Procedures

Containment of Exempt Dealings - Procedures

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1. Purpose and Objectives

This document explains the process required to obtain permission to experiment with dealings classified as Exempt.

2. Definitions, Terms, Acronyms

Dealing - any type of genetically modified involvement

Exempt Dealing - a type of genetically modified dealing, one that poses a very low risk

GM/GMO - Genetically modified/Genetically modified organism

IBC - Institutional Biosafety Committee, a committee that is established by an Accredited Organisation, as required by the OGTR

OGTR - Office of the Gene Technology Regulator

3. Procedure Scope/Coverage

These procedures apply to all persons undertaking research on genetically modified organisms.

4. Procedure Statement

The OGTR has classified exempt dealings as those that pose a very low risk to the health and safety of persons and the environment. The OGTR states that the only requirement is that the dealing must not be released into the environment.

UQ researchers must be compliant with the requirements when working with GMOs classified as Exempt Dealings, as described in the Gene Technology Regulations 2001.

5. Determination of Exempt Dealings

Descriptions of dealings that are exempt from licencing can be found in Schedule 2, Parts 1 of the Gene Technology Regulations 2001. In addition, Schedule 2, Part 2 of the Gene Technology Regulations lists host/vector systems that have been classified as exempt by the OGTR. This information will assist in determining whether the proposed dealing falls within the exempt classification.

6. Containment Requirements

There is a legislative requirement that exempt dealings not be intentionally released into the environment. To achieve this, the exempt dealings must be performed within containment facilities.

The OGTR has produced a guidance note for use by institutions in ensuring that their facilities meet the requirement of containing exempt dealings, Guidance Notes for the Containment of Exempt Dealings. The University of Queensland has determined that Exempt Dealings must be performed in at least a PC1 certified facility.

Further advice can be sought from the Biosafety Advisors.

7. Exempt Dealing Evaluation Report/Application Form

The University of Queensland requires all researchers to complete the Exempt Dealing Evaluation Report/Application Form for dealings with GMOs that are classified as Exempt. This form is to be submitted to the UQ IBSC for assessment.

You must provide sufficient information in the application form to allow the IBSC to determine whether the proposed dealing is classified as exempt.

The chief investigator must complete all sections and sign the application before forwarding it to the Biosafety Advisor for initial appraisal.

In addition to the Exempt Dealing Evaluation Report/Application Form, the application must be accompanied by a completed Biosafety UQ Compulsory Form. Failure to include all the necessary paperwork will result in the forms being returned.

7.1 Permission to undertake dealings

Once the IBSC has evaluated the application and determined that the dealings are classified as Exempt, the Biosafety Advisor will notify the applicant of the outcome and provide the UQ IBC dealing identifier.

Dealings must not be undertaken until permission has been granted by the IBSC.

8. Contact for Additional Information

Biosafety Advisors

Email: biosafety@uq.edu.au

Webpage: www.uq.edu.au/ohs and click ‘biosafety’

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael

Forms

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Exempt Dealing Evaluation Report - Form

Exempt Dealing Evaluation Report - Form

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Description: 

Use this form to seek permission from The University of Queensland Institutional Biosafety Sub-Committee to work with genetically modified material classified as Exempt on any premises owned or controlled by The University of Queensland.

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael