Version 2.1 issued 1 September 2006

These guidelines contain the requirements for certification of a Physical Containment Level 2 (PC2) Arthropod Facility pursuant to section 90 of the Gene Technology Act 2000 (the Act)

The Conditions of Certification detail the usual conditions that will apply to a PC2 Arthropod Facility pursuant to section 86 of the Act and are attached to this document.

The standards that are referenced in the requirements and conditions are also attached to this document.

A separate document - Explanatory Information on Guidelines for Certification of Physical Containment Facilities - contains details about the process of certification.

Requirements for Certification

CONTAINMENT REQUIREMENTS THAT MUST BE MET IN ORDER FOR A PHYSICAL CONTAINMENT LEVEL 2 (PC2) ARTHROPOD FACILITY TO BE CERTIFIED BY THE GENE TECHNOLOGY REGULATOR (THE REGULATOR).

Section 90 of the Gene Technology Act 2000

These are the requirements for the certification of PC2 Arthropod Facility issued under section 90 of the Act and corresponding State legislation. These requirements apply to applications for certification of PC2 Arthropod Facilities received on or after the day on which these guidelines take effect.

Definitions

Unless defined otherwise in these guidelines words and phrases used in the guidelines have the same meaning as the Act and the Gene Technology Regulations 2001 (the Regulations).

Words in the singular include the plural and words in the plural include the singular.

Where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning.

airlock
An area or room between a pair of doors that separates the work area inside a facility from access corridors, other laboratories, or other spaces outside the facility.

The airlock permits the movement of equipment and personnel without affecting the inward flow of air into the work area, since at least one door is kept closed at all times.

The airlock can function as a clothes change room (showers may be included), but must not be used for performing any procedures on organisms.

The term airlock is used only in relation to PC3 and PC4 facilities.

anteroom
An area or room between a pair of doors through which access is had to the work area inside a facility.

The anteroom does not have to perform the same airflow control function as an airlock, but an airlock can perform the role of anteroom.

The anteroom must not be used for performing any procedures on organisms.

competent person
A person who has acquired through training, qualifications or experience, or a combination of these, the knowledge and skill enabling that person to perform a specified task.

dealings or deal with
In relation to a GMO, means the following:
  1. conduct experiments with the GMO;
  2. make, develop, produce or manufacture the GMO;
  3. breed the GMO;
  4. propagate the GMO;
  5. use the GMO in the course of manufacture of a thing that is not the GMO;
  6. grow, raise or culture the GMO;
  7. import the GMO;
and includes the possession, supply, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of the paragraphs (a) to (g).

decontamination
A physical or chemical process which kills or renders non-viable the organisms used in the facility, but does not necessarily result in sterility.

facility
The whole of the space that is to be certified by the Regulator to a specific level of containment. A certified facility comprises the work area and any anteroom or airlock used to enter or leave the facilitys work area.

procedures
The meaning of procedures includes any activity involving work with organisms inside a facility.

work area
Any area inside a facility that is not performing the function of an airlock or anteroom.

Procedures on GMOs may take place in the work area and any procedures in the work area are subject to the conditions on the certification instrument.

General

1. To be granted certification a facility must meet each of the containment requirements for certification of a PC2 Arthropod Facility unless the facility receives an exemption from meeting a particular requirement from the Regulator or a delegate of the Regulator.

Facility requirements

2. The facility must be a fully enclosable space contained within walls, doors, windows, floors and ceilings. Doors and windows must be lockable.

3. Any joints between structural components of the facility must be sealed with a material that cannot be penetrated by the GMO being contained.

4. Any openings in the walls, ceiling or roof, such as air vents, must be screened with mesh that has an aperture size small enough to prevent the escape of the arthropods being contained in the facility.

5. The facility must have an anteroom, except if the facility is used to contain only non-infected Drosophila melanogaster. Entry to the facility must be through the anteroom. The anteroom and work area(s) must have mechanisms and/or procedures in place to control arthropods that may escape from their primary containers. An adjoining facility certified by the Regulator to PC2 may operate as an anteroom provided the adjacent PC2 facility employs measures to monitor and control escaped arthropods.

If the facility will be used to contain only non-infected Drosophila melanogaster, the function of the anteroom may be fulfilled by other rooms or corridors (whether or not certified by the Regulator), provided the doors and windows of these other areas are closed or screened. The work area, and any other space serving as the anteroom, must have measures in place to control escaped Drosophila melanogaster.

NOTE: Measures for monitoring and for controlling arthropods may include using traps, regular monitoring, accounting procedures for live and trapped arthropods and methods for attracting arthropods away from doors. Procedures should be documented.

6. All facility access doors must be self-closing. When shut, the doors must be capable of preventing the escape of the GMOs being contained in the facility (e.g. by the use of seals on all edges of doors). Emergency exits must not be used except in emergencies.

7. If the facility has drainage exits, they must be fitted with barriers (e.g. floor wastes or plugs) to prevent rodents or any other pests from entering the facility via the drains. If the drains do not have traps (e.g. "s" traps or "p" traps permanently filled with water) the barriers on the drains must also be able to prevent the escape of the GMOs being contained in the facility.

8. Open spaces between and under benches, cabinets and equipment must be accessible for cleaning.

9. If the work in the facility will involve genetically modified (GM) pathogens, or there will be hand contact with any stage of the life cycle of GMOs that could persist on the hands after exit from the facility, the facility must contain either a wash basin fitted with tap(s) of the hands-free operation type or some other means of decontaminating hands.

NOTE: Alternatives to wash basins, such as dispensers filled with decontaminant solutions, are considered suitable, provided the dispensers can be operated without using the hands.

10. Where any device or system that may cause contamination of a potable water supply will be connected directly or indirectly to any part of a water service a risk assessment of the GMOs used in the facility must be undertaken to determine whether backflow prevention on the water supplied to the facility is necessary. The backflow prevention risk assessment must be provided with the application for certification.

If backflow prevention is necessary, then backflow prevention measures must be implemented in accordance with the requirements of Section 4 of AS/NZS 3500.1:2003 Plumbing and drainage - Part 1: Water services.

NOTE: More information on the risk assessment can be found in the Office of the Gene Technology Regulator (OGTR) Policy on Backflow Prevention in Certified Facilities on the OGTR website.

Section 4 of AS/NZS 3500.1:2003 specifies the requirements and methods for the prevention of contamination of potable water within the water service and the water main and provides for the selection and installation of backflow prevention devices.

11. If the work in the facility will involve GM pathogens, or there will be contact with any stage of the life cycle of GMOs that could persist on clothing after exit from the facility, then designated storage or hanging provisions for protective clothing must be available in the facility.

Containment equipment requirements

12. To monitor for the presence of escaped arthropods, the work area(s) must be fitted with at least one arthropod trap effective for the GMOs being contained in the facility.

Capacity to comply with certification conditions

13. The facility must be able to demonstrate that it is capable of complying with the conditions of certification that will be applied to a certified PC2 Arthropod Facility, as attached to these requirements.

Conditions of Certification

Conditions are imposed on facilities by the Regulator at the time of certification pursuant to section 86 of the Act. The condition clauses in this section are the ones that can be expected, in most cases, to be included on the certification instrument as the conditions of certification for a Physical Containment Level 2 (PC2) Arthropod Facility.

Definitions

Unless defined otherwise in these conditions words and phrases used in the conditions have the same meaning as the Act and the Gene Technology Regulations 2001 (the Regulations).

Words in the singular include the plural and words in the plural include the singular.

Where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning.

airlock
An area or room between a pair of doors that separates the work area inside a facility from access corridors, other laboratories, or other spaces outside the facility.

The airlock permits the movement of equipment and personnel without affecting the inward flow of air into the work area, since at least one door is kept closed at all times.

The airlock can function as a clothes change room (showers may be included), but must not be used for performing any procedures on organisms.

The term airlock is used only in relation to PC3 and PC4 facilities.

anteroom
An area or room between a pair of doors through which access is had to the work area inside a facility.

The anteroom does not have to perform the same airflow control function as an airlock, but an airlock can perform the role of anteroom.

The anteroom must not be used for performing any procedures on organisms.

The term anteroom is used only in relation to PC1 and PC2 facilities.

autoclave
Pressure steam steriliser.

competent person
A person who has acquired through training, qualifications or experience, or a combination of these, the knowledge and skill enabling that person to perform a specified task.

dealings or deal with
In relation to a GMO, means the following:
  1. conduct experiments with the GMO;
  2. make, develop, produce or manufacture the GMO;
  3. breed the GMO;
  4. propagate the GMO;
  5. use the GMO in the course of manufacture of a thing that is not the GMO;
  6. grow, raise or culture the GMO;
  7. import the GMO;
and includes the possession, supply, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of the paragraphs (a) to (g).

decontamination
A physical or chemical process which kills or renders non-viable the organisms used in the facility, but does not necessarily result in sterility.

facility
The whole of the space that is to be certified by the Regulator to a specific level of containment. A certified facility comprises the work area and any anteroom or airlock used to enter or leave the facilitys work area.

procedures
The meaning of procedures includes any activity involving work with organisms inside a facility.

work area
Any area inside a facility that is not performing the function of an airlock or anteroom.

Procedures on GMOs may take place in the work area and any procedures in the work area are subject to the conditions on the certification instrument.

Work not permitted in this facility type

1. The following work must not be conducted in this facility:
  • work with any GMO that under the Act, or under the conditions of a licence, requires containment in any physical containment level higher than PC2;
  • work with GM micro-organisms unless they are being used in conjunction with the arthropods being contained in the facility;
  • the housing/keeping/rearing of animals (other than terrestrial arthropods) or aquatic organisms; or
  • the growing of any plants other than non GM plants that are required as part of a dealing with GM arthropods.

Compliance with certification conditions

2. All the conditions listed under the heading of Facility Conditions, Containment Equipment and Facility Management must be complied with at all times whether or not the facility is being used for a dealing with a GMO. The certification holder must notify the Regulator in writing when the facility is no longer able to meet these conditions. This notification may include an application for a variation to the conditions and must also include an alternative, effective strategy to manage any risks associated with dealings with GMOs in the facility.

The conditions listed under Personal Protective Clothing and Equipment and Work Practices must be complied with at all times if a dealing with a GMO is being conducted in a facility. This condition applies whether or not work with a non-GMO is occurring in the facility at the same time.

NOTE: A GMO dealing includes possession, supply, use, transport and disposal of a GMO for the purposes of a dealing. Storage of a GMO, for example, constitutes a dealing with a GMO.

Facility conditions

3. The facility must be labelled with the following adhesive signs:
  1. a Physical Containment Level 2 (PC2) sign, as supplied by the OGTR; and
  2. a biohazard symbol.
The signs must be placed on or next to each access door to the facility so that persons entering the facility are able to clearly see they are entering a certified PC2 facility. If security is a concern, the signs may be displayed inside the anteroom, on or next to the door leading into the work area.

NOTE: An external anteroom door is an access door to the facility.

Signs may be stuck onto removable fixtures, such as backing boards or plastic frames, which must be secured to the door or wall and must not be transferred to any other location.

4. The facility must be maintained as a fully enclosable space contained within walls, doors, windows, floors and ceilings. Doors and windows must be maintained so they are lockable.

Any changes to the physical structure of a facility must not affect compliance with these conditions of certification. Prior to any structural changes that will affect the containment of GMOs, the applicant must cease all dealings with GMOs and request a suspension of the certification, in writing, from the Regulator.

In order to lift the suspension, the facility must be inspected after the structural changes are completed to ensure that the facility meets the requirements for certification. Dealings with GMOs may not commence until the Regulator has lifted the suspension by approval in writing.

NOTE: The certification holder can arrange for any competent person to inspect the facility to assess compliance with these conditions of certification. Proforma inspection checklists are available on the OGTR web site but their use is not mandatory. A record of the result of the inspection may be requested by the Regulator to support requests to lift the suspension of the certification, but in all cases the outcome of the inspection must be notified before the suspension can be lifted.

5. Any joints between structural components of the facility must remain sealed with a material that cannot be penetrated by the organism being contained.

6. Any openings in the walls, ceiling or roof, such as air vents, must remain screened with mesh that has an aperture size small enough to prevent the escape of the arthropods being contained in the facility.

7. The facility must have an anteroom, except if the facility is used to contain only non-infected Drosophila melanogaster. Entry to the facility must be through the anteroom. The anteroom and work area(s) must have mechanisms and/or procedures in place to control arthropods that may escape from their primary containers. An adjoining facility certified by the Regulator to PC2 may operate as an anteroom provided the adjacent PC2 facility employs measures to monitor and control escaped arthropods.

If the facility is used to contain only non-infected Drosophila melanogaster, the function of the anteroom may be fulfilled by other rooms or corridors (whether or not certified by the Regulator), provided the doors and windows of these other areas are closed or screened. The work area, and any other space serving as the anteroom, must have measures in place to control escaped Drosophila melanogaster.

8. All facility access doors must be maintained so they are self-closing and so that when shut they are capable of preventing the escape of the GMOs being contained in the facility (e.g. by the use of seals on all edges of doors). Emergency exits must not be used except in emergencies.

9. If the facility has drainage exits, they must be fitted with barriers (e.g. floor wastes or plugs) to prevent rodents or any other pests from entering the facility via the drains. If the drains do not have traps (e.g. "s" traps or "p" traps permanently filled with water) the barriers on the drains must also be able to prevent the escape of the GMOs being contained in the facility.

10. Open spaces between and under benches, cabinets and equipment must be accessible for cleaning.

11. If the work in the facility involves GM pathogens, or there is hand contact with any stage of the life cycle of GMOs that could persist on the hands after exit from the facility, the facility must contain either a wash basin fitted with tap(s) of the hands-free operation type or some other means of decontaminating hands.

NOTE: Alternatives to wash basins, such as dispensers filled with decontaminant solutions, are considered suitable, provided the dispensers can be operated without using the hands.

12. Where any device or system that may cause contamination of a potable water supply is connected directly or indirectly to any part of a water service, and no such connections were made prior to the certification of the facility, a risk assessment of the GMOs used in the facility must be undertaken to determine whether backflow prevention on the water supplied to the facility is necessary. The new or any revised backflow prevention risk assessment must be provided to the OGTR within 30 days of the assessment.

Where such connections had been made prior to certification, the backflow prevention risk assessment conducted at the time of certification it must be reviewed:
  • before different GMOs are used in the facility;
  • where any new device or system is connected directly or indirectly to any part of a water service; or
  • changes are made to the previously existing connections.
If installation of backflow prevention becomes necessary, then backflow prevention measures must be implemented in accordance with the requirements of Section 4 of AS/NZS 3500.1:2003.

Any new or reviewed backflow prevention risk assessments must be available on request to authorised OGTR staff.

Any backflow prevention measures in place at the time of certification must be maintained until a change in the measures is indicated by a review of the risk assessment.

NOTE: More information on the risk assessment can be found in the OGTR 'Policy on Backflow Prevention in Certified Facilities' on the OGTR website.

Section 4 of AS/NZS 3500.1:2003 specifies the requirements and methods for the prevention of contamination of potable water within the water service and the water main and provides for the selection and installation of backflow prevention devices.

13. If the facility is fitted with any testable water supply backflow prevention devices (in accordance with AS/NZS 3500.1:2003), these devices must pass a test every 12 months. These tests must be conducted in accordance with AS 2845.3:1993 by a licensed plumber accredited to test backflow prevention devices. Documentation of the most recent test results must be made available to the Regulator, if requested.

14. If the work in the facility involves GM pathogens, or there is contact with any stage of the life cycle of GMOs that could persist on clothing after exit from the facility, then designated storage or hanging provisions for protective clothing must be available in the facility.

15. If the work in the facility involves GM pathogens, or any immobile stage of the life cycle of GMOs that could persist on facility surfaces, a supply of disinfectants effective against these GMOs must be available in the facility for decontamination purposes. Containers of disinfectants must be clearly labelled with the contents and, where necessary, the expiry date.

Containment equipment conditions

16. All life stages of arthropods in the facility must be contained in primary containers that are designed to prevent the escape of the arthropods being contained.

17. The work area(s) must continue to be fitted with at least one arthropod trap effective for the GMOs being contained in the facility.

Facility management

18. Access to the facility must be restricted to authorised persons.

NOTE: Access can be restricted by means such as: keys, key cards or combination locks for entry to the facility; or controlled access to the building where the certified facility is only a part of a larger building.

19. All facility personnel must be trained in the use of equipment present in the facility and also in the procedures to be used in the facility. Records of this training must be kept and made available to the Regulator if requested.

NOTE: The required training should include transport, disposal, identification of hazards associated with the GMO and emergency procedures, certification requirements and licence conditions.

20. 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.

21. The facility must be inspected at least once every 12 months. The inspection report must detail the extent of compliance with the conditions of certification and a copy of the last 5 years inspection reports must be provided to the Regulator if requested.

NOTE: The certification holder can arrange for any competent person to inspect the facility to assess compliance with these conditions of certification. Proforma inspection checklists are available on the OGTR web site but their use is not mandatory for annual inspections. Inspection reports should not be sent to the Regulator unless requested.

Personal protective clothing and equipment

22. The following personal protective clothing must be worn by personnel performing procedures in the facility:
  1. laboratory coat or gown, or equivalent, to protect the arms and front part of the body (only required when performing procedures that involve GM pathogens or where there is contact with any stage of the life cycle of GMOs that could persist on the clothing after exit from the facility); and
  2. gloves (only required when performing procedures that might lead to contamination of the hands, if working with GM pathogens that are hazardous to humans).
23. Protective clothing must be checked for arthropods, and any arthropods removed, before removal from the facility.

If the work in the facility involves GM pathogens, or there is contact with any stage of the life cycle of GMOs that could persist on the clothing after exit from the facility and that cannot be readily removed as above, then laboratory coats, gowns or equivalent, must be removed before leaving the facility and stored in designated storage or hanging provisions. This condition does not apply if moving directly to another containment facility, certified to PC2 by the Regulator, that is directly connected to the facility.

Work practices

24. Facility doors must remain closed while work is being undertaken in the facility and must be locked when the facility is unattended.

25. The facility windows must be closed and locked while GMOs are in the facility.

26. Work benches, surfaces and equipment must be decontaminated after completion of procedures involving GM pathogens or any stage of the life cycle of GMOs that could persist on facility surfaces.

27. All work surfaces and equipment where maintenance is to be carried out must be decontaminated prior to maintenance taking place if procedures involving GM pathogens or any stage of the life cycle of GMOs that could persist on facility surfaces have been conducted there.

28. Decontamination of GMOs must be performed as follows:
  • arthropods must be rendered non-viable prior to disposal.
  • Liquid and solid wastes containing GMOs must be decontaminated prior to disposal.
  • Equipment must be decontaminated prior to use in another location.
  • Protective clothing contaminated with GM pathogens must be taken off as soon as practicable and decontaminated prior to reuse. Protective clothing that has not been contaminated with GM pathogens may be washed using normal laundry methods.
  • Only trained personnel are to clean contaminated equipment and surfaces, or handle contaminated material.
NOTE: Decontamination can take place in the work area of the facility, or at another location providing the organisms or waste are transported to the decontamination site in accordance with any transport guidelines and other relevant guidelines, as in force from time to time, issued by the Regulator.

29. Decontamination can be effected by: pressure steam sterilisation (autoclaving) or other heat treatment; chemical treatment; incineration; or by any other method approved in writing by the Regulator.

Any heat treatment must be performed using a combination of temperature and time that has been validated as effective against the organisms being rendered non-viable.

Chemical disinfectant treatment must be effective against the organisms being rendered non-viable.

Incineration must be performed in a high temperature, high efficiency incineration facility that has been approved by the relevant government authority in the jurisdiction where the incinerator is located.

30. Where 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 in accordance with Clauses 6.6.3 or 6.6.4 of AS/NZS 2243.3:2002.
  2. The coldest part of the load must be exposed to a minimum temperature of 121°C for at least 15 minutes in accordance with Clause 6.6.5 of AS/NZS 2243.3:2002.
  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).


  4. The efficacy of the decontamination treatment must be validated at least monthly by the use of:

  5. thermocouples or resistance thermometers, to ensure that the required temperature has been achieved; or
  6. chemical indicators which progressively change colour with the time exposed at the specified temperature; or
  7. biological indicators such as spore strips; or
  8. enzyme indicators.
Calibration of the autoclave thermometer and timers, and pressure testing of the vessel, must be performed annually by a competent person. The results of the autoclave tests, including evidence of the calibration of the equipment used, must be kept for the previous 5 years and made available to the Regulator, if requested.

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

31. Organisms that are not GMOs must not be removed from the facility while a dealing with a GMO is occurring in a facility unless:
  1. procedures are implemented to ensure that dealings with GMOs do not mix with or contaminate work with any other organisms that are not part of the dealing;
  2. the above procedures are documented; and
  3. all primary containers and transport containers are decontaminated prior to removal from the facility.
If mixing or cross-contamination of any other work by GMOs occurs, or is suspected to have occurred, then the other work must be handled and disposed of in accordance with the conditions of certification, as if it were dealing with a GMO.

NOTE: Means of preventing cross-contamination of other work by GMO dealings could include physical separation of the work, or separation by working at different times and ensuring any contaminated surfaces are decontaminated prior to commencing different work.

32. Viable GMOs must not be removed from the facility unless:
  1. they are to be transported to a containment facility certified by the Regulator to at least PC2;
  2. to be rendered non viable prior to disposal; or
  3. written permission has been given by the Regulator for transport to another destination.
33. All GMOs, and material contaminated with GMOs, being transported out of the facility must be transported in accordance with any transport guidelines and other relevant guidelines, as in force from time to time, issued by the Regulator.

34. Viable GM arthropods or arthropods containing GM micro-organisms from the facility must not be stored outside the facility.

35. All primary containers must be labelled to enable identification of the organisms being contained.

36. Any unintentional release or suspected unintentional release of GMOs from the facility must be reported to the Regulator as soon as practicable.

37. Persons who have been performing procedures in the facility that involve GM pathogens or where there has been hand contact with any stage of the life cycle of GMOs that could persist on the hands after exit from the facility, must decontaminate their hands before leaving the work area. This can be achieved by washing, or use of appropriate chemical decontaminant.

NOTE: Alternatives to wash basins, such as dispensers filled with disinfectant solutions, are considered suitable, provided the dispensers can be operated without using the hands.

Standards referenced in this document

AS followed by a number or other identification is a reference to the Australian Standard so numbered or identified, as in force or existing from time to time.

‘AS/NZS followed by a number or other identification is a reference to the Australian New Zealand Standard so numbered or identified, as in force or existing from time to time.

AS/NZS 2243.3
Safety in laboratories
Part 3: Microbiological aspects and containment facilities

AS 2845.3
Water supply - Backflow prevention devices
Part 3: Field testing and maintenance

AS/NZS 3500.1
Plumbing and drainage
Part 1: Water services

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