Records kept (C68) C2 Facility cleanability Surfaces are able to be decontaminated (relates to R3), i.e. smooth impermeable to resistant to damage by cleaning agents (Applies to surfaces where contamination is likely to occur e.g. walls, floors, benches, furniture, ceilings) Open spaces between and under benches etc. must be accessible for decontamination (relates to R4) Walls (C2, R3) Floors (C2, R3) Benches (C2, R3) Furniture, including seating (C2, R3) Ceilings/other (C2, R3) Accessible (C2, R4) C14, C68 Pests Effective pest prevention strategies must be documented and implemented. Records must be kept. Pest prevention (C14) Details. Any pests observed? Records kept (C68) C2, C68 Hand and Eyewash Hand washing facilities present (relates to R7): dedicated washbasin with potable water and hands-free operation, or suitable means, such as hands-free dispensers of decontaminant solution Eye wash present – plumbed or single-use packs (R7) Emergency drench showers present. (R7) Hand wash (C2, R7) How is it operated? Plumbed? Chemical disinfectant? Eyewash (C2, R7) Plumbed or portable? Location? Maintained? Drench shower (C2, R7) Location? Records kept (C68)
C16 Containment Equipment (other) Other equipment used to process GMOs (e.g. centrifuges, filtration systems) must be designed to contain GMOs (including aerosols) Note: an N/A response to this question could mean, for example, that no other containment equipment is used. Present Details Designed to contain GMOs How? HEPA? 0.2 um? C16 Secondary Containment Equipment e.g. Bunding Must be sufficient to contain the volume of held in the largest single container, or group of containers where interconnection could result in leakage from multiple containers, plus the volume of any disinfectant that might be used and any expected general fluid movement (relates to R24). Bunding Max volume Other Details e.g. type, volume C17, C26 C42, C54, C56, C61, C67, C68 Liquid Treatment System (LWTS) Fully enclosed pipes, tanks and other components (relates to R25 a) Robust construction materials capable of decontaminated for inspection/maintenance (R25 b) Likelihood of damage must be minimised (e.g. by location) (R25 c) Pipes capable of being inspected and labelled appropriately. If not inspectable, must be double skinned or have leak detection mechanisms in place (R25 d) to pipes, tanks etc. filtered to prevent release of GMOs (R25 e) Strategies in to ensure seal integrity of LWTS and components (drain pipes, holding tanks and vent lines) (R25 f) Screening provided to limit solids leaving the work area via the LWTS (R25 g) Secondary containment provided (e.g. bunding) in room/s or area/s housing LWTS (R25 h): sufficient to contain the volume of liquid waste held in the largest single container, or group of enclosed (C17, R25 a) Location? Authorised persons only? Materials (C17, R25 b) Able to be inspected? Materials used? Likelihood of damage minimised (C17, R25 c) How? By location? Pipes (C17, R25 d) Labelled appropriately? Capable of inspection/double skinned/leak detection? filtered (C17, R25 e) 0.2 µm? HEPA? Seal integrity (C17, R25 f) Strategies? Screening for solids (C17, R25 g)
Bunding (C17, R25 h) Max volume? Smooth, impermeable, able to decon? secondary containment (C17, R25 h) Details e.g. type, volume Contingency plan (C17, R25 i) Specialised equipment? Decontamination – prevents release of GMOs (C42) Decontamination - Validated (C54) How? Monitored for effectiveness (C26) As per TSDs? Labelled to show monitoring (C56) As per TSDs?
containers where interconnection could result in leakage from multiple containers, plus the volume of any disinfectant that might be used and any expected general fluid movement; and smooth, impermeable to water, easily cleanable, and resistant to damage by the cleaning/ decontamination agents to be used. Documented contingency plan and means in place to respond to leakage of waste containing GMOs/failure of LWTS. Must include details of specialised equipment to be used for responses (R25 i) Decontamination of the LWTS: carried out in a way that prevents release of GMOs use a combination of time and temperature validated as effective against GMO being used Clearly labelled to show has been monitored for effectiveness etc. as per TSD’s Results of monitoring and calibration must be kept. Records of maintenance must be kept. Note: an N/A response to this question could mean, for example, that no LWTS external to facility used to treat GMOs. Results and records kept (C68) C16, C27, C28, C38, C39, C58, C68 Biological Safety Cabinets Must be present if dealings (other than those within a LWTS or closed systems) will produce aerosols containing GMOs (Relates to R22). Dealings (other than those within a LWTS or closed system) that produce aerosols containing Risk Group 2 microorganisms must be performed in a BSC or other aerosol containment device approved by the Regulator. BSCs must be inspected and tested at least once every 12 months and after relocation/maintenance/HEPA replacement. Where testing has shown a BSC is defective, it must be clearly marked to show that it is not to be used for Present, number (C16, R22) Type; location? Tested (C27) At every 12 months? Test date (sticker); test results (sticker); NATA accredited? Clearly marked if defective (C28) Used for dealings that produce aerosols (C38)
Carried out by trained personnel (C44) GMOs and organisms infected with GMOs (C49) Details Floor drainage (C46) Details Sink Drainage (C47) Details Solid waste (C47) Details Surfaces and equipment (C45, C46, C48, C50) Details Chemical treatment effective against type of GMO (C53) Details
C63-C65 Removal and storage >25L only with written permission from Regulator. <25L and not exempt: In accordance with TSDs; and to at least PC2 level facility; OR another location for storage; OR for decontamination (or disposal if the method of disposal is also the method of decon); OR to another location agreed to in writing by Regulator. Decontaminate exterior surfaces as required by transport guidelines, before and after transport. Labelling to show name, address and contact details of sender. Note: an N/A response to this question could mean, for example, that viable GMOs are not removed from the facility. Approval for >25L (C63) Details <25L (C64) Volumes? Double contained (<25L; C64) Type? Unbreakable? Surfaces decontaminated (<25L C64) How? Before and after transport? Appropriate destination (<25L; C64) Certified facility? Storage Unit? For In accordance with TSDs (<25L; C65) Details C66 Removal of non-GMOs from the facility Non-GMOs must not be removed from facility while dealings with GMOs are being conducted unless: procedures to ensure that work with the are not contaminated with GMOs have been documented; the above procedures have been implemented; and all primary containers and transport containers are decontaminated prior to removal from the facility. Note: an N/A response to this question mean, for example, that non-GMOs are not removed from the facility while dealings with GMOs are being conducted. Documented procedures to prevent Specify procedures. Documented? External decontamination prior to removal from facility Disinfectant used? All persons trained (C31)
(C32 a.) Details Identification of (C32 b.) Details Spill and decon (C32 c.) Details Emergency procedures (C32 d.) Details PPE (C32 e.) Details Reporting requirements (C32 f.) Details Cert requirements (C32 g.) Details Licence requirements (C32 h.) Details Structure and operation (C32 i.) Details
C25, C54 Autoclave Calibration of the autoclave thermometer and timers must be performed annually by a competent person. Test results must be kept and provided to the Regulator on request. C25, C54 External liquid waste treatment system (LWTS) (if present) Calibration of the thermometer and timers must be performed annually by a competent person. Test results must be kept and provided to the Regulator on request. Results of any maintenance of LWTS. C2, C29 Backflow prevention Testable backflow prevention devices must be tested at least every 12 months. Documentation of test results must be provided to the Regulator on request. Risk assessment for backflow prevention (where applicable). C21, C23 Closed system for large-scale culture Inspection and testing of the integrity of any closed system (reusable or must be undertaken before each use. Records must be kept and made available to OGTR if requested. C14 Pest control A record of pest prevention strategies/control activities must be kept and provided to the Regulator on request. C31 Training records All personnel must be trained in procedures and facility details. Records must be kept and provided to the Regulator on request. C27 BSCs BSCs must be inspected and tested every 12 months, or after relocation, maintenance, or after HEPA filters are replaced. A certificate summarizing test results and date of next test must be fixed to the cabinet. C36 (R21) Respiratory protection Documented risk assessment of whether respiratory protection is deemed necessary.