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Invitation to Comment on draft revised Guidelines for Certification of a PC2 Laboratory (Version 3.2), Plant Facility (Version 3.2), Animal Facility (Version 3.2), Aquatic Organism Facility (Version 3.1) and Invertebrate Facility (Version 3.1)

The Gene Technology Act 2000 (the Act) contains provisions for the Gene Technology Regulator (the Regulator) to issue technical or procedural guidelines about the requirements for the certification of physical containment (PC) facilities.

The draft revised Guidelines for Certification of a PC2 Laboratory (Version 3.2), Plant Facility (Version 3.2), Animal Facility (Version 3.2), Aquatic Organism Facility (Version 3.1) and Invertebrate Facility (Version 3.1) (formerly Arthropod) are now ready for external comment.

All organisations accredited by the Regulator to conduct dealings involving gene technology have been asked to provide direct feedback, as well as a range of other expert groups, authorities and applicants.

In drafting these revised certification guidelines we have taken into account recent amendments to the Gene Technology Regulations 2001, OGTR inspections of certified PC2 facilities in Australia, relevant national and international standards, analysis of comparable overseas guidelines, assessments of the risks associated with the organisms likely to be contained in these facilities and the issue of the Guidelines for Transport, Storage and Disposal of GMOs in September 2011.

Where possible and appropriate, the revised certification guidelines are consistent with the Australian/New Zealand Standard (AS/NZS) 2243.3:2010 Safety in Laboratories Part 3: Microbiological safety and containment, and the Australian Quarantine Inspection Service (AQIS) requirements.

Format
The draft revised Guidelines have been updated to ensure, as afar as practicable, a consistent format across all types of facilities. This includes the separation of the guidelines into three parts:

    • Part A: Requirements for Certification;
    • Part B: Conditions of Certification; and
    • Part C: Behavioural Requirements.
There is also an attachment to the guidelines listing the standards referenced in the document.

Certification guidelines are intended to be read and interpreted in conjunction with background information contained in the Regulator’s Explanatory Information on Guidelines for Certification of Physical Containment Facilities. An electronic version of this document is available from the OGTR website. Once the revised guidelines are finalised, this document will be updated accordingly.

Comments can be sent by mail to the OGTR at the address on this web page or via email. If you have any specific queries please contact the OGTR by telephone on 1800 181 030 or via email.

After the closing date, the OGTR will finalise the guidelines taking into account the comments received. Once finalised, the revised guidelines will be issued and the current guidelines revoked.

The final Guidelines for Certification of a PC2 Laboratory (Version 3.2), Plant Facility (Version 3.2), Animal Facility (Version 3.2), Aquatic Organism Facility (Version 3.1) and Invertebrate Facility (Version 3.1) will be sent to all accredited organisations and expert organisations that have been consulted. A copy will also be placed on the OGTR web site.

A copy of each draft revised guideline can be downloaded from the links below.

Guidelines for Certification of a PC2 Laboratory (Version 3.2) (RTF 486 KB)
Guidelines for Certification of a PC2 Laboratory (Version 3.2) (PDF 217 KB)

Guidelines for Certification of a Plant Facility (Version 3.2) (RTF 511 KB)
Guidelines for Certification of a Plant Facility (Version 3.2) (PDF 232 KB)

Guidelines for Certification of a Animal Facility (Version 3.2) (RTF 492 KB)
Guidelines for Certification of a Animal Facility (Version 3.2) (RTF 228 KB)

Guidelines for Certification of a Aquatic Organism Facility (Version 3.1) (RTF 530 KB)
Guidelines for Certification of a Aquatic Organism Facility (Version 3.1) (PDF 230 KB)

Guidelines for Certification of a Invertebrate Facility (Version 3.1) (RTF 515 KB)
Guidelines for Certification of a Invertebrate Facility (Version 3.1) (PDF 225 KB)

Comments should be forwarded to the OGTR by close of business on 18 MAY 2012.

Office of the Gene Technology Regulator

MDP 54 PO Box 9848 Canberra ACT 2601
Telephone: 1800 181 030
Facsimile: 02 6271 4202
E-mail: ogtr@health.gov.au
OGTR website http://www.ogtr.gov.au