Procedures

Notifiable Low Risk Dealings - Procedures

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1. Purpose and Objectives

This document explains the process required to obtain permission to experiment with genetically modified organisms falling into the category of 'Notifiable Low Risk Dealings' (NLRDs).

2. Definitions, Terms, Acronyms

Dealing - as defined by the OGTR – conduct experiments with GMOs; make, develop, produce, manufacture GMOs; breed; propagate; use GMOs in the manufacturing of non GM products; grow, raise, culture GMOs; import GMOs; transport or store GMOs

Exempt Dealing - a type of GM 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

NLRD - Notifiable Low Risk Dealing, a GM dealing as described by the OGTR

OGTR - Office of the Gene Technology Regulator

PC1-3 - Physical Containment level 1-3

3. Procedures Scope/Coverage

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

4. Procedures Statement

These procedures assist workers in ensuring that they are compliant with the requirements, when working with genetically modified organisms classified as Notifiable Low Risk Dealings, as described in the Gene Technology Regulations 2001 (C'th).

5. Notifiable Low Risk Dealings

NLRDs are dealings that have been assessed as posing low risk to the health and safety of people and the environment. They are assessed by the UQ IBC subcommittee (IBSC) throughout the year with the list of the NLRDs approved by the IBSC submitted to the OGTR with the annual report.

In order to be approved, an NLRD:

  • must meet the requirements of an NLRD as described in Schedule 3, Part 1 and Part 2 of the Gene Technology Regulations 2001,
  • must only be performed in containment facilities that are of an appropriate level and type,
  • must only be performed by persons trained in the techniques and processes required for working with GMOs, and
  • must be transported, stored and disposed of in accordance with the OGTR Guidelines for Transport, Storage and Disposal of GMOs, 2011.

5.1 How to determine whether a dealing is an NLRD

In order to determine what type of dealing you are undertaking (i.e. Exempt, NLRD or licence) and what facility type and containment level you require to undertake such dealings (i.e. PC1, PC2, PC3), please consult the Gene Technology Regulations, Schedules 2 and 3.

Types of NLRD are found in Schedule 3, Parts 1 to 2 of the Gene Technology Regulations 2001 (C'th). The facility type and containment level must match the NLRD type. That is, a PC2 NLRD must be undertaken in at least a PC2 facility. The facility must also be of the appropriate type for the dealings being undertaken (i.e. laboratory, plant, animal, aquatic or invertebrate facility).

Please ensure that you have both access to and permission to use the correct level and type of physical containment facility.

5.2 NLRD application form

The University of Queensland requires all researchers undertaking work with NLRDs to complete and submit an application form to the IBSC for assessment.

The application form must contain sufficient information so that the IBSC can determine whether to approve the dealing as a NLRD or to seek further information to make a determination. Exemplars of NLRD applications can be found on the Biosafety FAQ site.

The OGTR does not allow changes or variations to be made to a NLRD, therefore it is imperative that the scope of the dealing is broad enough to cover the work you are undertaking.

The chief investigator will need to complete all sections and sign the application before forwarding it to a UQ Biosafety Advisor (OHS Division) for initial appraisal.

In addition to the NLRD 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.

5.3 NLRD assessment

All NLRD applications undergo a two stage assessment.

The applications undergo initial appraisal by a UQ Biosafety Advisor. During this process, you may be required to provide further information regarding the proposed project before it is submitted to the IBSC.

Applications are then presented to the IBSC to complete indepth analysis of the proposed dealings. Following IBSC consideration of the application, you may be required to provide additional information that will allow IBSC members to come to a final decision on whether to approve the application or reject it.

NLRD applications are to be sent to the Biosafety Advisor no later than two weeks prior to the IBSC meeting. IBSC meets eight times a year and the dates can be found here.

It is in your interest to submit the application as soon as possible before the next scheduled IBSC meeting.

5.4 Undertaking dealings

The applicant will receive notification from a UQ Biosafety Advisor once permission has been granted by the IBSC. Work may only be undertaken once permission has been granted.

5.5 Notification of changes

If you wish to make any changes to the dealings (i.e. scope of work, facilities) you must notify a Biosafety Advisor. Depending on the changes you wish to make, a new application may be required.

If the work is to cease or the applicant is going to leave the University, you must notify the IBSC through a Biosafety Advisor as soon as possible.

5.6 Conditions

NLRDs are approved with the following conditions:

  • Only authorised persons may conduct work on the NLRD (authorised persons are defined as those who have received appropriate training and are deemed competent by the project supervisor).  All persons authorised to work on the GMOs without supervision must be listed in the table in Appendix 1 of the NLRD application form.
  • The following classes of persons must be supervised at all times while working on GMOs:
    • Undergraduate students
    • Work experience students
  • Transport, storage and disposal must be done in accordance with the current OGTR Guidelines for Transport, Storage and Disposal of GMOs. You must ensure that you keep an accurate record of all GM material/GMOs that are stored. (For more information see PPL 2.40.07 Storage and Labelling Requirements for GMOs)
  • If you supply GMOs to others not covered by your NLRD, it is YOUR responsibility to advise the recipient that they require authorisation under the Gene Technology Act to possess the GMOs (i.e. appropriate dealing and facility to work in).
  • Any material in storage that falls under a NLRD category also requires a current NLRD to continue storage.

6. Contact for Additional Information

Biosafety Advisor
UQ OHS Division
Phone: 336 52365
Email: biosafety@uq.edu.au

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael

Forms

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Notifiable Low Risk Dealings - Form

Notifiable Low Risk Dealings - 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 organisms falling into the category of 'Notificable Low Risk Dealings' 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