Transitional Facilities for Processing Imported Salmonids

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Contents

1. Introduction

  • Scope of Part One and Part Two
  • References
  • Definitions

Part One: Requirements of the Operator

  • 2. Approval of a Transitional Facility and Operator
  • 3. Quarantine Manual
  • 4. Structural and Operational Requirements

Part Two: Requirements of the Supplier

  • Scope of Part Two
  • 5. Service Requirements
  • 6. Technical Requirements

Transitional Facility/Operator Registration

1. Introduction

Scope of Part One

This MAF Reg Standard specifies the structural and operating requirements for facilities processing imported salmonids which have been directed on arrival in New Zealand to a transitional facility as a requirement of an import health standard. This Standard also specifies how operators and facilities may be approved.

The primary purpose for the quarantine of imported salmonids is to minimise the risk that any associated organism will:

  • Cause unwanted harm to natural and physical resources or human health in New Zealand; or
  • interfere with the diagnosis, management, or treatment, in New Zealand, of pests or unwanted organisms. [From the definition of risk goods, section 2, Biosecurity Act, 1993.]

The primary purpose of quarantine is to minimise the risk of potentially contaminated by-product coming into contact with New Zealand fish species.

Scope of Part Two

The supplier shall provide the Chief Veterinary Officer with a service to supervise the operation of transitional facilities for processing imported salmonids which are required to operate according to Part One of this Standard.

1.1 References

This Standard is an approved standard in terms of sections 39 and 40 of the Biosecurity Act, 1993.

The following publications are referred to in this MAF Reg Standard:

  • AS/NZS Standard 9002 [1994]: Quality Systems - Model for quality assurance in production, installation and servicing. Published by Standards New Zealand.
  • British Standard EN45004 (1995) General criteria for the operation of various types of bodies performing inspection.
  • Import health standards for imported salmonids which have a requirement for transitional facilities.

1.2 Definitions

For the purposes of this MAF Reg Standard the following definitions apply:

Approval
Means approved by the Director-General, MAF or his/her delegate. The Chief Veterinary Officer and National Manager (Animal Quarantine) are delegatees for this Standard.
Audit
An evaluation to determine the degree of conformity with prescribed criteria and provide a basis for ongoing improvement.
Biosecurity clearance
"Means a clearance under section 26 of this Act for the entry of goods into New Zealand:" Biosecurity Act, 1993.
Biosecurity direction
Authority from an inspector to move uncleared goods to a transitional facility, containment facility or biosecurity control area.
Chief Veterinary Officer
Is the chief technical officer [as defined in section 101 of the Biosecurity Act 1993] of MAF with animal health responsibilities.
Contaminated by-product
Is all product, other than the end product, resulting from the processing or packaging of salmonids undertaken by the processing premises. Examples of contaminated by-product are trimmings of fish, imported packaging materials and water contaminated by contact with imported salmonids.
Director-General
Means the chief executive of the Ministry of Agriculture and Forestry or his/her delegate.
Import Health Standard
A document issued under section 22 of the Biosecurity Act, 1993, which specifies the requirements to be met for the effective management of risks associated with importation of risk goods before those goods may be imported, moved from a biosecurity control area or a transitional facility, or given a biosecurity clearance. An example of an import health standard is, "The import health standard for the importation of wild ocean caught Pacific salmonids into New Zealand from Canada."
Inspector
A person appointed as an inspector under the Biosecurity Act, 1993.
Internal audit
An audit carried out by the company or organisation to evaluate its own performance in relation to the Standard or prescribed criteria.
MAF Regulatory Authority (MAF Reg)
The body within the Ministry of Agriculture and Forestry responsible for regulatory functions.
National Manager (Animal Quarantine)
The contact person for matters relating to this Standard.
Address: National Manager (Animal Quarantine)
MAF Regulatory Authority
Box 2526
Wellington

Fax: (04) 4744 133
E-mail: corrink@maf.govt.nz

Operator
The person who has overall responsibility for the facility, its maintenance and operation in terms of section 40 of the Biosecurity Act, 1993.
Organism
"(a) Does not include a human being or a genetic structure derived from a human being:
(b) Includes a micro-organism:
(c) Subject to paragraph (a) of this definition, includes a genetic structure that is capable of replicating itself (whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity):
(d) Includes an entity (other than a human being) declared by the Governor-General by Order in Council to be an organism for the purposes of this Act:
(e) Includes a reproductive cell or developmental stage of an organism:
(f) Includes any particle that is a prion:" Section 2, Biosecurity Act, 1993.
Permit
A numbered document, issued as a requirement of the import health standard.
Procedure
A document that specifies, as applicable, the purpose and scope of an activity; what shall be done and by whom; when, where, and how it shall be done; what materials, equipment and documentation shall be used; and how it shall be controlled.
Processing Premises
A premise, approved by the Director General in terms of section 39 of the Biosecurity Act, that processes salmonids imported under the requirements of an import health standard before the product is offered for sale.
Quarantine
"Means confinement of organisms or organic material that may be harbouring pests or unwanted organisms." Section 2, Biosecurity Act, 1993.
Risk goods
"Means any organism, organic material, or other thing or substance, that (by reason of its nature, origin, or other relevant factors) it is reasonable to suspect constitutes, harbours, or contains an organism that may:
  1. Cause unwanted harm to natural and physical resources or human health in New Zealand; or
  2. Interfere with the diagnosis, management, or treatment, in New Zealand, of pests or unwanted organisms:" Section 2, Biosecurity Act, 1993.
Salmonids
For the purposes of this Standard they are risk goods which have been directed as a requirement of an import health standard to a transitional facility approved under this Standard. They include for example: fish flesh within the genera Oncorhynchus, Salmo and Salvelinus.
Supervisor
The person employed by the supplier who inspects the transitional facility and audits the operation of quarantine [See 5.2.2].
Supplier
The party responsible for the performance of the inspection and audit work under a contractual arrangement with the MAF Regulatory Authority.
Transitional facility
Any place approved as a transitional facility in accordance with section 39 for the purpose of inspection, storage, treatment, quarantine, holding, or destruction of specified types of uncleared goods; or part of a port declared to be a transitional facility in accordance with section 39. From section 2, Biosecurity Act, 1993.
Uncleared goods
Means imported goods for which no biosecurity clearance has been given.
Unwanted organisms
"Means any organism that a chief technical officer believes is capable or potentially capable of causing unwanted harm to any natural and physical resources or human health:" Section 2, Biosecurity Act, 1993.

Part One: Requirements of the Operator

2. Approval of a Transitional Facility and Operator

2.1 Approval of a Transitional Facility

A transitional facility shall be approved by the National Manager (Animal Quarantine) in accordance with section 39 of the Biosecurity Act, 1993. It shall have an approved operator and be constructed and operated in accordance with this Standard. [It is expected that the facility will comply with the requirements of the Resource Management Act, 1991, Building Act, 1991 and any other relevant legislation.]

The supervisor is prepared to consider applications before construction or alteration of a facility in order to provide advice on whether the proposed facility is likely to comply with this Standard.

When the facility and operational procedures [detailed in the quarantine manual or alternative quality system] meet the requirements of this Standard the supervisor shall recommend to the National Manager (Animal Quarantine) that the facility be approved as a transitional facility.

Approval will be in writing and usually for twelve months.

2.1.1 Modifications to an approved facility

If, subsequent to approval, the facility is to be modified, the supervisor is to be advised. A new floor plan may be required and the facility may be inspected to check that it meets the Standard.

2.1.2 Renewal of approval

Approval of the facility for another 12 months is dependent on a satisfactory external audit and a recommendation from the supervisor to the National Manager (Animal Quarantine).

2.2 Approval of an Operator

A transitional facility operator shall be approved by the National Manager (Animal Quarantine) in accordance with section 40 of the Biosecurity Act, 1993.

The operator is responsible for the operation of the transitional facility and ensuring that mechanisms are in place for resourcing the facility. If the facility is leased, the lessee, responsible for the operation of the transitional facility, shall apply to be the operator and the contract with the owner shall clearly identify who is responsible for the maintenance of the premises and the resourcing of the operation. No part of the lease contract shall override the requirements of this Standard in the operation of quarantine. This contract shall be made available to the supervisor who shall be satisfied that the contract does not override the requirements of this Standard.

Any person wishing to be an operator shall apply to the National Manager (Animal Quarantine) through the supervisor using the forms in pages 23 and 24 of this Standard.

Approval will be in writing.

2.2.1 Collection of personal information on individuals

In regard to any information being collected on the application for approval of an operator, this is personal information [being information identifying or being capable of identifying an individual person]. Notification is hereby provided, in accordance with Principle 3 of the Privacy Act 1993, to individuals of the following matters:

  • This information is being collected for the purposes relating to the approval of an operator as per section 40 of the Biosecurity Act, 1993.
  • The recipient of this information, which is also the agency that will collect and hold the information is the Ministry of Agriculture and Forestry, PO Box 2526, Wellington.
  • You are reminded that under Principles 6 and 7 of the Privacy Act, 1993, you have the right of access to, and correction of, any personal information which has been provided.

2.3 Procedure for Approval of a Facility and an Operator

Any person wishing to have a transitional facility approved and be approved as an operator shall establish contact with the supervisor or supplier. [The supplier's identity may be obtained from the National Manager (Animal Quarantine).]

An application for approval of a facility and operator shall be made by the applicant when the following requirements have been met:

  • the facility meets the specifications of this Standard,
  • a quarantine manual or an alternative quality system has been approved by the supervisor as meeting the required elements set down in section 3 of this Standard,
  • the application forms on pages 22, 23 & 24 of this Standard have been completed by the prospective operator. [Note the additional documentation required.]

When the applicant is able to satisfy the supervisor that the requirements for approval have been met, the supervisor will forward the completed application forms and make a recommendation to the National Manager (Animal Quarantine) for approval of the facility and operator.

2.4 Cancellation of Approval

The Chief Veterinary Officer may cancel approval of a facility,

  • when the time specified in the approval expires or an event specified in the approval occurs,
  • if the facility no longer complies with this Standard,
  • if the National Manager (Animal Quarantine) is satisfied that the facility is no longer used for the purpose or one or more of the purposes specified in the approval,
  • if the operator ceases to be an operator of a facility,
  • if the operator is no longer a fit and proper person,
  • if the operator requests cancellation.

The Chief Veterinary Officer may cancel approval of an operator:

  • if no longer satisfied that the facility is being operated according to this Standard,
  • if the operator requests cancellation.

Notice of cancellation shall be given in writing to the operator.

3. Quarantine Manual

The operator shall prepare, maintain and implement a quality assurance programme and procedures based on the principles of AS/NZ 9002, code of good manufacturing practice or similar quality programme [accreditation with other agencies such as Telarc is not required].

The quality assurance programme and any amendments shall address the requirements of this Standard. It shall be documented in a quarantine manual or in an alternative quality system.

The quality assurance programme and any amendments shall be approved by the supervisor.

The items listed below are the minimum requirements for the quarantine manual.

3.1 General

Describe the main functions of the organisation importing the salmon.

3.2 Quarantine Requirement

Document the procedures used in the transitional facility to meet all of the requirements of the import health standard and section 4 in this Standard.

Provide a floor plan showing the general layout of the facility and show in the plan the areas where imported salmonids are evaluated, processed or stored.

3.3 Management

Identify the operator. Identify the manager if one is nominated by the operator. Specify and document the responsibilities of the operator and also the manager if one is appointed. Identify other users of the transitional facility.

3.4 Training

Nominate a person or position responsible for training. Describe how the training programme is to be implemented, the time scale for implementation and refresher courses.

Training must be available to new and existing staff. Document training records for all staff.

3.5 Internal Controls

Identify quality assurance systems used in the facility.

The operator shall carry out an internal audit of its activities at least once every six months to verify that its activities continue to comply with the requirements of the quality system.

The quality system adopted to satisfy the requirements of this Standard shall be reviewed at least once a year by the management to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements.

All audit and review findings and any corrective actions that arise from them shall be documented.

3.6 Version

Record the version number and issue date of the quarantine manual on each page. Updates are to be approved by the supervisor who shall also hold an up to date copy of the quarantine manual.

4. Structural and Operational Requirements

4.1 General Requirements

General requirements for transitional facilities holding imported salmonids are:

  • The processing premises shall be operated in accordance with this Standard, the import health standard and any other relevant legislation, such as the Food Act 1981, the Food Hygiene Regulations 1974, the Meat Act 1981 and the Fish Export Processing Regulations 1995.
  • The processing premises must not be a packing house licensed under the Meat Act 1981.
  • The transitional facility shall be a covered building and the area where the imported salmonids are stored and/or processed shall have a sealed floor. The surfaces of the floors and walls shall be washable and kept clean.
  • The transitional facility shall be constructed and operated in a manner to ensure that imported salmonids are separated from other product and securely contained within the transitional facility.
  • The imported salmonids shall be isolated so that no direct or indirect contact with animals can occur.
  • An inventory shall be maintained of imported salmonids in the transitional facility.
  • Imported salmonids may be transferred between transitional facilities provided that they have been approved for processing imported salmonids and are accompanied by a written authority from the supervisor. An application for transfer, which includes details of the proposal, shall be made in writing to the supervisor.

Appropriate inventory control is required at departure and on arrival of the salmonids.

4.2 Waste Management Plan

The operator shall have a waste management plan that describes how all of the waste associated with the importation and processing of salmonids shall be managed to minimise the risk of potentially contaminated by-product making contact with New Zealand fish species. The following requirements shall be included in the plan:



  • Imported packaging shall be disposed of by incineration or other authorised method. (A contracted waste management company may be used.)
  • Non-liquid contaminated by-products shall be disposed of by either:
    • complete incineration or
    • rendering at a minimum of 85°C for at least 15 minutes.
  • Disposal may be on-site or after transportation to a contracted company such as a waste management contractor or pet food/fertiliser manufacturer.
  • Liquid wastes may be discharged into an approved sewage treatment system.

4.3 Biosecurity Clearance

Imported salmonids which meet the conditions of the import health standard and have been processed in facilities managed according to this Standard shall be issued a biosecurity clearance by the supervisor.

Audits shall be at the expense of the operator and charges will be in accordance with the Biosecurity (Cost) Regulations 1993.

4.4 External Audit

The operator shall provide the supervisor or any other representative of the Chief Veterinary Officer, access to the facility, records and documents for the purpose of audit. During these audits the operator shall be available to assist and ensure that all relevant procedures and records are made available to the supervisor.

4.4.1 Systems audit at commencement of processing

If the processing of imported salmonids is discontinued for more than six weeks the operator shall give the supervisor at least 2 weeks notice of the impending commencement of processing. This notice should be sufficient to ensure that the supervisor is able to perform a systems audit against this Standard and the quarantine manual before approving the commencement of processing.

4.4.2 Fortnightly visits

The supervisor shall visit the premises each fortnight throughout the period when imported salmonids are being processed. During these visits the inspector may focus on specific aspects of the operation or perform a full audit against this Standard. Additional audits will be conducted as required especially if non-compliance is found.

4.4.3 Non-compliance

Incidents of non-compliance will be dealt with by issuing:

  • a critical situation report for situations that may present a serious risk to biosecurity. The Chief Veterinary Officer may direct that all imports of processing imported salmonids will cease immediately and may not be permitted to recommence until the non-conformity is rectified.
    eg. uncleared salmonids being moved out of a transitional facility without approval.
  • a corrective action request [CAR] for a non-compliance which is not a serious risk to biosecurity. Work will permitted to continue but the facility will be given a specified period of time to rectify the non-conformity.
    eg. Training of staff does not occur as stated in the quarantine manual.

4.5 Records

The operator is required to demonstrate compliance with this Standard by keeping records as required for the quality assurance programme and documented in the quarantine manual or equivalent quality system. Such records should be kept for a minimum of five years after biosecurity clearance, export or destruction of the imported salmonids and include as a minimum:

  • Records of transitional facility and operator approval applications and approvals.
  • Copies of permits to import, import health standards, biosecurity directions and biosecurity clearances.
  • Records of dates, weights, processing details, end-product destination and invoices for every consignment of imported salmonids.
  • Records of the quantity of by-product treated on-site related to the quantity of imported salmonids.
  • Records of internal audits and corrective actions.
  • Records of external audits and corrective actions.

Part Two: Requirements of the Supplier

Scope of Part Two

Part Two of this MAF Reg Standard specifies the requirements for the supplier of supervision of transitional facilities for processing imported salmonids in New Zealand to ensure that they are operating in compliance with Part One of this Standard.

Service Ooutline

The supplier shall provide the Chief Veterinary Officer with a service to supervise the operation of transitional facilities which are required to operate according to Part One of this Standard.

5. Service Requirements

5.1 General Requirements

Supervision shall be administered in accordance with this Standard using a national quality management system based on ISO 9002 and any relevant legislation.

The supplier shall maintain a register of transitional facilities and supervisors for which they are responsible.

The supplier shall provide quarterly reports to the Chief Veterinary Officer giving an update on the supplier's management structure and key personnel (refer section 5.2). and results of internal reports and corrective actions.

The supplier and employees shall have no financial interest in the transitional facilities or any other affiliations that could be construed as conflict of interest as defined in Standard EN45004.

The supplier's quality system may be audited annually and each supervisor may be audited at a transitional facility by the Chief Veterinary Officer.

5.2 Key Personnel

Within one month of receipt of this Standard, the supplier shall make formal arrangements for provision of the key personnel listed below. The National Manager (Animal Quarantine) shall be notified in writing of these arrangements.

5.2.1 Management representative

The management representative (reporting to senior management) shall have defined authority and responsibility for ensuring that there are systems in place to meet the requirements of this specification and that these systems are implemented and maintained.

5.2.2 Supervisors

The supplier shall nominate supervisors in consultation with the Chief Veterinary Officer.

Qualifications: The supervisor shall be an inspector as defined by the Biosecurity Act 1993.

The supplier shall be responsible for the training of supervisors, so that they know their responsibilities for this Standard. The supervisor shall also have an understanding of the principles of quarantine, quality systems and auditing, the import health standard, the relevant legislation and some appreciation of the business and objectives of the operator.

6. Technical Requirements

6.1 Approval of a Transitional Facility

The supervisor shall be prepared to consider applications before construction or alteration of a facility in order to provide advice on whether the proposed facility is likely to comply with the Standard.

The requirements for approval are described in sections 2.1 & 2.3 of this Standard and the supervisor shall inspect the facility before making a recommendation on approval.

If the quality system is accredited by an external agency as described in section 3 then it is not necessary to forward the full documentation. However, the supervisor shall be satisfied that the requirements of this Standard are addressed in the quality system.

6.1.1 Modifications to a facility

If, subsequent to approval, the facility is to be modified, a new floor plan may be required and any new procedures shall be approved by supervisor in order to ensure that the facility continues to meet the Standard. The National Manager (Animal Quarantine) is to be advised so that central records can be updated.

6.1.2 Renewal of approval

The National Manager (Animal Quarantine) shall be advised when the results of an annual audit for renewal of approval for the facility are satisfactory. Approval for the facility can renewed and, if appropriate, the permit to import the salmonids can also be renewed.

6.2 Approval of an Operator

Section 40 of the Biosecurity Act provides that if the Director General is satisfied:

  • that the applicant is a fit and proper person to be the operator of the transitional facility or containment facility specified in the application; and
  • the applicant is able to comply with the operating standards for that facility,

s/he may approve the applicant as the operator of the facility.

In order to meet the second criterion above, the operator shall have the technical and financial resourcing mechanisms in place to maintain that facility.

Where the facility is leased, the supervisor shall examine the contract and be satisfied that the contract does not override the requirements of the Standard.

The supervisor shall make a recommendation to the National Manager (Animal Quarantine) taking these requirements into consideration.

6.3 Cancellation of Approval of a Facility and/or an Operator

Cancellation of approval will occur at a time specified in the approval or upon the occurrence of an event specified in the approval.

Also, if the supervisor is satisfied that the transitional facility;

  • no longer complies with this Standard or
  • is no longer being used for the purpose or one or more of the purposes specified in the approval,

he/she shall discuss the issue with the operator. Then, if necessary, and after informing the operator of his/her intention in writing, the supervisor shall make a recommendation to the National Manager (Animal Quarantine) that approval of the facility should be cancelled.

If the supervisor is satisfied that the operator;

  • is not operating the facility according to this Standard or
  • is no longer a fit and proper person or
  • ceases to be the operator or requests cancellation,

he/she shall discuss the issue with the operator. Then, if necessary, and after informing the operator of his/her intention in writing, the supervisor shall make a recommendation to the National Manager (Animal Quarantine) that approval of the operator should be cancelled. If an alternative operator cannot be approved then approval of the facility shall also be cancelled.

6.4 Supervision of a Transitional Facility

6.4.1 Audit

The supervisor shall inspect the transitional facility and audit its operation at least once every fortnight.

Particular attention shall be given to:

  • the procedures of the quarantine manual,
  • the requirements of this Standard (see section 4),
  • requirements of the import health standard.

The supervisor may focus on specific randomly chosen aspects of the operation or do a complete systems audit against this Standard. A record shall be made at each visit of the number of unprocessed cartons of imported salmonids and this shall be correlated to the number of cartons present at the previous visit and the number processed.

The supervisor shall make a recommendation for annual renewal of approval of the facility if it meets these requirements - see 6.1.3.

6.4.1.1 Systems audit at commencement of processing

Where there has been a break in the processing of imported salmonids at the processing facility for six weeks or more the supervisor shall perform a systems audit against this Standard at least one week before the commencement of processing of imported salmonids. If the operator passes the audit then the supervisor shall give approval for the processing of the imported salmonids.

6.4.2 Non-compliance

Incidents of non-compliance will be dealt with by issuing:

  • a critical situation report for situations that may present a serious risk to biosecurity. eg. solid waste released without treatment.

The National Manager (Animal Quarantine) shall be advised immediately and the Chief Veterinary Officer may direct that all work using imported salmonids is to cease immediately and may not be permitted to recommence until the non-conformity is rectified.

  • a corrective action request [CAR] for a non-compliance which is not a serious risk to biosecurity, eg. training of staff does not occur at the frequency stated in the quarantine manual.

Work will be permitted to continue but the facility will be given a specified period of time to rectify the non-conformity.

The issuance of corrective action requests (CAR) during any of the above audits/visits will necessitate that follow up audits be performed which specifically address compliance to the subject of the CAR.

The results of six monthly internal audits organised by the operator shall be evaluated and if necessary these should be discussed with the operator.

6.4.3 Issue of biosecurity clearance

When batches of the imported salmonids are processed according to the requirements of the import health standard the supervisor may issue a biosecurity clearance for the product.

6.4.4 Transfer of imported salmonids between transitional facilities

When an application is made for a written authority to transfer imported salmonids between transitional facilities the supervisor shall, by communication with the supervisor of the receiving facility, be satisfied that:

  • the receiving facility is an approved transitional facility for imported salmonids,
  • the method of transfer shall be of comparable security to that of the originating transitional facility,
  • provision has been made for appropriate inventory control on dispatch and on arrival.

The written authority may be for single or multiple transfers within a specified time not exceeding the approval period of the facility.

6.4.5 Cost recovery

The supplier shall recover the costs associated with administering this Standard in accordance with the Biosecurity (Cost) Regulations 1993.

6.4.6 Reporting requirements

The supervisor shall provide to the National Manager (Animal Quarantine) a quarterly report on the biosecurity clearances issued and any major non-conformities encountered during that period.

As the re-issue of the permit to import and renewal of approval of the transitional facility will be dependent on satisfactory results of a systems audit the supervisor shall advise the National Manager (Animal Quarantine), as soon as practicable, on the final outcome of this annual audit.

6.4.7 Records

The supervisor is required to keep records of visits and audits of the operator for a period of three years. These records shall include biosecurity clearances, audit findings and reports of critical situation or CARs and the results of follow-up visits.

Transitional Facility/Operator Registration

Application forms and information on registering as a transitional facility and operator can be found on the MAF Biosecurity New Zealand website at http://www.biosecurity.govt.nz/regs/trans/register.

Page last updated: 30 April 2008