Form - University of Queensland

advertisement
IBC reference No.
Institutional Biosafety Committee
_____________________________
Exempt Dealing Evaluation Report
Does your proposed Exempt work fall into one or more of the categories listed below?
Please note this also includes possession (storage) of this material.
Read each category carefully. If your work with genetically modified organisms (GMOs) is
listed in the following descriptions, print this document out, sign and date it (below), and
forward it to the IBSC secretary (biosafety@uq.edu.au). At this point you may commence the
work.
For ANY work being conducted with GMOs that is not described below, or if you are unsure,
contact the IBSC secretary for advice on how to proceed further, or consult the Gene
Technology Regulations (2011) http://www.ogtr.gov.au/pubform/legislation.htm

Any dealing with a genetically modified nematode (Caenorhabditis elegans) unless:
(a) an advantage is conferred on the animal; or
(b) the animal becomes capable of producing or secreting an infectious agent.
NOTE: All transgenic rodent work (knockout, knockdown, transgenic etc) must be done under a Notifiable
Low Risk Dealing (NLRD) or Licenced Dealing (contact Biosafety Approvals Adviser for details).

A dealing with an animal into which genetically modified somatic cells have been introduced, if:
(a) The somatic cells cannot give rise to infectious agents as a result; and
(b) The animal is not infected with a virus capable of recombining with the GM nucleic acid of the
somatic cells.

A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication
defective viral vector, if (a) the in vivo modification occurred as part of a previous dealing; and (b) the
replication defective viral vector is no longer in the animal; and (c) no germ line cells have been
genetically modified; and (d) the somatic cells cannot give rise to infectious agents as a result of the
genetic modification; and (e) the animal is not infected with a virus that can recombine with the
genetically modified nucleic acid in the somatic cells of the animal.

A dealing involving a host/vector system listed on page 2 and producing no more than 25 litres of GMO
culture in each vessel, provided that the gene of interest:
(a)
(b)
(c)
(d)
(e)

does not code for a vertebrate toxin with an LD50 of less than 100 g/kg; and
does not code for a vertebrate toxin with an LD50 of 100 g/kg or more, if the intention is to
express the toxin at high levels; and
is not uncharacterised nucleic acid from an organism producing a vertebrate toxin;
does not include a viral sequence that can lead to production of replication competent virions in the
host cell.
must satisfy either of the following requirements:
(i) the gene must not be uncharacterised DNA derived from organisms implicated in, or with a
history of causing, disease in human beings, animals, plants or fungi; or
(ii) if the gene is derived from such disease-causing organisms, then the gene must be
characterised and not known to alter the host range or mode of transmission, or increase the
virulence, pathogenicity or transmissibility of the host or vector.
A dealing involving shotgun cloning or the preparation of a cDNA library, in a host/vector system
mentioned in the bacterial class below, if the donor nucleic acid is not derived from either a pathogen or a
toxin-producing organism.
University of Queensland, 2014
1
Institutional Biosafety Committee
Part 2 Schedule 2: Host/vector systems for Exempt dealings
Class
Bacteria
Host
Escherichia coli strains K12, B, C, Nissle 1917: any
derivative that does not contain:
(a)
generalised transducing phages; or
(b)
genes able to complement the
conjugation defect in a non-conjugative plasmid
Vector
1.
Non-conjugative plasmids
2.
Bacteriophage
(a)
lambda
(b)
lambdoid
(c)
Fd or F1 (eg M13)
3.
None (non-vector systems)
Agrobacterium tumefaciens — disarmed strains
1.
Non-tumorigenic disarmed Ti plasmid
Agrobacterium rhizogenes — disarmed strains
vectors, or Ri plasmid vectors
Agrobacterium radiobacter
2.
None (non-vector systems)
Note: Several other specific bacterial species and strains are included in this listing - consult the Biosafety Approvals Advisor
or http://www.ogtr.gov.au/pubform/legislation.htm for further information.
Fungi
Kluveromyces lactis
1.
All vectors
Neurospora crassa – laboratory strains
2.
None (non-vector systems)
Pichia pastoris
Saccharomyces cerevisiae
Schizosaccharomyces pombe
Trichoderma reesei
Yarrowia lipolycta
Slime
Dictyostelium species
1.
Dictyostelium shuttle vectors
moulds
2.
None (non-vector systems)
Tissue
Animal or human cell cultures
1.
Non-conjugative plasmids
culture
(including packaging cell lines)
2.
Non-viral vectors, or defective viral vectors
unable to transduce human cells
3.
Avipox vectors (attenuated vaccine strains)
4.
Baculovirus (Autographa californica nuclear
polyhedrosis virus), polyhedrin minus
5.
None (non-vector systems)
Plant cell cultures
1.
Non-tumorigenic disarmed Ti plasmid vectors,
or Ri plasmid vectors, in Agrobacterium tumefaciens,
A. rhizogenes or A. radiobacter
2.
Non-pathogenic viral vectors
3.
None (non-vector systems)
In addition to the above, unfixed material derived from genetically modified organisms is deemed as being in the
Exempt category so long as the there is no virus or micro-organism capable of replication in the samples, and the
donor DNA meets the above criteria. Any work using nanoparticle as a delivery system is also deemed as being in
the Exempt category, so long as the host is listed above AND the DNA meets the above criteria.
I declare that:
1) My research group conducts Exempt dealings with GMOs, including possession, that are
described in one or more of the categories listed on this form. I will submit applications for dealings
with GMOs not listed on this form (eg NLRD, DNIR) to the IBC for approval.
2) If my work changes to include dealings not described here, or if I am unsure about the category of
work, I will contact the Biosafety Approvals Advisor for advice.
3) The work will be done in accordance with the OGTR “Guidelines for the Containment of Exempt
Dealings” and the “Guidelines for the Transport of GMOs (Exempt Dealings)”.
Project supervisor
Name:
School/phone/email:
Signature:
Date
/
/
After signing and returning this form, you may conduct any of the kinds of dealings
described on this form until such time as the Gene Technology Regulations are altered
and/or your receive other advice from the IBC.
University of Queensland, 2014
2
Download