Institutional biosafety and gene technology
In 2019 the Gene Technology Review Committee was replaced by an Institutional Biosafety Committee (IBC)
The Committee is responsible for ensuring the University meets all legislative obligations regarding the safety and regulatory aspects of research and teaching activities involving:
- Genetically Modified Organisms
- Biosecurity Material
- Security Sensitive Biological Agents; and
- General Biohazardous/Biological Material
The Committee Terms of Reference are available here
Meeting dates 2019
The IBC meets on a Thursday from 12.00 noon – 3.00 pm 4 times per year in Building 20 Room 109 (Research Services Office Meeting Room).
The Agenda deadlines and meeting dates for 2019 are as follows:
|Wednesday 13 March 2019||Thursday 28 March 2019|
|Wednesday 22 May 2019||Thursday 6 June 2019|
|Wednesday 14 August 2019||Thursday 29 August 2019|
|Wednesday 23 October 2019||Thursday 7 November 2019|
Agenda items must be submitted to: email@example.com by 12 noon on the deadline day. Items received after this date and time will be placed on the papers of the next meeting.
2019 Committee Members
|Dr Martina Sanderson-Smith||Chair|
|Professor Chao Deng||Member|
|Professor Nicholas Dixon||Member|
|Ms Katie Cicero||Member|
|Mr Mark Stephenson||Member|
|Ms Melinda Chylinski||Member|
|Mr Alan Champion||Member|
|Mr Mark Webb||Member (external)|
|Ms Michelina Weatherall / Ms Penny Potter||Executive officer|
Work Health and Safety Act 2011
Gene Technology Act 2000
Biosecurity Act 2015
National Health Security Act, 2007
AS/NZS 2243.3:2010 Safety in Laboratories - Microbiological Safety and Containment
AS/NZS 2243.1 Safety in laboratories—Planning and operational aspects
Office of Gene Technology Regulator
The purpose of the following guide is to simplify the process of applying for approval to conduct research that uses or creates genetically modified organisms (GMOs).All work that uses or creates GMOs must be approved by the University of Wollongong Gene Technology Review Committee (UoW GTRC), and in some cases, by the Australian Office of the Gene Technology Regulator (OGTR). Failure to obtain approval can lead to prosecution.
Research with GMOs is divided into 3 categories. In increasing order of risk, these are Exempt Dealings, Notifiable Low Risk Dealings (NLRDs), and Licensed Dealings. The following information is designed to help researchers determine which category their proposed research falls under, and to guide them through the application process.
These are any dealings with GMOs that fail to meet the criteria for either Exempt Dealings or NLRDs and may be classified as DNIRs (Dealings Not Involving Intentional Release) or DIRs (Dealings involving an Intentional Release). These dealings must be licensed by the Gene Technology Regulator.
Examples of dealings that must be licensed are the cloning of genes that code for vertebrate toxins, and cases in which the host and/or vector are capable of causing disease in humans. Complete details of those dealings that should be licensed are available here.
Once you have decided that you should apply for a licensed dealing, you should complete either an Application for a DNIR or an Application for a DIR. Such dealings require approval from the UoW GTRC, as well as the OGTR. Research involving Licensed Dealings must be carried out in a laboratory certified to at least Physical Containment Level 2 (PC2).
These are dealings with GMOs that are considered to pose negligible risks. If the proposed research meets the following three criteria, it is probably an Exempt Dealing. (1) It will employ standard laboratory strain host/vector systems, and will clone DNA that (2) does not code for a vertebrate toxin, and (3) is not derived from a micro-organism able to cause disease in humans. To determine whether the proposed research is an Exempt Dealing, check that your host/vector system is listed here, and whether your donor DNA (i.e. the fragment that will be cloned) fully meets the Exempt Dealings criteria.
Exempt Dealings require approval from the UoW GTRC, but not by the OGTR. Examples are given below. Research involving Exempt Dealings does not need to be carried out in a certified laboratory, but the laboratory should meet a number of conditions. Once you have decided that you should apply for an Exempt Dealing, you should complete a Notification of Exempt Dealing. An example is provided.
This should then be forwarded to the UoW GTRC (Penny Potter, Research Office), for assessment at its next meeting. You will be notified as to whether you may proceed soon thereafter.
These are dealings with GMOs that are considered to pose low risks provided certain risk management conditions are complied with. NLRDs are now divided into those that should be conducted in a certified PC1 laboratory, and those that should be conduced in a certified PC2 laboratory.
Examples of NLRDs that can be conducted in a PC1 laboratory Complete details here
A. Any dealing with genetically modified mice or rats, unless:
i. an advantage is conferred on the animal by the genetic modification; or
ii. because of the genetic modification, the animal is capable of secreting or producing an infectious agent.
B. A dealing involving a replication defective vector derived from Human adenovirus in a host considered Exempt, if the donor nucleic acid:
i. cannot restore replication competence to the vector, and
ii. does not confer an oncogenic modification in humans.
Examples of NLRDs that can be conducted in a PC2 laboratory Complete details here
A. Any dealing involving a host and vector that are not considered Exempt (i.e. are not listed as an Exempt host/vector system), providing:
i. the host or vector are incapable of causing disease in otherwise healthy human beings, animals, plants or fungi;
ii. the donor DNA is fully characterised and is unlikely to increase the capacity of the host or vector to cause harm.
B. Any dealing involving a host and vector that are considered Exempt (i.e. as an Exempt host/vector system), but the donor nucleic acid:
i. is pathogenic; or
ii. is uncharacterised nucleic acid from an organism known to cause disease in otherwise healthy human beings, animals, plants or fungi.
C. A dealing involving the introduction of a replication defective viral vector unable to transduce human cells into a host not considered Exempt if the donor nucleic acid cannot restore replication competence to the vector.
Once you have decided that you should apply for an NLRD, you should complete an application form. An example will be provided. Such dealings require approval from the UOW GTRC, as well as the OGTR. The completed application form should be forwarded to the UoW GTRC (Penny Potter, Research Office), for assessment at its next meeting. This will then be forwarded to the OGTR for consideration.
Any NLRDs involving micro-organisms classified as Risk Group 3 must be undertaken in a PC3 Facility.
Transportation off Campus by Road, Rail or Air All packaging and paperwork for the transportation of Genetically Modified Organisms (GMOs) must meet the relevant transport codes, (eg road, rail, and air) whether the material is being self-delivered, or sent by courier via the Distribution Centre.
See the following for information:
Please refer to the Office of the Gene Technology Regulator (OGTR) Guidelines for the Transport, Storage and Disposal of GMOs or detailed information and guidance for transport of PC1, PC2 and PC3 GMOs. An excerpt summarising the requirements for transporting PC2 GMOs is provided below.
Packages should be sent by accredited courier only. Please contact the Distribution Centre for details of accredited couriers available. Note the package will need to be prepared by an accredited packer if going by air. See a list of accredited packers. Courier declaration forms for transportation by accredited courier are available from the Distribution Centre. A copy should be held by the Unit.
2. Packaging and transport of PC2 GMOs
Packaging should include the following essential elements:
(a) An inner packaging comprising:
- A sealed unbreakable primary container(s);
- Absorbent material in sufficient quantity to absorb the entire contents placed between the primary container(s) and the secondary packaging; if several primary receptacles are placed in a single secondary packaging, they should be individually wrapped so as to prevent contact between them.
(b) An outer packaging of adequate strength for its capacity, mass and intended use, comprising:
The primary container wrapped in absorbent material packed inside a sealed, unbreakable secondary container. Secondary containment is not required for small animals containing GM micro-organisms (e.g. mice) when transported in a sealed cage fitted with HEPA-filtered vents.
(c) The outer layer of packaging should be clearly labelled to indicate that it contains GMOs, and must clearly show the name, address and contact details of the sender, so that the sender can be contacted should the container be lost, damaged or misdirected. This is not required where transport takes place entirely within a building.
(d) The external surface of the primary and secondary container must be decontaminated prior to and after transport.
The GMO Storage Inventory Database requires a login in. View database site
The Office of the Gene Technology Regulator has been established within the Australian Government Department of Health to provide administrative support to the Gene Technology Regulator in the performance of the functions under the Gene Technology Act 2000. Office of Gene Technology Regulator website
The Gene Technology Regulations 2001 (The Regulations) took effect on 21st July 2001 and replaced the voluntary system that had been overseen the by the Genetic Manipulation Advisory Committee (GMAC). Pursuant to legal obligations of the University, the Gene Technology Review Committee has been established to review all dealings with genetically modified organisms (GMOs). The Gene Technology Review Committee will ensure that the use of all GMOs within the University is conducted in compliance with the Gene Technology Act (2000) and Gene Technology Amendment Act 2007; and the Gene Technology Regulations 2001 and Gene Technology Amendment Regulations 2007.
The Gene Technology Review Committee shall:
- Ensure that the use and generation of BMOs in research and teaching complies with Commonwealth and State Legislation and the codes of practice adopted by the relevant authorities;
- Review applications for accreditation of the University of Wollongong with the Office of the Gene Technology Regulator and any other relevant authority;
- Inspect new physical containment facilities and review applications from University staff for certification of such facilities prior to submission to the Office of the Gene Technology Regulator;
- Inspect any existing approved physical containment facilities on an annual basis or more frequently when required;
- Review applications by researchers for work that involves genetically modified organisms (GMOs). These include Exempt Dealings, Notification of a Low Risk Dealing (NLRD), and Licence for Dealing not Involving Intentional Release of a GMO into the Environment (Contained Dealing) (DNIR);
- Develop policy and procedures to oversee the use of GMOs in research and teaching;
- Maintain a register of all exempt dealings, notifiable low risk dealings and licensed dealings undertaken within the organisation;
- Maintain a register of people authorised by the Gene Technology Review Committee to work in the organisation's containment facilities;
- Ensure that all persons involved in genetic manipulations are informed of the University's policy and procedures in relation to the use of GMOs in research and teaching;
- Ensure that all research and teaching units have in place documented procedures and practices for working safely with GMOs.