The University Recombinant DNA Monitoring Committee is continuing to accept applications for dealings involving the use of GMOs, which are reviewed out of session. For submissions to be actioned appropriately, please ensure applications are sent via email to firstname.lastname@example.org a minimum of 6 weeks before the expiry of your existing dealing, or for new dealings, 8 weeks before the anticipated start of your work.
Information from the Office of the Gene Technology Regulator (OGTR)
This information applies to all research groups who have been approved by the Deputy Vice-Chancellor (Research and Innovation) to continue work involving GMOs. Relevant information is below and is also available on the OGTR website.
Please note that all GM work approved to continue must only be conducted by persons who have completed the required Biological Safety and Gene Technology Practices training.
Information for facility managers and those continuing work with GMOs in certified facilities
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 email@example.com to apply to suspend certification until the inspection can be carried out.
Where supply shortages occur (for example, decontamination solutions, PPE and consumables), OGTR have stated that:
"Institutions may consider the use of alternative decontaminants. The TGA instructions for disinfectant testing may be helpful and provides guidance on the testing of the effectiveness of decontaminants. Please note that this guidance document uses 'disinfectant' whereas 'decontaminant' is used in guidelines that are issued by the OGTR. AS/NZS 2243.3:2010, Appendix F, is a recommended source of information when selecting and using chemical decontamination agents. Please be aware that work should not proceed where you cannot provide a decontaminant that is effective against the GMO being used in the lab."
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 firstname.lastname@example.org as soon as possible.
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 email@example.com 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 firstname.lastname@example.org. No changes are to be made without prior approval.
Information for DNIR licence holders
The following is communication from the OGTR to DNIR licence holders, and is also available on the OGTR website:
"The OGTR appreciates that important work is being conducted under licences and that licence holders wish to continue this work. Licence conditions must be complied with even in these difficult times.
General Principles for licence holders:
- Your priority is to ensure that GMOs or viable GM material are not dispersed and that the work is being conducted safely.
- Consider alternative approaches to your standard work practices that still ensure that you meet licence conditions.
- You may wish to update your contingency plans and SOPs to ensure that licence conditions will continue to be met and risks are managed under a variety of circumstances. These include:
- effectiveness of current containment requirements
- impact of reduced workforce availability
- impact of restrictions on travel/transport of GMOs
- impact of travel restrictions on conducting inspections
- complying with reporting obligations."