Conditions are imposed on facilities by the Regulator at the time of certification pursuant to section 86 of the Gene Technology Act 2000 (the Act) and, as applicable, corresponding State legislation. The condition clauses in this section are the ones that can be expected, in most cases, to be included in the certification instrument as the conditions of certification for a Physical Containment Level 3 (PC3) Animal Facility.

The definitions and acronyms found in Part A of this document also apply to this Part.

Obligations of the certification holder in respect of users of the facility

1. The certification holder must have the authority to admit persons to the facility and exclude persons from the facility.

2. While any dealings with GMOs are being conducted in the facility, the certification holder must ensure that access to the facility is restricted to authorised persons.

3. For the purposes of condition 2, an authorised person is a person who:
  1. intends to undertake dealings, and has been trained in accordance with the conditions of certification that apply to the PC3 Animal Facility; and
  2. has signed, dated and provided to the certification holder a record of the training referred to in paragraph 3(a) above; and
  3. has not been excluded from the facility by the certification holder on the direction of the Regulator; or
  4. is an individual, who does not intend to undertake dealings and has the permission of the certification holder, the facility manager or other representative of the certification holder, to enter the facility.
4. While the facility is in operation, any person covered by Condition 3(i) who enters the facility must be supervised by persons trained in accordance in accordance with the conditions of certification that apply to the PC3 Animal Facility.

5. If the Regulator requests the certification holder to provide a signed and dated record of the training provided to a particular authorised person, the signed and dated record of that training must be made available to the Regulator within a time period stipulated by the Regulator.

6. If the Regulator directs the certification holder to exclude a person, from entry to the facility on the grounds that the person:
  1. has behaved, or is behaving, in a manner which contravenes the Work Practices; or
  2. has behaved, or is behaving, in a manner which has caused, or which may cause, GMOs to escape from the facility; or
  3. has behaved, or is behaving, in a manner which has exposed, or exposes, other persons in the facility to a GMO in circumstances where the exposure causes, or is capable of causing, a threat to the health and safety of those other persons;
the certification holder must exclude that person from the facility unless and until otherwise directed by the Regulator.

7. If the Regulator directs the certification holder to admit a person, to the facility subject to conditions, the certification holder must only admit the person, subject to those conditions.

8. For the purposes of Condition 7, before admitting a person, subject to conditions, the certification holder must notify the person(s) of any conditions that apply to them.

9. If the Regulator invites the certification holder to make a submission on whether or not a person should:
  1. be excluded from entry to the facility; or
  2. be admitted to the facility subject to conditions;
the certification holder may make such a submission within a time period stipulated by the Regulator.

10. The Regulator or a person authorised by the Regulator must, at all reasonable times, be allowed to enter the facility for the purposes of auditing or monitoring the conditions applying to the facility and any dealings being conducted in it.

Work not permitted in this facility

11. The following work must not be conducted in this facility:
  1. dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC3 or any GMO that is a Risk Group 4 organism as specified in AS/NZS 2243.3;
  2. unless otherwise authorised by the Regulator, dealings with animals infected with GMOs where the work area of the facility forms the primary containment measure;
  3. the housing/keeping/rearing of any invertebrates, or aquatic organisms other than those integral to the dealings with GMOs being conducted in the facility;
  4. the growing of any plants other than those integral to the dealings with GMOs being conducted in the facility; or
  5. any other work prohibited by notification in writing by the Regulator.

General conditions

12. If the certification holder is not the owner of the facility, fittings and/or containment equipment and does not have the authority to maintain the facility, fittings and/or containment equipment, the certification holder must notify the Regulator in writing if the owner of the facility, fittings and/or containment equipment is incapable of carrying out, or refuses to carry out, or otherwise does not carry out, any maintenance required in order for the certification holder to continue to comply with the conditions of certification.

13. The facility must be inspected at least once every 12 months by a person approved by the certification holder and qualified to assess the facility's compliance with the conditions listed under:
  1. Work not permitted in the facility;
  2. General conditions;
  3. Facility construction and access conditions;
  4. Containment equipment conditions;
  5. Laboratory services and equipment conditions;
  6. Ventilation conditions;
  7. Testing conditions;
  8. Work Practices
  9. Facility Management;
  10. Facility Manual; and
  11. Training.
An inspection report which records the extent of compliance with those conditions must be made. A copy of the last three years' inspection reports must be kept and made available to the Regulator if requested.

    NOTES: A checklist suitable for use during annual inspections of PC3 Animal Facilities is available on the OGTR web site - but its use is not mandatory. Annual inspection reports should not be sent to the Regulator unless requested.
Inspections are not required in the same year as an OGTR inspection for recertification.

14. Each access door to the facility must be labelled with the following adhesive signs:
  1. a current PC3 sign, supplied by the OGTR;
  2. a biohazard symbol; and
  3. emergency contact numbers (e.g. 24-hour contacts for medical emergency and for alarm response);
The signs identified in (a) to (c) must be placed so that persons entering the facility are able to clearly see that they are entering a certified PC3 facility.
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    NOTE: For security reasons, signs do not have to be placed on the outside wall of the facility, however, they must be visible prior to entering the airlock.
15. Emergency contact numbers (e.g. 24-hour contacts for medical emergency and for alarm response) must also be visible within the work area of the facility.

16. A supply of decontamination agents effective against the GMOs being dealt with in the facility must be available in the work area of the facility for decontamination purposes. All containers of decontamination agents must be labelled with the contents, concentration and, where appropriate, the expiry date. Decontamination agents must not be used after the expiry date.

17. The facility must be kept free of pests. A record of any pest prevention strategies or pest control activities must be kept and made available to the Regulator if requested, along with the dates and details of any pest control and/or eradication activities.

Facility construction and access conditions

18. The certification holder must ensure that the physical attributes of the facility and fittings are maintained so that the relevant 'Facility construction and access requirements' listed in Part A of this document continue to be met.

19. Prior to any structural changes that will affect the containment of GMOs in the facility; the applicant must request a suspension of the certification, in writing, from the Regulator. Before a suspension of the certification can be lifted, the facility must be inspected by a person qualified to assess the facility's compliance with the conditions listed under:
  1. General conditions;
  2. Facility construction and access conditions;
  3. Containment equipment conditions;
  4. Laboratory services and equipment conditions;
  5. Ventilation conditions; and,
  6. Testing conditions;
to ensure that the facility meets the conditions of certification. An inspection report which records the extent of compliance with these conditions must be made and provided to the Regulator with the request to lift the suspension. Dealings with GMOs may not commence until the Regulator has lifted the suspension by notice in writing.

    NOTE: Before suspension can be lifted an inspection by OGTR may be required. A variation to the conditions of certification may also be required and would be assessed on a case-by-case basis.

Containment equipment conditions

20. The certification holder must ensure that the physical attributes of the facility and fittings are maintained so that the relevant 'Containment equipment requirements' listed at Part A of this document continue to be met.

21. Use and decontamination of Class I and Class II BSC must be in accordance with the requirements of AS 2252.4.

Laboratory services and equipment conditions

22. The certification holder must ensure that the physical attributes of the facility and fittings are maintained so that the relevant 'Laboratory services and equipment requirements' listed in Part A of this document continue to be met.

23. All services and equipment must be used and maintained in accordance with the manufacturer's instructions or the relevant AS/NZS.

24. All services or equipment added to the facility after certification is issued must be tested, commissioned and found to meet the conditions of certification.

Ventilation conditions

25. The certification holder must ensure that the physical attributes of the facility and fittings are maintained so that the relevant 'Ventilation requirements' listed in Part A of this document continue to be met.

26. Any failure of the ventilation system (exhaust air fan or interlocked supply/exhaust system) that results in loss of the negative air pressure gradient or produces a positive air pressure must be reported to the Regulator as soon as reasonably possible.

Testing conditions

27. Biological safety cabinets must be inspected and tested in accordance with the requirements of AS 2252.4. This testing is required at least annually and additionally after relocation of a cabinet, after mechanical or electrical maintenance and after HEPA filters are replaced. The inspection and testing of cabinets must be carried out by a qualified person.

The cabinet(s) must pass tests for containment efficiency and a certificate, summarising the test results and the date of the next test, must be affixed to the cabinet.

Where testing has shown that the performance requirements for inward air velocity or HEPA filter integrity (Class I), or air barrier containment or exhaust HEPA filter integrity (Class II) are not met and the defect has not been corrected, the cabinet must be clearly marked to show that it is defective and must not be used for procedures involving GMOs until the defect has been corrected.

Records of the annual tests for the last 3 years must be kept and made available to the Regulator if requested.

28. Other containment equipment installed in the facility (e.g. IVC, change stations) must be inspected and tested at least annually. Testing must include HEPA filter integrity testing and the containment equipment must pass tests for containment efficiency and a certificate, summarising the test results and the date of the next test, must be affixed to the cabinet.

Where testing has shown that the performance requirements for HEPA filter integrity are not met and the defect has not been corrected, the equipment must be clearly marked to show that it is unsafe and must not be used for procedures involving GMOs until the defect has been corrected.

Records of the annual tests for the last 3 years must be kept and made available to the Regulator if requested.

29. Testing and maintenance of facility ventilation systems must be carried out at least annually and must include:
  1. testing of the pressure differentials;
  2. integrity testing of all HEPA filters in accordance with AS 1807.6 or AS 1807.7, as applicable, by a qualified person. The HEPA filter must be decontaminated prior to testing;
  3. checking directional airflow;
  4. verifying that the alarms operate when the air pressure in the facility is raised;
  5. calibration of transducers fitted to the air-handling system and validation of air-handling performance (i.e. an over-pressure or under-pressure response);
  6. calibration of pressure gauges;
  7. the air handling control system; and
  8. if applicable, the building management system.
Records of the tests in items (a) to (h), and of any maintenance conducted, must be kept for 3 years and made available to the Regulator if requested.

If any failures occur, dealings involving GMOs in the facility must cease until the failures are rectified and the ventilation system must be re-tested until compliance is achieved.

30. If the facility contains a liquid effluent decontamination system, it must be tested and maintained by a competent person at least annually and must include:
  1. calibration of all instruments that control or monitor critical process parameters;
  2. confirmation that all parameters of the system are operating within the specified limits (e.g. temperature, time, pH, concentration of chemical);
  3. checking and maintenance of equipment to ensure effective operating condition;
  4. checking of all safety and relief equipment.
Records of the tests in items (a) to (d), and of any maintenance conducted, must be kept for 3 years and made available to the Regulator if requested.
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31. The physical parameters and efficacy of the autoclave, or other heat-based equipment used to decontaminate GMOs, must be validated monthly.
The physical parameters of the autoclave must be validated by the use of:
  1. thermocouples or resistance thermometers, to ensure that the required temperature has been achieved; or
  2. chemical indicators which use a combination of moisture, heat and time and which progressively change colour with the time exposed at the specified temperature; or
  3. other methods approved in writing by the Regulator.
The efficacy of the autoclave must be validated by the use of:
  1. biological indicators such as spore strips; or
  2. bacterial enzyme indicators; or
  3. other methods approved in writing by the Regulator.
The results of each month's testing must be kept for the previous 12 months and made available to the Regulator, if requested.

32. Any heat-based equipment used to decontaminate GMOs must be calibrated annually by a person competent to do so. The results of the annual calibration for the previous 3 years must be kept and made available to the Regulator, if requested. When an autoclave is used for decontamination, annual calibration of the thermometer, timers, thermocouple and safety valves must be performed.

33. If any decontamination equipment is found to be defective and the defect has not been corrected, the equipment must be clearly marked to show that it is defective and must not be used for decontaminating GMOs, waste or equipment associated with dealings with GMOs until the defect has been corrected.

34. All testable water supply backflow prevention devices must pass an annual test, conducted in accordance with AS 2845.3, by a licensed plumber accredited to test backflow prevention devices. A record of the annual test for the last 3 years must be kept and made available to the Regulator if requested.

Work Practices

Entry and exit

35. The outer door of the facility must be kept locked at all times, except when authorised persons are entering or exiting the facility.

36. Airlock doors must remain closed at all times, except when authorised persons are entering or exiting the facility.

37. Persons must enter and exit the work area only through the airlock.

38. Emergency exits must only be opened in the event of an emergency.

39. Procedures with GMOs and/or animals must only take place in the work area.

40. The following personal protective clothing and equipment must be worn by all authorised persons in the work area:
  1. protective clothing to protect the front part of the body (e.g. long-sleeved, back-fastening, tight-wristed protective clothing);
  2. closed footwear;
  3. gloves; and
  4. eye protection.
    NOTE: The use of disposable overshoes should also be considered.
41. When exiting the work area and prior to entering the airlock, personal protective clothing and equipment must be removed and disposed of, or stored in designated storage or hanging spaces. If a facility contains multiple work areas, personal protective clothing and equipment should be removed before exiting each work area.

42. When exiting the work area and immediately prior to entering the airlock all persons must wash or decontaminate their hands. If a facility contains multiple work areas, all persons must wash or decontaminate their hands immediately before exiting each work area.

Containment equipment

43. Any procedures that may generate aerosols containing GM micro-organisms, such as opening of any animal primary containment devices, surgical procedures, post-mortem dissection, and animal inoculation, must be conducted in a BSC, or other specialised containment equipment approved in writing by the Regulator.

44. If centrifugation is undertaken, it must be carried out in sealed containers (tubes, buckets or rotors). Centrifuge containers must only be opened in a BSC.

Animal Handling

45. Procedures with animals must only be undertaken by authorised persons who have been trained to do so.

46. Handling of the animals containing GMOs, and any experimental procedures conducted on the animals, must be carried out in a way that minimises the possibility of escape of the animals and exposure of people to the GMOs.

47. When not being handled in the BSC or other specialised containment equipment, animals containing GMOs must be kept in ventilated cages or enclosures.

48. If an animal containing GMOs escapes within the facility, trapping devices must be used to capture the animal and the animal must be returned to its container or cage or euthanased.

Decontamination

49. Work benches, surfaces and equipment where procedures involving GMOs have taken place must be decontaminated immediately after each procedure and/or at the end of each working day.

50. Decontamination of the facility must take place:
  1. in the event of a spill of viable organisms occurring outside of primary containment (e.g. BSC) that cannot be effectively decontaminated by another means;
  2. prior to suspension, surrender, expiry or cancellation of certification; and
  3. prior to re-certification of the facility at a lower containment level, if stipulated by the Regulator.
    NOTES: For facilities that contain multiple work areas, an individual work area may be decontaminated without the need for the whole facility to be decontaminated.
Facilities may also require decontamination in the event of escape of an animal containing GMOs within the facility.

51. With the exception of transport of viable GMOs (in accordance with Conditions 60 and 61) to another certified PC3 facility, all items, including equipment, personal protective clothing, and waste, that are contaminated or potentially contaminated with GMOs, must be decontaminated prior to removal from the facility.

52. If the facility has floor drainage exits, all effluent from these drains must be decontaminated by heat treatment or chemical treatment before being discharged. If the facility has a sink, then all liquid effluent must be decontaminated prior to discharge down the sink.

53. Decontamination can be effected by autoclaving or other heat treatment, chemical treatment, or by any other method approved in writing by the Regulator.
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    NOTE: Autoclaving is the most reliable means of decontamination; however this method is not applicable in all situations.
54. If an autoclave is used for decontamination:
  1. loads must be packed and loaded to allow for the penetration of steam into the material being decontaminated;
  2. the coldest part of the load must be exposed to a minimum temperature of 121°C and 103 kPa for at least 15 minutes or at 134°C and 203 kPa for at least 3 minutes;
  3. measures must be taken to ensure that loads that have been processed can be differentiated from loads that have not (e.g. by use of autoclave tape); and
  4. all displaced or evacuated air, steam and liquid must be filtered or decontaminated before discharge.
55. If a double-ended autoclave is installed across the barrier, it must have a mechanism in place such that it cannot be opened on the clean side without a complete decontamination cycle being undertaken.

56. Any other heat-based treatment used for decontamination must be performed using a combination of temperature and time that has been validated as effective in rendering the GMOs non-viable.

57. Any chemical decontamination agent must be validated as effective in rendering the GMOs non-viable.

    NOTE: AS/NZS 2243.3 is a recommended source of information when selecting and using chemical disinfectant agents.

Spills

58. If any spill occurs in the facility, the spills procedure (see Conditions 66(r)(i)) must be implemented to decontaminate the spill as soon as reasonably possible.

59. Any known or suspected unintentional release of GMOs outside the facility must be reported to the Regulator as soon as reasonably possible.

Removal and Storage of GMOs

60. GMOs and material containing or potentially containing GMOs, including carcasses, blood, organs and tissues must not be removed from the facility unless:
  1. it is to be transported to another containment facility certified by the Regulator to at least PC3; or
  2. written permission has been given by the Regulator.
61. GMOs and material containing or potentially containing GMOs being transported out of the facility must be transported in accordance with any Transport Guidelines and other relevant guidelines issued by the Regulator.

62. GMOs must be stored within the work area of a PC3 facility.

GMOs must be stored in a sealed primary container, which has been surface decontaminated prior to enclosure within a sealed secondary container.

    NOTE: Where this is not practicable, due to space constraints or availability of appropriate storage devices within the PC3 facility work area, an exemption to this condition may be requested from the Regulator.

Personal effects

63. Non-essential personal effects, including handbags, personal mobile phones, personal organisers and other non-essential electronic equipment, which will not remain within the work area, must not be taken into the airlock.

Facility management

64. A facility manager must be appointed by the certification holder. The facility manager, or his or her delegate(s), must be capable of demonstrating an understanding of the technical aspects of facility design, operation and maintenance.

65. The certification holder must ensure that the facility manager or his or her delegate(s) is capable of undertaking the following functions:
  1. developing and maintaining documented policies and documented procedures for the safe operation of the facility;
  2. ensuring that access to the facility is restricted to authorised persons;
  3. ensuring that access to voids around the perimeter of the facility and the ventilation system of the facility is restricted to authorised persons;
  4. facilitating delivery of appropriate training to all persons as per the training conditions;
  5. development, documentation, implementation and annual review of a facility manual, as stipulated in condition 66 and 67;
  6. development, documentation, implementation and validation of decontamination procedures effective for all organisms and equipment used in the facility;
  7. provision of information to all authorised persons on changes to all facility operating procedures (e.g. entry and exit procedures, work practices, decontamination procedures and emergency plans);
  8. ensuring that successful decontamination of the facility is carried out;
  9. retention of documentation relating to the maintenance and testing of the facility equipment and services, including the air handling system, primary containment equipment (e.g. BSC, IVC), autoclave(s) and gaseous decontamination of the facility;
  10. co-ordination of immunisation of persons working within the facility, where appropriate;
  11. ensuring that current emergency contact numbers are clearly visible from inside and outside the facility (e.g. 24-hour contacts for medical emergency and for alarm response);
  12. ensuring that a record of all organisms (GM and non-GM) used in the facility since the most recent gaseous decontamination is kept and is made available to the Regulator if requested; and
  13. coordination of all work in the facility where multiple projects or work on different organisms is taking place in the facility.

Facility Manual

66. A facility manual must be readily available to all authorised users of the facility. The facility manual must document the following elements:
  1. the facility manager's contact details;
  2. a list of persons authorised to enter the facility;
  3. the persons to contact in case of emergency;
  4. copies of conditions imposed under the Gene Technology Legislation that must be followed, including:
    1. conditions of certification of the facility ;
    2. conditions imposed by any licences for dealings with GMOs;
    3. any relevant clauses of the Guidelines for the Transport of GMOs; and
    4. details of any other authorisations granted to deal with GMOs in the facility (e.g. NLRDs);
  1. the structure and operation (including design limits) of the facility;
  2. details of all organisms and animals being handled with in the facility, the risks associated with the use of these organisms and animals, and the management strategies for these risks;
  3. the procedures for the handling of animals within the facility;
  4. the procedures that must be followed by all persons entering and exiting the facility, and the use of personal protective clothing and equipment and the order in which these are removed;
  5. the procedures for the operation and use of BSC, IVC, and other specialised containment equipment approved in writing by the Regulator;
  6. the procedures for the use of normal and emergency communication systems;
  7. the procedures for the movement of all equipment into and out of the facility, including decontamination of that equipment;
  8. the procedures for decontamination, including operation and use of the autoclave;
  9. the procedures and circumstances for gaseous decontamination of the facility;
  10. the procedures for waste and effluent disposal, including transport procedures;
  11. the procedures for the transport of viable material inside the facility, including transport for storage of GMOs;
  12. the procedures for the transport of viable material outside the facility (e.g. transport to another PC3 facility);
  13. the circumstances or events which must be notified to the Regulator;
  14. the emergency response plans, including the procedures and use of specialised equipment required for responding to:
    1. spills in the facility (both inside and outside BSC) and spills while transporting viable material outside the facility;
    2. accidental exposure to organisms used within the facility, including procedures for the management and treatment of persons suspected to be infected or contaminated with/exposed to Risk Group 3 organisms;
    3. escape of animals containing GMOs within the facility;
    4. alarms for fire or loss of pressure;
    5. loss, theft or unintentional release of GMOs from the facility;
    6. failure of power or ventilation systems;
    7. fire and natural disasters;
    8. serious injury or medical emergencies to persons within the facility;
    9. security threats; and
    10. other life-threatening situations.
67. The facility manual must be reviewed at least annually and updated as necessary.

Training

68. Training, as identified in Condition 3 (a) of this Part, must include familiarisation with the elements of the facility manual (Condition 66).

69. Training must include theoretical instruction, and where applicable, supervised practical experience and assessment of competence.

70. Training of authorised persons must be reviewed at least annually and updated where necessary and whenever:
  1. licence conditions or certification conditions related to the facility change;
  2. the Guidelines for Certification of a PC3 Animal Facility change;
  3. there are new risks associated with GMOs dealt with in the facility;
  4. procedures or equipment used in the facility changes; or
  5. new GMOs or animals are used in the facility.
71. Training records must be updated at least annually and kept for a period of at least three years.

Health Monitoring

72. If the GMOs being or likely to be used are human pathogens, then consideration must be given to providing authorised persons with any available immunisation against the GMOs being used or likely to be used in the facility.

73. Where a zoonotic agent or human pathogen is in use, a documented system must be set up for reporting accidents and exposures to the micro-organisms, for monitoring employee absenteeism, and for the medical surveillance of illnesses that are potentially facility-associated. The Regulator must be informed of any such incidents as soon as reasonably possible.

Non-compliance

74. Any non-compliance with the conditions set out in these Guidelines for Certification of a Physical Containment Level 3 Animal Facility, including any unintentional release of GMOs from the facility, must be reported to the Regulator as soon as reasonably possible.Top of Page