Notification of issue of new Guidelines for the Certification of Physical Containment Level 3 Animal Facility
As part of the ongoing process to review all technical and procedural guidelines issued under the Gene Technology Act 2000, the Regulator has now issued revised guidelines for the certification of a PC3 Animal Facility.
The new PC3 certification guidelines incorporate comments from accredited organisations that currently hold PC3 certifications and a range of other experts. The main changes to the new guidelines are:
- • the requirements that must be met to become certified have been separated from the conditions that are likely to be applied after the certification is approved;
• the requirements and conditions now adopt a more outcome-focussed approach; and
• are consistent, wherever possible, with the relevant provisions of AS/NZS 2243.3 and AQIS documents
Before conducting dealings with GMOs in a PC3 facility, the facility must be certified. These new PC3 Animal Facility guidelines are effective from 28 June 2010 for new applications. No action needs to be taken in regard to existing certified facilities. These facilities will be given 12 months to comply with the new guidelines. Until certified against the new guidelines, these facilities must continue to comply with previous versions of guidelines and the certification conditions that apply to the facility.
Copies of the revised Guidelines can be downloaded from here.
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