Transitional Facilities for Ornamental fish and Marine Invertebrates

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CONTENTS

INTRODUCTION

    1. SCOPE
    2. REFERENCES
    3. DEFINITIONS

REQUIREMENTS OF THE OPERATOR

    4. APPROVAL OF A FACILITY AND AN OPERATOR

    4.1 Approval of a facility
    4.2 Approval of the operator
    4.3 Cancellation of approval

    5. QUARANTINE MANUAL

    5.1 General
    5.2 Quarantine requirements
    5.3 Management
    5.4 Training
    5.5 Internal controls
    5.6 Version

    6. STRUCTURAL AND OPERATIONAL REQUIREMENTS

    6.1 General requirements
    6.2 Structural requirements
    6.3 Security of the transitional facility
    6.4 Access to the transitional facility
    6.5 Shared quarantine
    6.6 Identification of ornamental fish
    6.7 Progeny of imported fish
    6.8 Removal of material from the facility
    6.9 Water disposal and treatment
    6.10 Cleaning and disinfection
    6.11 Disease surveillance and treatment
    6.12 Occurrence of an exotic disease
    6.13 Vermin control
    6.14 Contingency plans
    6.15 Costs
    6.16 Biosecurity clearance
    6.17 External audit

REQUIREMENTS OF THE SUPPLIER

    7. SERVICE REQUIREMENTS

    7.1 General requirements
    7.2 Key personnel

    8. TECHNICAL REQUIREMENTS

    8.1 Approval of a facility
    8.2 Approval of an operator
    8.3 Cancellation of approval
    8.4 Supervision of a facility

TRANSITIONAL FACILITY/OPERATOR REGISTRATION

Introduction

1. Scope

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

The secondary purpose is to prevent the introduction of ornamental fish and marine invertebrate species that have not been approved for importation.

1.1 Scope of requirements of the operator

This Standard specifies the structural and operating requirements for operators of facilities holding ornamental fish and marine invertebrates that have been directed on arrival in New Zealand to a transitional (quarantine) facility as a requirement of an import health standard. This Standard also specifies how operators and facilities may be approved.

1.2 Scope of requirements of the supplier

This Standard specifies the requirements for the supplier of supervision of transitional facilities for ornamental fish and marine invertebrates to ensure that operators are also in compliance with the Standard.

2. 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 Standard:

  • ISO 9001:2000 Quality Systems - Model for quality assurance in production, installation and servicing.
  • ISO/IEC 17020 General criteria for the operation of various types of bodies performing inspection.
  • Import health standard for ornamental fish and marine invertebrates.
  • Import health standard for Antarctic fish.

3. Definitions

For the purposes of this Standard the following definitions apply:

Approval

    Approved by the Director-General, MAF, or his/her delegate.

Approved disinfectant

    A disinfectant approved by MAF for animal disease prevention at the border. The supervisor has access to the list.

Approved seal

    A tamper-evident seal, such as MAF tape or seal, approved by MAF to ensure that between application and removal security has been maintained.

Audit

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

BACC

    Biosecurity Authorisation/Clearance Certificate.

Batch

    All ornamental fish or marine invertebrates in the same direct water system that share susceptibility to any pathogens from Appendix 1 of the Import Health Standard.

Batch test

    A representative number of fish (as determined by the supervisor and MAF) tested to show that the batch of fish is free from a specified disease of concern.
    Note: The number of fish required for a batch test will vary with such factors as the species of fish, number of fish in the batch and the disease agent being investigated, and will be determined by MAF on a case basis.

Biosecurity clearance

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

Biosecurity authorisation

    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

    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.

Direct water system

    Water system with flow or operating practices (eg use of the same nets and gloves without sterilisation, splash from lidless tanks) between tanks that allow potential pathogen transfer.
    Water treatments between tanks (eg UV filters) and operating practices must be approved by MAF for tanks to be considered as not in the same direct water system.

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.

High risk fish species

    Species of ornamental fish and marine invertebrates with approval to be imported to New Zealand that are susceptible to one or more diseases listed in Appendix 1 of MAF Import Health Standard for Ornamental Fish and Marine Invertebrates. These fish are listed in Appendix 1 of the Import Health Standard.

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.

Laboratory

    MAF approved veterinary diagnostic laboratory that is also a transitional facility.

Low risk fish species

    Species of ornamental and marine invertebrates with approval to be imported to New Zealand (fish listed in Appendix 2 and not specifically listed in Appendix 1 of the MAF Import Health Standard for Ornamental Fish and Marine Invertebrates).

MAF

    Ministry of Agriculture and Forestry New Zealand, the body responsible for regulatory functions associated with this standard.

Ornamental fish

    Approved species of fresh water fish, marine fish and marine invertebrates. The approved species are listed in the import health standard.

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 authorisations.

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

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

Quarantine period

    A minimum period of quarantine as specified in the import health standard.

Risk goods

    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:

    a. Cause unwanted harm to natural and physical resources or human health in New Zealand; or

    b. Interfere with the diagnosis, management, or treatment, in New Zealand, of pests or unwanted organisms: Section 2, Biosecurity Act, 1993.

Supervisor

    The veterinarian appointed to inspect the transitional facility and audit the operation of quarantine (See 5.2.2).

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.

Vermin

    Any rodents, birds or insects that may carry disease or disrupt quarantine with their activities.

Requirements of the operator

4. Approval of a facility and an operator

4.1 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.

4.1.1 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 by contacting the National Coordination Manager (live animals and certification) liveanimalsector@nzfsa.govt.nz

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.

4.1.2 Site approval

An application for site approval shall be submitted to the Director General 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:

  • Details of the proposal, including the proposed importation programme and the maximum number and type of ornamental fish and marine invertebrates that will be held in the facility.
  • A site plan of the property which shows the location of the proposed 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.
  • Agreement that the operator shall pay all costs required for the supervisor to carry out their required duties.
  • Detailed procedures to show how the ornamental fish and marine invertebrates are to be transported from the aircraft arriving in New Zealand to placement within the quarantine facility. Show the distance and an estimate of the time taken to travel to the facility.
  • Detailed plans of the proposed quarantine facility with notes as appropriate that show how the facility has been designed and will be operated to ensure the containment and isolation of ornamental fish. Include a plan of the proposed waste disposal system showing drainpipes, the natural underground drainage of the site and location of streams. Provide details of the municipal sewerage system or the on-site septic tank if appropriate (see section 6.9 for relevance).
  • Evidence that the facility shall be adequately separated from any thing and other premises (such as aquaculture facilities, slaughterhouses, processing plants) and bodies of water,through which contamination may be spread, so as to minimise the risk of spread of pathogenic agents.
  • 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 Director General shall be in writing and the supervisor shall be advised.

4.1.3 Facility approval

When the operator has met the requirements of section 4.1.2, section 5 and section 6 of this Standard, the supervisor shall be requested to inspect the quarantine manual and the 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 6) meets the requirements of this Standard,
  • the application form Link to PDF document (80 KB) 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 Director General, 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 4.2).

Approval of a transitional facility will be in writing. A facility will usually be approved for an unspecified time but it could be for a quarantine period.

Only when the facility and operator have been approved may the operator apply for a permit to import fish and use the facility for the quarantine of imported ornamental fish.

4.1.4 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 the containment. Minor modifications should be recorded and checked by the supervisor at the next visit.

4.1.5 Renewal of approval

If approval was cancelled at the end of a quarantine period the operator shall apply to the supervisor for renewal of approval before a permit to import may be issued for another shipment of fish.

4.2 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 5.3) 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 quarantine of ornamental fish and marine invertebrates.

The supervisor shall send the application forms to the Director General with the supervisor’s written recommendation for approval of the operator.

Approval of the operator will be in writing.

4.2.1 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.

4.2.2 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.

4.3 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, the 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.

5. Quarantine manual

The operator shall prepare, maintain and implement a quality assurance programme and procedures based on the principles of ISO 9001:2000: Quality management systems, or a similar quality system. Accreditation with other agencies such as IANZ 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 eg standard operating procedures.

The supervisor shall approve the quality assurance programme and any amendments.

The items listed below are the minimum requirements for the quarantine manual or alternative quality system.

5.1 General

Describe the main purpose of the business associated with the import of ornamental fish and marine invertebrates.

5.2 Quarantine requirements

Document the procedures used in the transitional facility to meet all of the requirements of the import health standard and section 6 in this Standard.

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

Provide a site plan showing the general layout of the facility and where imported ornamental fish and marine invertebrates will be held.

5.3 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.

5.4 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 quarantine 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.

5.5 Internal controls

Identify quality systems used in the facility.

The operator shall carry out an internal audit at least once every six months to verify that the activities associated with the facility continue to comply with the quality assurance programme.

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. If the facility is not in continuous use the operator shall perform an internal audit on each occasion that it is used.

All audit and review findings and any corrective actions shall be documented.

5.6 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.

6. Structural and operational requirements

6.1 General requirements

The quarantine facility shall be constructed and operated in a manner that shall contain in isolation the imported ornamental fish.

During the quarantine period:

  • the operator shall ensure that no ornamental fish, equipment, or materials are removed from the facility without approval of the supervisor, unless allowed in the current Import Health Standard for Ornamental Fish and Marine Invertebrates. The supervisor shall use a permit system and the conditions of removal shall address the risk of removing unwanted organisms from the facility.
  • the facility shall not be used for any purpose other than the quarantine of imported ornamental fish although scavenger fish and snails may be kept in the tanks for hygiene purposes.

6.2 Structural requirements

A fully enclosed building shall be provided for the access of people and the holding of ornamental fish and marine invertebrates.

Floors, walls, ceiling, shelves, benches and all other fixtures shall be constructed of materials that can be effectively cleaned and disinfected. They shall be maintained so that free water does not lie on the surface.

The ornamental fish and marine invertebrates shall be held in tanks. The tanks shall be kept clean and have at least one clear glass side for easy inspection of the fish. There shall be sufficient lighting to clearly observe their contents. Tanks shall be permanently identified so that records of the fish can be correlated with each tank.

Tank lids (or approved equivalent) prevent fish jumping out of tanks and minimise splash contamination, and may be required for fish to be considered as in a separate water system.

6.3 Security of the transitional facility

A prominent sign shall be displayed at the entrance to the facility to show that it is a quarantine facility and that unauthorised entry is prohibited.

Procedures shall be adopted to prevent unauthorised access to the facility.

The entrances to the facility shall be kept locked, except when in active use.

6.4 Access to the transitional facility

6.4.1 Access to the facility shall, in the main, be limited to those people identified in section 5.3, the supervisor and any representative of the chief technical officer.

6.4.2 People essential for the operation of the facility such as a plumber, electrician and carpenter may also be permitted entry by the operator. The supervisor shall approve any other visitors. The operator shall record the name of the supervisor, and the name address and phone number of all visitors, with the visit date in a logbook held near the entrance.

6.4.3 Operators shall ensure that visitors adhere to access procedures and are accompanied by a staff member (i.e. those people identified in section 5.3). The instructions of the operator or supervisor are to be followed at all times.

6.4.4 During quarantine, access to the facility shall only be via the personnel entrance, an outer changing room that provides for the storage of street clothes and footwear.

6.4.5 The operator shall provide protective clothing and footwear for staff and visitors to use in the facility, to prevent contamination of street clothes and footwear. This shall remain in the facility, and always be kept separate from street clothes. Disposable overshoes may be used provided they are destroyed after use.

6.4.6 The operator shall develop procedures for the movement of people to and from the facility that prevent the potential transfer of pathogenic agents from quarantined fish to non-quarantined fish. These procedures shall address the risk of transfer via the hands, arms, footwear and clothing. Procedures shall include the requirement for people who make contact with fish or water to wash their hands and forearms with soap and water before exit from the facility.

6.4.7 Procedures for access and exit shall be displayed at the entrance.

6.5 Shared quarantine

6.5.1 Each import shipment of ornamental fish and marine invertebrates shall be physically isolated from any other shipment, preferably in separate rooms. This isolation includes all equipment associated with the feeding and handling of fish and the water supply. Procedures shall address the risk of transfer of pathogenic agents from one shipment to another via agents such as water, equipment, people, their footwear and clothing.

6.5.2 Alternatively, successive shipments of ornamental fish and marine invertebrates may share the same quarantine period and therefore the same equipment and water circulation. In this event the clearance of all fish in the facility or the room shall be delayed until the last shipment is approved for release.

6.5.3 If ornamental fish and marine invertebrates are to be considered as not in the same direct water system for the purposes of clearance or disease investigation, the following requirements (the details of which must be approved by MAF) shall be met:

  • Water is not able to be transferred between tanks by splashing or dripping. If the tanks are in close proximity, this may include the need for tank lids.
  • Equipment such as nets, gloves (or arms if gloves are not used), feeding equipment, and thermometers shall not be used between the tanks, or shall be disinfected between the tanks.
  • Where water flow is between tanks, there must be a system for water sterilisation between tanks eg UV irradiation.
  • Each group of tanks shall be clearly marked to show the date of arrival of the fish.

6.6 Identification of ornamental fish

6.6.1 The operator shall be responsible for the identification of the imported ornamental fish and marine invertebrates. In cases where identification of fish or marine invertebrates is in doubt the supervisor may seek advice from MAF, and the operator of the transitional facility must provide proof of identity.

6.6.2 If an imported ornamental fish or marine invertebrate is not on the approved species list then the operator shall notify the supervisor within 7 days of importation. The operator shall re-export the fish or have them destroyed under the supervision of the supervisor.

6.7 Progeny of imported fish

The progeny of any ornamental fish which breed during the quarantine period may be shifted to another tank in the facility but are subject to all quarantine conditions that apply to the parent fish.

6.8 Removal of material from the facility

6.8.1 Nothing may be removed from the facility without the approval of the supervisor. The conditions of removal shall address the risk of removing pathogens and ornamental fish and marine invertebrates from the facility.

6.8.2 Equipment taken into the quarantine room shall not leave unless cleaned and disinfected as described in section 6.10.

6.8.3 Quarantine clothes may be taken away from the facility for laundering at the end of a quarantine period. If an exotic disease has been identified or an investigation is underway, or the operator has chosen euthanasia of fish rather than disease investigation, the clothes must be destroyed in a MAF-approved manner, or soaked in a MAF-approved solution such as 5 % volume/volume dishwashing detergent, nappy cleaner antiseptic, hand cleaner (chlorhexidine or chloroxylenol based) or salt (NaCl).

6.9 Water disposal and treatment

Provision shall be made so the accidental spillage of water from at least two of the largest fish tanks would be directed automatically to an approved disposal system or is contained for treatment.

All wastewater, when discharged from the quarantine facility shall enter directly into an approved municipal sewerage system, approved septic tank, or other approved disposal system.

Alternatively, wastewater shall be treated by chlorination or with ultra-violet light. Chlorinated water shall not be discharged directly into adjacent waterways.

6.9.1 Chlorination of waste water

6.9.1.1 All water to be treated must pass through a filter capable of removing suspended organic material prior to chlorination. http://www.biosecurity.govt.nz/border/transitional-facilities/bnz-std-abtrt

6.9.1.2 An amount of chlorine compound shall be added to the effluent in order to achieve a minimum concentration of free residual chlorine of 200 ppm (200 mg per litre) at 1 hour post treatment.

6.9.1.3 Before the treatment period commences, the chlorinated effluent shall be brought to a pH between 5.0 and 7.0.

6.9.1.4 Sodium hypochlorite (bleach) may be used at 1.6 millilitres of hypochlorite solution (12.5% available chlorine) per litre of water, while calcium hypochlorite powder (eg Pool Chlor, 65-70% available chlorine) may be used at 0.3 gram of powder per litre of water.

6.9.1.5 The tank shall be agitated for a period of not less than 10 minutes to ensure thorough mixing of hypochlorite, and the hypochlorite retained for a period of not less than 1 hour.

6.9.1.6 Tanks not achieving this free residual chlorine level at the allotted time shall be re-treated until the requirement is met.

6.9.1.7 The chlorine in the wastewater may be neutralised by adding sodium thiosulphate at a rate of 1.25 grams (2.5 ml of 50% sodium thiosulphate solution) per litre of treated wastewater, then agitated for not less than 10 minutes before discharge.

6.9.1.8 Chlorination records shall be maintained noting:

  • amount of compound added
  • volume of effluent
  • time that treatment period commenced
  • pH at commencement of the treatment period.

6.9.2 Ultraviolet (UV) light irradiation

6.9.2.1 All water to be treated must pass through a filter capable of removing suspended organic material and, where necessary, other filtration to ensure that the UV transmittance of the water is within manufacturer’s specifications prior to irradiation.

6.9.2.2 Commercial UV water treatment units operating in the spectral range of 190-280 nm (254 nm recommended) delivering doses of at least 130 mWs/cm2 are required. The dose is calculated as the product of the intensity (mW/cm2 ) and the exposure time in seconds (s). Servicing and maintenance must be done at least as frequently as required by the manufacturer of the UV sterilisation system. The bulbs must be monitored regularly to ensure they are working.

6.10 Cleaning and disinfection

6.10.1 Facilities shall be available for adequate disinfection of all equipment, filters, tanks etc. that come in contact with water or fish in quarantine.

6.10.2 Equipment and fish tanks shall be thoroughly cleaned before treatment with:

  • hypochlorite solution at 200 ppm for 5 minutes,
  • an approved iodophore solution containing 0.5% available iodine for 5 minutes, or
  • other approved disinfection methods.

6.11 Disease surveillance and treatment

6.11.1 The operator shall observe ornamental fish and marine invertebrates for signs of illness and abnormal behaviour periodically throughout the day. Daily records shall be kept by tank and species including at least the number of fish dead and a brief description of any abnormalities on the cadavers.

6.11.2 Ornamental fish and marine invertebrates shall be available for inspection by the supervisor who reserves the right to take specimens at any time for disease testing. The operator must provide the supervisor with packaging for the fish as required.

6.11.3 For species not considered high risk, the operator must maintain records as detailed in 6.11.1 and provide them to the supervisor as requested.

 

6.11.4 For species considered to be high risk, the operator must maintain records as detailed in 6.11.1 and provide them to the supervisor as requested. In addition, the operator must notify the supervisor if fish (by species or batch) display clinical signs of infection with pathogens listed in Appendix 1 of the MAF Import Health Standard for Ornamental Fish and Marine Invertebrates or increased/significant mortality.

6.11.5 Where the operator claims that mortalities are linked to non-listed pathogens, or to environmental causes, evidence must be presented to the supervisor. Evidence may include records regarding fish health on arrival, microscopy results, regular water quality parameter records, and other environmental or operational records.

6.11.6 If the supervisor decides a disease investigation is warranted based on clinical signs of illness or death of ornamental fish or marine invertebrates, the importer shall be given the option to test the fish (at the importer’s expense) or destroy/reship the affected fish.

6.11.7 If the supervisor instigates a disease investigation and the operator chooses not to have fish tested, all other fish in the batch must be tested negative, or euthanased and double-bagged before destruction by a MAF-approved method.

6.11.8 Testing or the decision not to test, and the consequences of a positive test result must be completed before other fish in the shipment are given biosecurity clearance. Other fish in the shipment may be given biosecurity clearance one week after being in a clean direct water system or on successful completion of quarantine as determined by the supervisor, whichever is the longer.

6.11.9 Dead fish shall be removed from tanks as soon as possible and kept in a freezer (or otherwise as directed) until released, directed for MAF-approved destruction, or taken for testing by the supervisor. The operator must have a system in place to identify dead fish by consignment. If to be used as information for disease investigation, high risk species must be identifiable by species and week of death, and low risk species by week of death.

6.11.10 All disease testing shall be conducted at the Investigation and Diagnostic Centre of Biosecurity New Zealand, Upper Hutt, Wellington.

6.11.11 The following are permitted for routine prophylactic use:

  • salt
  • formalin
  • methylene blue
  • malachite green
  • copper sulfate
  • chloramine-T
  • benzalkonium chloride
  • acriflavine
  • quinine sulphate
  • hydrogen peroxide
  • bay oil (Pimenta racemosa)
  • tea tree oil (melaleuca)

No other medication of chemicals or drugs is to be administered to ornamental fish or marine invertebrates without prior written approval from the supervisor.

6.11.12 Anthelmintic treatment protocols used in risk mitigation (see Appendix 1 of the Import Health Standard) shall be approved by the supervisor before use.

6.11.13 Treatments or prophylactic measures shall not interfere with disease surveillance and shall be recorded.

6.11.14 The supervisor may take water or other samples for testing at any time.

6.12 Occurrence of an exotic disease

6.12.1 If an exotic disease is diagnosed, the chief technical officer shall be notified within 24 hours. The chief technical officer may direct the management of disease control and extend the period of quarantine or order the destruction of the ornamental fish or marine invertebrates. If the chief technical officer orders destruction of a shipment, all shipments in the facility may be destroyed if there is doubt about the isolation of shipments.

6.12.2 In the event of a positive test result for an exotic disease all fish in the batch must be tested and shown to be free of the relevant disease organism/s, or euthanased (in which case testing is not mandatory). Other fish in the direct water system may be cleared one week after being moved to a clean direct water system or on successful completion of quarantine as determined by the supervisor, whichever is the longer.

6.12.3 In the event of a positive test result for an exotic disease, or when the operator chooses not to have fish tested:

  • All ornamental fish and marine invertebrates directed by the supervisor shall be destroyed.
  • All dead ornamental fish or marine invertebrates shall be double bagged and removed from the facility by the supervisor for disposal.
  • The protective clothing, packaging, tanks and equipment from the direct water system and any parts of the facility that are potentially contaminated shall be thoroughly cleaned and disinfected (section 6.10) or destroyed.
  • All fish testing and destruction, and cleaning must be under direction of the supervisor.

6.12.4 Approval shall be sought from the chief technical officer before the facility can be used again.

6.13 Vermin control

Surveillance shall be maintained for the presence of vermin and control activities undertaken if they are detected.

6.14 Contingency plans

Contingency plans shall be in place to take account of a vehicle breakdown or accident during transport of ornamental fish, and fire, flooding or any other emergency. Resources shall be identified and accessible for the contingency. The supervisor shall be advised of the emergency as soon as is possible.

6.15 Costs

The operator is required to pay all costs associated with the operation of the facility. The costs of approval and supervision of the facility shall be in accordance with the Biosecurity Act 1993 and its regulations.

6.16 Biosecurity clearance

The supervisor shall release animals from quarantine when all requirements of the Import Health Standard for Ornamental Fish and Marine Invertebrates are met.

6.17 External audit

The operator shall provide the supervisor, or any other representative of the 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 8.4. Additional audits will be conducted as required, and are based on the performance of the operator, especially if non-compliance is found.

For incidents of non-compliance see section 8.4.7

6.18 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:

  • Overseas supplier, country of origin, dates of arrival and release date.
  • Number of each ornamental fish and marine invertebrate species, in total, and by tank.
  • Details of clinical signs of disease, number affected in a tank and treatment.
  • Details of ornamental fish and marine invertebrate mortality by tank and species.
  • Details of water quality parameters.
  • Details of laboratory test results.
  • Details of destruction of packaging where MAF-approved methods are required.
  • Details of significant management changes, such as food changes, and power and aeration failures.
  • Biosecurity clearances.
  • Internal audits and corrective actions.
  • External audits and corrective actions.

Requirements of the supplier

7. Service requirements

7.1 General requirements

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 this Standard.

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 5.3), and results of internal audits 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.

7.2 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.

7.2.1 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.

7.2.2 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 is responsible to the chief technical officer for the approval of ornamental fish and marine invertebrate transitional facilities and the supervision of ornamental fish and marine invertebrate quarantine.

The supplier shall be responsible for the training of supervisors.

8. Technical requirements

8.1 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 4.1 of this Standard and the supervisor shall inspect the facility before making a recommendation on approval.

8.2 Approval of an operator

Requirements for approval are described in section 4.2.

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 Director General taking these requirements into consideration.

8.3 Cancellation of approval

The supervisor shall refer to section 4.3, 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.

8.4 Supervision of a facility

8.4.1 Minimum requirements for inspection

For the initial facility approval and renewal of approval see sections 4.1.3 and 4.1.5 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 is:

  • for fresh water fish, three times during the quarantine period (on arrival, at about 13-16 days and prior to release),
  • for marine fish and invertebrates, two visits (on arrival and prior to release).

Prior to the last supervisor visit, the operator shall forward records of fish mortality and any necessary evidence (see 6.11.4) required by the supervisor to make a decision on whether the fish may be released.

When a shipment arrives at the transitional facility the supervisor shall:

  • check the integrity of the seals on the container(s)
  • collect CITES documentation
  • check the shipment for plants. Supervise their destruction by treatment with steam treatment, incineration or another MAF-approved method
  • correlate the commercial fish list documents with the number (as close as possible) and species of ornamental fish and marine invertebrates
  • check for the presence of non-approved ornamental fish and marine invertebrate species
  • verify the number of fish remaining from previous shipments if in direct water systems with the new shipment.

At every visit the supervisor shall:

  • be satisfied that the operator and the facility continue to meet the requirements of this Standard
  • inspect the ornamental fish and marine invertebrates for any signs of disease
  • check for the presence of non-approved ornamental fish and marine invertebrate species
  • inspect quarantine records.

After release visit:

  • make arrangements for biosecurity clearance for fresh water ornamental fish when requirements of 8.4.6 are met.

8.4.2 Identification of ornamental fish species

The supervisor shall be familiar with the species of ornamental fish and marine invertebrates commonly imported and shall have access to suitable reference texts.

In cases where identification of fish or marine invertebrates is in doubt the supervisor may seek advice from MAF. The operator of the transitional facility must provide proof of identity in a manner approved by MAF.

8.4.3 Disease surveillance and treatment

When exotic disease is suspected, the supervisor may order any tests deemed necessary to be able to give biosecurity clearance to ornamental fish and marine invertebrates in the shipment that test negative or are not part of the disease investigation.

The chief technical officer may order further tests, and/or the destruction of fish, treatment of tank water, the cleaning and decontamination of equipment and facilities.

Diseased fish may only be treated with approval from the supervisor.

8.4.4 Submission of specimens to the laboratory

Specimens shall be submitted to the laboratory at the discretion of the supervisor.

All disease testing shall be conducted at the Investigation and Diagnostic Centre of Biosecurity New Zealand, Upper Hutt, Wellington.

The supervisor shall phone the laboratory before submitting samples, to advise the laboratory and receive direction on the type of samples to send. Packaging of specimens of potentially infectious material shall be in accordance with instructions from the laboratory.

The operator shall provide packing materials for specimens to be sent to the laboratory as required. Samples are to be dispatched in a clearly addressed sealed box by the fastest secure method. Samples must be accompanied by a BACC for transfer to the laboratory (a transitional facility).

8.4.5 Exotic disease

If an exotic disease is diagnosed, the chief technical officer shall be notified immediately.

The chief technical officer may order further tests, an extension of the quarantine period or the destruction of all fish. See section 6.11.

8.4.6 Biosecurity clearance

At the end of the quarantine period the supervisor shall consider if the following conditions have been met:

  • the conditions of the import health standard have been met and the documentation certification is in order,
  • the transitional facility has been operating according to this Standard,
  • the ornamental fish and marine invertebrate species are approved for importation,
  • the ornamental fish and marine invertebrates are in good health and there is no evidence of exotic disease.

The supervisor’s consideration shall include, but is not limited to:

  • type (freshwater or marine) and country of origin of ornamental fish and marine invertebrates,
  • date of arrival and proposed date of release,
  • probable cause of disease, mortality and morbidity,
  • laboratory findings.

Once satisfied that the conditions of this Standard have been met, the supervisor shall issue a biosecurity clearance in writing to the operator.

8.4.7 Non-compliance

For incidents of non-compliance the supervisor shall issue:

  • a critical situation report for situations that may present a risk to biosecurity. For example, fish are released prior to clearance; not notifying of significant deaths.

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 direct that all permits to import are cancelled and may not be re-issued until the non-conformity is rectified.

If the chief technical officer considers it necessary s/he may intervene in the management and operation of the facility in order to ensure compliance with the standards for that facility.

The chief technical officer may direct that all ornamental fish and marine invertebrates are kept for an extended quarantine period.

  • a corrective action request (CAR) for a non-compliance that is not a serious risk to biosecurity. For example, repairs and maintenance are unacceptable; not ensuring visitors wear protective clothing.

Quarantine 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.

8.4.9 Cost recovery

The supervisor shall recover the costs associated with supervision in accordance with the Biosecurity Act 1993 and its regulations.

8.4.10 Reporting requirements

The supervisor shall make an inspection record in the appropriate MAF database for each import of ornamental fish and marine invertebrates showing:

  • the date of arrival,
  • the country of origin,
  • the number of fish on arrival,
  • date of biosecurity clearance,
  • the number of fish released,
  • a summary report providing:
  • details of significant sickness, mortalities, treatments and laboratory findings,
  • the CARs issued and progress toward compliance.

8.4.11 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,
  • reports of major disease incidents and outcomes.

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: 21 April 2011