Download A Dummies` Guide to Responsibilites When Working with GMO`s

A Dummies’ Guide to Your Responsibilities
When Working with Genetically Modified Organisms in Research and
Teaching
Introduction
In Australia any work carried out at any institution which involves use of genetically modified organisms
(GMOs) is regulated by the Australian government through the Office of the Gene Technology Regulator
(OGTR). Such work must comply with various legislation and both CSU and yourself have a responsibility to
ensure work is carried out safely and poses no threat to health or the environment. Because of the relaxation
of laws and regulations in recent years on ‘dealings’ with GMOs there are various classes of dealings
depending on the risks associated with the work you are doing . Dealings mean production or use of GMOs.
These are as follows:
1.
Exempt Dealings (ED)
In general these are dealings with standard host vector systems where the organisms used are well
known and the risk of any escape of a GMO which might cause harm to the environment is low. Such
work can be carried out in PC1 or PC2 certified laboratories.
2.
Low Risk Notifiable Dealings (LRND)
These are dealings which pose some risk, but are highly unlikely to result in production of any harmful
organisms. Such work can be carried out in PC1 or PC2 certified laboratories, dependent on the
project.
3.
Dealings Not Involving Intentional Release (DNIR)
These are dealings which pose significantly higher risk than LRNDs and for example involve GM
pathogenic organisms, or GM organisms containing higher risk genes from pathogens or genes that
encode toxins or confer an oncogenic modification or immuno-modulatory function. These dealings
must be carried out in PC2 to PC4 certified laboratories, dependent on the project.
4.
Dealings Involving Intentional Release (DIR)
These are dealings which involve release of a GMO into the environment, and pose highly significant
but manageable risks.
In the first two dealings (ED and LRND) the institutional biosafety committee (IBC) at CSU is obliged to
keep a record of these and to determine and confirm with you their status as such and report to the
OGTR annuallyonly on LRND’s. In the latter cases application to the OGTR to carry out DNIR’s or
DIR’s must be made via the IBSC and permission from the OGTR and the IBSC must be obtained for
and prior to such work.
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What you should do if you want to carry out work involving creation or use of GMOs
1.
First of all, decide on the sort of work you want to do and which of the above categories the work falls
into. You should also decide whether it is teaching or research. In most cases it will either be an ED or
LRND.
The form for an ED is on the CSU Biosafety Committees website as are the guidelines for containment
and what constitutes an exempt dealing (on the form and below). If you are unsure which category
your work falls into, please contact the Presiding Officer of the IBC Nigel Urwin, [email protected]
0269332450 or 0429312611 School of Animal and Veterinary Sciences, CSU. Wagga Wagga for
advice. Alternatively visit the OGTR website for more information.
2.
You should then email or send the form to Ms. Ingrid Paton, Executive Officer, IBSC, Office of
Academic Governance, CSU Bathurst campus. The IBSC meets 4 times per year and the meeting
schedule is on the IBC website. The Committee will review your application and you will obtain either
formal permission or a recommendation that the work requires some other sort of classification. If the
work requires urgent permission then the Presiding officer can make an executive decision on whether
it constitutes an exempt dealing or not and the decision can be ratified at the following meeting so that
your work is not held up.
Determining if your work is an Exempt dealing or not
Below are simplified guidelines summarising the Gene Technology Regulations 2001 rules on the OGTR as
of July 2007. This can be found at
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/regsamend2007-3/$FILE/exempthandv61July07regsexcerpt.pdf
Before you submit your application to the IBC you should read these; they are surprisingly straightforward.
In brief exempt dealings are:
Where GM modification occurs in standard laboratory bacterial strains of E. coli, Bacillus species,
Agrobacterium, various fungi including Saccharomyces cerevisiae, slimemolds (Dictyostelium species),
tissue culture (animal, insect, plant or human) where vectors are non-conjugative, non-viral or defective viral
or disarmed. No more than 10L of recombinant organisms should be grown. Donor DNA (DNA being
transferred) should not be derived from a pathogen or toxin-producing organism and must be characterised
and should not include toxin genes.
Typical experiments that are exempt dealings might be:
Shotgun cloning or cDNA library construction of mammalian, plant or bacterial DNA (from non-pathogenic
strains) in E. coli.
Subcloning of characterised DNA sequences such as reporter genes e.g. GFP, lacZ, or promoters PCR
fragments for sequencing in E.coli.
Transient expression or stable transformation experiments using animal or plant cell cultures.
Typical experiments that fall into other categories are:
Shotgun cloning or cDNA library production from know pathogens.
Cloning toxin genes for which the toxin has an LD50 of less than 100µg/mL from which high level expression
might be expected.
Producing transgenic animals or plants where a transgene can be transmitted in the germline.
If your work is a LRND or higher risk category please contact the IBC for further information.
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