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About Gene Technology & Biosafety

Institutional Biosafety Committee Application Process

Table of contents:

2015 Macquarie University Biosafety Workshop

IBC application process

How to obtain approval to conduct research with GMOs

  1. Exempt dealings
  2. Notifiable Low Risk Dealings (NLRDs)
  3. Licensed Dealings

-   IBC review process

-  GMO Risk assessment

-   Review of biohazards at Macquarie University

-   Non GMO risk assessment


 

IBC application process

Any project/dealing involving genetically modified organisms (GMOs) must be submitted to the Macquarie University Institutional Biosafety Committee (IBC) on an appropriate application form and risk assessment. Work must not commence without written approval from the IBC.

Please email your completed application to biosafety@mq.edu.au

If you are unable to email your application, you can submit a hard copy to the following address:

Biosafety Secretariat

Research Office

Level 3, Research Hub

Building C5C

Macquarie University, 2109

You will be given a reference number and your application will then be forwarded to the Committee for review.


 

How to obtain approval to conduct research with GMOs

To gain approval to work with GMOs researchers first need to establish the level of dealing.  Dealings are divided into the following categories based on the level of risk to researchers, the community and the environment:

  1. ExemptDealings
  2. NotifiableLow Risk Dealings
  3. Licenseddealings (Dealings involving Intentional Release (DIR) and Dealings Not involving Intentional Release (DNIR).

Exempt Dealings

Exempt dealings are considered to pose the lowest level of risk. For more information about what constitutes an exempt dealing please refer to the Fact Sheet: What dealings with GMOs are classified as exempt dealings. Exempt dealings must be contained within a facility and must not involve the intentional release of a GMO into the environment.  The facility does not need to be certified by the OGTR. Please refer to the guidance notes for containment of exempt dealings.

Notifiable Low Risk Dealings (NLRDs)

Notifiable Low Risk Dealings (NLRDs) are considered to be of intermediate level of risk and require that the work in conducted in facilities that have meet all the required certification guidelines. NLRDs must be conducted within a facility certified to be at least Physical Containment Level 1 or Physical Containment Level 2 depending on the type of GMO involved. GMOs produced/used as part of an NLRD must not be released into the environment. For more information about NLRDs refer to Schedule 3, Parts 1 and 2 of the Gene Technology Regulations 2001. If GMOs produced/used by an NLRD are to be transported, they must be transported in accordance with the Guidelines for transport, storage and disposal of GMOs

Please note that all NLRDs are limited to 5 years. No variations to NLRDs are permitted. If the scope of work changes, a new NLRD application must be submitted to the IBC. If there is any doubt about whether work is within the scope of an existing NLRD, the IBC must be consulted for advice.

Licensed Dealings

Licensed Dealings are considered to have the highest level of risk and require approval from both the IBC, and the Office of the Gene Technology Regulator.  All dealings with GMOs that are not Exempt Dealings or NLRDs, need to be licensed by the Regulator. These types of dealing are subdivided into Dealings involving Intentional Release (DIR) and Dealings Not involving Intentional Release (DNIR). For more information about licensed dealings refer to Schedule 3, Part 3 of the Gene Technology Regulations 2001.

Amendment of Gene Technology Act (effective from 2011)

The OGTR introduced new regulations and guidelines for working with GMOs in September 2011. Further information can be found here.

As a result of the amended regulations, many dealings have been downgraded. For example work conducted with either transgenic or knock out animals is now classified at a Notifiable Low Risk Dealing PC1 (PC1 NLRD) and can be conducted in a Physical Containment level 1 laboratory. Some dealings previously classified as NLRD have been changed to Exempt Dealings.

General information on OGTR Regulations can be found on the OGTR website.

In order to conduct dealings with GMOs, researchers must submit the relevant application to the IBC for review. Application forms can be downloaded from here.


 Please check these web pages regularly so that you are kept up to date regarding changes to legislation and Biosafety Committee policies, procedures and clearance requirements.


 

IBC review process

The IBC reviews applications between February 1 and November 30. Applications can be submitted for review any time during this period. Applications are reviewed via an expedited review process, which means the Committee does not need to be in session in order to consider applications. 

Notification of the Committee's feedback is sent to the Chief Investigator by email, and often researchers will be asked to provide clarifications or make changes to the application. Depending on the requested modifications, the responses received and the time taken to review responses, the review process from submission to final approval may take some time.


Applicants are encouraged to contact the Secretary by email at biosafety@mq.edu.au or call 02 9850 4194 for information about the application process.

GMO Risk assessment

Identifying and managing risks to health and safety is a legal requirement and all researchers undertaking dealings with GMOs must also complete a risk assessment. This document is entitled "Biohazard- Risk Assessment Form GMO" and is available at the WHS website.

A completed risk assessment must be submitted with your application to the IBC. If you have not attached a risk assessment then you will be asked to provide one.


Review of biohazards at Macquarie University

If you are conducting research with biohazards, such as human and animal tissue and blood, that are not GMOs then you do not need to submit an application to the IBC.  However, in order to facilitate the oversight of biohazards at Macquarie University, the Health and Safety unit has established the Biohazard Committee to review risk assessments for research being conducted with biohazards that are not GMOs.

The Biohazard Committee's role is to ensure that work involving biohazards is conducted in a manner that eliminates or reduces the risk to as low as is practicable when working with the biohazard.

The Committee is responsible for reviewing risk assessments for work conducted with biohazards. You must obtain Biohazard Committee approval prior to work commencing. The risk assessment form for biohazards (non-GMOs) is entitled "Biohazard- Risk Assessment Form Non GMO" and is available at the WHS website.

Non GMO risk assessment

The Committee does not require the specific details of a research project (such as the project rationale or scientific details) unless they relate to the choice of risk reduction methods being employed.

A risk assessment should include the following information:

  1. It must identify all the relevantbiohazardous risks.
  2. The risk level must be assessed.
  3. Researchers should identify andfollow procedures to reduce the risk to an acceptable level.
  4. Identify and use standards in riskreduction or elimination. e.g. Australian standards for sterilization/decontamination.

Once approved by the Committee the risk assessment must be reviewed annually by the author to ensure it is still relevant. If there have been any changes in circumstances which may make the risk assessment insufficient any amendments must be submitted to the Committee.   

Researchers should submit their completed risk assessment form (for research with non-GMOs) to biohazard@mq.edu.auFor further information about the Biohazards Committee, please email biohazard@mq.edu.au


or phone + 61 2 9850 9728.

For further information regarding Health and Safety at Macquarie University, please see the following the WHS website