Griffith University Biosafety Committee
Exempt Dealing Evaluation Report
(To be completed and submitted electronically) All explanatory text and examples are written in
orange italics.
UBC reference number:
UBC date of approval:
1.
This reference number will be advised upon receipt of application
Project supervisor:
Relevant qualifications:
Relevant experience:
Completion date of last Griffith University
Biosafety Training Session
Name of Operations/Business Manager to be
informed of result:
School:
Research Centre:
Group (Health or SEET):
Nathan/Parklands/Southport/Logan
Campus:
Internal postal address:
Business hours contact number:
Email address:
Staff working on project:
Please list all personnel undertaking dealings
with GMOs, include their relevant
qualifications and experience as well as the
completion date of last Griffith University
Biosafety Training Session.
Click here to link to the UBC website
2.
Project title:
Commencement date:
Completion date:
Note that the completion
date must not be more than
5 years after the date of
assessment by the UBC
Please categorise this application into one or more of the following fields:
Virology
Immunology
Microbiology
Cancer
(Y/N)
Will this project involve the use of animals?
If yes, please provide your AEC reference number, date of approval and
date of expiry:
NOTE – If the project requires AEC approval work with GMOs cannot
be undertaken without first having obtained this approval. Please
contact the Animal Ethics Secretary if you require further information
about AEC approvals at: animal-ethics@griffith.edu.au Tel: 07 373
56618
Ref: (E.g. MSC/01/13/AEC)
Approval: (E.g. 7/2/13)
Expiry: (E.g. 7/2/16)
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3.
Facilities used:
(i)
Nathan/Parklands/
Southport/Logan
Building:
Room:
Are these facilities certified?
(Y/N)
Name of
Facility
Manager:
Has this Manager approved the use of this facility?
(ii)
Campus:
Nathan/Parklands/
Southport/Logan
Containment Level:
Building:
(Y/N)
Name of
Facility
Manager:
Has this Manager approved the use of this facility?
Campus:
Nathan/Parklands/
Southport/Logan
Containment Level:
Building:
(Y/N)
Name of
Facility
Manager:
Has this Manager approved the use of this facility?
Campus:
Nathan/Parklands/
Southport/Logan
Containment Level:
Building:
(Y/N)
Name of
Facility
Manager:
Has this Manager approved the use of this facility?
Campus:
Nathan/Parklands/
Southport/Logan
(Y/N)
Room:
Are these facilities certified?
(v)
(Y/N)
Room:
Are these facilities certified?
(iv)
(Y/N)
Room:
Are these facilities certified?
(iii)
4.
Campus:
Containment Level:
Building:
(Y/N)
Room:
Are these facilities certified?
(Y/N)
Name of
Facility
Manager:
Has this Manager approved the use of this facility?
Containment Level:
(Y/N)
Is this a storage application for your Exempt Dealing GMO? (Y/N)
(If yes, please complete Section 5 and provide the following information: List of vectors and what genes are inserted into which host
that is being stored. Then go to Section 9 – Exemption Category)
5.
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 and all references to host
cells, vectors, genes of interest, transfection systems, etc should include some explanation of them.
Please write the names of the genes and/or proteins in full the first time rather than using acronyms.
(Fields will automatically increase in size as you type)
6.
Please describe the main experimental procedures of the work
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7.
Please provide details of disposal methods for GMOs, including specific details on what method or
chemical will be used for disposal of different wastes e.g. liquid waste, solid waste, animal
carcasses
8.
Are the GMO’s being transported between facilities (either inside the same building or between
buildings) or off campus?
Yes/No
If yes, please indicate why it will be required and what arrangements will be made. Transport
includes: between the facilities listed in your answer to Part 3; from a laboratory to an autoclave or
animal house; across corridors which are not part of a certified facility, to storage facilities external
to the facility where activities are being undertaken etc.
9.
Exemption category
2
3
3A
4
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.
Any 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.
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.
(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)
(ii)
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;
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;
Example
Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows
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that, in relation to the capacity of the host or vector to cause harm, it:
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)
(ii)
5
(a)
Is missing at least 1 gene essential for viral multiplication that:
(A)
Is not available into the cell into which the nucleic acid is introduced;
and
(B)
Will not become available during the dealing; and
Cannot restore replication competence to the vector.
Any 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.
10.
Describe the biological source of the donor DNA to be used – include the genus, species and strain
or organ/tissue as applicable. Include details (including function etc) of the specific genes to be
involved in the dealing
11.
Describe the host organism or tissue to be used – include the genus, species and strain where
applicable. If not a commonly used laboratory strain, include the name of the strain from which it is
derived. – Please refer to Part 2 of Schedule 2 Host/vector systems for exempt dealings which
determines the host/vector system relevant to Item 4 of Part 1.
12.
Describe the vectors or methods to be used to transfer donor DNA to the host. Include information
regarding the origin and properties of the vector and confirm that all bacterial plasmid vectors are
non-conjugative. If your project involves the use of a replication defective viral vector (unable to
transduce human cells), please provide an explicit description of the assay you intend to perform to
exclude the presence of replication competent virus.
13.
If you believe the protein/gene is characterised, and unlikely to increase the capacity of the host or
vector to cause harm, or secrete a toxin, briefly explain why, referring to what is known about its
structure, function and/or genetics.
14.
Statement of compliance
I certify that the GMO dealings associated with this project will comply with conditions and requirements as
required by the OGTR and Griffith University Biosafety Committee at all times. (Electronic signature or e-mail title
accepted)
Signature of Project Supervisor:
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Date:
School and Faculty Recommendation
Head of School/Centre Director or Dean
Date:
Comments (if applicable):
Please email the completed Exempt Dealing Evaluation Report to the Griffith University Biosafety Committee:
ubc@griffith.edu.au
15.
UBC Declaration
The UBC has evaluated this dealing and agrees that it is an exempt dealing as specified as specified by Schedule
2 of the Gene Technology Regulations 2001.
Name of IBC:
Griffith University Biosafety Committee
Name of UBC Chair:
Professor Ned Pankhurst
Signature of UBC Chair:
Date:
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