Further Enquiries:

Research Branch
THE UNIVERSITY OF ADELAIDE
SA 5005
AUSTRALIA
Research Branch Email

Telephone: +61 8 8313 5137
Facsimile: +61 8 8313 3700

ORECI Facsimile:
+61 8 8313 7325
ORECI Email

Changes to Gene Technology Regulations 2001

The Gene Technology Regulations 2001 have been revised and changes are due to commence on 1 September 2011. Some categories of GMO dealings will change as a result of the Amendment Regulations and this may affect existing authorisations.

The Institutional Biosafety Committee (IBC) will separately contact GMO Dealing Supervisors to review each dealing in accordance with the new Regulations.

In summary, the Amendment Regulations 2011 introduce the following changes:

addition of GM laboratory guinea pigs and GM Laboratory rabbits to Notifiable Low Risk Dealings (NLRDs);
amended definition of oncogenic modification which will affect the categorisation of some existing dealings (and possibly work not currently authorised);
changes to the classification of some viral vectors including dealings involving host/vector systems able to transduce human cells will no longer be classified as exempt;
introduction of new PC3 NLRD category (when dealings involve microorganisms in Risk Group 3 of AS/NZS 2243.3:2010 (Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment));
dealings with GM Risk Group 4 microorganisms (i.e. as per AS/NZS 2243.3:2010) will be classified as licensable;
increase from 10L to 25L for volume culture of GMOs per vessel as exempt;
new hosts in the list of host/vector systems for exempt dealings;
change from 90 days to 90 working days for time limit for Regulator to make decisions about licences and variations to licences;
limit to GMO dealing authorisation periods;
changes to some other minor administrative matters.

In addition, there is a requirement for transport, storage and disposal of GMOs as part of NLRDs to be undertaken in accordance with the new Guidelines for Transport, Storage and Disposal of GMOs which also commence on 1 September 2011. The Regulator may also require compliance with the Guidelines for the Transport, Storage and Disposal of GMOs as a condition of a licence, or of a certification.

For further reference, copies of the above documents as well as explanatory information is available on the Office of the Gene Technology Regulator (OGTR) website at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gtr-review