Transitional Facilities for Ornamental fish and Marine Invertebrates

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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 facility and an 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 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.

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.

Scope of Part Two

Part Two of this Standard specifies the requirements for the supplier of supervision of transitional facilities for ornamental fish and marine invertebrates 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:

• ISO 9002 [1994]: 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.

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 (Import Management) (see page 6) is the contact person for this Standard.

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 proof seal e.g. Tyden seal, lead seal or padlock, 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.

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.

Laboratory

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

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

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

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

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.

Ornamental fish

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

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

Rodents and other vertebrate animals.

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:

• Details of the proposal, including the proposed importation programme and the maximum number and type of ornamental fish 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.
• As the supervisor is required to make frequent 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 ornamental fish 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 which 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 4.9 for relevance).
• The facility shall not be located near to a foodfish (fish farmed for human consumption including recreational fishing) farming/hatchery operation.
• 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 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 32 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 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 the fish and use the facility for the quarantine of imported ornamental fish.

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

2.1.5 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.

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 quarantine of ornamental fish.

The supervisor shall send the application forms on page 33 & 34 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/NZ 9002, code of good manufacturing practice or 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 e.g. 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.

3.1 General

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

3.2 Quarantine Requirements

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.

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 will be 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 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.

3.5 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.

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

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. 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.

4.2 Structural Requirements

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

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

The ornamental fish 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.

Tanks must be fitted with lids (or approved equivalent) to prevent fish jumping out of the tanks and to minimise splash contamination.

4.3 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.

4.4 Access to the Transitional Facility

Access to the facility shall, in the main, be limited to those people identified in section 3.3, the supervisor and any representative of the chief technical officer.

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

Visitors shall adhere to access procedures and be accompanied by a staff member (i.e. those people identified in section 3.3). The instructions of the operator or supervisor are to be followed at all times.

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.

The operator shall provide protective clothing and footwear for staff and visitors to use in the facility. 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.

The operator shall develop procedures for the movement of people to and from the facility which 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.

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

4.5 Shared Quarantine

Each import shipment of ornamental fish shall be physically isolated from each other, 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.

Alternatively, successive shipments of fish 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.

If shipments of fish, with different quarantine periods, are held in the same room then the following additional requirements shall be met:

• Each shipment shall be held in a discrete group of tanks physically separated from tanks holding fish of another shipment. The separation distance shall be sufficient to prevent the splashing of tank water from one group to another.
• Equipment such as nets, feeding equipment, and thermometers shall be dedicated solely to each shipment of ornamental fish.
• Each group of tanks shall be clearly marked to show the date of arrival of the fish.

4.6 Identification of Ornamental fish

The operator shall be responsible for the identification of the imported ornamental fish.

If an imported ornamental fish 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.

4.7 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.

4.8 Removal of Material from the Facility

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 from the facility.

Equipment taken into the quarantine room shall not leave unless cleaned and disinfected as described in section 4.10.

Quarantine clothing washed with washing powder may be taken away from the facility for drying.

4.9 Water Disposal and Treatment

Provision shall be made to contain (and treat if required) the accidental spillage of water from at least two of the largest fish tanks.

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.

4.9.1 Chlorination of waste water

All water to be treated must pass through a filter capable of removing suspended organic material prior to chlorination.

An amount of chlorine compound shall be added to the effluent in order to a achieve a minimum concentration of free residual chlorine of

• 200 ppm (200 mg per litre) at I hour post treatment.

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 (e.g. Pool Chlor, 65-70% available chlorine) may be used at 0.3 gram of powder per litre of water.

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

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

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

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

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,
• 20 hour or 30 minute post-treatment concentration determined by an approved test method.

4.9.2 Ultraviolet (UV) light irradiation

All water to be treated must pass through a filter capable of removing suspended organic material prior to irradiation.

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).

4.10 Cleaning and Disinfection

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

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,
• other approved disinfection methods.

4.11 Disease Surveillance and Treatment

The operator shall observe fish for signs of illness and abnormal behaviour periodically throughout the day.

Ornamental fish shall be available for inspection by the supervisor who reserves the right to take specimens at any time for disease testing.

The operator shall notify the supervisor within 24 hours of any deaths or changes of behaviour in the ornamental fish where more than 20% of a tank are affected over a 5-day period. Dead fish shall be removed from tanks as soon a possible and kept under refrigeration, or otherwise as directed, until the supervisor has examined them. The operator shall have a system to identify the tank of origin of these fish.

The cause of death shall be established, if possible. The operator shall provide materials for the packaging of samples for further examination.

Dead fish may be taken for incineration by the supervisor or they may with approval be held as preserved specimens in 10% formaldehyde.

No medication of chemicals or drugs is to be administered to ornamental fish without the approval of the supervisor. Treatments or prophylactic measures shall not interfere with disease surveillance and shall be recorded (see section 4.17).

4.11.1 Occurrence of an exotic disease

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.

If the chief technical officer orders destruction of a shipment, all shipments in the facility may be destroyed if there is some doubt about the isolation of shipments.

If the ornamental fish are to be destroyed and the facility requires decontamination the following procedures are likely to be authorised:

• The ornamental fish shall be destroyed.
• All dead ornamental fish shall be double bagged and removed from the facility for incineration.
• The interior of the facility, fish tanks and equipment etc shall be thoroughly cleaned and disinfected (section 4.10).
• The water shall be treated with chlorine.

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

4.12 Vermin Control

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

4.13 Contingency Plans

Contingency plans shall be in place to take account of a vehicle breakdown during transport of ornamental fish, fire, flooding or any other emergency. If an outbreak of exotic disease occurs provision shall be made to treat the water (chlorination or ultra-violet light). Resources shall be identified and accessible for the contingency. The supervisor shall be advised of the emergency as soon as is possible.

4.14 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.

4.15 Biosecurity Clearance

The supervisor shall release animals from quarantine when the requirements of the import health standard are met (section 6.4.6).

4.16 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

4.17 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 species, in total, and by tank.
• Details of clinical signs of disease, number affected in a tank and treatment.
• Details of ornamental fish mortality by tank.
• Details of significant management changes, such as food changes, and power and aeration failures.
• Biosecurity clearances.
• 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 ornamental fish 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; a national quality system based on ISO/IEC 17020 and any relevant legislation.

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 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.

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

The chief technical officer shall approve supervisors before they are appointed.

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 the 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 transitional facilities and the supervision of ornamental fish quarantine.

The supervisor may assign inspections to an inspector.

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.

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.

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. S/he shall make as many visits as considered necessary but the minimum number of visits are:

• for fresh water fish, three times during the quarantine period (on arrival, about 16-19 days and prior to 6 weeks),
• for marine fish and invertebrates, two visits (on arrival and prior to 3 weeks).

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

• check the integrity of the seals on the container(s).
• check the shipment for plants. Supervise their destruction by treatment with hypochlorite or by incineration.
• correlate the invoice with the number and species of ornamental fish as each bag is removed from the container.
• check for the presence of non-approved ornamental fish species.

At every visit the supervisor shall:

• check that the operator and the facility continue to meet the requirements of this Standard.
• inspect the ornamental fish for any signs of disease.
• match numbers of ornamental fish species entering quarantine with supplier records.
• check for the presence of non-approved ornamental fish species.
• inspect quarantine records.

At 16-19 days:

• identify and remove for destruction any remaining ornamental fish that are not on the approved list.

At about 19 days:

• make arrangements for biosecurity clearance for marine ornamental fish and invertebrates when requirements of 6.4.6 are met.

At about 40 days:

• make arrangements for biosecurity clearance for fresh water fish when requirements of 6.4.6 are met.

6.4.2 Identification of ornamental fish species

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

The supplier shall identify a person who has expertise in fish identification. If there is doubt about the identity of ornamental fish species, the supervisor may take the fish and the invoice list of species to this person. After inspection live fish shall be returned to the quarantine facility.

6.4.3 Disease surveillance and treatment

The supervisor is responsible, wherever possible, for establishing the cause of disease associated with high morbidity or mortality, and when exotic disease is suspected. Specimens shall be submitted to the laboratory at the discretion of the supervisor.

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

Dead fish shall be taken for incineration by the supervisor or they may be held as preserved specimens in 10% formaldehyde.

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

6.4.4 Submission of specimens to the laboratory

The supervisor shall phone the laboratory before submitting samples to advise the laboratory and receive direction on the type of samples to send. The packaging of specimens of infectious material shall be in accordance with instructions from the laboratory. Samples are to be dispatched in a clearly addressed sealed box by the fastest secure method.

6.4.5 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 4.11.

6.4.6 Biosecurity clearance

At the end of the quarantine period the supervisor shall make a recommendation (preferably by e-mail) to the chief technical officer through the national manager for the release of animals when satisfied that:

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

The recommendation shall include, but is not limited to:

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

When approved the supervisor shall issue a biosecurity clearance in writing to the operator.

6.4.7 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, a non-approved fish is imported.

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 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, a notice is not placed at the entrance of the transitional facility showing that access is restricted.

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.

6.4.9 Cost recovery

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

6.4.10 Reporting requirements

The supervisor shall make an inspection record in IMPACT for each import of ornamental fish showing:

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

6.4.11 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.