Facilities for Microorganisms and Tissue Cultures: 2007 (Draft)

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ERMA New Zealand, in accordance with section 11(1)(fb) of the Hazardous and Substances and New Organisms Act 1996, approves this Standard – Facilities for Microorganisms and Tissue Cultures: 2007 as a standard for containment facilities.

Rob Forlong
Chief Executive
ERMA New Zealand
(for Environmental Risk Management Authority)

MAF, in accordance with section 39 of the Biosecurity Act 1993, approves this Standard – Facilities for Microorganisms and Tissue Cultures: 2007 as a standard for transitional facilities.

Debbie Pearson
Director – Pre-Clearance
Biosecurity New Zealand
Ministry of Agriculture and Forestry

Contents

Foreword

The Environmental Risk Management Authority (ERMA New Zealand) is responsible for making decisions on applications to introduce and/or develop new organisms (including genetically modified organisms) in New Zealand.

Biosecurity New Zealand, a division of the Ministry of Agriculture and Forestry (MAF), is the lead agency in New Zealand’s biosecurity system. It is responsible for preventing the importation of unwanted pests and diseases, and for controlling, managing or eradicating them should they arrive.

Biosecurity New Zealand is also the agency responsible for enforcing approvals and containment controls imposed by ERMA New Zealand.

The Biosecurity Standards Group of Biosecurity New Zealand develops import health standards and operational standards in order to exercise those enforcement responsibilities.

This Standard – Facilities for Microorganisms and Tissue Cultures: 2007, is a joint ERMA New Zealand - MAF Standard prepared by Biosecurity New Zealand (Biosecurity Standards Group) in collaboration with ERMA New Zealand.

This version cancels and replaces the previous version (Standard 154.03.02: 2002 - Containment Facilities for Microorganisms).

Significant amendments from the previous version are:

Extension to include transitional facility requirements for:

  • imported tissue cultures;
  • unwanted microorganisms;
  • any other microorganism considered by a chief technical officer to be a risk good.

Clarification of registers.

Provision of an audit escalation pathway and audit dispensation guidelines.

Review and Amendment

This Standard is subject to review and amendment at any time, to ensure that it continues to meet current needs.

Reviews and amendments, in the form of new versions, will be notified to operators of facilities approved under this Standard.

Operators are responsible for ensuring that the most recent version of this Standard is being used.

This Standard is accessible on:

www.biosecurity.govt.nz/regs/trans/stds

www.biosecurity.govt.nz/regs/trans/stds

The MAF Unwanted Organisms Register is accessible by the following link:

http://mafuwsp6.maf.govt.nz/uor/searchframe.htm (offsite link to mafuwsp6.maf.govt.nz)

Contact Person

For all operational issues, please contact the Inspector responsible for your facility.

The person responsible for all matters relating to the review and amendment of this Standard is a senior adviser within the Operational Standards Team of Biosecurity New Zealand. This person can be contacted through the office below:

Operational Standards Team
Biosecurity New Zealand
Ministry of Agriculture and Forestry
PO Box 2526
WELLINGTON

Phone: (04) 894 0476
Fax: (04) 894 0662
Email: standards@maf.govt.nz

1. Introduction

1.1 PURPOSE

This Standard was developed to meet the requirements of the Biosecurity Act 1993 and the Hazardous Substances and New Organisms (HSNO) Act 1996, in regard to setting minimum specifications for the containment of:

  • all microorganisms and tissue cultures (including all genetically modified microorganisms) subject to a new organism approval issued under the HSNO Act; and
  • any microorganism or tissue culture considered by a chief technical officer (CTO) to be risk goods in New Zealand. This includes unwanted organisms, (which may also be new organisms), imported tissue cultures and unidentified microorganisms that are imported or discovered in post-entry quarantine or during an incursion response.

Work with new and/or risk organisms, including genetically modified organisms, is subject to compliance with statutory regulations specified in the Biosecurity Act 1993 and the HSNO Act 1996. Other legislation, such as Occupational Safety and Health regulations will also be directly relevant to work with new organisms in containment.

1.2 GENERAL

This Standard should be read in conjunction with AS/NZS2243.3:2002 Safety in Laboratories Part 3: Microbiological aspects and containment facilities, which sets out requirements, responsibilities and general guidelines relating to safety in laboratories where microorganisms are handled. The joint Australian/New Zealand Standard sets out the minimum physical containment levels for working with various risk groups of microorganisms and is incorporated in the HSNO (Low-Risk Genetic Modification) Regulations 2003.

Before any of the aforementioned microorganisms and tissue cultures can be imported into New Zealand, a permit to import is required from MAF. The permit may require further conditions to be met in addition to the requirements of an import health standard or the controls in an ERMA New Zealand approval.

All facilities approved to this Standard are subject to regular audits by MAF Quarantine Service (MAFQS).

1.3 MICROORGANISMS AND TISSUE CULTURES THAT ARE NEW ORGANISMS

Microorganisms and tissue cultures that are new organisms must be held in containment facilities.

Approval for these organisms to be imported into, and/or developed, in containment facilities, is given subject to containment controls imposed by ERMA New Zealand or, in regard to low risk genetically modified organisms1, by Institutional Biological Safety Committees (IBSC) under delegation from ERMA New Zealand.

New organisms held in a containment facility are not eligible for release into New Zealand. The primary purpose of containment is to prevent their escape.

1.4 MICROORGANISMS AND TISSUE CULTURES THAT ARE RISK GOODS

Microorganisms and imported tissue cultures that are considered by a CTO to be a risk good, are required to be held in transitional facilities. Risk goods are goods that it is reasonable to suspect constitute, contain or harbour an organism that may:

  • cause unwanted harm to natural and physical resources or human health in New Zealand; or
  • interfere with the diagnosis, management, or treatment, in New Zealand, of pests or unwanted organisms.

Risk goods may also include new organisms that are unwanted organisms, such as Mycoplasmas.

All tissue cultures are considered to be risk goods, as they may contain or harbour new and/or unwanted organisms.

Permission to import microorganisms in these categories is given, subject to conditions required by MAF, through a permit to import and an import health standard.

In order to hold and propagate unwanted organisms2 the permission of a CTO is required (sections 52 and 53 Biosecurity Act 1993). Operators should contact the Operational Standards Team in the first instance to make arrangements to obtain CTO permission.

2 Scope

This Standard specifies the minimum requirements for the containment of:

  • microorganisms and tissue cultures that are new organisms (including genetically modified organisms);
  • microorganisms that are unwanted organisms1;
  • imported tissue cultures;
  • any other microorganisms and tissue cultures that are considered by a CTO to be risk goods;
  • unidentified microorganisms from border interceptions, post-entry quarantine, or incursion investigations.

This Standard specifies:

  • the minimum requirements of a Quality Management System;
  • the minimum structural and operating requirements; and
  • how facilities and operators may be approved.

3 References

The following documents contain provisions which, through reference in this text, constitute requirements of this Standard. For dated references, the latest version of these publications apply.

  • Australian/New Zealand Standard 2243.3: 2002 – Part 3: Safety in Laboratories: Microbiological Aspects and Containment Facilities.
  • Australian/New Zealand Standard ISO 9001: 2000 Quality Management Systems – Requirements.
  • Biosecurity Act 1993.
  • Biosecurity New Zealand Standard 155.04.03: 2005 – A Standard for Diagnostic Facilities which undertake the Identification of New Organisms, excluding Animal Pathogens.
  • Biosecurity (Costs) Regulations 2006.
  • Cartagena Protocol on Biosafety 2000.
  • Hazardous Substances and New Organisms (HSNO) Act 1996.
  • Hazardous Substances and New Organisms (organisms not genetically modified) Regulations 1998.
  • HSNO (Low-Risk Genetic Modification) Regulations 2003.
  • Import and Exports (living modified organisms) Prohibition Regulations 2005.
  • Import Health Standards. www.biosecurity.govt.nz/commercial-imports/plant-imports/relevant-import-health-standards-and-application
  • International Air Transport Association (IATA) Dangerous Goods Regulations (2005).
  • NZS/ISO/IEC 17025: 2005 - General Requirements for the Competence of Testing and Calibration Laboratories.
  • Privacy Act 1993.

Many of the New Zealand legislative documents can be accessed via the following site: http://www.pco.parliament.govt.nz/legislation/accessing.shtml (offsite link to www.pco.parliament.govt.nz)

4 Terms and Definitions

For the purposes of this Standard the following terms and definitions apply::

Act, the

The Biosecurity Act 1993

audit

A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled

Authority (the)

Environmental Risk Management Authority. A quasi-judicial decision-making body (and also the Governing Board of ERMA New Zealand).

biosecurity clearance

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

NOTE: Goods given biosecurity clearance by an Inspector are released to the importer without restrictions.

biosecurity direction

Written authority from an Inspector, given under section 25 of the Biosecurity Act (1993), to move uncleared goods from a transitional facility or biosecurity control area to another transitional facility, containment facility or biosecurity control area, or to export those goods from New Zealand.

chief technical officer (CTO)

The persons appointed by the Director-General as chief technical officers under section 101 of the Biosecurity Act 1993.

containment facility

A place approved in accordance with section 39 of the Biosecurity Act 1993, for holding organisms that should not, whether for the time being or ever, become established in New Zealand.

controls (HSNO Act 1996)

Any obligations or restrictions imposed on any hazardous substance or new organism, or on any person in relation to any hazardous substance or new organism, by this or any other Act or any regulations, rules, codes, or other documents made in accordance with the provisions of this or any other Act for the purposes of controlling the adverse effects of that substance or organism on people or the environment..

corrective action request (CAR)

A request for a corrective action within a report prepared by an Inspector, necessary to remedy a non-compliance found during a facility audit.

critical situation report (CSR)
A report prepared by an Inspector detailing any critical or major non-compliances found during a facility audit.

develop

Under section 2 of the HSNO Act 2003 develop, in relation to new organisms,

  • (a) means:
    • (i) genetic modification;
    • (ii) regeneration of a new organism from biological material of the organism that cannot, without human intervention, be used to reproduce the organism;
    • (iii) fermentation of a microorganism that is a new organism;
  • (b) does not include field testing.

Director-General

The chief executive of the Ministry of Agriculture and Forestry.

ERMA New Zealand

Is made up of the following three components:

  • The Authority - makes decisions on applications to import hazardous substances and new organisms (including genetically modified organisms) into New Zealand, as well as their development and particular use in New Zealand, under the Hazardous Substances and New Organisms (HSNO) Act 1996;
  • Ngā Kaihautū Tikanga Taiao - a committee to advise and assist the Authority from a Māori perspective; and
  • the Agency - the administrative support organisation for the Authority. The Agency’s role includes advising applicants and evaluating and reviewing applications to assist the Authority.

fermentation vessel

A container for liquid culturing or 'bulking up' of microorganisms, often used for the production of chemicals such as alcohol. For the purpose of the HSNO Act a fermentation vessel must be so designed as to prevent the release of the organism into the surrounding environment.

genetically modified organism (GMO)

Unless expressly provided otherwise by regulations, any organism in which any of the genes or other genetic material:

  • (a) have been modified by in vitro techniques; or
  • (b) are inherited or otherwise derived, through any number of replications, from any genes or other genetic material which has been modified by in vitro techniques.

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..

Inspector

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

Institutional Biological Safety Committee (IBSC)
Committees with delegated authority from ERMA New Zealand under sections 19, 40 and 42 of the HSNO Act 1996 to assess applications for the:

  • (a) development of low-risk genetically modified organisms in containment; and
  • (b) importation of low-risk genetically modified organisms into containment.

IBSCs also assign containment levels for organisms as prescribed in the HSNO (Low-Risk Genetic Modification) Regulations 2003.

in vitroo

Used to describe the experimental reproduction of biological processes in artificial environments, usually outside living organisms.

Living Modified Organism (LMO)

Includes genetically modified organisms and organisms produced by the fusion of cells from different taxonomic families.

low-risk genetic modification

Refers to modifications as defined in the HSNO (Low-Risk Genetic Modification) Regulations 2003.

microorganism

A microscopic organism including protozoa, fungi, archaea, bacteria, viruses and unicellular algae.

new organism

Under section 2 of the HSNO Act 1996 new organism means (with some qualifications):

  • (a) an organism belonging to a species that was not present in New Zealand 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 belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand.

non-compliance

An incidence where the requirements of MAF Standards, conditions and HSNO approvals are not met. Three levels are defined:

  • (a) critical non-compliance - A breach in containment, or a situation that may present a serious risk to biosecurity, the environment, or to the health and safety of people and communities, or result in a decrease in confidence to prevent the occurrence of a serious risk;
  • (b) major non-compliance - A major non-compliance is defined as an incident that may cause or may lead to a biosecurity risk;
  • (c) minor non-compliance - An incident that results in the decrease in confidence in the quality management processes but may not immediately cause or lead to a biosecurity risk.

operator

The person or organisation, approved by the Director-General, who has overall responsibility for a facility, under section 40 of the Biosecurity Act 1993..

organism

Under section 2 of the HSNO Act 1996, an organism:

  • (a) does not include a human being:
    • (ab) includes a human cell:
  • (b) includes a micro-organism:
  • (c) includes a genetic structure, [other than a human cell], 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 to be an organism for the purposes of the Biosecurity Act 1993:
  • (e) includes a reproductive cell or developmental stage of an organism.

permit to import

A written order issued by the Director-General of MAF authorising the importation of risk goods to a specified facility..

pest

An organism specified as a pest in a pest management strategy.

Quality Management System

The term ‘quality management system’ in this standard means the quality, administrative and technical systems that govern the operations of a facility.

risk goods

Any organism, organic material, or other thing, or substance, that (by reason of its nature, origin, or other relevant factors) may constitute, harbours, or contain 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.

tissue culture

A culture of tissue (plant or animal) growing in a culture medium (in vitro).

transitional facility

  • (a) Any place approved as a transitional facility in accordance with section 39 of the Biosecurity Act 1993 for the purpose of inspection, storage, treatment, quarantine, holding, or destruction of uncleared goods; or
  • (b) A part of a port declared to be a transitional facility in accordance with section 39 of the Biosecurity Act 1993.

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 the Authority has declined approval to import that organism; and
    • (ii) Any organism specified in Schedule 2 of the Hazardous Substances and New Organisms Act 1996; but
  • (b) Does not include any new 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 the Authority and taking into account any comments made by the Authority concerning the organism, believes that the organism is capable or potentially capable of causing unwanted harm to any natural and physical resources or human health.

vermin

Organisms that are to be excluded from the facility, e.g. rodents, birds, invertebrates etc.

5 AAcronyms

CAR Corrective Action Request

CSR Critical Situation Report

CTO chief technical officer

GMO Genetically Modified Organism

HSNO Hazardous Substances and New Organisms

IBSC Institutional Biological Safety Committee

LMO Living Modified Organism

MAF Ministry of Agriculture and Forestry

MAFQS Ministry of Agriculture and Forestry Quarantine Service

PC Physical Containment

QMS Quality Management System

6 Approval

6.1 APPROVAL OF A FACILITY

6.1.1 General provisions and requirements

Containment and transitional facilities must be approved in accordance with section 39 of the Biosecurity Act 1993. They must have an operator and be constructed and operated in accordance with this Standard (section 8)..

The facilities must comply with:

  • all controls specified by ERMA New Zealand or an IBSC in the approval of new organisms to be contained in the facility;
  • all conditions specified by MAF on a permit to import and in an import health standard, where applicable; and
  • all conditions related to a pest or unwanted organism, specified by a CTO on an exemption, issued pursuant to sections 52 and 53 of the Biosecurity Act 1993, where applicable.

6.1.2 Procedure for approval

Any person wishing to have a facility approved should follow the procedure below:

  • establish contact with the Inspector responsible for the facilities in the applicable geographical area;
  • prior to construction or establishment of the facility, discuss the general provisions and requirements of approval to ensure compliance with this Standard; and
  • prepare a Quality Management System (section 7).

When the operator considers the requirements of this Standard have been met, the Inspector must be requested to inspect the facility and the Quality Management System.

When the Inspector is satisfied that:

  • the operator has met the requirements of sections 6.1.1 and 8 of this Standard;
  • the Quality Management System meets the requirements of this Standard; and
  • the facility application form has been satisfactorily completed by the prospective operator (appendix 1),

then the application form and a copy of the Quality Management System must be sent by the Inspector to the contact person (Biosecurity New Zealand) together with the Inspector’s written recommendation for approval.

Approval of a containment or transitional facility will be in writing..

A facility may be approved for an unspecified time, a specified time or until a specified event.

6.1.3 Modifications to an approved facility

Subsequent to approval, any major modifications to the facility or changes in containment procedures must be notified to the Inspector. Major modifications will require inspection by the Inspector and approval by Biosecurity New Zealand to ensure the facility continues to meet this Standard..

Modifications to a facility may be major or minor structural or operational changes.

Major modifications are those that potentially affect the integrity of containment, such as construction or removal of walls, or significant changes in the description of work to be carried out.

An operator considering major modifications to an approved facility should follow the procedure below:

  • Prior to modification of the facility, contact the Inspector to discuss the modifications and determine whether continued compliance with this Standard is likely.
  • After modifications have been completed, arrange for an on-site inspection with the Inspector to ensure that existing ERMA approvals can be complied with. A new floor and/or site plan may be required.

Minor modifications are those not affecting the integrity of containment, such as changes in procedure or Quality Management System updates. Minor modifications should be recorded and checked by the Inspector at the next visit.

6.2 APPROVAL OF THE OPERATOR

6.2.1 General provisions and requirements

The operator is ultimately responsible for ensuring that organisms are held in containment..

The operator is a person, normally an individual (business owner, director or manager), but may be the Crown, a corporation sole, or a body of persons (whether corporate or unincorporate). If the operator is the Crown, corporation sole, or a body of persons, then an individual must be nominated who has delegated and written authority for the resourcing and operation of the facility, as per the provisions under section 6.1. This individual will nominally be the operator.

The operator is responsible for the operation of a facility, ensuring mechanisms are in place for resourcing the facility to operate to this Standard (section 6.1.1) and ensuring that the requirements of the Quality Management System (section 7) can be met.

An operator must be approved by the Director-General 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 operate the facility;
  • has the authority to resource and operate the facility; and
  • has the technical and financial resourcing mechanisms in place to maintain that facility.

6.2.2 Procedure for approval

A person wishing to be approved as an operator of a facility should follow the procedure below::

contact the Inspector responsible for the supervision of facilities in the applicable geographical area to discuss the general provisions and requirements of approval; and

complete the application form and consent to disclosure forms in Appendix II, and send to the Inspector, with any attachments.

The Inspector must be satisfied that the requirements of section 6.2.1 of this Standard, can be met.

The Inspector will forward the application to the contact person together with their written recommendation for approval.

Approval of a facility operator will be in writing.

6.2.3 Leased facilities

If a facility, or part of a facility, is leased, the lessee responsible for the operation of the leased facility may apply to be the operator. This includes situations where parts of a facility have been leased to, or used non-gratia by, another facility operator. Arrangements for management of the facility will be determined through discussion between the owner and the lessee in consultation with the Inspector and must be approved by the Inspector..

The lease contract, or non-gratia arrangement, with the owner must clearly identify the operator responsible for the maintenance of the facility and meeting the general provisions and requirements for approval (section 6.1.1.).

The lease must be made available to the Inspector who must be satisfied that no part of the lease contract must override the requirements of this Standard for the operation of the facility.

6.2.4 Personal information on individuals

In accordance with Principle 3 of the Privacy Act 1993, all information collected on applicants, identifying, or capable of identifying, an individual person, is personal information..

The information is collected for purposes relating to the approval as an operator under 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.

Under Principles 6 and 7 of the Privacy Act 1993, an individual has the right of access to, and correction of, any personal information which has been provided.

6.2.5 Changes to Operator

The Inspector must be notified of any proposed changes to the facility operator, or individuals nominally appointed as operator. Prospective new operators must complete an application according to section 6.2.2..

NOTE: It is illegal for a facility to operate without an approved operator (Section 40 (6) of the Biosecurity Act 1993).

6.3 CANCELLATION OF APPROVAL OF A FACILITY OR OPERATOR

A facility’s approval may be cancelled in accordance with section 39 of the Biosecurity Act 1993 if:

  • the facility no longer complies with the requirements of this Standard; or
  • the Director-General is satisfied the facility is no longer used for the purpose specified in the approval.

An operator’s approval may be cancelled in accordance with section 40 of the Biosecurity Act 1993 if the Director-General is satisfied that:

  • the operator is no longer operating the facility in compliance with this Standard;
  • the operator is no longer a fit and proper person to operate the facility; or
  • the operator has ceased to act as operator of the facility.

Notice of cancellation will be given in writing to the operator

7 Quality Management System

7.1 GENERAL PROVISIONS AND REQUIREMENTS

The operator must prepare, maintain and implement a Quality Management System (QMS) based on the principles of, but not requiring accreditation to, AS/NZS ISO 9001:2000, AS/NZS ISO 17025:2005, or similar recognised quality system.

This means that the QMS must demonstrate the adoption of policies and procedures to:

address how the requirements of this Standard are to be met; and

measure and monitor the effectiveness of containment procedures and demonstrate how this process is used to continually improve the QMS.

The QMS should be documented as a “containment manual” or in an alternative quality system format. Facilities accredited to AS/NZS ISO 9001:2000 or NZS ISO/IEC 17025: 2005, for example, do not need a separate manual, provided that the requirements of this Standard are covered in their quality system and can be readily accessed.

The Inspector must approve the quality management system and have access to a current copy.

The items included in section 7.2 are the minimum specific requirements of the QMS.

7.2 SPECIFIC REQUIREMENTS

7.2.1 Containment

Describe the main functions of the organisation and the reason(s) for holding or working with the microorganisms and/or tissue cultures.

Document procedures describing how the facility will be operated to meet:

  • containment controls set by ERMA New Zealand or an IBSC, and/or conditions specified by permit(s) to import, import health standard(s), and CTO exemptions;
  • how work practices will meet these controls and/or conditions and how the facility will monitor this; and
  • the structural and operational requirements of this Standard (section 8).

Provide a floor plan showing:

  • the general layout of the facility;
  • the location and identity of laboratories within the facility, identifying areas of physical containment (PC); and
  • the storage location of microorganisms and/or tissue cultures that are subject to the requirements of this standard.

7.2.2 Management

Identify the operator and the individual nominally appointed as the operator, if applicable, and specify the responsibilities of the operator in relation to complying with the requirements of this Standard. Specify how the operator will:

  • keep under review the policies and implementation of containment procedures and ensure they are effective;
  • communicate to the organisation the importance of complying with the regulatory requirements and the escalation implications of non-compliance;
  • take full account of the advice of delegated managers, including biological safety officers and IBSCs where applicable;
  • implement initial and continued training programmes commensurate with the level of containment;
  • ensure that containment procedures are documented and put into practice;
  • implement a safety programme which is consistent with biosecurity requirements, such as the AS/NZS 2243.3:2202;
  • prepare and implement emergency plans and procedures.

Identify all other individuals with management responsibility and specific delegations and specify their responsibilities. This includes delegated managers, project leaders, curators and other approved users.

7.2.3 Training programme

The QMS must include a training programme that ensures that all people who work in the facility are familiar with the principles of containment and the procedures used in the facility to maintain containment. All people should have appropriate working knowledge commensurate with their responsibilities within the facility.

The training programme must describe how people working in the facility will be made aware of, and understand:

  • the requirements of this Standard;
  • the statutory and regulatory requirements which relate to work with microorganisms in containment, including for example the HSNO (Low-risk Genetic Modification) Regulations 2003.
  • the principles and practice of containment as established in AS/NZS 2243.3.2002, Part 3: Safety in Laboratories - Microbiological Aspects and Containment Facilities;
  • the controls specified by ERMA New Zealand or an IBSC in the development or import of new microorganisms and tissue cultures contained in the facility;
  • the controls specified by ERMA New Zealand or an IBSC for approvals received through transfer from another facility;
  • the conditions specified by MAF in any permit to import and import health standard relating to unwanted microorganisms, tissue cultures and any other microorganism determined by a CTO to be a risk good; and
  • amendments to this Standard.

The QMS must also specify how the training programme is to be implemented and the frequency of refresher courses.

Records of training should be documented for all people working in the facility.

7.2.4 Internal audit

The operator must ensure that an internal audit is carried out at least once every six months to assess the effectiveness of containment policies, risk management, and operational procedures.

Particular emphasis of the internal audit must be placed on verifying that the registers (section 8.6) are accurate and up to date, the training programme is being implemented, is effective, and any corrective actions have been resolved in a timely manner.

All internal audit reports and any corrective actions, including completed actions, must be documented.

7.2.5 Amendments

The operator must update the QMS to incorporate:

  • controls of any subsequent approvals granted by ERMA New Zealand or an IBSC;
  • controls accompanying any transfers from another facility;
  • conditions required by any subsequent permits to import;
  • exemptions granted by a CTO; and
  • any subsequent amendments made to this Standard and any relevant import health standard or operational standard.

The operator must review the QMS at least once a year to ensure that it is appropriate and effective, and to introduce any identified changes or improvements.

Reviews of the QMS must be documented and a copy of the new version must be sent to the Inspector.

7.2.6 Document control

The operator must have a document control system to record any amendments to the QMS.

The version number and issue date of the documented QMS must be recorded on each page. The nature of amendments, and the person responsible, must be recorded.

8 Structural and Operational Requirements

8.1 GENERAL PROVISIONS AND REQUIREMENTS

Facilities must be constructed and operated in a manner to ensure that microorganisms and tissue cultures are securely contained and held only within the facility.

The requirements of this Standard may be supplemented by:

  • additional controls specified by ERMA New Zealand or an IBSC, when approving a new microorganism or tissue culture in a containment facility,
  • additional conditions specified by MAF in a permit to import or import health standard, or
  • exemptions granted by a CTO3.

8.2 PHYSICAL CONTAINMENT

AS/NZS 2243.3:2002 stipulates the minimum requirements of physical containment (PC) and includes all requirements of AS/NZS 2982.1:1997 - Laboratory Design and Construction – Part I: General Requirements. Appendix B of AS/NZS 2982.1:1997 specifies additional PC requirements for microbiological laboratories.

The minimum requirements for PC1 and PC2 will be those identified in AS/NZS 2243.3:2002 except for the deviations described as follows:

  • the specifications of section 4.8.3(a) relating to ceilings are not required. However, ceilings must, at a minimum, be constructed of a semi-rigid material4. Operators of facilities not currently meeting the ceiling requirements of AS/NZS 2243.3:2002 should seek advice on whether to instigate a work programme to reach compliance. It is highly recommended that new facilities endeavour to meet the ceiling specifications of AS/NZS 2243.3:2002:
  • emergency drench showers (section 4.8.3(e)) and non-slip floors (section 4.8.3(a)) are not required:
  • fly screens are not required on opening windows (Appendix B 4(d) of AS/NZS 2982.1:1997) unless specified by ERMA New Zealand and/or MAF:
  • ventilation in PC2 laboratories – where a risk assessment shows that it is required5, specific types of work must be conducted in a laboratory with either:
    • a ventilation system that establishes a negative pressure in the laboratory so that there is a directional airflow into the working area. (refer to AS/NZS 2243.3: 2002, section 4.8.3.f); or
    • a class II biological safety cabinet (refer to AS/NZS 2243.3: 2002, section 6.7):
    • laboratories that contain fermentation vessels must have a spill management system in place that is able to contain the full volume of any potential spills, which includes scientifically validated methods for devitalisation and procedures for the subsequent disposal of the culture.

The minimum requirements for PC3 and PC4 will be those identified in AS/NZS 2243.3:2002.

8.2.1 Physical containment of unidentified microorganisms

This section relates to facilities working with unidentified microorganisms, primarily those isolated from border interceptions or found within New Zealand which are suspected of being risk goods.

Facilities working with unidentified microorganisms must have documented procedures for determining the risk category of organisms, with reference to OIE or AS/NZS 2243.3: 2002 risk grouping determinations, and must assign the appropriate level of containment.

Facilities contracted to hold microorganisms in these categories must be registered to this Standard.

The minimum physical containment level for a laboratory working with unidentified microorganisms from animals is PC2. For investigations into suspected unwanted (under the Biosecurity Act 1993) or new (as defined by the HSNO Act 1996) organisms, the level of containment required for diagnostic samples will be determined by Biosecurity New Zealand. Exotic disease organisms, which may be risk group 3 and above (as defined by OIE or 2243:3 risk groupings), may be required to be held at PC3.

Unidentified microorganisms found on plants intercepted at the border, held in transitional facilities (post-entry quarantine), or held as part of incursion investigations must be held at PC2 with the following additional requirements:

  • External windows must be closed and sealed;
  • Areas used as offices by laboratory personnel must be separated from the laboratory;
  • A pressure steam sterilizer for decontamination of laboratory wastes must be available, preferably located in the laboratory where the waste is generated. Where the steriliser is outside the laboratory, the wastes must be bagged and placed in an unbreakable container with a secure lid for transport to the steriliser. Unsterilised wastes must not be stored outside the facility. Transport containers must have provision for penetration of steam during sterilizing.
  • To reduce the risk of escape of viable airborne microorganisms or propagules, the movement of potentially contaminated air must be controlled by either:
    • provision of a ventilation system that establishes a negative pressure in the facility so that there is a directional airflow into the working area. The pressure differential must be achieved by means of an independent room exhaust fan discharging to the outside atmosphere through a HEPA filter (section 4.8.3; AS/NZS 2243.3: 2002). Additionally, all fume hoods that discharge to the outside atmosphere must be fitted with HEPA filters; or
    • conducting all work in a Class II biological safety cabinet (section 6.7; AS/NZS 2243.3). Only preparations in which the organism is killed or contained (e.g. slides, sealed tubes, etc.) may be handled outside the cabinet.

Note: If a new or unwanted organism identified in a diagnostic laboratory is to be propagated for further work (including development under the HSNO Act 1996) an ERMA New Zealand approval is required and/or a CTO permission under section 53 of the Biosecurity Act 1993.

ERMA approval is not required to undertake identification of potentially new organisms, only once that organism has been identified as new, and the requirement is to hold or propagate further.

8.2.2 Exposure of plants or animals to experimental organisms

Where microorganisms are used on experimental organisms (such as plants or animals) the operator must hold a copy of the approval and the containment controls set by the Authority for the microorganism (if it is a new organism).

Minimum containment requirements identified in the relevant MAF Biosecurity New Zealand and ERMA New Zealand Standards must be provided to ensure no escape from containment or other adverse effects.

NOTE: Any work involving the manipulation of animals, as defined in the Animal Welfare Act 1999, must be in accordance with the code of recommendations and minimum standards for the welfare of animals. This requirement is independent of this Standard.

8.3 ERMA NEW ZEALAND APPROVAL & IBSC DECISION DOCUMENTATION

The operator must hold documented evidence of approval and containment controls set by ERMA New Zealand or an IBSC, as appropriate, and any exemptions granted by a CTO, for the following:

  • microorganisms and/or tissue cultures that are new organisms but not genetically modified;
  • genetically modified microorganisms and/or tissue cultures that contain low-risk genetic modifications (as defined in the HSNO (Low-Risk Genetic Modification) Regulations 2003), specifying the category6 to which the modification belongs and the PC level;
  • genetically modified microorganisms and/or tissue cultures that contain genetic modifications that are not low-risk genetic modifications (as defined in the HSNO (Low-Risk Genetic Modification) Regulations 2003);
  • microorganisms that are unwanted organisms. A copy of the exemption granted by a CTO will specify the PC level and any additional conditions.

NOTE: Under sections 52 and 53 of the Biosecurity Act 1993, the propagation of unwanted organisms requires CTO approval.

8.4 STORAGE

Microorganisms and tissue cultures may not always be in active use, especially those under inactive ERMA New Zealand approvals, and may form part of a culture collection. They must be adequately labelled and securely stored to prevent unauthorised access. Lockable freezers must be used where unauthorised persons may have access to the freezer room.

8.5 ACCESS

In addition to the access requirements for each PC level described in AS/NZS 2243.3: 2002:

  • signs must indicate that unauthorised entry to the facility is prohibited;
  • procedures must be established to prevent unauthorised access to the facility; and
  • entrances to the facility must be kept locked, except when in active use.

Access to the facility must, in the main, be limited to trained personnel authorised to work in the facility. However, visitors essential for the operation of the facility may be permitted entry. Their visit must be recorded in a visitors log book. They must adhere to access procedures and be accompanied by trained personnel as indicated above.

Entry and exit procedures must be available at the entrance to the facility, covering such things as laboratory coats and protective clothing, signing access log books, and hand washing.

8.6 TREATMENT AND DISPOSAL OF BIOLOGICAL WASTE

The requirements for treatment and disposal of biological waste (including viable microorganisms organisms and tissue cultures) are described in AS/NZS 2243.3: 2002. Devitalisation and disposal procedures of biological waste must be scientifically validated.

No viable microorganisms or tissue cultures may be removed from a facility, except with approval from the inspector. New organisms are subject to treatment and disposal in accordance with controls as set by ERMA New Zealand which may be in addition to the requirements of this Standard. Procedures must be established to ensure that no accidental or unintended removal occurs.

8.7 REGISTERS

8.7.1 Register of ERMA New Zealand and IBSC Approvals

The operator must maintain a register of all ERMA New Zealand approvals and IBSC decisions and containment controls7 for new microorganisms and/or new tissue cultures.

For each ERMA/IBSC decision number(s) or code(s), the register must record or identify:

  • whether work is active or ceased permanently (noting date);
  • the project leader or curator.

In addition for GMOs it must be possible to:

  • identify the name of the project(s);
  • provide a description of the:
    • species and strain of host;
    • vector and insert DNA;
    • donor species DNA.

For some ERMA New Zealand approvals and IBSC decisions it is not practical to identify and describe all GMOs developed as intermediaries within a project. Where development leads to a GMO, or a collection of GMOs (such as cDNA libraries) that will be held and stored, that GMO or collection must be recorded in the register. For every GMO developed including intermediaries it must be possible to track to the appropriate ERMA New Zealand approval or IBSC decision.

The register must be updated within 10 days of receipt of an ERMA New Zealand approval, IBSC decision, or transfer of material to the facility.

8.7.2 Records of microorganisms and tissue cultures

Records must be kept listing the microorganisms and tissue cultures held in the facility for the following categories:

  • imported microorganisms which are not new;
  • imported tissue cultures which are not new;
  • unwanted microorganisms that are not new;
  • other microorganisms which are risk goods but not on MAF’s Unwanted Organism Register.

The records must be able to distinguish listings for microorganisms in each of these categories.

The records must include microorganisms and tissue cultures imported through transfer from another facility.

8.7.3 IBSC approvals

IBSC approvals are institution specific unless otherwise stated. Therefore transfer of genetically modified organisms for further development is not permitted.

NOTE: another facility’s approval cannot be used for further development of a genetically modified organism.

8.7.4 ERMA New Zealand GMD approvals

ERMA New Zealand GMD approvals are institution specific and organisms developed under this type of approval cannot be transferred to another facility.

NOTE: another facility’s approval cannot be used for further development of a genetically modified organism.

8.8 TRANSFER OF MICROORGANISMS AND TISSUE CULTURES

8.8.1 General requirements

Copies of the transfer documents are available from the facility Inspector. All material being transferred between facilities or shipped overseas must be packaged as per IATA regulations according to risk. These regulations define the requirements for certification, the maximum quantities that can be transported by cargo or passenger aircraft, the external labelling requirements (including the identifying United Nations number) and the details to be included in the attached Shippers Declaration for Dangerous Goods where applicable.

Operators should ensure to the best of their ability that goods being imported into New Zealand should be packaged as per IATA regulations according to risk.

The minimum requirement is for for microorganisms and tissue cultures to be packaged according to Packing Instruction No. 650 of the IATA Dangerous Goods Regulations.

All products that are infectious or potentially infectious for humans or animals must be packaged according to Packaging Instructions No. 602 of the IATA Dangerous Goods Regulations.

AS/NZS2243.3.2002 provides some detail on the packaging and transport requirements for microorganisms, however the IATA Dangerous Goods Regulations are updated annually and the current edition should be consulted.

8.8.2 Transfer within New Zealand

Transfer applications should be given to the facility Inspector. The operator, or approved signatory, must authorise in writing, an application8 to the Inspector for transfer of a new microorganism or tissue culture (including GMOs) to another facility within New Zealand or overseas.

Persons with signatory approval for transfers must be approved by the facility Inspector.

The facility Inspector will send a copy of the approved application to the operator of the receiving facility by fax or email.

The approved transfer application form (and ERMA New Zealand decision control documents) must accompany the transfer.

The Inspector must seek approval from a chief technical officer for transfers of any microorganisms or tissue cultures having a containment requirement of PC3 or above.

The receiving facility must be registered to this Standard and approved as having the appropriate PC level to contain the microorganism or tissue culture.

The operator of the receiving facility, or person with delegated authority, must confirm receipt of the microorganism or cell line to the Inspector of that facility.

8.8.3 Multiple transfers

Before authorisation is given to facilities requesting a multiple transfer, MAF must be confident that those facilities will keep accurate records of all transfers and will engage with receiving facilities in terms of meeting transfer requirements and confirming receipt of items. This process must be clearly documented in facility manuals before transfers are able to be authorized. No multiple transfers will be issued if the procedures for recording and tracking of the items are not specifically documented in the sender's manual and the receiving facility manual.

8.8.4 Transfer to a facility overseas (export)

The export of non-GMOs must meet the requirements of Section 8.8.1.

The export of Living Modified Organisms (LMOs)9 overseas is governed internationally by the Cartagena Biosafety Protocol, and nationally by the Import and Exports (living modified organisms) Prohibition Regulations 2005. All exporters are required to comply with the regulations. Exporters intending to export LMOs overseas should first contact ERMA New Zealand to seek advice on the process.

Exporters will need to complete a Transfer Request form which must also include ERMA’s Biosafety Clearing House10 Reference Number (BCH Record ID) to verify the export has been approved. No additional documentation is required, other than what would routinely accompany the export.

8.9 CONTINGENCY PLANS

The operator must ensure that contingency plans are in place for:

  • the accidental spillage of microorganisms or tissue cultures within the facility (see AS/NZS 2243.3:2002); and
  • the release of microorganisms or tissue cultures outside the facility through accident, deliberate action, natural disaster, fire, sabotage, theft, or any other emergency.

Contingency plans must ensure that resources are identified and made available for the contingency.

In the event of any spillage or breach of containment of the organism, the contingency plan for the attempted retrieval or destruction of the organism that has escaped must be implemented immediately.

The release of microorganisms or tissue cultures from a facility constitutes a non-compliance, through a breach of containment. In such an event, the Inspector must be advised as soon as practicable and at least within 24 hours.

8.10 VERMIN CONTROL PROGRAMME

A vermin control programme must be instituted that describes how pest animals such as rodents, birds and invertebrates are to be excluded, how surveillance for their presence is to be maintained and what control activities will be undertaken if detected.

8.11 EXTERNAL AUDIT

The operator must provide Inspectors, or any other representative of a CTO, and enforcement officers, access to the facility, records and documents for inspection and audit. The operator must be available to assist and ensure that all relevant procedures and records are made available.

MAF reserves the right to audit at any time, especially if a non-compliance is found.

8.12 AUDIT FREQUENCY DISPENSATION FOR CONSISTENTLY WELL RUN FACILITIES

There is provision for MAF to grant dispensation to facility operators who continually perform well in their external audits, which enables the Inspector to decrease the frequency of audits. The compliance history for the facility over the last two years will be considered. If there are no CSRs or major CARs, and fewer than two minor CARs (promptly resolved) over the last two years, then the operator can request dispensation from MAF. If a CSR, major CAR or greater than two minor CARs are identified in any subsequent audit, the dispensation will be cancelled and the original audit frequency will be resumed.

8.13 NON-COMPLIANCE

Non-compliances are reported to the facility through the facility audit report for all corrective action requests (CAR). This report details the non-compliance and lists the corrective actions required and the timeframe for these corrective actions to be completed. Critical non-compliances are reported to the operator and MAF Biosecurity New Zealand through a Critical Situation Report (CSR) for critical and major non-compliances.

Incidents of non-compliance are managed by MAF through an escalation pathway based on the level and frequency of non-compliance. Escalation ranges from a minor breach of ERMA New Zealand/IBSC controls, requiring notification to ERMA New Zealand by MAF through its regular reporting procedures, through to serious breaches, requiring investigation and possible prosecution.

Operators that receive CARs or CSRs as a result of an audit may, at the discretion of the Inspector and in consultation with Biosecurity New Zealand, be subject to an increased number of audits or inspections until the Inspector can be confident that the facility is again compliant with this Standard. The principles of natural justice will be followed such that any non-compliances found during an audit or inspection can be appealed by the operator to the Inspector. Non-compliances will be graded according to the following criteria:

8.13.1 Critical non-compliance

A critical non-compliance is defined as an incident that caused or could have caused a significant biosecurity risk. It may be a breach in containment, or a situation that may present a serious risk to biosecurity, the environment, or to the health and safety of people and communities, or result in a decrease in confidence to prevent the occurrence of a serious risk. Cancellation of approval for that facility may be considered.

Examples of critical non-compliances include (but are not limited to) the following:

  • releasing organisms from a transitional facility without biosecurity clearance;
  • releasing organisms from a containment facility without an ERMA approval;
  • a significant structural failure in the containment provisions of a facility;
  • operating a facility without an approved operator;
  • operator allowing uncleared good to be transferred to non-approved premises;
  • making major modifications to buildings or facility services (e.g. Air handling systems) without MAF approval;
  • using an ERMA New Zealand approval specific to another facility.

In the event of a critical non-compliance, the operator must:

  1. notify the Inspector immediately;
  2. discontinue any activity that presents a biosecurity risk;
  3. take immediate corrective action to restore compliance.11

The following procedures must apply:

  • an investigation and report, via a critical situation report, must be lodged by the Inspector within 24 hours;
  • the Inspector may direct that all work using microorganisms or tissue cultures ceases immediately until the non-compliance is rectified.

At least one revisit audit will be required to ensure that the non-compliance has been effectively resolved and measures have been to taken to prevent its recurrence.

8.13.2 Major non-compliance

A major non-compliance is defined as an incident that may cause or may lead to a biosecurity risk. Corrective actions need to be implemented immediately in order to retain confidence that the facility continues to meet the requirements of this Standard.

Major non-compliances include (but are not limited to) the following:

  • failure of the operator to detect significant and obvious non-compliances;
  • lab coats not being worn;
  • failure to keep appropriate records and copies of documents and MAF directions/approvals;
  • activities conducted outside the scope of the ERMA New Zealand approval;
  • failure to operate the facility to the specifications of this Operational Standard and relevant HSNO approvals; e.g.
    • lab coats not being worn;
    • cracked lino floors.

In the event of a major non-compliance the operator must:

  • notify the Inspector within 24 hours;
  • take immediate corrective action to restore the facility or operating system to a compliant condition;
  • discontinue any activity that presents a biosecurity risk.

8.13.3 Minor non-compliance

A minor non-compliance is defined as an incident that results in a decrease in confidence in the management of the facility but may not immediately cause or lead to a biosecurity risk.

Minor non-compliances include (but are not limited to) the following:

  • manuals not up to date;
  • transfers and inventory not accurate;
  • boxes on the floor;
  • failure to maintain staff training records;
  • missing signage.

In the event of a minor non-compliance, the operator must:

  • take corrective action to rectify the non-compliance within an acceptable time frame;
  • record the incident and notify the Inspector on the next audit or visit.

In addition to critical, major and minor non-compliance, Inspectors may find reason to make recommendations to assist a facility with compliance to a standard. These are not non-compliances, however if attention is not given to these items they may become future non-compliances. These recommendations are not subject to corrective action requests.

8.14 COSTS

The operator is required to pay all costs associated with the approval and inspection of a facility in accordance with the Biosecurity Act 1993 and its regulations12.

8.15 RECORDS

The operator must keep records as required for the Quality Management System.

Records must be kept for a minimum of seven years from receipt, preparation or amendment and must include, as a minimum:

  • records of the facility (plans, specifications, structural details);
  • facility and operator approvals;
  • copies of permits to import and conditions, biosecurity clearances, import health standards, and authorisations for transfer from MAF;
  • copies of decisions and controls from ERMA New Zealand or an IBSC; and
  • records of internal and external audits and corrective actions.

Records relating to the organism/tissue culture itself must be kept for a minimum of seven years after the new organism is destroyed.

9 Appendices

Appendix 1 Application Form for Approval of a Facility for Microorganisms and Tissue Cultures

Appendix 2 Application Form for Approval of an operator of a Containment/Transitional Facility

Collection of Personal Information on Individuals

Appendix 3 Consent to Disclosure of Information

Appendix 1 Application Form for Approval of a Transitional or Containment Facility

APPLICATION FOR APPROVAL OF A

TRANSITIONAL OR CONTAINMENT FACILITY

(Pursuant to section 39 of the Biosecurity Act 1993)

An application for approval of a transitional or containment facility must be made to the Director-General, using this form.

This application form is an approved form in accordance with section 39(2) of the Biosecurity Act 1993.

Send the completed application form and other documentation to the Inspector who will be responsible for supervision of the transitional or containment facility (contact details are listed in the relevant Standard).

If there is any change to the contact details provided in this application, you must inform Biosecurity New Zealand, PO Box 2526, Wellington, in writing.

Refer to the Privacy Act notice on page 35 regarding the collection of personal information on individuals.

Type of Facility (transitional or containment):

Name of Facility:

Purpose of Facility:

Physical Location (attach a site plan)13:

Postal Address:

Telephone No: Facsimile:

E-mail:

Nature of the Goods to be held in the Facility:

Proposed Physical Containment level(s):

Full Name of Operator:

Full Name of Facility Manager14:

Applicant Declaration:

I,

(full legal name)

being the applicant for the approval of the above transitional/containment (delete one) facility, declaring that the above facility meets the requirements of:

ERMA New Zealand and MAF Biosecurity New Zealand Standard - Facilities for Microorganisms and Tissue Cultures: 2007

apply to have it approved by the Director-General as a transitional/containment (delete one) facility for the purpose stated above.

I include with this application:

A copy of the approved Quality Assurance Programme.

A site plan of the facility showing the relationship of the facility to other rooms or buildings.

Full Name of Applicant:

Signature of Applicant:

Date:

Appendix 2 Application Form for Approval as an Operator of a Transitional or Containment Facility

APPLICATION FOR APPROVAL AS AN OPERATOR OF A TRANSITIONAL OR CONTAINMENT FACILITY

(Pursuant to section 40 of the Biosecurity Act 1993)

An application for approval as an operator of a transitional or containment facility must be made to the Director-General, using this form.

This application form is an approved form in accordance with section 40(1) of the Biosecurity Act 1993.

Send the completed application form and other documentation to the Inspector who will be responsible for supervision of the transitional or containment facility (contact details are listed in the relevant Standard).

If there is any change to the contact details provided in this application, you must inform Biosecurity New Zealand, PO Box 2526, Wellington, in writing.

Refer to the Privacy Act notice at the end of this form regarding the collection of personal information on individuals.

Type of Facility (transitional or containment):

Name of Facility:

Purpose of Facility:

Physical Location:

Postal Address:

Telephone No: Facsimile:

E-mail:

Full Legal Name of Proposed Operator:

Designation:

Full Legal Name of Facility Manager15:

Applicant Declaration:

I,

(full legal name)

being the person (the proposed operator) responsible for the facility named above, declare that:

  • (a) I am able to comply with the ERMA New Zealand and MAF Biosecurity New Zealand Standard – Facilities for Microorganisms and Tissue Cultures: 2007.
  • (b) I will ensure that the operation of the facility is in accordance with this Standard.

I hereby apply for approval as the operator of the above facility.

I include with this application:

Evidence showing that I meet the requirements to be an operator (section 6.2.1).

A signed copy of the consent to disclosure of information by the New Zealand Police.

Signature of Applicant:

Date:

Collection of Personal Information on Individuals

In regard to any personal information being collected on this application for approval of a transitional or containment facility operator under the Biosecurity Act 1993 (that is personal information about an identifiable individual), notification is hereby provided in accordance with Principle 3 of the Privacy Act 1993, to individuals of the following matters:

  1. This information is being collected for purposes relating to approval of a transitional or containment facility operator and administration of the Biosecurity Act 1993.
  2. The recipient of this information, which is also the agency that will collect and hold the information, is Biosecurity New Zealand, PO Box 2526, Wellington.
  3. The collection of information is authorized under section 40 of the Biosecurity Act 1993. The provision of this information is necessary in order to process this application. Failure to provide information is likely to result in the return of this application form to the applicant and ultimately may result in a refusal by the Director-General, to approve the applicant as an operator of a transitional or containment facility.
  4. 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.

Appendix 3 Consent to Disclosure of Information

CONSENT TO DISCLOSURE OF INFORMATION

Licensing & Vetting Service Centre
Officer of the Commissioner
PO Box 3017
WELLINGTON

I,

[Surname] [Fore Names]

[Maiden or any other names used]

Sex: [M/F] Date and Place of Birth:

Nationality:

Residential Address:

Suburb:

City:

New Zealand Drivers Licence Number:

hereby consent to the disclosure by the New Zealand Police of any information they may have pursuant to this application to be registered as an operator of a transitional or containment facility, to the Ministry of Agriculture and Forestry.

Signed: Date:

COMMENTS OF THE NEW ZEALAND POLICE

  • 1 HSNO (Low-Risk Genetic Modification) Regulations 2003
  • 2 http://www.biosecurity.govt.nz/commercial-imports/unwanted-organisms-register (offsite link to www.biosecurity.govt.nz)
  • 3 The CTO can be reached by contacting the Operational Standards Team contact person in the first instance.
  • 4 This allows laboratories constructed using a suspended tiling system to comply.
  • 5 Either by ERMA New Zealand (for new organism approvals), by MAF in a permit to import, or by a CTO.
  • 6 Category A developments require a minimum of PC1 containment. Category B developments require a minimum of PC2 containment.
  • 7 Containment controls include this MAF/ERMA Standard as well as those additional controls set by The Authority.
  • 8 Application Forms are obtained from the Inspector (MAFQS)
  • 9 LMOs include GMOs – see definition.
  • 10 http://bch.biodiv.org/ (offsite link to bch.biodiv.org)
  • 11 This should be done in consultation with the Inspector.
  • 12 Biosecurity (Costs) Regulations 2006
  • 13 Showing relationship of the facility to other rooms or buildings
  • 14 If the operator is the Crown, corporation sole, or a body of persons.
  • 15 If the operator is the Crown, corporation sole, or a body of persons.

Page last updated: 30 April 2008