ROYAL NORTH SHORE HOSPITAL
INSTITUTIONAL BIOSAFTEY COMMITTEE
Form to Request Exemption Status
for Dealing with Genetically Modified
Organisms (GMOs)
Notifying Organisation Name:
____________________________________________________________
Accreditation Number*: ACCR _________________[ IBC use only ]
* If organisation is accredited by the Gene Technology Regulator
Exempt Status Project Title:
IBC use only
IBC Project Reference Number:
Is this notification accompanied by an application for a declaration that certain information
be treated as Confidential Commercial Information (CCI) ?
Yes
No
If the CCI is covered by previous CCI application(s), please provide the CCI application
number(s) here:
____________________________________________
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General Information
Form to Request Exemption Status for Dealing with Genetically Modified Organisms (GMOs)
This form should only be completed if you wish to request Exempt Dealing status for work complying with the Gene
Technology Act 2000 [subsection 32 (3)] (www.ogtr.gov.au) governing the use of recombinant DNA and genetically
modified organisms (GMOs). A dealing with a GMO is only an Exempt Dealing if it meets all of the following
conditions:
 it does not involve an intentional release of the GMO into the environment.
 it is mentioned in the amended changes to exempt dealings from July 2007 as Part 1 of Schedule 2, Gene
Technology Regulations 2001 as amended 2007 (http://www.ogtr.gov.au/pubform/exemptdealings.htm );
 it does not involve genetic modification, other than a modification described in the categories below;
 it is conducted in accordance with Australian Standard AS/NZS 2243.3:2002 (Safety in Laboratories:
Microbiology) for Physical Containment Level 1
Accuracy of information
Please answer all questions unless otherwise indicated in terminology understandable by a non-scientist. Please
check that the information provided in this notification is true and accurate. The Act provides for penalties to a person
who knowingly gives information to the Regulator that is false or misleading.
Confidentiality
If you wish to make an application for a declaration that specifies information is Confidential Commercial Information
(CCI) for the purposes of the Act, you must also complete the CCI application form available at www.ogtr.gov.au and
submit it at the same time as this notification.
Privacy
Any personal information is safeguarded by the Privacy Act 1988. This prevents the submitted personal information
from being used for purposes other than assessing the certification application, or other circumstances specified by
the Gene Technology Act 2000 (Commonwealth). In certain circumstances information supplied as part of a
notification may, according to their specific needs, be given to the following:
 an officer or employee of the Department of Health and Ageing;
 an officer or employee of a State government agency or organisation;
 Courts, Tribunals and/or other Commonwealth agencies where it is an obligation under law to provide it;
 law enforcement authorities; and
 the relevant Minister.
Authorisation
Please ensure that if you are completing this notification on behalf of the organisation, you hold the proper authority to
submit this application on behalf of the organisation.
Resubmission of amended form
If amendments have been requested by the IBSC committee, please provide a cover letter outlining the amendments
AND an amended version of the original IBC Exempt Status Application with all changes to the protocol underlined
and bolded.
For further information
Phone: 9926 4590 or E-mail: Research@nsccahs.health.nsw.gov.au
The completed notification can be lodged at the following address:
Research Office
Secretary, RNSH IBC
Research Office, Level 13 Kolling Building (6)
Royal North Shore Hospital
In addition, a pdf file of the completed form should be emailed to: Research@nsccahs.health.nsw.gov.au
Please note: you should retain a copy of your completed notification for your own records.
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Part 1: Exemption Category
Tick box as appropriate.
OGTR
Item No.
Description of dealing
2. Any 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. 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 recombinant infectious agents; or
(b) the animal is not infected with a virus that is capable of recombining with the genetically
modified nucleic acid in the somatic cells.
4. A 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.
(a) the donor DNA:
(i) is not derived from micro-organisms implicated in, or with a history of causing
disease in human beings, other animals, plants or fungi,
(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 for vertebrates with an LD50 of less than 100 µg/kg; and
(c) must not code for a toxin for vertebrates with an LD50 of 100 µg/kg or more, if the intention
is to express the toxin at high levels; and
(d) must not be uncharacterised DNA from a toxin-producing organism; and
(e) must not include a viral sequence unless the donor nuclaeic 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;
(B) will not become available during the dealing
(ii) is incapable of correcting a defect in the host/vector system leading to
production of replication incompetent virions; and
must not confer an oncogenic modification
5. Any dealing involving shot-gun cloning opr 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
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Part 2: Notification Contact Details
Details of the person the OGTR can contact regarding this Exempt Status for Dealing with
GMOs Form (usually the Project Supervisor)
Preferred first
name:
Surname:
Personal title:
(eg Ms/Mr/Dr)
Job title:
Phone number:
Fax number:
Mobile number:
E-mail
address:
Street number and name:
Town/City:
Postcode:
State:
Country:
Postal address:
(if different)
Details of the Institutional Biosafety Committee that has considered the classification of
this Exempt Status for Dealings with GMOs
Name of IBC:
Royal North Shore
Name of IBC Chairperson:
Anthony Ashton
Business telephone number:
9926 4500 (reception); 9926 4828 (office)
Facsimile number:
9926 5266
E-mail address:
anthony.ashton@sydney.edu.au
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Additional Project Personnel: Detail Personnel involved with this project including name,
qualifications, microbiological or other relevant experience and role in the project team
(Delete or add personnel as required).
Additional Personnel 1
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and PC2/GMO
Experience Relevant to the
dealings in this project
Additional Personnel 2
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and PC2/GMO
Experience Relevant to the
dealings in this project
Additional Personnel 3
Surname
First Name
Title
Job Title
Phone Number
Fax Number
Mobile Number
Email
Project Role and PC2/GMO
Experience Relevant to the
dealings in this project
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Part 3:
Description of the Exempt Dealings and GMO(s)
Name of Organisation
1.
2.
_______________________________________
Reference Number __________________________
Why do you consider the project should be exempt from the Guidelines? List specifically how the project meets the relevant criteria for exemption,
as listed in Part 1 of this application (i.e Item no./Description).
Describe the aim of the work (maximum half page).
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3.
Describe the main experimental procedures of the work (maximum 1 page).
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4.
Describe the details of the biological system. Note: Any substantial change in the system will require submission of another proposal.
BIOLOGICAL SOURCE
OF DONOR DNA
(genus/species/
tissue/cell)
HOST ORGANISM/
TISSUE/CELL
(genus/species/strain)
VECTOR(S) OR METHOD
OF DNA TRANSFER
(include full description
of any vectors)
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If you believe the protein/gene is characterised, non-pathogenic and nononcogenic, briefly explain why, referring to what is known about its
structure, function and/or genetics
(with reference to published literature support).
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If the work involves
animals indicate ACEC
approval No. and
expiry date
5.
Give a brief assessment of possible hazards associated with the work. Include details of any special biological containment features of the host species or
toxins produced by the species.
6.
Please outline the management and disposal strategy for Exempt Status for Dealings with GMO waste. Please specify the strategies for solid waste,
and liquid waste, biological spills, bacterial broth, animal carcasses, etc as appropriate. Specify the decontamination agent, final concentration (v/v% or
w/v%) and contact time. [Please refer to OGTR guidelines and the Australian Laboratory Standard AS/NZ2243(.3) for approved waste management
options]
7.
Do you request permission to store GMOs generated in this application beyond the approval expiry date? Note that this is for storage only, if you intend to
use the GMO generated in this application for other studies then a separate dealing application is required.
No
Yes
A register of the GMO description and location must be maintained by the investigator/institute in line with OGTR guidelines version 3.1 (issued 2007)
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8.
Part 4: Containment Facilities
Please provide information for all facilities to be used in connection with this Exempt Status Form
FACILITY NAME
eg. lab group/division
a.Please
FACILITY ADDRESS
TYPE
eg. room, level, building
eg.PC1a
PC2
OGTR ID
CERT
/
CERT
/
CERT
/
CERT
/
CERT
/
note that the NSLHD IBC have no certified PC1 laboratories
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EXPIRY DATE
Part 5: Declaration
Declaration of the organisation submitting this notification
This declaration must be signed by the CEO or another person with the authority to sign on behalf
of the organisation (laboratory).
PART A
 Please provide approval for use of the indicated laboratory in Part 4
Laboratory Representative/Head of Group
Printed
name:
Signature:
Job title:
Date:
PC2 Manager for the proposed laboratory
Printed
name:
Job title:
Signature:
Level ***; PC2 Floor Manager
Printed
name:
Job title:
Date:
Signature:
Level ***; PC2 Floor Manager
Date:
Kearn’s Facility Manager (as required)
Printed
name:
Giselle Bellamy
Signature:
Job title:
PC2 Manager, Kearn’s Facility
Date:
PART B
I DECLARE THAT:

I am duly authorised to sign this declaration;

The Institutional Biosafety Committee detailed in Part 1 of this form has confirmed that the
dealings listed in this notification are Notifiable Low Risk Dealings;

Persons undertaking these dealings have been notified in writing that the dealings are NLRDs;
and

Personnel involved in the dealings have appropriate training and experience.
Organisation Representative
Printed
name:
Job title:
Karyn Joyner
Signature:
COO, Research
Date:
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