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- Guidelines for Certification of a Physical Containment Level 2 Laboratory(PDF 251 KB)
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Version 3.2– Effective 1 March 2013
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Laboratory issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Once a facility is certified, the certification instrument imposes conditions on the facility pursuant to section 86 of the Act. The conditions of certification (Part B), detail the usual conditions that will apply to a PC2 Laboratory. Individual certification conditions may differ from these in some respect but generally an applicant can expect that their conditions will closely follow those published here. Once issued, the conditions may be varied by the Gene Technology Regulator as necessary and appropriate.
When planning a new facility, proposing to apply for certification of an existing facility or varying an existing certification, an assessment of the risks of GMOs escaping in an emergency event should be undertaken. Emergency events include, but are not limited to flooding, coastal storm surges or land slippage. If the risk assessment determines that there is a greater than negligible risk from the emergency event, then the applicant should develop a risk management plan to assist them in minimising the risks of the emergency event.
The risk management plan may include, for example, removal or destruction of GMOs and decontamination of equipment and surfaces or other measures well before the event impacts the facility. Consideration should be given to the resources needed to implement the risk management plan, and their availability, during such events.
A list of the Australian/New Zealand Standards that are referenced throughout this document is also attached.
A separate document - Explanatory Information on Guidelines for Certification of Physical Containment Facilities - contains details about the process of certification. This document can be downloaded from the OGTR website.