Facilities for work with GMOs

 

Certification of facilities by the OGTR

 

Which containment level is required for which dealing?

  • A facility must be certified by the OGTR before it can be used for work conducted under an Notifiable Low Risk Dealings (NLRD) or Dealings Not involving Intentional Release (DNIR) authorisation. 
  • The type  of certified facility (e.g. laboratory or animal facility) and the level of containment (e.g. PC1, PC2) must be suited to the type of GMO and the activities being conducted (Refer to table below and OGTR Guideline)
Type of dealing Facility
NLRD 1.1 dealings       OGTR-certified PC1 (at least)
NLRD 2.1 dealings OGTR-certified PC2 (at least)
NLRD 2.2 dealings OGTR-certified PC3 (at least)
Exempt dealings Facilities in which only Exempt dealings are conducted
do not need to be certified, but must meet some
minimum containment requirements. 

 

How do I get my facility certified by the OGTR?

  • Heads of School and Centre Directors must ensure that all facilities in which GMO dealings are conducted have a designated facility manager.
  • If certification is required, the facility manager must contact the GTRC Support Officer for the application and submission details. The process often involves filling out an application with attached floor plan, physical inspection by the Biosafety Coordinator, seeking approval from the DVC(R) and submitting application to the OGTR.

    Please note that the OGTR may take up to 90 working days to make a decision on an application so it is essential to contact the GTRC Support Officer early.

  • Facilities that have been certified by the OGTR must display signage on all entrances to the facility.


BACK TO TOP

 

Managing an OGTR certified facility

 

What records need to be in place for GTRC Annual Inspection?

Facility managers must ensure that the facility/laboratory has current, documented procedures in place, preferably in the form of a safety manual. This may include: 

  • Facility certification and any approved variation
  • Register of authorised personnel and evidence that people are informed of any special condition that might come with the certification.
  • Record of Assessment (RoA) for all GMO dealings (Exempt, NLRD, DNIR) conducted within the facility.
  • Pest control strategies.
  • Transport and decontamination strategies (refer to OGTR Guidelines for the Transport, Storage and Disposal of GMOs
  • Autoclave annual calibration & boiler inspection, monthly vadiation record with biological indicator.
  • Defective equipment procedure.
  • Spills/Escape procedure.
  • Emergency procedure.
  • Supply and receipt of GMOs.
  • Standard Operating Procedures (SOPs) for external organisations using UNSW services facilities.
  • Restricted access/after hour arrangements.
  • Training record for all personnel working in the facility, including facility induction and other specific training condition. For example, people working in OGTR certified PC facility must show evidence of receiving training on Part C Behavioural Requirement, people using gene technology must show evidence of completion of the Gene Technology Regulations at UNSW online training. See the Biosafety and Gene Technology Training Page to find out the specific training required for each facility type.

Maintaining compliance

  • The facility must continue to comply with the relevant certification requirements.
  • All OGTR certified PC2 facilities (laboratories & animal facilities) will be inspected at least annually by members of the GTRC. 
  • In addition to scheduled annual inspections, certified facilities can be inspected by the OGTR without prior notice.
Click here for inspection report template for PC2 Laboratory. 
Click here for inspection report template for PC2 Animal Facility.
 

BACK TO TOP

 

How do I vary, suspend or surrender my facility certification?

If you wish to vary, suspend or surrender a certification, contact the GTRC Support Officer (ph. +61 2 9385 7244) for details. 


BACK TO TOP

 

Use of OGTR-certified service facilities at UNSW by researchers from other institutions

Researchers from other institutions must seek their own institution's IBC approval to cover the transport to UNSW and the work conducted at UNSW. The researcher, prior to using the service facilities at UNSW, should submit a copy of this approval as well as the modified application to the GTRC Support Officer for noting at the UNSW GTRC monthly meeting.


BACK TO TOP

 

What should I do in an emergency?

Unintentional release of PC1 or PC2 GMOs

Any incident involving unintentional release of a GMO into the environment, including down the laboratory sink, must be reported to the UNSW GTRC Support Officer, RECS, ph. 9385 7244 as soon as possible.

Should an incident occur on a weekend or public holiday, the incident must be reported first thing on the next business day.


Emergencies requiring Ambulance, HAZMAT or Fire brigade

  • University security: CALL  9385 6666

  • Unintentional release or containment concerns relating to quarantine material must be reported directly to DAFF on 8318 6923 or 1800 020 504 (free phone)


Spills and Unintentional Release

Before beginning any project involving GMOs, a thorough risk assessment must be completed that will identify the appropriate response to a particular biological agent, including the identification of resources such as PPE and decontaminant.  It is important that workers are trained in basic spills clean-up procedures.

AS/NZS 2243.3. section 9, describes the handling of most types of spills and must be consulted when completing the initial risk assessment.

If a spill occurs and you are in doubt, evacuate workers from the area, make the workplace safe, and seek assistance by calling UNSW security 9385 6666.

The following guideline describes the general process for cleaning up a spill outside a Biological Safety Cabinet that involves a moderate volume (as determined by a risk assessment) of PC2 GMOs:

  1. Contain the source of the spill and prevent the spill from spreading


  2. The area should be vacated for 30 minutes to allow any aerosols to settle.


  3. Check clothing, and if contaminated, it should be removed and placed in a biohazard bag for decontamination. Wash exposed skin and put on a clean gown. 


  4. If spilled material has soaked through clothing take a complete shower in a regular shower (i.e. not an emergency shower) where possible.  Use the eyewash to flush the eyes and face if necessary.


  5. Use signage to warn others to keep out of the area of the spill and notify the area supervisor.


  6. Assemble the clean-up team (at least 2 people). One member of the team should help ensure that other members are not inadvertently contaminating themselves.  Bring together all the necessary materials, including the appropriate decontaminant, absorbent material and waste bags.


  7. Personal protective clothing appropriate for the agent that has been spilled should be worn during clean up. As a minimum, this will usually include a lab gown, eye goggles, gloves and respiratory protection (P2/N95 disposable face mask).


  8. Any sharp objects should be removed using forceps and disposed of into a sharps container, or as appropriate.


  9. Cover the spill with absorbent material such as vermiculite, paper towels soaked in the appropriate disinfectant. Surround the edges of the spill with paper to prevent it spreading further when disinfectant is added.


  10. If adding further disinfectant, start at the perimeter of the spill and work towards the centre.


  11. Allow the disinfectant to act by leaving it there for at least 10 minutes.


  12. Carefully mop up the spill and disinfectant solution working from the outside inwards, and transfer all contaminated objects and liquids to a waste container for contaminated material.


  13. Repeat the above 4 steps at least one more time to ensure full decontamination and clean-up.


  14. Be sure to wipe down other surfaces (for example, chairs, lab benches) that may have been splashed, or where aerosols may have settled with the disinfectant solution.


  15. Remove gloves and wash hands. Put on new gloves and remove goggles and respiratory protection into a BSC for later decontamination.  Remove gown then remove gloves and wash hands.  Disposable PPE is discarded with the contaminated waste.  Reusable gowns must be autoclaved before laundering. 


  16. Report the incident to your supervisor and also electronically on H2O.


  17. Any suspected or real loss of GMO outside the facility, including down the laboratory sink, must be reported to the RECS unit ASAP.

 BACK TO TOP