MAF Biosecurity Authority Animal Biosecurity Standard Transitional Facilities for Non-Compliant Dogs and Cats

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Table of Contents

1. Introduction

Part One: Requirements of the Operator

2. Approval of a facility and an operator
 3. Quarantine manual
 4. Structural and operational requirements

Part Two: Requirements of the Supplier

5. Service requirements
 6. Technical requirements

Transitional Facility/Operator Registration

1. Introduction

Scope of Part One

This Standard specifies the structural and operating requirements for facilities holding imported non-compliant dogs and cats. These animals have been directed on arrival in New Zealand to a transitional facility because there is incomplete certification, uncertainty with animal identification or any other problem that cannot be solved within a reasonable time. This Standard also specifies how operators and facilities may be approved.

The primary purpose of isolation is to minimise the risk of introducing infectious agents and prevent their transmission to susceptible species in New Zealand.

Scope of Part Two

Part Two of this Standard specifies the requirements for the supplier of supervision of transitional facilities for non-compliant dogs and cats to ensure that operators are in compliance with 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 Biosecurity Authority Standard:

AS/NZS Standard 9001:2000: Quality Systems - Model for quality assurance in production, installation and servicing. Published by Standards New Zealand.

ISO/IEC 17020: General criteria for the operation of various types of bodies performing inspection.

Import health standards for imported dogs and cats from Australia, United Kingdom, Eire, Sweden, Norway, Singapore and Hawaii or any other importation that does not have a requirement for post-arrival quarantine.

Veterinary Clinic Standards of the New Zealand Veterinary Association (NZVA).

1.2 Definitions

For the purposes of this Standard the following definitions apply:

Approval
Approved by the Director-General, MAF, or his/her delegate.  The Chief Technical Officer, National Manager (Import Management) and National Adviser (Import Management) are delegatees for this Standard. The National Manager (see page 6) is the contact person for this Standard.

Audit
An evaluation to determine the degree of conformity with prescribed criteria and provide a basis for ongoing improvement.

Biosecurity clearance
A clearance under section 26 of the Biosecurity Act 1993, for the entry of goods into New Zealand.

Biosecurity direction
Authority from an inspector, given under section 25 of the Biosecurity Act, to move uncleared goods to a transitional facility, containment facility or biosecurity control area.

Chief Technical Officer
Is the chief technical officer [as defined in section 101 of the Biosecurity Act, 1993] of MAF with responsibility for animal health in New Zealand. The delegatees identified in the definition of approval (see above) are the people to contact where reference is made to a chief technical officer in this Standard.

Director-General
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.

Impact
A MAF database for recording operational information relating to imports of risk goods.

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.

Isolation (quarantine)
Confinement of organisms or organic material that may be harbouring pests or unwanted organisms. Section 2, Biosecurity Act, 1993.

MAF Biosecurity Authority
The body within the MAF responsible for regulatory functions associated with this standard.

National Manager
The nominal contact person for matters relating to this Standard.
Address: National Manager, Import Management
MAF Biosecurity Authority
Box 2526
Wellington
Fax: (04) 4744 132

Email contacts for Import Management:
corrink@maf.govt.nz
 mulqueenk@maf.govt.nz

Non-compliant dogs and cats
Imported dogs and cats from rabies-free countries that for any reason cannot be given a biosecurity clearance on arrival in New Zealand.

Operator
The person who has overall responsibility for the facility, its maintenance and operation in terms of section 40 of the Biosecurity Act, 1993.

Permit
Authorisation issued by the supervisor for entry/exit of people, animals and goods onto or off the transitional facility. For the purpose of this Standard a permit will include biosecurity directions.

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.

Quarantine (isolation)
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.

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 contract with the MAF Biosecurity Authority. MAF Quarantine Service is the present supplier.

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
Imported goods for which no biosecurity clearance has been given. Section 2, Biosecurity Act 1993.

Unwanted organisms
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 Facility and an Operator

2.1 Approval of a Facility

A transitional facility shall be approved 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 also expected that the facility will comply with the requirements of the Resource Management Act, 1991, Building Act, 1991 and any other relevant legislation.]

A facility may not be approved unless there is an approved operator.

2.1.1 Procedure for approval of a transitional facility

Any person wishing to have a facility approved and to be approved as an operator shall establish contact with the supervisor. [The supervisor's identity may be obtained from the supplier.]

The supervisor will 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.

2.1.2 Site approval

An application for site approval shall be submitted to the national manager through the supervisor before construction of a facility is considered. [If the site is not approved then there is no value in investing resources into developing the facility.]

The application for site approval shall provide the following:

  • A site plan of the property which shows the location of the isolation facility and the entrances to the site. Boundaries of neighbouring properties shall be shown. The physical location of the property shall be clearly shown in relation to roads in the area.
  • As the supervisor is required to make visits to the facility (see 6.4.1) the operator shall agree to pay the costs associated with these visits.
  • Detailed procedures shall be provided to show how the non-compliant dogs and cats are to be transported from the place of arrival in New Zealand to placement within the isolation facility.
  • Evidence from the relevant regional council and/or district council that the proposed operation satisfies planning requirements under the Resource Management Act, Building Act or any other relevant legislation under which these Councils have jurisdiction. The Director-General shall also be satisfied that the Local Authority has been properly informed about the project and, if appropriate, has issued a building consent to construct the facility.
  • A recommendation from the supervisor for site approval, which includes verification of the site’s physical location. Site approval from the national manager shall be in writing and the supervisor shall be advised.

2.1.3 Facility approval

When the operator has met the requirements of section 2.1.2, section 3 and section 4 of this Standard, the supervisor shall be requested to inspect the quarantine manual and the isolation facility. When the supervisor is satisfied that the operator has met the structural requirements of a facility as required in this Standard,

  • the quarantine manual (section 3) meets the requirements of this Standard,
  • the application form on page 21 of this Standard has been completed satisfactorily by the prospective operator, the application form and a copy of the quarantine manual shall be sent by the supervisor to the national manager, together with the supervisor’s written recommendation for approval of the facility. The prospective operator may apply for registration as an operator at this time (see section 2.2).

Approval of a transitional facility will be in writing. A facility will usually be approved for an unspecified time.

Only when the facility and operator have been approved may the operator hold non-compliant dogs and cats.

2.1.4 Modifications to an approved facility

Subsequent to approval, any facility modifications or changes to procedures must be notified to the supervisor.

A new floor and/or site plan may be required. Major modifications will require approval and inspection by the supervisor to check that the facility continues to meet the Standard. A major modification is defined as a modification that potentially affects the integrity of isolation. Minor modifications should be recorded and checked by the supervisor at the next visit.

2.2 Approval of the Operator

The operator is responsible for the operation of a facility and ensuring that mechanisms are in place for resourcing the facility.

An operator shall be approved in accordance with section 40 of the Biosecurity Act, 1993. If the Director-General is satisfied:

  • that the applicant is a fit and proper person to be the operator of the 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.

The operator shall satisfy the supervisor that s/he has the technical and financial resourcing mechanisms in place to maintain that facility. The technical resources shall be provided by a person or persons in authority (identified in section 3.3) with the qualifications, training and experience for ensuring that both the structure of the facility and the operating procedures used in the facility are appropriate for the isolation of dogs and cats.

The supervisor shall send the application forms at the end of this Standard to the national manager with the supervisor’s written recommendation for approval of the operator.

Approval of the operator will be in writing.

2.2.1 Leased facilities

If the facility is leased, the lessee responsible for the operation of the facility shall apply to be the operator. The contract with the owner shall clearly identify who is responsible for the maintenance of the premises and the resourcing of the operation.

The supervisor shall be satisfied that no part of the lease contract shall override the requirements of this Standard for the operation of the facility.

2.2.2 Collection of personal information on individuals

In regard to any information being collected on the application for approval as 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 as 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 Cancellation of Approval

A facility is no longer approved when the time specified in the approval expires or an event specified in the approval occurs. In addition a chief technical officer may cancel approval of a facility if:

  • the facility no longer complies with this Standard,
  • the chief technical officer is satisfied that the facility is no longer used for the purpose(s) specified in the approval.
  • the operator ceases to be an operator of the facility,
  • the operator is no longer a fit and proper person,
  • the operator requests cancellation.

The chief technical officer may cancel approval of an operator if:

  • no longer satisfied that the facility is being operated according to this Standard,
  • the operator ceases to be an operator of the facility,
  • the operator is no longer a fit and proper person,
  • 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/NZS Standard 9001:2000, code of good manufacturing practice or similar quality programme. Accreditation by the NZVA to the Veterinary Clinic Standard is desirable but not essential. 

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 supervisor shall approve the quality assurance programme and any amendments.

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

3.1 General

Describe the main business of the veterinary clinic.

3.2 Quarantine requirements

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

Describe the structural components of the facility and how it shall be maintained.

Provide a floor plan showing the general layout of the isolation facility and show in the plan the areas where non-compliant dogs and cats are to be processed and held.

3.3 Management

Identify the operator. Identify the manager if the operator nominates one. Identify the staff working in the facility.

Specify and document the responsibilities of the operator, the manager and staff.

3.4 Training

Nominate a person or position responsible for ensuring that all people who work in the facility are familiar with the principles of quarantine and the procedures of the facility which ensure isolation and containment.

Describe how the training programme is to be implemented, the time scale for implementation and refresher courses.

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 activities within the facility at least once every six months to verify that they comply with the requirements of the quality assurance programme. If the facility is not in continuous use the operator shall perform an internal audit during each processing period.

The quality system shall be reviewed at least once a year by the management to ensure that it is appropriate and effective, and to introduce any necessary changes or improvements.

All audit and review findings and any corrective actions 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 manual.

4. Structural and Operational Requirements

4.1 General requirements

General requirements for transitional facilities holding non-compliant dogs and cats are:

  • The isolation facility shall be operated in accordance with this Standard and the following sections of the New Zealand Veterinary Association Veterinary

Clinic Standard:

  • the premises section that address the isolation of dogs and cats,
  • the waste disposal section
  • The non-compliant dogs and cats shall be held securely until a biosecurity clearance is given by an inspector.
  • The transitional facility shall be constructed and operated in a manner to ensure that non-compliant dogs and cats are kept separated from other animals so that no direct or indirect contact with other animals can occur.
  • Records shall be maintained of non-compliant dogs and cats kept in the transitional facility.
  • Non-compliant dogs and cats may be transferred between transitional facilities provided that they have been approved for non-compliant dogs and cats 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.

4.2 Waste management plan

The operator shall have a waste management plan that meets the requirements of the NZVA standard and describes how all of the waste associated with the non-compliant dogs and cats shall be managed to minimise the risk of potentially contaminated material making contact with animals in New Zealand.

4.3 Biosecurity clearance

Non-compliant dogs and cats that subsequently meet the conditions of the import health standard shall be issued a biosecurity clearance by the supervisor. The operator may give the dogs and cats to the owner or agent when written conformation of biosecurity clearance has been received.

4.4 External audit

The operator shall provide the supervisor or any other representative of a chief technical officer, access to the facility, records and documents for inspection and audit. The operator shall be available to assist and ensure that all relevant procedures and records are made available to the supervisor.

The supervisor will conduct inspections and on-site audits as specified in section 6.4.  Additional audits will be conducted as required, especially if non-compliance is found.

For incidents of non-compliance see section 6.4.7

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. The operator shall, for auditing purposes, maintain for three years the following records filed with each shipment:

  • Records of the transitional facility and operator approval.
  • Records of non-compliant dogs and cats held, their importers, dates of arrival and release.
  • Copies of biosecurity directions and biosecurity clearances for non-compliant dogs and cats held.
  • 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 Biosecurity Authority Standard specifies the requirements for the supplier of supervision of transitional facilities for non-compliant dogs and cats to ensure that operators are in compliance with Part One of this Standard.

Service Outline

The supplier shall provide the chief technical officer with a service to supervise the activities of operators who are required to operate transitional facilities according to Part One of this Standard.

5. Service Requirements

5.1 General Requirements

Supervision shall be administered in accordance with this Standard and ISO/IEC 17020.

The supplier shall provide quarterly reports to the chief technical 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.

The chief technical officer may audit the supervisor at each transitional facility.

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 chief technical officer 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 Standard and that these systems are implemented and maintained.

5.2.2 Supervisors

Qualifications: The supervisor shall be a registered veterinary surgeon and an inspector as defined by the Biosecurity Act, 1993. The supervisor shall be able to demonstrate that s/he has an understanding of the principles of quarantine, quality systems and auditing, the import health standard, the requirements of this Standard, the relevant legislation and some appreciation of the business and objectives of the operator.

The supplier shall ensure that a person appointed to be a supervisor of a transitional facility is able to describe in a way that can be clearly understood by the operator of these facilities:

  • the commonly used means for meeting the transitional facility requirements as specified in this Standard,
  • the circumstances in which such means can fail to comply, and
  • the steps that should be taken to re-establish compliance.

The supervisor may assign inspections to an inspector.

5.2.3 Inspectors

The supervisor shall ensure that inspectors know the relevant requirements of this Standard in relation to their duties. They shall be responsible to the supervisor.

The suppler shall be responsible for the training of supervisors and inspectors so that they know their responsibilities for this Standard.

6. Technical Requirements

6.1 Approval of a Facility

The supervisor shall be prepared to consider applications before construction 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 section 2.1 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, the supervisor shall satisfy him/herself that the requirements of this Standard are addressed in the quality assurance programme.

6.2 Approval of an Operator

Requirements for approval are described in section 2.2.

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 taking these requirements into consideration.

6.3 Cancellation of Approval

The supervisor shall refer to section 2.3, and if satisfied that the facility

  • no longer complies with this Standard, or
  • is no longer being used for the purpose(s) specified in the approval,

he/she shall discuss the issue with the operator. If the issue is not resolved to the satisfaction of the supervisor, and after informing the operator of his/her intention in writing, the supervisor shall make a recommendation to the chief technical officer 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,
  • is no longer a fit and proper person,
  • ceases to act as the operator or requests cancellation,

he/she shall discuss the issue with the operator. If the issue is not resolved to the satisfaction of the supervisor, and after informing the operator of his/her intention in writing, the supervisor shall make a recommendation to the chief technical officer 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 Facility

6.4.1 Minimum requirements for inspection

For the initial facility approval and renewal of approval see sections 2.1.3 and 2.1.5 respectively.

The supervisor shall have a schedule for regular inspection of the facility and audit of operator's procedures. The supervisor shall make as many visits as considered necessary but the minimum number of visits are:

  • Subsequent to approval. The supervisor shall audit the operation every two months until the supervisor is confident that the operation of the facility complies with the standard and all non-compliances are cleared.
  • At least once every six months when there are no non-compliances. 

Particular attention shall be given to the procedures of the quarantine manual and the requirements of this Standard (see section 4).

6.4.1.1 Revisits

A revisit should be considered when the supervisor is not wholly confident that the operator is complying. For example, visits should be undertaken under any of the following conditions:

  • There are several actions that need to be taken and the supervisor is not wholly confident of the operator’s ability to meet the requests. For example, the operator through inexperience is having difficulty managing a quality system or efforts are not focussed on complying with the Standard.
  • The operator is not able to meet the CAR within the allotted time period.
  • The operator is repeatedly incurring several CARs at each visit and some are related to earlier problems.

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. e.g. non-compliant dogs and cats held in non-isolation kennels.
    The supervisor shall advise the chief technical officer immediately and the action taken may be in accordance with section 126 of the Biosecurity Act:
    The supervisor shall give a direction in writing to the operator of the facility specifying the suspected failure to comply or unsatisfactory circumstances, stating what the operator is required to do to remedy the situation and specifying the time within which the direction must be complied with.
    The chief technical officer may intervene in the management and operation of the facility in order to ensure compliance with the standards for that facility.
  • a corrective action request [CAR] for a non-compliance which is not a serious risk to biosecurity, e.g. training of staff does not occur at the frequency stated in the quarantine manual.

Isolation will be permitted to continue but the operator will be given a specified period of time to rectify the non-conformity. The issuance of a 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.

6.4.3 Issue of biosecurity clearance

When the non-compliance has been addressed and the requirements of the import health standard have been met the supervisor shall issue a biosecurity clearance for the dogs and cats. This shall be given to the importer to present to the operator or sent by some agreed method to the operator.

6.4.4 Transfer of non-compliant dogs and cats between transitional facilities

When an application is made for an authority to transfer non-compliant dogs and cats 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 non-compliant dogs and cats,
  • the method of transfer shall be of comparable security to that of the originating transitional facility,
  • provision has been made to confirm the arrival of the animals.

6.4.5 Cost recovery

The supplier shall recover the costs associated with administering this Standard in accordance with the Biosecurity Act 1993 and its regulations.

6.4.6 Reporting requirements

For each non-compliant dog and cat that is held in isolation the supervisor shall use the transitional facility IMPACT inspection function to record:

  • the date of arrival,
  • the country of origin,
  • the importer’s name and identity of the dog or cat,
  • date of biosecurity clearance,
  • nature of the non-conformity,

Records shall be made as appropriate for:

  • the CARs issued and progress toward compliance.

6.4.7 Records

The supervisor is required to keep records of inspections and audits of the operation of quarantine. These records which are to be archived shall include:

  • audit findings,
  • reports of critical situation reports, 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