post-mortem inspection must be carried out by an official assessor or animal products officer, under the supervision of an official veterinarian; and final disposition for all suspect animals is to be determined by the official veterinarian; and full time, continuous on-site presence by an official veterinarian at all times when slaughtering is in progress except where a good level of compliance has been consistently demonstrated, and in this case supervision may take the form of: (i) a daily onsite overview visit by the official veterinarian; and (ii) direct supervision of the animal product business, whilst slaughtering is in progress, by an official assessor or animal products officer acceptable to the accountable veterinarian; and (iii) the official veterinarian must be available at all times to be recalled to the animal product business if required; and (iv) the official veterinarian must make decisions regarding the suitability for processing of any suspect animals; and (v) visits by the official veterinarian must occur at random times during the slaughter period. 44 Class four Class four supervision requires: official veterinary performance based visits, in conjunction with full time, off chain, continuous supervision by an animal products officer or official assessor acceptable to the accountable veterinarian; and ante-mortem and post-mortem examinations to be conducted by an official assessor or an animal product officer; and an official veterinarian must be available at all times while slaughtering is in progress to make judgments on any ante-mortem or post-mortem suspects. 45 Class five Class five supervision requires: performance based verification to be performed by a recognised verification agency with an annual visit by a veterinarian under the employ of the recognised agency; and ante-mortem and post-mortem examinations must be conducted by an official assessor or an animal product officer. 46 Class six Class six supervision requires: performance based verification to be performed by a recognised verification agency with veterinary visits at the discretion of a veterinarian under the employ of the recognised agency; and ante-mortem and post-mortem examinations must be conducted by an official assessor or an animal product officer. 47 Alternative classes Alternative classes of supervision may be specified by the Director General.

20 48 Interpretation of class supervision clauses (1) Where the verification frequency and/or intensity has been modified and the verification is allocated to an official veterinarian, an official assurance verifier may undertake the increased tasks if approved to do so by the official veterinarian. (2) Full time, continuous on-site presence by an official veterinarian" in clauses 41, 42 and 43 may be interpreted in accordance with the following authorised variations and procedures: slaughter premises may be without continuous on-site supervision by an official veterinarian for up to 3 consecutive working days but no more than 10 accumulated days in a calendar year; and the absentee days cannot be combined to produce a continuous or semicontinuous period of 4 to 10 days; and any absence of less than one day s duration is counted as a full day; and (d) daily visits by an official veterinarian must take place; and (e) the veterinarian must be available for contact at all other times during slaughter; and (f) all animals intended for slaughter must have been subjected to and passed antemortem inspection by an official veterinarian; and (g) an official veterinarian must undertake ante-mortem inspection of suspect animals; and (h) an official veterinarian must inspect slaughtered animals retained for veterinary inspection; and (i) the non-continuous on-site supervision is restricted to the following situations: (i) animal or public health emergencies or any other circumstance, where the absence is specifically authorised by the Director (Animal Products); and (ii) medical conditions or illness where the absence is specifically authorised by the Agency Team Leader; and (iii) investigations associated with incoming raw materials or animals or despatched products are required urgently because the eligibility for the European Union may be in doubt and urgent resolution is necessary where the absence is specifically authorised by the Agency Team Leader; and (iv) training is required to maintain competency where the absence is specifically authorised by the Agency Team Leader; and (j) (k) records of all absences and relevant authority must be maintained on-site; and records are to include medical certificates, training details or other documents supporting justification of the absence, where appropriate. (3) Without limiting the circumstances under which the provisions of sub-clause 48(2)(i) would apply, the Director (Animal Products) authorises the following: the official veterinarian may be absent from the premises during slaughter and dressing for the purposes of taking scheduled meal breaks of no more than one hour s duration. The absence must be authorised by the appropriate Agency Team Leader. Repetitive meal break absences of the same type (breakfast/lunch/dinner) for the same person and premises may receive a single, initial authorisation; and the veterinarian may be absent from the premises during slaughter and dressing to undertake specific verification programmes. Such programmes will specify that this sub-clause applies to the programme. The programmes will be subject to an annual plan and activity schedule and be approved by the Director (Animal Products). The absence of the veterinarian from the premises must not exceed 3 hours per standard working day.