A standard for diagnostic facilities which undertake the identification of new organisms, excluding animal pathogens

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CONTENTS

REVIEW

This Biosecurity New Zealand Standard is subject to periodic review. Amendments will be made to the signed original as required.

ENDORSEMENT

This Biosecurity New Zealand Standard is hereby approved.

_________________________

Deputy Chief Technical Officer

Date:

AMENDMENT RECORD

Amendments to this standard will be given a consecutive number and will be dated.

Please ensure that all amendments are inserted, obsolete pages removed, and the record below is completed.

Amendment No:

Entered by:

Details:

Date:

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D. McLennan

Removed: Step 7.3 & form (requirement for quarterly reports) as covered in ISO standard 174-025 and by the other MAF requirements in this standard. Police form updated.

Aug 2006

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SIGNED ORIGINAL

Name Address

Operational Standards Team Biosecurity New Zealand
ASB Bank House
101-103 The Terrace
Wellington

 

CONTACT PERSONS

The contact persons to deal with matters relating to this Standard are:

Tamsin Smales
Senior Adviser Biosecurity NZ Pre-Clearance

Phone: (04) 474 4249
Fax: (04) 498 9888
E-mail: tamsin.smales@maf.govt.nz

Barry Wards
Senior Adviser Biosecurity NZ Pre-Clearance

Phone: (04) 498 9612
Fax: (04) 498 9888
E-mail: barry.wards@maf.govt.nz

Postal address:

Biosecurity New Zealand
P.O. Box 2526
Wellington

1.0 INTRODUCTION

Organism identification or diagnosis, especially of organisms not known to occur in New Zealand, requires recognised expertise in various scientific disciplines (bacteriology, entomology, mycology, nematology, virology etc.) and laboratory equipment is generally required. Such work must be undertaken in a MAF-approved diagnostic facility [which must also be an approved transitional facility].

The key elements of a well functioning diagnostic facility are the presence of a quality system and the ability of the facility to demonstrate technical competence and generate technically valid results.

1.1 Scope

This standard sets out the general requirements for the approval of diagnostic facilities in New Zealand which undertake the identification of organisms, including new organisms, and excluding animal pathogens.

This standard will be applicable to facilities which undertake the identification of the following new organisms:

  1. Plant microorganisms, including bacteria, fungi, viruses, viroids and phytoplasmas.
  2. Invertebrates including molluscs, insects, spiders, nematodes and mites.
  3. Vertebrate identifications, including reptiles and amphibians.
  4. Plants including higher plants, mosses and aquatic weeds [and other organisms as listed on Form 1 [at the back of this standard]].
  5. This standard covers the identification of new organisms that are dead or alive.

This standard excludes the following work:

  1. The identification of animal pathogens [covered under the Biosecurity Authority Standard AS 50-007 for the New Zealand Animal Health Reference Laboratory].
  2. Specific containment requirements [see Form 1 at the back of this standard].
  3. Occupational health and safety requirements in the work place [OSH requirements].
  4. The identification of human pathogens [except for those that may be isolated from plant tissues].

NOTE: Facility operators must note the obligations imposed under the Biosecurity Act 1993 that may apply to the operation of a transitional facility, e.g. section 52 concerning communication of pests or unwanted organisms and section 53 concerning duties of owners or persons in charge of pests or unwanted organisms.

2.0 REFERENCES

The following documents are referred to in this Standard:

  • Australian Quarantine and Inspection Service, Quarantine Approved Premise Criteria for Class 5 premises, Department of Agriculture, Fisheries and Forestry, [draft copy].
  • Australia/New Zealand Standard, Part 3, Safety in Laboratories, AS/NZS 2243.3:2002.
    {Amendment No.1 to AS/NZS 2243.3:2002 [AS/NZS 2243.3/Amdt 1/2003-04-29]}
  • The Biosecurity Act 1993.
  • General requirements for the competence of testing and calibration laboratories NZS/ISO/IEC17025:1999.
  • Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes ILAC-G13:2000.
  • The Hazardous Substances and New Organisms (HSNO) Act 1996.
  • ISO/IEC Guide 43-1:1997 (E) Proficiency testing by inter-laboratory comparisons – Part 1: Development and operation of proficiency testing schemes.
  • For information on the other MAF Standards mentioned in this standard please refer to Form 1 at the back of this standard.

3.0 DEFINITIONS

Animal
Any member of the animal kingdom, excluding humans.

Authorised Person
A person for the time being appointed as an authorised person by a Chief Technical Officer under s103 of the New Zealand Biosecurity Act (1993).

Biosecurity New Zealand
The section within MAF responsible for regulatory biosecurity functions.

Chief Technical Officer
A person appointed by the Director-General as a chief technical officer under s101 of the New Zealand Biosecurity Act (1993).

Explanatary note, the CTO’s powers includes the following:

  • making recommendations to the Director-General on the issuance of import health standards
  • intervening in the management of or operation of transitional or containment facilities to ensure compliance with conditions, and
  • giving direction as to the disposal or treatment of seized goods and the destruction of imported goods
  • receiving reports of notifiable organisms
  • having the power to require information relating to organisms
  • declaring controlled areas and placing restrictions on movement into, within, or out of those areas
  • appointing inspectors and authorised persons for the purposes of administering and enforcing the provisions of the Biosecurity Act.
  • determining an organism as an “unwanted organism”.

CTO
Chief Technical Officer

Decontamination
Removal and/or sterilisation of contaminants within a transitional facility, containment facility, or biosecurity control area.

Diagnostic Facility
A transitional or containment facility for the purpose of identifying organisms, including new organisms.

Director-General
Chief executive of the Ministry of Agriculture and Forestry.

Environmental Risk Management Authority New Zealand
The authority established under the New Zealand Hazardous Substances and New Organisms Act 1996.

ERMA
Environmental Risk Management Authority New Zealand

Frozen
The definition of frozen for Non-Fruit Fly Host Material is:
The product must have been subject to freezing until the core temperature is held at (or below) minus 10°C for a minimum of 7 days.

The definition of frozen for Fruit Fly Host Material is:
The product must have been subject to freezing until the core temperature has been held at (or below) minus 18°C for a minimum of 7 days.

Import health standard
A standard issued under s22 of the New Zealand Biosecurity Act (1993) by the Director-General on the recommendation of a Chief Technical Officer, specifying the requirements to be met for the effective management of risks associated with the importation of risk goods.

Inspector
A person appointed under section 103 of the New Zealand Biosecurity Act 1993 to undertake administering and enforcing the provisions of the New Zealand Biosecurity Act 1993.

ISO
International Standardisation Organisation

MAF
The Ministry of Agriculture and Forestry.

Microorganism
A living microscopic organism. It includes bacteria, mycoplasmas, phytoplasmas, rickettsiae, viruses and viroids. It does not include naked DNA or plasmids.

New Organism
Under the New Zealand HSNO Act 1996

  • (1) A new organism is—
    (a) An organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:
    (b) An organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand at the time of promulgation of the relevant regulation:
    (c) An organism for which a containment approval has been given under this Act:
    (ca) an organism for which a conditional release approval has been given:
    (cb) a qualifying organism approved for release with controls:
    (d) A genetically modified organism:
    (e) An organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand.
  • (2) An organism is not a new organism if
    (a) the organism is not a genetically modified organism and—
    (i) an approval is granted under section 38 to release an organism of the same taxonomic classification; or
    (ii) the organism is a qualifying organism and an approval has been granted under section 38I to release an organism of the same taxonomic classification without controls; or
    (iii) an organism of the same taxonomic classification has been prescribed as not a new organism; or
    (b) the organism is a genetically modified organism and—
    (i) an approval is granted under section 38 to release an organism of the same taxonomic classification with the same genetic modification; or
    (ii) the organism is a qualifying organism and an approval has been granted under section 38I to release an organism of the same taxonomic classification with the same genetic modification without controls; or
    (iii) an organism of the same taxonomic classification with the same genetic modification has been prescribed as not a new organism; or
    (c) the new organism was deemed to be a new organism under section 255 and other organisms of the same taxonomic classification were lawfully present in New Zealand before the commencement of that section and in a place that was not registered as a circus or zoo under the Zoological Gardens Regulations 1977.
  • (2A) A new organism does not cease to be a new organism because—
    (a) it is subject to a conditional release approval; or
    (b) it is a qualifying organism approved for release with controls.
  • (3) Despite the provisions of this section, an organism present in New Zealand before 29 July 1998 in contravention of the Animals Act 1967 or the Plants Act 1970 is a new organism.
  • (4) Subsection (3) does not apply to the organism known as rabbit haemorrhagic disease virus, or rabbit calicivirus.

Nursery Stock
Whole plants or parts of plants imported as propagation material excluding seeds. Some examples are cuttings, scions, budwood, root divisions, bulbs, corms, tubers and rhizomes.

Operator
A person approved by the Director-General under s40 of the New Zealand Biosecurity Act (1993) to operate a specified transitional or specified containment facility. Note: the term accredited operator as used in previous Biosecurity Authority standards prior to 30 January 2004 is an approved operator.

Organism
Within New Zealand, an organism, defined by section 2(1) of the New Zealand Biosecurity Act (1993):

  • (a) Does not include a human being or a genetic structure derived from a human being;
  • (b) Includes a micro-organism;
  • (c) Subject to paragraph (a) of this definition, includes a genetic structure that is capable of replicating itself (whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity):
  • (d) Includes an entity (other than a human being) declared by the Governor-General by Order in Council to be an organism for the purposes of this Act:
  • (e) Includes a reproductive cell or developmental stage of an organism:
  • (f) Includes any particle that is a prion.

Packaging
Product used in supporting, protecting or carrying a commodity [ISPM, 2003].

Pathogen
Micro-organism causing disease [ISPM Pub. No. 3, 1996].

PEQ
Post-entry quarantine

Plants
Living plants and parts thereof, including seeds and germplasm [FAO, 1990; revised IPPC, 1997]

Post-entry quarantine
Quarantine applied to a consignment after entry [FAO, 1995]

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.

Propagation material
Whole plants or parts of plants intended for growing purposes excluding seeds.

Quarantine
Within New Zealand, quarantine, defined by the New Zealand Biosecurity Act 1993, means confinement of organisms or organic material that may be harbouring pests or unwanted organisms.

Transitional Facility
An approved facility for the purpose of inspection, testing, storage, treatment, quarantine, holding or destruction of uncleared goods, which may be harbouring pests or unwanted organisms, until a biosecurity clearance is given by an inspector.

Uncleared goods
Imported goods for which no biosecurity clearance has been given.

Unit
A single undivided plant or plant product entity, often used in sampling procedures.
For fresh fruit and vegetables: a unit is an individual piece of produce. e.g. for bananas a unit is one hand, for grapes a unit is one bunch.
For nursery stock: e.g. a unit is one plant, one bulb or one cutting. For tissue cultures it is the vessel containing the cultures.
For fresh cut flowers and foliage: e.g. a unit is an individual fresh flower, a single piece of foliage or a stem as appropriate.

Unwanted organism
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; and
(a) Includes-
i. Any new organism, if ERMA has declined approval to import that organism; and
ii. Any organism specified in the Second Schedule of the Hazardous Substances and New Organisms Act 1996; but
(b) Does not include any organism approved for importation under the Hazardous Substances and New Organisms Act 1996, unless-
i. The organism is an organism which has escaped from a containment facility; or
ii. A chief technical officer, after consulting ERMA NZ and taking into account any comments made by ERMA NZ concerning the organism, believes that the organism is capable or potentially capable of causing unwanted harm to any natural and physical resources of human health:

4.0 APPROVAL

4.1 Approval of a Diagnostic Facility for the Identification of New Organisms, excluding Animal Pathogens

A diagnostic laboratory must be approved as a transitional facility by the Director-General in accordance with section 39 of the Biosecurity Act 1993.

For additional requirements to this standard refer to Form 1 [at the back of this standard].

4.2 Approval of a Diagnostic Facility Operator

An operator must be approved by the Director-General in accordance with section 40 of the Biosecurity Act 1993.

4.3 Application Procedure for Approval

4.3.1 In order for a diagnostic facility to be approved as a transitional facility under section 39 of the Biosecurity Act 1993 an application must be made to the Ministry of Agriculture and Forestry using the approved form at the back of this Standard [Form 2].

4.3.2 In order for an operator of a diagnostic facility to be approved as a transitional facility operator under section 40 of the Biosecurity Act 1993 an application must be made to the Ministry of Agriculture and Forestry using the approved form at the back of this standard [Form 3]. This includes a New Zealand Police consent form for disclosure of convictions [Form 4].

4.3.3 The facility shall develop and maintain a quality system in accordance with all the requirements of NZS/ISO/IEC 17025:1999 [exceptions will be dealt with on a case by case basis, for example small laboratories using a very small number of tests] and this standard. The facility must be externally accredited to NZS/ISO/IEC 17025:1999 by an Accreditation Body which is internationally recognised for the accreditation of testing laboratories, e.g. a member of the Mutual Recognition Arrangement within an international or regional co-operation of Accreditation Bodies.


4.3.4 A quality manual must be submitted to the Ministry of Agriculture and Forestry for approval, prior to approval of the facility.

4.3.5 Biosecurity New Zealand or a Biosecurity New Zealand-approved agency will conduct a site audit. Approval of the facility by the Director-General shall be granted only after all non-conformances identified have been rectified.

4.3.6 Following approval, the procedures specified in the quality manual must be subject to document control. MAF must be notified of any amendments to the procedures.

5.0 CANCELLATION OF APPROVAL OF THE DIAGNOSTIC FACILITY OR OPERATOR

Where the Director-General is no longer satisfied that the facility operator is operating the facility in accordance with this standard or where the operator has ceased to act as operator of the facility or is no longer a fit and proper person to operate the facility, the Director-General may cancel the operator’s approval in accordance with section 40 of the Biosecurity Act 1993.

Where, the facility no longer complies with the requirements of this standard or the Director-General is satisfied that the facility is no longer used for the purpose or one or more of the purposes specified in the facility’s approval, the Director-General may cancel the facility’s approval in accordance with section 39 of the Biosecurity Act 1993.

6.0 QUALITY SYSTEM

6.1 The quality manual must clearly specify the scope of the activities for which the facility is applying for approval as a diagnostic facility, e.g. virology testing for Vitis species, entomology identifications for cut flowers etc.

6.2 To facilitate amendments, the quality manual must be prepared in loose-leaf form, have a number and date on each page and include a table of contents.

6.3 The documented quality system must include procedures and work instructions that clearly show how the facility will deliver the services required by Biosecurity New Zealand.

6.4 The quality manual and related quality documentation must contain the

communication pathways with the MAF inspector(s) or approved person(s) responsible for granting or recommending the granting of biosecurity clearance for the consignment [if applicable]. The procedure for determining if an organism is a new organism or not must also be described.

7.0 ORGANISATION AND MANAGEMENT

7.1 The operator must ensure that the laboratory is organised and operated in such a way that all the requirements of this standard are met.

7.2 The facility must be legally identifiable [the owner of the facility must be specified in the quality manual].

7.4 Identification of New Organisms

In addition to sections 441 and 461 of the Biosecurity Act 1993, should facility staff strongly suspect the presence of, or identify a new organism in PEQ or from the border, then the contact person at the front of this standard must be alerted.

If a new organism is detected in New Zealand [i.e. general surveillance] or an unusual occurrence of an organism known to be present in New Zealand is suspected or identified, then the exotic disease and pest emergency hotline 0800 809 966 must be alerted.

The appropriate contacts must be alerted on the same day that the organism is identified or suspected.

The following information must be provided to the contact person:

  • suspected disease/ results of tests (including method of diagnosis/identification).
  • species and number of organisms affected;
  • import permit number [if applicable, e.g. post entry quarantine].

1Biosecurity Act 1993

Section 44 General duty to inform

(1) Every person is under a duty to inform the Ministry, as soon as practicable in the circumstances, of the presence of what appears to be an organism not normally seen or otherwise detected in New Zealand.

Section 46 Duty to report notifiable organisms

(1) Every person who—

(a) At any time suspects the presence of an organism in any place in New Zealand; and

(b) Suspects that it is for the time being declared to be a notifiable organism under subsection (2) of section 45 of this Act; and

(c) Believes that it is not at the time established in that place; and

(d) Has no reasonable grounds for believing that the chief technical officer is aware of its presence or possible presence in that place at that time,—

shall without unreasonable delay report to the chief technical officer its presence or possible presence in that place at that time.

(2) Every person who—

(a) At any time suspects the presence of an organism in a place in the region, or in any part of the region, of a regional council; and

(b) Suspects that it is for the time being declared to be an organism notifiable within the region or part under subsection (3) of section 45 of this Act; and

(c) Believes that it is not at that time established in that place; and

(d) Has no reasonable grounds for believing that the chief technical officer is aware of its presence or possible presence in that place at that time,—

shall without unreasonable delay report to the chief technical officer its presence or possible presence in that place at that time.

{Note: Failure to comply with this section is an offence. See s154(m).}

8.0 AUDIT AND REVIEW

8.1 In addition to all of the requirements as stated in clause 4.13 and 4.14 of NZS/ISO/IEC 17025: 1999, the operator must ensure that:

8.1.1 An internal audit of the facility’s activities is carried out at least once every six months to verify that the operations continue to comply with the requirements of the quality system. Where the audit findings cast doubt on the correctness or validity of the facility’s test results, the operator must take immediate corrective actions and notify the Ministry of Agriculture and Forestry in writing [the contact person].

8.1.2 The quality system is reviewed at least once a year to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements. Written records of this review shall be maintained by the quality manager and made available to Biosecurity New Zealand on request [a quality manager is described in clause 4.1.5 i, of NZS/ISO/IEC 17025].

8.2 Biosecurity New Zealand, or a Biosecurity New Zealand approved agency, shall also audit the facility operations and quality system at least once every year at the facility’s expense.

8.3 Biosecurity New Zealand may also carry out unannounced audits of the facility to check for compliance with the requirements of this standard [at the expense of the diagnostic facility].

9.0 COSTS

MAF costs involved in the approval process and compliance auditing/inspection of the diagnostic facility shall be recovered in accordance with the Biosecurity (Costs) Regulations 2003.

10.0 PERSONNEL

In addition to all of the requirements as stated in clause 5.2 of NZS/ISO/IEC 17025: 1999, the operator must ensure that:

  • a) The facility has sufficient personnel having the necessary education, training, technical knowledge and experience for organism sampling and identification.
  • b) Facility scientists maintain a programme of training and awareness of significant high impact pests.
  • c) Key personnel have access to the appropriate journals and up-to-date reference textbooks in their field of expertise.
  • d) The facility has a diagnostician with experience in a relevant laboratory discipline, on-duty whenever the facility is functioning.
  • e) The quality manual must refer to training programmes for new or inexperienced staff.
  • f) The facility management and technical staff have no direct vested interest in test results produced by the facility so that there is a high level of confidence in the integrity and independence of judgement of the facility staff. [where a conflict of interest exists the facility management must document how they are going to manage the conflict of interest, e.g. they must show MAF a copy of the employment contract].

11.0 ACCOMMODATION AND ENVIRONMENT

11.1 Containment requirements [the following may or may not be relevant]

The requirements below [a-i] are taken directly from AS/NZS 2243.3:2002, PC3 requirements.

In addition to all of the requirements as stated in clause 5.3 of NZS/ISO/IEC 17025: 1999, the operator must ensure that the facility is able to contain the new organisms that are being tested/identified and that the facility complies with the following requirements as are relevant to the facility.

  • a) Windows in the facility are closed and locked or sealed.
  • b) A pressure steam steriliser for decontamination of laboratory wastes is available, preferably located within the laboratory.
  • c) Where a pressure steam steriliser is not available within the laboratory, laboratory wastes are to be bagged and placed in an unbreakable container with a secured lid for transport to the pressure steam steriliser.
  • d) Wastes are not stored outside the facility before they are sterilised.
  • e) Transport containers used for waste and for protective clothing have provision for penetration of steam during sterilising.
  • f) HEPA filters are used in the facility for the outflow of air (and for fumehoods) [if appropriate, e.g. work involving culturing of fungi].
  • g) The facility door is kept locked when the room is unoccupied.
  • h) Protective clothing is not worn outside the facility and is transported in closed bags or boxes for sterilisation before laundering.
  • i) Outer clothing and personal effects are kept in storage facilities situated adjacent to the facility area and are not taken into the facility.
  • j) Personnel wash their hands with liquid soap and warm water after handling regulated/quarantine material, and before leaving the facility.
  • k) A high level of cleanliness is maintained in the facility and measures are taken to ensure good housekeeping in the facility at all times.
  • l) The area where inspections/ tests are to be conducted on live new organisms capable of escaping/spreading is within an enclosed area and effectively sealed to prevent new organism escape of all life stages.
  • m) The area where potentially new or unwanted organisms are to be handled, inspected or tested has a prominent sign labelled as follows:

DIAGNOSTIC FACILITY
 

MAF Registration Number:
 

QUARANTINE AREA

UNAUTHORISED ENTRY PROHIBITED
 

Name of Facility Operator:

  • n) The sign is permanently affixed, clearly visible and professionally made. The sign has a yellow background with black lettering and a minimum fit to A4 size.
  • o) The diagnostic facility is sealable to permit decontamination with gases or disinfectants.
  • p) The general accommodation and working environment comply with the procedures for Physical Containment Level 2 facilities specified in the Australian/New Zealand Standard - Safety in Laboratories Part 3 Microbiological aspects and containment facilities AS/NZS 2243.3 2002.

11.2 Premises Location

A site plan of the property must be included in the quality manual showing the location of the diagnostic facility on the site and all facility entrances and access points identified. Boundaries of neighbouring properties shall be shown. The physical location of the property shall be clearly shown in relation to roads in the area.

12.0 FACILITY WASTE

12.1 Prior to disposal, facility waste, which may contain new organisms must be effectively decontaminated by pressure steam sterilisation, incineration, appropriate chemical treatment [refer to AS/NZS 2243.3:2002], by freezing [see definition of frozen] or by another approved method.

12.2 The disposal procedures must comply with the procedures for Physical Containment Level 2 facilities specified in the Australian/New Zealand Standard - Safety in Laboratories Part 3 Microbiological aspects and containment facilities AS/NZS 2243.3 2002.

12.3 Autoclave indicator tests should be used at regular intervals to monitor the microbiological killing power of the sterilization process [if appropriate]. They shall be placed in several positions in the load, including those least likely to attain sterilisation conditions. [Use of standard autoclave indicator tapes should be used routinely when autoclaving].

13.0 MOVEMENT OF UNWANTED OR SUSPECTED UNWANTED ORGANISMS AND QUARANTINE MATERIAL BETWEEN TRANSITIONAL FACILITIES

In addition to all of the requirements as stated in clause 5.8 of NZS/ISO/IEC 17025: 1999, the operator must ensure that extreme care is always taken in transporting quarantine material and unwanted or suspected unwanted organisms within and between transitional facilities. Approval from the MAF inspector must be obtained before movement between facilities can occur.

A person who moves an organism that is known to be an unwanted organism must ensure that, in doing so, the organism is not communicated, released or spread in breach of section 52 of the Biosecurity Act 1993 or that the movement may result in the person acting in such a manner as is likely to encourage or cause the propagation, breeding, or multiplication of the pest or unwanted organism in breach of section 53 of the Biosecurity Act. Section 154 (m) of the Biosecurity Act provides that it is an offence to fail or refuse to comply with sections 52 or 53 of the Act.

14.0 EQUIPMENT AND REFERENCE MATERIALS

Please refer to clause 5.5 of the NZS/ISO/IEC 17025:1999 Standard.

15.0 RECORDS

In addition to all of the requirements as stated in clause 4.12 of NZS/ISO/IEC 17025: 1999, the facility operator shall, on a consignment basis, maintain copies/records of:

  • a) relevant biosecurity/quarantine directives [e.g. the relevant MAF Standards]
  • b) arrival date of the consignment and/or specimen(s) in the diagnostic facility
  • c) any treatment undertaken on arrival at the diagnostic facility
  • d) results of diagnostic tests or pest identification

All the records listed above must be retained for a period of at least 7 years and be available to the Chief Technical Officer or his or her authorised representative on request.

16.0 ACCESS TO THE DIAGNOSTIC FACILITY

The operator must, at any reasonable time, provide access to MAF, or an authorised representative of MAF, for inspection/audit purposes. Visitors to the facility must be accompanied by an authorised user and sign a visitors register.

17.0 SECURITY OF THE DIAGNOSTIC FACILITY

17.1 The diagnostic facility operator shall have adequate procedures for controlling access to any restricted area(s) of the facility and the movement in and out of all specimens associated with imported material.

17. 2 Access to the facility must be limited to personnel who are authorised users.

17.3 The MAF inspector must be informed immediately of any incidents which could significantly compromise the quarantine security of the facility.

17.4 The operator shall have adequate procedures for inspecting the facility after an earthquake, flooding, high winds etc.

18.0 REPORTING OF NEW ORGANISM ESCAPE

18.1 The operator must report to the Ministry of Agriculture and Forestry inspector the escape of any new organism from the facility as soon as practically possible.

18.2 As part of the quality system the operator must prepare a contingency plan to contain, or, if directed by an inspector, authorised person or Chief Technical Officer, destroy, any new organism that may be suspected or confirmed to be in the facility.

19.0 DESTRUCTION OF WASTE MATERIAL

The operator must ensure that all material [including biosecurity risk material e.g. packaging] that does not receive biosecurity clearance is destroyed unless approval is obtained from an inspector to retain or store the material or organisms. [Records of destruction must be kept for post entry quarantine facilities].

20.0 PARTICIPATION IN INTER-LABORATORY COMPARISON TESTING

20.1 All approved diagnostic facilities, or diagnostic facilities seeking approval need to participate, where possible, in inter-laboratory comparisons to verify the integrity of the laboratory results produced. Access to inter-laboratory comparisons can be achieved through the following mechanisms:

  • (i) Participation in a formal proficiency testing scheme operated in accordance with ISO/IEC Guide 43-1:1997 – Proficiency testing by inter-laboratory comparisons – Part 1: Development and operation of proficiency testing schemes; or;
  • (ii) Participation in a formal proficiency testing scheme operated by a recognised provider, or;
  • (iii) Participation in less formal inter-laboratory comparisons with one or more other laboratories organised by one of the participating laboratories.

Preference should be given to the option(s) in the order listed above.

20.2 Prior to approval of a diagnostic facility, a proficiency testing plan should be agreed upon [where possible] between MAF and the diagnostic facility as to the suitability of the option(s) chosen. Where option (iii) in paragraph 20.1 above is proposed, the plan needs to state the other laboratories intended as participants in the scheme.

Laboratories chosen for inter-laboratory comparison testing must be selected on the basis of their ability to meet the testing requirements in terms of technical competence and any specific requirements relevant to the testing. The facility being approved must state whether the chosen facility is accredited to NZS/ISO/IEC 17025 or any other quality standard.

20.3 Where a diagnostic facility is preparing its own samples for inter-laboratory testing, it needs to have the appropriate resources and documented procedures for the overall process of preparation and distribution of test materials, and for the analysis of the results, including:

  • Material preparation, a description of the type of material that will be sent to the testing facility (e.g. budwood or fresh leaves or freeze dried tissue).
  • All appropriate customs declaration forms should be completed to ensure that delays in customs clearance are minimized. The diagnostic facility will need to comply with national and international regulations applicable to test item transport.
  • Ensuring adequate packaging and labelling;
  • Ensuring appropriate transport and distribution arrangements;
  • Ensuring adequate reporting to MAF;
  • The facility must control packaging processes to ensure conformity with relevant transport requirements and to prevent deterioration of the sample in transit; it is very important that fresh leaf samples are kept cool at all times, but not frozen.
  • Ensuring that material labels are securely attached to the material packaging of individual units and designed to remain legible and intact within the period of use.
  • Positive controls should be sent with the samples.
  • How results from participating laboratories will be analysed and the criteria for judging the performance of participants as satisfactory or otherwise.

NOTE: Validation of identification by an independent party for post-clearance [post biosecurity clearance, i.e. general surveillance] samples may also serve as an inter-laboratory comparison.

20.4 An inspector [where a conflict of interest may exist, e.g. for facilities testing their own material] is to select [after consultation with the contact person] the number and type of samples used in the inter-laboratory comparison and the tests to be performed, and will collect and send these samples to the laboratories.

20.5 Inter-laboratory comparison testing reports.

Results of inter-laboratory comparison testing by each diagnostic facility are to be sent to the contact person for review following compilation of the results.

20.5.1 Where the diagnostic facility participates in a proficiency scheme of an external provider [options (i) or (ii) in 20.1 above], the following information is to be provided:

  • Name and address of the testing facility
  • Copy of the proficiency testing report provided from the external provider
  • Clear indication of the facility’s results and performance (proficiency testing reports normally code facility identifiers for anonymity)
  • Relevant specific permit numbers associated with the test results.

20.5.2 Where the diagnostic facility arranges its own inter-laboratory comparisons [option (iii) in 20.1 above], the following information shall be provided:

  • Name and address of the testing facility
  • A compilation of the results from each participating facility, clearly showing the test(s) conducted
  • Clear indication of the facility’s results and performance
  • Relevant specific permit numbers associated with the test results.

20.6 Where the results of an inter-laboratory comparison show an unsatisfactory performance on the part of the diagnostic facility being approved, the Senior Adviser Biosecurity NZ Pre-Clearance must be notified in writing of the results, the investigation into the reasons for the non-conformance and the corrective action taken to prevent a reoccurrence.

21.0 WORK WITH UNWANTED, SUSPECTED UNWANTED AND NEW ORGANISMS

  • a) The diagnostic facility may NOT propagate, breed, or multiply an unwanted organism or pest or suspected unwanted organism or pest for any purpose, or act in such a manner as is likely to encourage or cause the propagation, breeding, or multiplication of the pest or unwanted organism, unless the facility has the permission of a CTO. [For an approval from the CTO please send an email to the contact person].

    Propagation or multiplication could include the following: culturing a fungal or bacterial unwanted organism or suspected unwanted organism on media for identification purposes, or inoculating herbaceous indicator plants with virus that is an unwanted or suspected unwanted organism etc.
  • b) If the facility seeks to propagate, breed, or multiply an unwanted organism, pest or a suspected unwanted organism or pest for identification purposes, the facility MUST obtain the permission of a CTO. Failure to obtain CTO approval would result in a failure to comply with section 53 of the Biosecurity Act 1993 [which is an offence under section 154 (m) of the Biosecurity Act]
  • c) For the diagnostic facility to develop [see HSNO Act definition of develop] a new organism ERMA approval is required. Even if ERMA approval to develop a new organism is obtained, the approval of a CTO would also be required if the organism is to be propagated, bred or multiplied and the organism is an unwanted organism or a pest.
  • d) All identified new organisms must be destroyed unless written approval from ERMA is obtained (Section 25, HSNO Act 1996). Approval from MAF will also be required where the organism may be an unwanted organism or pest.

Form 1

REQUIREMENTS FOR CONTAINMENT IN ADDITION TO THIS STANDARD

TYPE OF NEW ORGANISM CONTAINMENT LEVEL

MAF STANDARD
VIRUSES/VIROIDS/PHYTOPLASMAS [of plants]  
To identify new: viroids/viruses/phytoplasmas. MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
For virus and viroid diagnosis positive controls will be needed, please apply to MAF to use the following ERMA approval. To import virus/viroid positive controls. ERMA approval NOC01004 ‘To import into containment plant viruses and viroids capable of mechanical transmission (in an ‘inactive’ state) for disease diagnostic tests on plant quarantine and surveillance samples, under section 40(1)(a) of the HSNO Act’.
Laboratories working with viruses often need to use bovine serum albumin or chicken albumin, a permit is needed for these products and they must be used in a transitional facility for biological products. MAF Standard Transitional Facilities for Biological Products 154.02.17.
FUNGI [of plants]  
To identify LOW RISK fungi that DO NOT require culturing for identification. MAF Standard Transitional Facilities for Biological Products 154.02.17 [although this standard is for biological products if the lab is already approved to this standard it would be sufficient containment for low risk fungi] or MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
To identify fungi that require culturing for identification. MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
To identify HIGH RISK fungi that DO NOT require culturing for identification. MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
For some fungal diagnosis positive controls will be needed, please apply to MAF to use the following ERMA approvals.

ERMA APPROVALS [to import new organisms ( fungi)]

1) NOC99023
To import into containment microorganisms for the International Collection of Microorganisms from Plants (ICMP) as a reference collection in the investigation of plant quarantine outbreaks of plant diseases and for international and NZ research use.

2) GMC99008, GMC99009, GMC99011, GMC99014, GMC99015, GMC99016, GMC99017, GMC99018, GMC99019, GMC99020, GMC99021, GMC99022, NOC99013, NOC99014, NOC99019, NOC99020, NOC99021, NOC99022, NOC00003
Import into Containment any New Organism under section 40(1)(a) of the Hazardous Substances and New Organisms (HSNO) Act 1996, made in accordance with section 259 for the approval of existing new microorganisms.

2) NOC99018
To import into containment unknown fungi for diagnostic purposes, and for ongoing scientific research projects in the fields of systematics and taxonomy.
BACTERIA [of plants]  
To identify bacteria. MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
ARTHROPODS AND OTHER INVERTEBRATES  
To identify dead insects or mites [dead insects may pose a risk e.g. parasitoids emerging]. MAF Standard Transitional facilities for Biological Products 154.02.17 or MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
To identify live insects/mites that do not require rearing on for identification. MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
To identify live insects/mites that require rearing on for identification. MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
Identification of live or dead fruit flies/other high impact insects. MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
AQUATIC WEEDS  
To identify aquatic weeds. Autoclave all waste before pouring it down the drain. MAF Standard Transitional facilities for Biological Products 154.02.17 or MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
LEECHES  
To identify leeches. MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
MARINE AND FRESH WATER PLANTS  
To identify marine and fresh water plants. Autoclave all waste before pouring it down the drain. MAF Standard Transitional facilities for Biological Products 154.02.17 or MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
MAMMALIAN PATHOGENS ON PLANTS  
To identify mammalian pathogens on plants. MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
MOLLUSCS  
To identify molluscs. MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
MOSSES (BRYOPHYTES)  
To identify mosses. MAF Biosecurity Authority Standard 154.03.02 Containment Facilities for Microorganisms.
NEMATODES  
To identify live or dead nematodes. MAF standard Transitional and Containment Facilities for Invertebrates,154.02.08.
NEW PLANT SPECIES  
To identify new plant species. MAF Standard 155.04.09 Containment facilities for new organisms (including genetically modified organisms) of plant species.
VERTEBRATES INCLUDING REPTILES AND AMPHIBIANS  
To identify vertebrates MAF Biosecurity Authority Standard 154.03.03 Containment for Vertebrate Laboratory Animals.

Form 2

Transitional Facility/Operator Registration

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

Page last updated: 30 April 2008