Australia
June 20, 2011
Source: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gtr-review
Gene Technology Amendment Regulations 2011
The Gene Technology Amendment Regulations 2011 (the Amendment Regulations 2011) were made on 2 June 2011 and are due to commence on 1 September 2011.
The Amendment Regulations 2011 will amend the Gene Technology Regulations 2001.
These amendments are the outcome of a review undertaken by the Gene Technology Regulator (the Regulator). The proposals for amendment were made in response to suggestions from regulated organisations, as well as operational experience gained in the Office of the Gene Technology Regulator (OGTR).
The Amendment Regulations 2011 were finalised, taking into account feedback received during the consultation.
The amendments relate to technical and operational matters that will enhance the effectiveness of the Regulations and assist user compliance by making them clearer and easier to understand.
The Amendment Regulations 2011 introduce changes in scheduling of some Exempt dealings; scheduling of some Notifiable Low Risk Dealings (NLRDs); classification of some viral vectors; oversight and timeframes of NLRDs; as well as other minor administrative matters.
The Amendment Regulations 2011 will also require transport, storage and disposal of GMOs as part of NLRDs to be undertaken in accordance with the Guidelines for Transport, Storage and Disposal of GMOs issued by the Gene Technology Regulator on 2 June 2011. These new guidelines also commence on 1 September 2011.
Commencement
The Amendment Regulations 2011 are due to commence on 1 September 2011.
The delayed commencement is intended to allow time for the regulated community to become familiar with the changes and be ready to implement and comply with them by 1 September 2011.
Until 1 September 2011, all dealings with GMOs continue to be conducted in accordance with the Commonwealth’s Gene Technology Regulations 2001 (as amended in 2009) or, where applicable, corresponding State/Territory legislation.
Links to the amended regulations
The Gene Technology Amendment Regulations 2011 (due to commence on 1 September 2011)
Future Law Compilation of the Gene Technology Regulations 2001
Link to supporting material
(note that updates will occur periodically)
Explanatory Statement to the Gene Technology Amendment Regulations 2011
Guidelines for the Transport, Storage and Disposal of GMOs (commence on 1 September 2011)