Office of the Gene
Technology Regulator:
www.ogtr.gov.au
In accordance with previous advice, the
Gene Technology Amendment Regulations 2006 (the Amendment Regulations)
will commence on 31 March 2007. These Amendment Regulations amend
the Australian Government Gene Technology Regulations 2001 (the
2001 Regulations).
Electronic copies of the compilation can be
accessed directly through the Federal Register of Legislative Instruments
(FRLI) website (www.frli.gov.au)
or via the OGTR website (see
www.ogtr.gov.au/regsreview/regsamend.html).
The Amendment Regulations make a number of changes to
the way dealings with genetically modified organisms (GMOs) are classified
and administered. Most of the changes are intended to reduce the
regulatory burden associated with low risk dealings with GMOs conducted in
contained facilities.
Please note that in relation to existing
dealings no immediate action is required in order to comply with these
changes to the 2001 Regulations. You have time to familiarise
yourself with the amendments and plan appropriate action in order for your
organisation to minimise any administrative impact.
In this context, I am providing you with an
update on proposed actions by my Office to assist organisations in
managing the implementation of these changes. I also want to take this
opportunity to inform you about other changes that will result from
implementation of recommendations of the independent “Statutory Review of
the Gene Technology Act 2000 and the Gene Technology Agreement
2001” (the Review of the Act), including amendments to both the
Gene Technology Act 2000 (the Act) and the 2001 Regulations.
Amendment Regulations –
requirement for licensing of dealings previously classified as NLRDs
While most of the changes will
result in a reduction of regulatory burden, from a compliance viewpoint I
particularly wish to highlight that some dealings with GMOs previously
classified as notifiable low risk dealings (NLRDs) under the 2001
Regulations (such as dealings with non-third generation lentiviral
vectors) will require a licence following commencement of the Amendment
Regulations.
However you should note that, in relation to
this change, the Amendment Regulations provide a 12 month transitional
period to enable organisations to identify any such existing NLRDs and
apply to the Gene Technology Regulator (the Regulator) for a licence to
enable continuation of these dealings.
All new dealings of this type, which
have not been notified to the Regulator before commencement of the
Amendment Regulations, will require a licence before work
commences.
Changes to containment
requirements for exempt dealings
The Amendment Regulations replace the
requirement to conduct exempt dealings according to the physical
containment level one (PC1) requirements of AS/NZS 2243.3 with the
requirement to comply with guidelines issued by the Regulator. You will
be receiving separate correspondence from me regarding these new
‘Guidelines for the Containment of Exempt Dealings’. Once issued, these
guidelines will be available from my website (see
http://www.ogtr.gov.au/pubform/handbook.htm#guidelines).
Possible implications of the
independent Review of the Gene Technology Act 2000 and Gene Technology
Agreement 2001
The independent Review of the Act was
completed in 2006, and the State, Territory and Australian Governments’
Response to the recommendations of the Review (All Governments’ Response)
was tabled in Parliament on 16 November 2006.
The All Governments’ Response agreed to
implement the majority of recommendations of the Review of the Act, and
the Australian Government introduced the Gene Technology Amendment Bill
2007 (the Bill) into the Australian Parliament on 28 March, 2007. The
Review report, the All Governments’ Response and details on the Bill are
available from the Gene Technology Ministerial website (http://www.health.gov.au/internet/wcms/publishing.nsf/Content/gene-gtmc.htm).
Implementation of some of the recommendations
of the Review of the Act will require further amendments to the 2001
Regulations. It is anticipated that the Bill and Gene Technology
Amendment Regulations 2007 will commence on 1 July 2007.
Notably, implementation of recommendation 6.1
of the Review would remove the current requirement to conduct exempt
dealings according to specified containment standards. This change is
intended to further reduce the regulatory burden for low risk dealings.
The All Governments’ Response noted that implementation of this proposal
would require the Regulator to review the list of exempt dealings in the
2001 Regulations, as amended by the Amendment Regulations, to determine
whether any would require reclassification, i.e. would still require PC1
containment. Therefore the list of exempt dealings may be changed
further, but the precise changes will not be clear until these proposed
amendments have been tabled in Parliament.
In light of these likely changes, I suggest
that your organisation consult my Office before taking action to surrender
certifications for facilities used for dealings classified as exempt
dealings under the Amendment Regulations. My Office will email your
organisation with details of any further amendments to the 2001
Regulations when they become available.
Information sessions and other
supporting information
In order to assist your organisation to comply with the Amendment
Regulations, and keep you up to date with other regulatory changes, the
OGTR intends to present a series of information sessions that will cover a
range of topics including:
-
Changes to the
2001 Regulations, and the implications for stakeholders;
-
Revisions to
various guidelines, including certification and transport guidelines;
-
Anticipated
further changes to legislation flowing from the independent Review of
the Act.
The information sessions will take place in
capital cities during the second quarter of 2007. My Office will contact
you with further details regarding timing and venues. These sessions were
initially planned to occur prior to the commencement of the Amendment
Regulations but were delayed because we expect that the implications of
implementation of the independent Review of the Act will be clearer by
that time.
In the interim I refer you to information
on my website (see
http://www.ogtr.gov.au/regsreview/regsamend.html),
including the following documents:
A set of frequently asked question and
answers about the Amendment Regulations will also soon be added to this
web page.
Again, I would like to stress that you do
not need to act immediately in response to the commencement of the
Amendment Regulations. The explanatory information available on the OGTR
website should assist you to identify how the changes will affect the
dealings being conducted by your organisation and the most appropriate way
to respond.
If you have any queries regarding the
changes to the Gene Technology Regulations 2001 and the
implications for your organisation, please do not hesitate to contact the
OGTR by email at
OGTR@health.gov.au
or freecall on 1800 181 830.
Dr Sue D Meek
Gene Technology Regulator