Form to Request Exemption Status for Dealing with Genetically Modified Organisms (Gmos)

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 Project Reference Number: / IBC use only

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:

______

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)] ( 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 (
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 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 GeneTechnologyAct2000 (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:

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:

Please note: you should retain a copy of your completed notification for your own records.

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.

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

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)

Surname: / Preferred first name:
Personal title:
(eg Ms/Mr/Dr) / Job title:
Phone number: / Fax number:
Mobile number: / E-mail
address:
Street number and name:
Town/City: / State:
Postcode: / 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: / Co-chair - Karin Aubrey and Giles Best
Business telephone number: / 9926 4500 (reception); 99264961 (Karin); 99264860 (Giles);
Facsimile number: / 9926 4020
E-mail address: / or

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 ______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).

Describe the main experimental procedures of the work (maximum 1 page).

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) / If you believe the protein/gene is characterised, non-pathogenic and non-oncogenic, briefly explain why, referring to what is known about its structure, function and/or genetics
(with reference to published literature support). / If the work involves animals indicate ACEC approval No. and expiry date

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.

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, etcas 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]

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.

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)

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 / FACILITY ADDRESS
eg. room, level, building / TYPE
eg.PC1a
PC2 / OGTR ID / EXPIRY DATE
CERT /
CERT /
CERT /
CERT /
CERT /

a.Please note that the NSLHD IBC have no certified PC1 laboratories

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Part 5: Declaration

Declaration of the organisation submitting this notification

This declaration must be signed by theCEOor 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: / Signature:
Job title: / Level ***; PC2 Floor Manager / Date:
Printed name: / Signature:
Job title: / 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: / Signature:
Job title: / COO, Research / Date:

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