Containment Facilities For Vertebrate Laboratory Animals

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Contents

Endorsement
Review
Amendment Record
1. Introduction
2. Approval of a containment facility and an operator
3. Containment manual
4. Structural and operational requirements

Endorsement

The Authority in accordance with the Hazardous and Substances and New Organisms (HSNO) Act 1996 approves this Standard for the containment of laboratory animals.

____________________ ______________

Bas Walker Date
Chief Executive
ERMA New Zealand

for

Environmental Risk Management Authority

This Standard for the containment of laboratory animals has been approved.

____________________ ______________

Derek Belton Date
Chief Technical Officer
Director Animal Biosecurity
Ministry of Agriculture and Forestry

Review

This MAF Biosecurity Authority Standard is subject to review and amendment at any time, to ensure that it continues to meet current needs. Amendments will be issued to holders of controlled copies and operators of containment facilities approved under this Standard.

The standard is accessible on http://www.biosecurity.govt.nz/animals.htm

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: Date:
1

2

3

4

5

1. Introduction

Scope

This MAF Biosecurity Authority Standard specifies the structural and operating requirements for operators of facilities holding laboratory animals that are new organisms, including genetically modified organisms. It also specifies how these facilities and their operators may be approved.

Background

This Standard applies to laboratory animals that are new organisms, i.e. those that have not been approved for release in New Zealand (e.g. hamsters) and genetically modified laboratory animals.

New organisms may be given approval to be held in containment subject to containment controls imposed by the Environmental Risk Management Authority (the Authority). These new organisms are not eligible for release into New Zealand and the primary purpose of containment is to prevent their escape. They are defined as ‘restricted organisms’ in the Biosecurity Act 1993 and must be held permanently in a containment facility approved under this Act.

In general, and in addition to an approval from the Authority, before any laboratory animal may be imported into New Zealand, a permit to import is required from MAF. Laboratory animals are directed to a containment facility approved to this Standard as a requirement of an import health standard that may specify a period of quarantine on arrival. The primary purpose of quarantine is to minimise the risk of introducing an unwanted organism. On satisfactory completion of the quarantine requirements laboratory animals that are new organisms, such as transgenic rats and mice, will be required to remain in a containment facility.

1.1 References

The following publications are referred to in this MAF Biosecurity Authority Standard:

  • Australian/New Zealand Standard 2243.3: 2002 Safety in laboratories: Microbiological aspects and containment facilities. (AS/NZS 2243.3:2002)
  • Australian/New Zealand Standard ISO 9001:2000 Quality management systems
  • Import health standards for laboratory animals
  • Live Animal Regulations, International Air Transport Association (IATA)
  • Biosecurity Act 1993
  • Hazardous Substances and New Organisms Act 1996 (HSNO)
  • HSNO (Low-Risk Genetic Modification) Regulations 2003

1.2 Definitions

For the purposes of this Standard the following definitions apply:

Approval of a facility and an operator

Approved by the Director-General, MAF, or his/her delegate. The chief technical officer, national manager (Import Management) and national adviser (Import Management) are delegatees for this Standard. The national manager (see below) is the contact person for this Standard.

Audit

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

Authorised movement

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

Biosecurity clearance

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

Chief technical officer

The chief technical officer (as defined in section 101 of the Biosecurity Act.) of MAF with responsibility for animal health in New Zealand. The National Manager, Import Management is the person to contact where reference is made to the chief technical officer in this Standard.

Containment facility

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

Controls

Containment conditions imposed by the Authority or the Institutional Biological Safety Committees (IBSC) for an organism as per section 45 (2) of the HSNO Act. These are additional to those required in this Standard and include assignation of the physical containment level.

Genetically modified organism

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. Section 2, HSNO Act.

Incident

An occurrence involving new organisms, which includes acts of non-compliance either through the failure to have a HSNO approval or a breach of conditions or controls, which is not a declared emergency but either presents or could have presented an unintended risk to the health and safety or the environment. This includes events where an unintended risk was narrowly averted and a series of events that may indicate a trend that causes concern.

Institutional Biological Safety Committee (IBSC)

Has delegated authority from the Authority to assess proposals for development of low-risk genetically modified organisms in containment under sections 19 and 42 of the HSNO Act. They also assign containment levels for approvals made, as prescribed in the HSNO (Low-Risk Genetic Modification) Regulations 2003.

IMPACT

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

Import health standard

A document issued under section 22 of the Biosecurity Act, 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 as an inspector under the Biosecurity Act.

Internal audit

An audit carried out by the company or organisation to evaluate its own performance in relation to the Standard or prescribed criteria.

Laboratory animal

A vertebrate, being a new organism, which is used in a laboratory as an experimental animal. Examples include a hamster and a genetically modified animal such as a sheep, rat, bird or fish. Includes any viable or heritable genetic material e.g. embryos, semen and ova.

MAF Biosecurity Authority

The body within the Ministry of Agriculture and Forestry responsible for regulatory functions.

National Manager, Import Management

The nominal contact person for matters relating to this Standard.

Address: National Manager, Import Management
MAF Biosecurity Authority
Box 2526
Wellington
Fax: (04) 4744 132
Email: corrink@maf.govt.nz mulqueenk@maf.govt.nz

New organism

An organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:

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:

an organism for which a containment approval has been given under this Act:

a genetically modified organism:

an organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand.

Section 2A, HSNO Act.

Operator

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

Organism

Does not include a human being or a genetic structure derived from a human being:

Includes a micro-organism:

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:

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 the Biosecurity Act:

Includes a reproductive cell or developmental stage of an organism:

Section 2, HSNO Act.

Permit to import

A numbered document issued as a requirement of the import health standard.

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.

Release

In relation to new organisms, means to allow the organism to move within New Zealand free of any restrictions other than those imposed in accordance with the Biosecurity Act or the Conservation Act 1987. Section 2, HSNO Act.

Restricted organism

Any organism for which a containment approval has been granted in accordance with the HSNO Act (including any approval deemed to have been granted under sections 254 (1), 254 (3), 254 (8) (a), 255 (l), 255 (2), 256, 258 (1), and 258 (3)): Section 2, Biosecurity Act.

Supervisor

An inspector appointed under the Biosecurity Act. This person, employed by the supplier, inspects containment facilities and audits the operation of containment.

Supplier

The party responsible for the performance of the inspection and audit work under a contract with the MAF Biosecurity Authority. MAF Quarantine Service is the present supplier.

The Authority

Environmental Risk Management Authority responsible for administering the Hazardous Substances and New Organisms Act 1996.

Tissue culture

The growth of cells, including tissues and organs, outside the organism in an artificial media of salts and nutrients. This standard applies only to tissue cultures that are determined by the Authority to be a new organism.

Vermin

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

2. Approval of a Facility and an Operator

2.1 Approval of a Facility

A containment facility shall be approved in accordance with section 39 of the Biosecurity Act. The facility shall be constructed and operated in accordance with this Standard and shall comply with all of the controls specified by the Authority or the IBSC in the approval of new organisms to be contained in the facility.

(It is also expected that the facility will comply with the requirements of the Resource Management Act, 1991, Building Act, 1991 and any other relevant legislation.)

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

2.1.1 Procedure for approval of a containment facility

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

The supervisor shall consider applications before construction or alteration of a facility, in order to provide advice on whether the proposed facility is likely to comply with this Standard.

When the operator has met the requirements of sections 3 & 4 of this Standard, the supervisor shall be requested to inspect the containment manual and the facility. When the supervisor is satisfied that:

  • the operator has met the structural and operational requirements of a containment facility as required in this Standard, and has met, or made provision for the containment controls specified by the Authority,
  • the containment manual (section 3) meets the requirements of this Standard,
  • the application form on page 21 of this Standard has been completed satisfactorily by the prospective operator,

the application form and a copy of the containment manual shall be sent by the supervisor to the chief technical officer, together with the supervisor’s written recommendation for approval of a containment facility.

Approval of a containment facility shall be in writing. A facility may be approved for specified species of laboratory animals, for an unspecified time, a specified time or until a specified event.

2.1.2 Modifications to an approved facility

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

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

2.2 Approval of the Operator

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

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

  • that the applicant is a fit and proper person to be the operator of the facility specified in the application; and
  • the applicant is able to comply with the operating standards for that facility.

The operator shall satisfy the supervisor that s/he has the technical and financial resourcing mechanisms in place to maintain that facility.

The technical resources shall be provided by a person or persons in authority (identified in section 3.3) with the qualifications, training and experience for ensuring that both the structure of the facility and the operating procedures used in the facility are appropriate for the containment of the species of laboratory animals being held.

The supervisor shall send the application forms on page 22 & 23 to the contact person together with the supervisor’s written recommendation for approval of the operator. Approval of the operator will be in writing.

2.2.1 Leased facilities

If the facility is leased, the lessee responsible for the operation of the facility shall apply to be the operator. The contract with the owner shall clearly identify who is responsible for the maintenance of the premises and the resourcing of the operation. The supervisor shall be satisfied that no part of the lease contract shall override the requirements of this Standard for the operation of the facility.

2.2.2 Collection of personal information on individuals

In regard to any information being collected on the application for approval as an operator, this is personal information [being information identifying or being capable of identifying an individual person]. Notification is hereby provided, in accordance with Principle 3 of the Privacy Act 1993, to individuals of the following matters:

  • This information is being collected for the purposes relating to the approval as an operator as per section 40 of the Biosecurity Act.
  • The recipient of this information, which is also the agency that will collect and hold the information, is the Ministry of Agriculture and Forestry, PO Box 2526, Wellington.
  • You are reminded that under Principles 6 and 7 of the Privacy Act, 1993, you have the right of access to, and correction of, any personal information which has been provided.

2.3 Cancellation of Approval

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

  • the facility no longer complies with this standard, including controls specified by the Authority,
  • a chief technical officer is satisfied that the facility is no longer used for the purpose or one or more of the purposes specified in the approval,
  • the operator ceases to be an operator of the facility,
  • the operator is no longer a fit and proper person,
  • the operator requests cancellation.

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

  • s/he is no longer satisfied that the facility is being operated according to this standard, including controls specified by the Authority,
  • the operator ceases to be an operator of the facility,
  • the operator is no longer a fit and proper person,
  • the operator requests cancellation.

Notice of cancellation shall be given in writing to the operator.

3. Containment Manual

The operator shall prepare, maintain and implement a quality assurance programme and procedures based on the principles of AS/NZ 9002, a code of good manufacturing practice or similar quality system. Accreditation with other agencies such as International Accreditation of New Zealand (IANZ) is not required.

The quality assurance programme and any amendments shall address the requirements of this Standard. It shall be documented in a containment manual or in an alternative quality system, e.g. Standard Operating Procedures. Facilities with, for example, laboratory accreditation to ISO 9001, ISO 17025 or IANZ’s Code of Laboratory Management Practice, do not need a separate manual provided the requirements of this Standard are covered in their quality system.

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

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

3.1 General

Describe the main functions of the organisation and the reasons for holding the laboratory animals.

3.2 Containment Requirements

Write procedures describing how the containment facility will be operated to meet:

  • any containment controls set by the Authority,
  • the requirements in section 4 of this Standard.
  • the requirements of the import health standard

Describe the structural components of the facility. Provide a floor plan of the facility and show where the laboratory animals will be held and where the work will be done with them.

3.3 Management

Identify the operator. Identify the manager if the operator nominates one. Specify and document the responsibilities of the operator, manager (if one is appointed) and the technical advisor(s) (see section 2.2).

Identify the principal investigators (scientists) using the facility and their responsibilities.

3.4 Training

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

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

3.5 Internal Controls

Identify quality systems used in the containment facility.

The operator shall carry out an internal audit of the containment facility activities at least once every six months to verify that its activities continue to comply with the requirements of the quality system.

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

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

3.6 Version

Record the version number and issue date of the containment manual, or alternative quality system, on each page. Updates are to be approved by the supervisor who shall also hold an up-to-date copy of the manual.

4. Structural and Operational Requirements

4.1 General Requirements

The laboratory animals may only be held in an approved containment facility.

The containment facility shall be constructed and operated in a manner to ensure that laboratory animals are securely contained and housed. This facility may be a single room or a suite of rooms.

It is recommended that the environment in which animals are caged or penned is capable of being controlled for parameters such as air exchange, temperature and lighting. Floor surfaces should be smooth but resistant to slipping and hard wear. Floors and walls should be smooth, impervious to liquids and easily cleaned.

Small animals such as hamsters and rats shall be held within secure cages that prevent their escape. The cage room shall be designed and operated as a sealed unit in case an animal escapes or is dropped during handling. For example, the floor drains are covered with a suitable grill to prevent the escape of animals and the door is shut when animals are handled.

Procedures shall ensure that no accidental removal of animals can occur via people or material leaving the facility.

The facility shall provide for:

  • the receipt of animals, equipment, bedding and feed,
  • the maintenance and care of animals,
  • cage washing,
  • the disposal of dead animals and bedding wastes. Incineration or deep burial shall dispose of dead laboratory animals.

These generic requirements may be supplemented by containment controls specified by the Authority or the IBSC when approving the new organism in containment (see also 4.2). There may also be conditions specified in the import health standard set by MAF.

4.1.1 Containment of aquatic laboratory animals

All tanks shall be clean and of a design to permit ease of observation of their contents and be readily accessible for ready inspection of the laboratory animals. There shall be sufficient lighting to clearly observe their contents. The tanks shall be permanently identified so that the appropriate records can be correlated with each tank.

Provision shall be made to prevent the escape of the animals their eggs and gametes via water discharged during containment or in the event of an accidental

spillage of tank water (e.g. tank breakage).

4.1.2 Exposure of animals to organisms

Where animals are inoculated with other organisms the minimum requirements for containment shall be based upon a risk assessment of all organisms involved, taking into account their abilities to escape and potential to result in adverse environmental or human health effects.

4.1.3 Manipulation of animals

Any work involving the manipulation of animals shall be in accordance with a code of ethical conduct approved by an Animal Ethics Committee. Further information on ethical codes can be obtained from the Manager, Animal Welfare and Environment, MAF Biosecurity Authority, PO Box 2526, Wellington. This requirement is independent of this Standard.

4.2 Containment Controls

The operator shall have access to records showing the approval of the IBSC or the Authority for the laboratory animals held or developed in the facility.

4.2.1 Deviations from PC2 requirements of AS/NZS 2243.3:2002

Additional minimum requirements specified by the IBSC or the Authority for Physical Containment 2 (PC2) will be those identified in the AS/NZS 2243.3:2002 except for the differences described below:

A sign identifying the type of animal containment facility and listing procedures applicable, including emergency and maintenance procedures shall be posted inside the facility near the entrance. [Replaces 10.8.1. (a) in AS/NZS 2243.3:2002]

The animal containment facility shall be constructed with impermeable and easily cleaned surfaces. Any openings in the walls, roof or ceiling, such as windows, vents and air conditioning or ventilation inlets and outlets, shall be screened from insects at the containment boundary with fine mesh screens (or an approved equivalent) having maximum apertures of no greater than 0.25 mm (for stainless steel the mesh wire diameter shall be at least 0.16 mm with 51% free area). The screens shall be of stainless steel or equally suitable material with regards to its mechanical strength under the airflow load, its ability to remain undamaged with regular vigorous cleanings needed to remove dust, fibre, animal or plant sheddings, its corrosion resistance and its resistance to attack by insects from either inside the containment facility of from the local environment outside the facility. [Replaces 10.8.1. (b) in AS/NZS 2243.3:2002]

A handwash basin complete with hands-free mixing taps shall be provided near the containment facility exits. [Replaces 10.8.1. (e) in AS/NZS 2243.3:2002]

Protective clothing, gloves and footwear shall be worn if a risk analysis shows it to be necessary. It is recommended that this clothing not be worn in other areas. [Replaces 10.8.2. (c)(iv) in AS/NZS 2243.3:2002]

Bedding material and waste from cages or pens used to house animals infected with known or suspect pathogens shall be disposed of in a manner that destroys infective material and avoids infection of workers, and shall be handled in such a manner as to minimise the creation of aerosols. [Replaces 10.8.2. (c)(v) in AS/NZS 2243.3:2002]

Pens and cages from un-infected animals shall be decontaminated after use and washed regularly. Cages from infected animals shall be decontaminated in a manner that destroys infective material and avoids infection of workers before they are cleaned and washed. [Replaces 10.8.2. (c)(vi) in AS/NZS 2243.3:2002]

4.2.2 Minimum requirements for Physical Containment 3 and 4

The Authority will specify minimum requirements for Physical Containment 3 and 4.

4.3 Access to the Containment Facility

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

The entrances to the facility shall be kept locked, except when in active use. The use of security cameras and electronic swipe cards is encouraged.

Access to the facility shall, in the main, be limited to those people identified in section 3.3, however, visitors essential for the operation of the facility may be permitted entry. They shall adhere to access procedures and be accompanied by a principal investigator (i.e. one of the people identified in the section 3.3).

A prominent sign shall be displayed inside the entrance of the containment facility to show that it is a containment facility and that unauthorised entry is prohibited. Procedures for access and emergencies shall also be posted here.

4.4 Removal of Animals from the Containment Facility

No laboratory animals may be removed from the facility except with authorisation from the supervisor. Procedures shall ensure that no accidental removal occurs.

Small animals such as rabbits and rats may be moved temporarily (up to 48 hours) from the facility for experimental work. Procedures shall ensure that:

  • animals are transported and held awaiting manipulation in cages which meet IATA standards,
  • the period of time that animals are removed from the containment facility shall be kept to a minimum,
  • the animals shall be kept under the direct care of a staff member.
  • If the animals are unattended, the cages shall be kept in a locked room.

Movements of animals shall be recorded in the register (see section 4.5).

Larger animals may be moved under similar conditions. The supervisor shall specify these for each case.

4.5 Register of Laboratory Animals

A register shall be maintained of the species and strains of animals held in containment. These records shall be correlated to:

  • the permanent marking of animals through ear tagging, toe clipping or whatever means are appropriate for the laboratory animal species,

or, if this is not feasible:

  • the individual cages in which small animals such as hamsters and rats are held, and the physical location (i.e. room number) of these cages.

Checks of animal numbers shall be undertaken periodically, in agreement with the supervisor, to ensure that the operator has an accurate record of mature animals (except for aquatic species) and the capacity of the facility is not exceeded.

4.6 Transfer of the Laboratory Animal to another Containment Facility

The operator shall make an application in writing to the supervisor for transfer of laboratory animals to another laboratory animal containment facility.

The receiving facility must be approved as having the appropriate containment level to contain the laboratory animals.

The laboratory animals may be transferred if accompanied by a written authority from the supervisor of the originating facility.

The transport container shall meet the requirements of Live Animal Regulations, International Air Transport Association (IATA) and shall be sealed before transfer.

The operator of the receiving facility shall confirm receipt of the laboratory animals to the supervisor of that facility. The transfer of the laboratory animals shall be noted in the registers of both facilities.

The export of laboratory animals shall require a written authority from the supervisor and a record in the register.

4.7 Contingency Plans

The containment manual shall describe the contingency plans in place to take account of:

  • the accidental release or escape of laboratory animals including viable or heritable material, within and outside the facility,
  • fire, sabotage, theft, or any other emergency.

Resources shall be identified and made accessible for the contingency. If there is an escape of laboratory animals from containment action shall be immediately taken to prevent further escape and to recover and return to containment the escaped animals. If the animals cannot be recovered an eradication programme with an associated monitoring programme shall be instituted. The supervisor shall be advised as soon as is possible.

4.8 Vermin Control

Procedures shall describe how vermin 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.

4.9 External Audit

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

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

4.9.1 Non-compliance

Incidents of non-compliance will be dealt with by issuing:

  • a critical situation report for situations that may present a risk to biosecurity. The chief technical officer may direct that the non-conformity is rectified immediately and measures taken to prevent recurrence, e.g. laboratory animals being moved out of a containment facility without approval.
  • a corrective action request for a non-compliance that is not a serious risk to biosecurity. Work will be permitted to continue but the facility will be given a specified period of time to rectify the non-conformity, e.g. procedures for access are not available at the entrance.

4.10 Costs

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

4.11 Records

The operator shall demonstrate compliance with this Standard by keeping records as required for the quality assurance programme and documented in the containment manual. Such records should be kept for a minimum of five years after export or death of the laboratory animal and include as a minimum:

  • Records of the containment facility and operator approvals.
  • Copies of permits to import, IBSC approvals, containment controls specified by the Authority, release approvals, authorisations for movement, biosecurity clearances and authorised movements.
  • A register of the laboratory animals in the containment facility [section 4.4].
  • Records of internal audits and corrective actions.
  • Records of external audits and corrective actions.

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