Download Griffith University Institutional Biosafety Committee

Griffith University Institutional Biosafety Committee
Exempt Dealing Evaluation Report
(To be completed and submitted on-line)
IBC Reference No:
1.
This reference number will be advised upon receipt of application
Project Supervisor:
Staff working on project:
School:
Research Centre:
Group (Health or SEET):
Campus:
Select one campus
Internal Postal Address:
Business Hours Contact Number:
Email Address:
Click here to link to the IBC website
2.
Project Title:
Commencement Date:
3.
Completion Date:
Facilities used:
(i)
Campus:
Select one campus
Building:
Are these facilities certified?
(ii)
Campus:
Select one campus
Containment Level:
Building:
Are these facilities certified?
(iii)
Campus:
Select one campus
Campus:
Select one campus
Building:
Campus:
Select one campus
Building:
Campus:
Select one campus
Are these facilities certified?
4.
Room:
Containment Level:
Building:
Are these facilities certified?
(vi)
Room:
Containment Level:
Are these facilities certified?
(v)
Room:
Containment Level:
Are these facilities certified?
(iv)
Room:
Room:
Containment Level:
Building:
Room:
Containment Level:
Is this a storage application for your Exempt Dealing GMO?
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(if yes, go to Section 9 – Exemption Category)
5.
Project summary: Briefly describe the project, including the aims of the proposed dealing, method
of producing GMO’s and their use. (This should be written in plain English)

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 JUST PROVIDING ACRONYMS.
(This field will automatically increase in size as you type – there is no limitation to size of field)
6.
Please provide details of disposal methods for GMO’s
(This field will automatically increase in size as you type – there is no limitation to size of field)
7.
Are the GMO’s being transported between facilities or off campus?
8.
If yes, please specify transport details
9.
Exemption Category
2
3
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.
(1)
Any dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no
more than 10 litres of GMO culture in each vessel containing the resultant culture.
(2)
The donor nucleic acid:
(a)
Must satisfy either of the following requirements:
(i)
It must not be derived from organisms implicated in, or with a history of causing, disease
in human beings, animals, plants or fungi; or
(ii)
It 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; 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)
(f)
5
Is missing at least 1 gene essential for viral multiplication that:

Is not available into the cell into which the nucleic acid is introduced, and

Will not become available during the dealing; and
Is incapable of correcting a defect in the host/vector system leading to
production of replication competent virions; and
Must not confer an oncogenic modification.
Any dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system
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mentioned in item 1 of part 2 of this schedule, if the donor nucleic acid is not derived from either:
10.
(a)
A pathogen; or
(b)
A toxin-producing organism.
GMO
Class of GMO
Details
Algae
Animal
Bacteria
Fungi
Plant
Protozoa
Virus
11.
Modified trait(s) and gene(s) responsible
Class of modified trait
Details
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
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Reporter/marker gene expression
Immuno-modulatory protein expression
Other
12.
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 GU-IBC at all times. (electronic signature or e-mail title accepted)
Signature of Project Supervisor:
Date:
Please email the completed Exempt Dealing Evaluation Report to the Griffith University Institutional Biosafety
Committee: [email protected]
13.
IBC Declaration
The IBC 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 – IBC
Name of IBC Chair:
Dr. Ian Peak
Signature of IBC Chair:
Date:
Version
No:
V01.2
APPROVED DOCUMENT ON INTRANET ONLY – UNCONTROLLED DOCUMENT WHEN PRINTED.
Description
Document Custodian
Approving Authority
Date
Review Date
Exempt Dealing
Project Application
Lynette Wilde
Griffith University IBC
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08 September
2010
01 July 2012