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January 21, 2005
Invitation to comment on the Risk
Assessment and Risk Management Plan for limited and controlled
release of genetically modified wheat: DIR 054/2004, comments
close 4 March 2005 - posted 21 January 2005
DIR 054/2004 - Field trial of
genetically modified wheat with altered grain starch
Australia’s Gene Technology Regulator (the Regulator) is
responsible for administering the national regulatory system
that seeks to protect the health and safety of people and the
environment by identifying risks posed by, or as a result of,
gene technology and managing those risks.
The Regulator has received an application for a licence to
intentionally release genetically modified (GM) wheat (Triticum
aestivum L.) into the environment:
CSIRO
proposes to conduct a limited and controlled release of six
lines of GM wheat with altered starch characteristics. The
aim in conducting the proposed release is to assess the
in-field performance and to generate seed stocks of the GM
wheat lines for further research (subject to future
approvals). The proposed release would take place at one
site covering a maximum total area of 0.25 ha in the
Australian Capital Territory from May 2005 to January 2007.
Starch is
an important energy storage compound in plants which can
vary in its structural composition. In the GM wheat lines
specific genes involved in starch synthesis have been turned
off or ‘silenced’. This has resulted in GM wheat plants
which produce grain with an increased proportion of amylose
starch. This type of starch is also known as ‘resistant’
starch because it is digested differently to other starch.
Foods made with resistant starch are thought to have
benefits for human health. All the GM wheat lines proposed
for release also contain an antibiotic resistance gene that
was used as a selectable marker in the laboratory.
Following consultation with the expert groups and authorities
prescribed in the Gene Technology Act 2000 (the Act), the
Regulator has prepared a risk assessment and risk management
plan (RARMP) for this application.
The RARMP
suggests that the proposed release would not pose significant
risks to human health and safety and the environment as a result
of the genetic modification. The RARMP identifies a range of
proposed licence conditions, including containment conditions
that would be imposed if a licence was issued.
In accordance with the Act, the Regulator invites written
submissions from the public and interested organisations on
matters relating to the protection of human health and safety
and the environment in order to finalise this plan. Please
note that issues such as food safety and labelling, herbicide
use and marketability and trade implications do NOT
fall within the scope of the evaluations conducted under the
Act, as these are the responsibility of other agencies and
authorities.
The full risk assessment and risk management plan, summary
information, and a set of Questions and Answers can be obtained
from the Office of the Gene Technology Regulator’s website or by
contacting the Office (see below). Copies of the licence
application are also available. Please quote application number
DIR 054/2004.
The
Gene Technology Act 2000 specifies a minimum 30 day
consultation period. However, I have extended the comment period
to 6 weeks. The RARMP will then be finalised, to take into
account matters raised
in submissions
that relate to the protection of people and the environment. I
will then make a decision on whether or not to issue a licence
as soon as possible thereafter.
BACKGROUND:
http://www.ogtr.gov.au/ir/dir054.htm
Submissions should be forwarded to the Regulator by close of
business on 4 March 2005.
Office of the
Gene Technology Regulator
PO Box 100 WODEN ACT 2606
Telephone: 1800 181 030
Facsimile: 02 6271 4202
http://www.ogtr.gov.au
E-mail:
ogtr@health.gov.au |
