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 Laboratory. A PC3 facility must be certified by the OGTR before any dealings with GMOs are conducted in the 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 and conditions have been updated for consistency with the recently revised PC3 Animal and Invertebrate Guidelines;
  • the requirements and conditions have been updated, wherever possible, to maximise the outcomes-focussed approached adopted by this office in recent years; and
  • the requirements and conditions have been made consistent, wherever possible, with the relevant provisions of AS/NZS 2243.3:2010 and DAFF Biosecurity (formerly AQIS) documents.

Applications for new certifications:
The new Guidelines for Certification of a PC3 Laboratory (Version 3.1) will be effective from 28 May 2012 for new applications.

Currently certified labs:
No immediate action needs to be taken for laboratories that are already certified against Version 2.1 of the Guidelines. These facilities must continue to comply with the previous version of the guidelines and the certification conditions that apply to the facility, until they are reassessed by the OGTR as part of the usual certification cycle.
      Current certifications that expire before 28 May 2013:
      PC3 laboratories that expire between now and 28 May 2013 will be assessed against the new guidelines when the OGTR inspects the facility prior to recertification. If a laboratory is not compliant with the new guidelines when inspected, the organisation will have until 28 May 2013 to ensure that the facility becomes compliant with the new Guidelines.

      Current certifications that expire after 28 May 2013:
      PC3 laboratories with certifications that expire after 28 May 2013 will be assessed against the new Guidelines before recertification.

Should you have any questions about the new guidelines, please contact us. Copies of the revised Guidelines can be downloaded from the OGTR web site.