rDNA Monitoring - Facility responsibilities

Information for facility managers and those working with GMOs in certified facilities 

Facility Inspections

While some flexibility regarding time frames for annual PC2 inspections may be appropriate, inspections are considered by OGTR to be a critical risk-management tool. As such, full exemptions from this requirement must be submitted via the Ethics Office to OGTR and are unlikely to be granted.

If no GM work is currently happening, facility managers can contact rdna.officer@anu.edu.au to apply to suspend certification until the inspection can be carried out.

Supply shortages 

Where supply shortages occur (for example, decontamination solutions, PPE and consumables), OGTR have stated that:  

When conducting experiments involving the use of GMOs under an approved dealing, research groups must have all the equipment, consumables, PPE and approved disinfectants and/or sanitisers to complete their experiments prior to the commencement of work. Information regarding possible supply chain interruptions is available from the Association of Biosafety for Australia and New Zealand. 

If facility managers have any concerns regarding their ability to meet the conditions of PC2 certification, please email rdna.officer@anu.edu.au as soon as possible. 

Testing/calibrating equipment 

Where there is an inability to test/calibrate decontamination or containment equipment, OGTR have indicated 'The Physical Containment Guidelines stipulate annual maintenance on a set of equipment to ensure it is functioning effectively. If this annual maintenance cannot be achieved, a risk assessment should be conducted and a risk management strategy sent to rdna.officer@anu.edu.au so that it can be submitted to OGTR as part of a Certification Variation request]. The risk management strategy could include considerations of alternative validation measures such as including spore tests in autoclave runs and storing the waste until it has been demonstrated that the kill was effective, or build in a safety margin by increasing time or temperature in autoclave runs.' 

Please note that if any changes to testing or calibration are required, facilities should email rdna.officer@anu.edu.au. No changes are to be made without prior approval.