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Invitation to comment on draft revised Guidelines for Certification of a PC2 Culture Facility

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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 Culture Facility are the result of an ongoing review of certification guidelines by the Office of the Gene Technology Regulator (OGTR).

The draft revised Guidelines for Certification of a PC2 Culture Facility (formerly Constant Temperature Room) 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 and authorities.

Amendments

Change of Name

The draft revised guidelines have changed name from Guidelines for Certification of a PC2 Constant Temperature Room to Guidelines for Certification of a PC2 Culture Facility. This is to better reflect the main purpose of the facility type i.e. for culturing genetically modified organisms (GMOs).

Scope

Further to the change of name, the draft revised guidelines aim to better specify the types of dealings undertaken in such a facility type. As a result, laboratory procedures may not be conducted outside of primary containment and thus GMOs must be stored within sealed primary containment for the duration of containment in the facility.

Format

The draft revised Guidelines for Certification of a PC2 Culture Facility has been updated to reflect the format of certification guidelines for other facility types e.g. PC2 Laboratory. 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 (www.ogtr.gov.au). Once the revised guidelines are finalised, this document will be updated accordingly.

I would appreciate your comments by 20 August 2010. Comments can be sent by mail to the OGTR at the address on this letter or via email to ogtr@health.gov.au. If you have any specific queries please contact my office by telephone on 1800 181 030 or via email to ogtr@health.gov.au.

After the closing date, the OGTR will finalise the guidelines, taking into account the comments received. The Regulator will then issue the new Certification Guidelines for a PC2 Culture Facility version 2.1 and revoke the current Guidelines for the Certification of PC2 Constant Temperature Rooms.

The final Certification Guidelines for a PC2 Culture Facility version 2.1 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.

While all new facilities seeking certification will need to meet the new certification requirements, existing facility certifications will be varied after one year to apply the conditions of certification as they appear in the new guidelines. You are also welcome to provide comments on the proposed implementation of these guidelines and, in particular, the application of the certification conditions by way of variation as proposed.

A copy of the draft revised Guidelines for Certification of a PC2 Culture Facility can be downloaded here. Alternatively, a hard copy of the documents can be obtained by contacting the Office of the Gene Technology Regulator at the address below.
Comments should be forwarded to the Regulator by close of business on 20 August 2010.