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 2 (PC2) Invertebrate Facility.
Where a specific condition in this document conflicts with a condition of a licence, the Gene Technology Regulations 2001 (the Regulations), or any applicable guidelines issued under Section 27(d) of the Act, then the condition of a licence, the Regulations, or applicable guidelines prevails.
Definitions and acronyms
The definitions and acronyms found in Part A of this document also apply to Parts B and C.
Obligations of the certification holder in respect of users of the facility
1. 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.
2. For purposes of condition 1, an authorised person is a person who:
- intends to undertake dealings, and has been trained in accordance with the Behavioural Requirements listed at Part C of this document;
- has signed, dated and provided to the certification holder a record of the training referred to in paragraph 2(a) above; and
- has not been excluded from the facility by the certification holder on the direction of the Regulator; or
- is an individual, or class of person, 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.
3. If the Regulator requests the certification holder to provide a signed and dated record of the training provided to a particular authorised person, or class of person, the signed and dated record of that training must be available to the Regulator within a time period stipulated by the Regulator.
- NOTE: These records may be in an electronic format.
- has behaved, or is behaving, in a manner which has caused, or which may cause, GMOs to escape from the facility; or
- 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;
5. If the Regulator directs the certification holder to admit a person, or class of person, to the facility subject to conditions, the certification holder must only admit the person, or class of person, subject to those conditions.
6. For the purposes of condition 5, before admitting a person, or class of person, subject to conditions, the certification holder must notify the person(s) of any conditions that apply to them.
7. If the Regulator invites the certification holder to make a submission on whether or not a person, or class of person, should:
- be excluded from entry to the facility; or
- be admitted to the facility subject to conditions;
8. If the certification holder is not the owner of the facility and does not have the authority to admit and exclude persons from the premises, the certification holder must not allow dealings in the facility until such authority is obtained in writing from the owner of the facility. If the certification holder does not have the capacity to prevent dealings from occurring, the certification holder must notify the Regulator of this in writing as soon as practicable.
9. 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 type
10. Unless otherwise agreed to in writing by the Regulator, the following work must not be conducted in this facility:
- dealings with any GMO that under the conditions of a licence or legislation requires containment in any physical containment level higher than PC2;
- the housing/keeping/rearing of any terrestrial vertebrates, or aquatic organisms, for longer than the minimum time required to complete procedures on them;
- the growing of any plants unless they are integral as part of a dealing with GM invertebrates or invertebrates containing GMOs;
- dealings with GM invertebrates, or non GM invertebrates containing GM micro-organisms, where part of the life cycle is in water and where the volume in a single container is greater than 25 litres;
- cultures of GMOs where the volume in a single container is greater than 25 litres; or
- any other work prohibited in writing by the Regulator.
11. 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.
12. The facility must be inspected at least once every 12 months by a person who has acquired through training, qualifications or experience, or a combination of these, the knowledge and skills enabling that person to assess the facility’s compliance with the conditions listed under the ‘General conditions’ and ‘Facility and fittings conditions’. 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.
- NOTE: A checklist which may be used for annual inspections of PC2 Invertebrate 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.
- a current PC2 sign, as supplied by the OGTR; and
- a biohazard symbol, if any dealings being undertaken in the facility involve GM micro-organisms, including viral vectors where the parent organism satisfies the criteria for classification as a Risk Group 2 organism under AS/NZS 2243.3.
Signs may be attached 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.
14. A supply of decontamination agents effective against the GMOs being dealt with in the facility must be available in the facility for decontamination purposes. All containers of decontamination agents, including any solutions for decontaminating hands, must be labelled with the contents and the expiry date (if applicable). Decontamination agents must not be used after the expiry date.
15. A strategy to control pests and any invertebrates which have escaped from a primary container must be implemented and maintained in the facility. Where GMOs in the facility have the potential to be disseminated via animals, including invertebrates, there must be strategies in place to prevent the entry or exit of animals including invertebrates via the anteroom.
Facility and fittings conditions
16. The certification holder must ensure that the physical attributes of the facility and fittings are maintained so that the ‘Facility and fittings requirements’ listed in Part A of this document continue to be met.
17. Prior to any structural changes that will affect the containment of GMOs in the facility, the applicant must either:
- request a suspension of the certification, in writing, from the Regulator; or
- request a variation to the area of certification in writing, from the Regulator, to allow dealings to continue in a part of the facility unaffected by the structural changes.
- NOTE: For example, it may be possible to apply for a variation to temporarily partition the facility to provide containment for GMOs at one end while the other end is being modified. Once the work is complete another variation would be required to re-instate the area removed from the certification.
19. Where any Class I or Class II biological safety cabinet is installed and used for procedures with GMOs, it must be inspected and tested in accordance with the performance requirements of Section 5.2 Critical for cabinet function of AS 2252.1 and Section 5.2 Critical performance tests for cabinet function of AS 2252.2, respectively. This testing is required at least every 12 months and additionally after relocation of a cabinet, after mechanical or electrical maintenance and after high efficiency particulate air (HEPA) filters are replaced. The inspection and testing of cabinets must be carried out by a qualified person.
20. The certificate summarising the test results and the date of the next test, must be affixed to the cabinet.
21. 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 that produce aerosols containing GMOs.
22. Where the certification holder is the owner, or the entity with control of, any autoclave, or any other heat-based equipment used in decontaminating GMOs, that autoclave or other heat-based equipment must be:
- monitored monthly, for effectiveness, and
- calibrated annually,
- NOTE: Details on periodical monitoring and annual calibration of decontamination equipment are specified in the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs as in force from time to time.
- NOTE: Compliance with the above requirement may be achieved by placing a notice on the autoclave, or other heat-based equipment, containing dates and results of calibration and monitoring. Details on periodical monitoring and annual calibration of decontamination equipment are specified in the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs as in force from time to time.
25. Any backflow prevention measures in place either at the time of certification or installed at a later time must be maintained until a change in the measures is indicated by a review of the backflow prevention assessment.
26. Where the facility does not comply with AS/NZS 2243.3 in relation to backflow prevention requirements for water supplied to the facility, and no backflow prevention assessment has been conducted previously, an assessment must be undertaken to determine whether backflow prevention on the water supplied to the facility is necessary considering the GMOs that are being dealt with in the facility.
27. Where there is an existing assessment on the need for backflow prevention, it must be reviewed when:
- any new cross-connection, device or system that may cause contamination of a water supply is connected directly or indirectly to any part of the water service to the facility; or
- connections were made prior to certification and were assessed as not requiring backflow prevention measures, but a new GMO is to be dealt with in the facility that presents different risks from the GMOs assessed at the time of certification.
- NOTE: AS/NZS 3500.1 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.
30. If the water supplied to the facility is fitted with any testable water supply backflow prevention devices, these devices must pass a test every 12 months. These tests must be conducted in accordance with AS 2845.3 by a licensed plumber accredited to test backflow prevention devices. Any failures must be rectified and the device re-tested until compliance is achieved. Documentation of the last three years’ test results must be kept and made available to the Regulator if requested.
31. If the backflow prevention device is found to be defective and the defect has not been corrected, any equipment attached to the water supply must be clearly marked to show that it must not be used when attached to the water supply system until the defect has been corrected.