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Version 2.1 – Effective 1 July 2007

The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 4 (PC4) Facility 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 PC4 Facility. 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.

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 obtaining and maintaining certification. This document can be downloaded from the Office of the Gene Technology Regulator (OGTR) website.

The OGTR will inspect PC4 Facilities prior to any decision on an application for certification.