Office Use Only
IBC Ref. No. : …………...................
EXEMPT DEALING APPLICATION FORM
FLINDERS INSTITUTIONAL BIOSAFETY COMMITTEE
Use this form to apply for approval for a project involving gene technology (including GMOs) classified
as an Exempt Dealing. Refer to Schedule 2 of the Gene Technology Regulations 2001 for information
regarding Exempt Dealings: http://www.comlaw.gov.au/Details/F2011C00732/Html/Text#_Toc302474560
1) Chief Investigator’s Details
Name:
Contact details: Phone:
Email:
Discipline/Department/School:
Room no.:
Are you employed by Flinders University?
Yes
/ No
If no, who are you employed by, and what is your affiliation with Flinders University?
2) Contact person for this application (if not the Chief Investigator as listed above)
Name:
Contact details: Phone:
Email:
Discipline/Department/School:
Room no.:
3) Project Information
Project Title:
Lay Summary: to be written in simple, understandable language
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
Page 1 of 10
4) Project Summary
Briefly describe the project, including the aims of the proposed dealing, method of producing
GMOs and their use (this should be written in plain English).
5) Genetically Modified Organism (GMO) Insert details where applicable
Class of GMO
Algae
Animal
Bacteria
Fungi
Plant
Protozoa
Virus
Human
Details
6) Modified Trait(s) and Gene(s) Responsible Insert details where applicable
Class of Modified Trait
Virus resistance
Fungal resistance
Bacterial resistance
Disease resistance
Pest resistance
Herbicide tolerance
Antibiotic resistance
Pesticide resistance
Abiotic stress resistance
Altered agronomic characteristics
Altered horticultural characteristics
Altered nutritional characteristics
Altered physical product characteristics
Altered physiological characteristics
Altered pharmaceutical characteristics
Attenuation
Antigen expression
Protein expression
Growth factor expression
Altered biosensor characteristics
Altered bioremediation characteristics
Altered biocontrol characteristics
Reporter marker gene expression
Immuno-modulatory protein expression
Other
Details
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
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7) Exemption Category
Using the information in the ‘Exemption Category Table’ attached at the back of this form,
nominate into which category your research falls and explain why. Please attach to this
application any relevant explanations, publications or commercial information.
Exemption category:
Justification:
8) Storage Information
Where will you store any GMOs associated with this project?
Building(s):
Room no(s).:
Location(s) – e.g. fridge/freezer:
9) Access to Other Facilities
Please list any other common service facilities or equipment (e.g. Confocal Microscopy Suite,
Bioprocessing Facility) in which the GMOs are likely to be handled and attach a signed letter of
approval or email from the Head of that section.
10) Department of Agriculture (formerly AQIS) Approval
Does this project require Dept. of Agriculture (formerly AQIS) approval
for importation? http://www.agriculture.gov.au/biosecurity
Yes
/ No
If yes, please provide the permit no.:
Please attach a copy of the permit with this application.
http://www.flinders.edu.au/mnhs/staff/safety-facilities/permits.cfm
11) Material Transfer Agreement (MTA)
Does this project require a Material Transfer Agreement (MTA)?
Yes
/ No
If yes, has the MTA been submitted?
Yes
/ No
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
Page 3 of 10
Yes
If yes, has the MTA been finalised?
/ No
If yes, please attach a copy of the signed MTA, if pending, please forward once approved.
12) Animals
Yes
Does this project involve the use of animals?
If yes, have you received approval from the Animal Welfare
Committee?
Yes
/ No
/ No
/ Pending
If yes, please attach a copy of the signed approval. If pending, please forward once approved.
AWC Approval No.:
If no, please ensure that you submit an application to the Animal Welfare Committee.
http://www.flinders.edu.au/research/researcher-support/ethics/committees/animal/animal_home.cfm
13) Human Tissue
Does this project involve the use of human tissue?
If yes, have you received approval from the Southern Adelaide
Clinical Human Research Ethics Committee (SACHREC)?
Yes
Yes
/ No
/ No
/ Pending
If yes, please attach a copy of the signed approval. If pending, please forward once approved.
Ethics Approval No.:
If no, please ensure that you submit an application to the SA HREC.
http://www.flinders.sa.gov.au/research/pages/ethics/
14) Is this research part of a student’s post-graduate project?
Yes
/ No
If yes, who is the student’s supervisor? Name:
15) Training – Chief Investigator / Supervisor
Yes
/ No
Yes
I have attended a Flinders Biosafety Training Day within the last 3 years
Please give details of relevant experience with gene technology and/or GMOs:
/ No
I have read the Biosafety Manual
Signature :
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
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Training – Other Personnel
Please ensure that all staff and students who will be working on this project fill in and sign the table
below (attach extra sheet if necessary)
Name
e.g. Robin Smith
Staff/
Student
Category*1
Have read
Biosafety
Manual
Research
staff
Yes
Have Received a Biosafety
Training Certificate
At Flinders
At another
institution
Yes/
If
Yes
If
If yes,
No
yes, /No yes,
where
year
year
Yes
2012 Yes 2005
Adel.
Uni
Signature
RSmith
*1Select
category from the following: research staff, research student (post-graduate),
undergraduate (including honours, placement and summer scholarship students).
NOTE: It is the supervisor’s responsibility to ensure that all students and staff involved in the
project attend the annual Biosafety Training Day and are familiar with the contents of the
Biosafety Manual:
http://www.flinders.edu.au/research/researcher-support/ebi/biosafety/about.cfm
16) Chief InvestigatorSignature
Risk Assessments associated with this dealing do not need to be forwarded with your application.
Please however sign below to acknowledge that you will adhere to all aspects of the OGTR
Guidelines for the Transport, Storage and Disposal of GMOs associated with this Exempt Dealing:
http://www.comlaw.gov.au/Details/F2011L00992
Name:
Signature: ……………………………………..
Date:
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
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STOP!
Have you attached the required supporting documentation?
Tick ✔
Attached Documentation
Grant application including scientific background information (if applicable)
Relevant explanations, publications or commercial information to justify the
exemption category.
Material Transfer Agreement (MTA) (if required)
Animal Welfare Committee approval (if required)
Clinical Human Research Ethics Committee approval (if required)
Department of Agriculture (formerly AQIS) permit (if required)
** Please submit this application form, together with any other required documentation to the
IBC via email: ibcadmin@flinders.edu.au
Please retain a copy of your completed application for your own records.
Office Use Only:



Reviewer:
Approved : Yes
/ No
Does this project involve the use of animals? Yes
/ No
o If yes, a copy of the approved application must now be sent to the Animal House
Approved by Reviewer: Name:
Signature: …………………………………………..
Date:
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
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EXEMPTION CATEGORY TABLE
Excerpt from Gene Technology Regulations 2001, effective 1st September 2011
Schedule 2 : Dealings exempt from licensing
http://www.comlaw.gov.au/Details/F2011C00732/Html/Text#_Toc302474560
Part 1
Item
Exempt dealings
Description of dealing
2
A dealing with a genetically modified Caenorhabditis elegans, unless:
(a) an advantage is conferred on the animal by the genetic modification; or
(b) as a result of the genetic modification, the animal is capable of secreting or producing an
infectious agent.
3
A dealing with an animal into which genetically modified somatic cells have been introduced, if:
(a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic
modification; and
(b) the animal is not infected with a virus that is capable of recombining with the genetically
modified nucleic acid in the somatic cells.
3A
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.
4
(1)
Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this
Schedule and producing no more than 25 litres of GMO culture in each vessel containing the
resultant culture.
(2) The donor nucleic acid:
(a) must meet either of the following requirements:
(i) it must not be derived from organisms implicated in, or with a history of causing, disease in
otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(ii) it must be characterised and the information derived from its characterisation show that it is
unlikely to increase the capacity of the host or vector to cause harm;
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
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EXEMPTION CATEGORY TABLE
Item
Description of dealing
Example
Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in
relation to the capacity of the host or vector to cause harm, it:
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility; and
(b) must not code for a toxin with an LD50 of less than 100 g/kg; and
(c) must not code for a toxin with an LD50 of 100 g/kg or more, if the intention is to express the
toxin at high levels; and
(d) must not be uncharacterised nucleic acid from a toxin-producing organism; and
(e) must not include a viral sequence, unless the donor nucleic acid:
(i) is missing at least 1 gene essential for viral multiplication that:
(A) is not available in the cell into which the nucleic acid is introduced; and
(B) will not become available during the dealing; and
(ii) cannot restore replication competence to the vector.
5
A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system
mentioned in item 1 of Part 2 of this Schedule, if the donor nucleic acid is not derived from either:
(a) a pathogen; or
(b) a toxin-producing organism.
Part 2
Item
1
Host/vector systems for exempt dealings
Class
Host
Vector
Bacteria
Escherichia coli K12, E. coli B,E. coli C
or E. coli 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
1. Non-conjugative plasmids
2. Bacteriophage
(a) lambda
(b) lambdoid
(c) Fd or F1 (eg M13)
3. None (non-vector systems)
Bacillus — specified species —
asporogenic strains with a reversion
frequency of less than 10–7:
(a) B. amyloliquefaciens
(b) B. licheniformis
(c) B. pumilus
(d) B. subtilis
(e) B. thuringiensis
1. Non-conjugative plasmids
2. Plasmids and phages whose host range does not
include B. cereus, B. anthracis or any other
pathogenic strain of Bacillus
3. None (non-vector systems)
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
Page 8 of 10
EXEMPTION CATEGORY TABLE
Item
Class
Host
Vector
Pseudomonas putida — strain KT 2440
1. Non-conjugative plasmids including certified
plasmids: pKT 262, pKT 263, pKT 264
2. None (non-vector systems)
Streptomyces — specified species:
(a) S. aureofaciens
(b) S. coelicolor
(c) S. cyaneus
(d) S. griseus
(e) S. lividans
(f) S. parvulus
(g) S. rimosus
(h) S. venezuelae
1. Non-conjugative plasmids
2. Certified plasmids: SCP2, SLP1, SLP2, PIJ101
and derivatives
3. Actinophage phi C31 and derivatives
4. None (non-vector systems)
Agrobacterium radiobacter
Agrobacterium rhizogenes — disarmed
strains
Agrobacterium tumefaciens — disarmed
strains
1. Non-tumorigenic disarmed Ti plasmid vectors,
or Ri plasmid vectors
2. None (non-vector systems)
Lactobacillus
1. Non-conjugative plasmids
Lactococcus lactis
2. None (non-vector systems)
Oenococcus oeni syn.Leuconostoc oeni
Pediococcus
Photobacterium angustum
Pseudoalteromonas tunicata
Rhizobium (including the genus
Allorhizobium)
Sphingopyxis
alaskensis syn.Sphingomonas alaskensis
Streptococcus thermophilus
Synechococcus — specified strains:
(a) PCC 7002
(b) PCC 7942
(c) WH 8102
Synechocystis species — strain PCC 6803
Vibrio cholerae CVD103-HgR
2
Fungi
Kluyveromyces lactis
Neurospora crassa — laboratory strains
Pichia pastoris
Saccharomyces cerevisiae
Schizosaccharomyces pombe
Trichoderma reesei
Yarrowia lipolytica
1. All vectors
2. None (non-vector systems)
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
Page 9 of 10
EXEMPTION CATEGORY TABLE
Item
Class
Host
Vector
3
Slime
moulds
Dictyostelium species
1. Dictyostelium shuttle vectors, including those
based on the endogenous plasmids Ddp1 and
Ddp2
2. None (non-vector systems)
4
Tissue
culture
Any of the following if they cannot
spontaneously generate a whole animal:
(a) animal or human cell cultures
(including packaging cell lines);
(b) isolated cells, isolated tissues or
isolated organs, whether animal or
human;
(c) early non-human mammalian
embryos cultured in vitro
1. Non-conjugative plasmids
2. Non-viral vectors, or replication defective viral
vectors unable to transduce human cells
3. Baculovirus (Autographa californica nuclear
polyhedrosis virus), polyhedrin minus
4. None (non-vector systems)
Either of the following if they are not
intended, and are not likely without
human intervention, to vegetatively
propagate, flower or regenerate into a
whole plant:
(a) plant cell cultures;
(b) isolated plant tissues or organs
1. Non-tumorigenic disarmed Ti plasmid vectors,
or Ri plasmid vectors, in Agrobacterium
tumefaciens, Agrobacterium radiobacter or
Agrobacterium rhizogenes
2. Non-pathogenic viral vectors
3. None (non-vector systems)
Flinders IBC Exempt Dealing Application Form. Current as at April 2015.
Page 10 of 10