• The “Working with GMOs” training consist of three modules

1. Working with GMO’s Requirements

2. Working with GMO’s Assessment

3. Statement of obligation for working with GMOs

• You will need to complete all three modules in order to work with GMOs.

1. 1

Working with Genetically Modified Organisms - GMO Training

2

Topics Covered:• Gene Technology Legislation• What is a Genetically Modified Organism?• Exempt Dealings• NLRD Dealings• Licenced Dealings – DNIR, DIR• PC1 Facilities• PC2 Facilities• PC2 Animal Facilities• Transportation and storage of GMOs• GMOs disposal• Loss, spill or escape of GMOs

Introduction to Working with GMOs

3

Gene Technology LegislationGene Technology Act (2000)The Act is to protect the health and safety of people and the environment by:• Identifying and managing risks posed by, or as a result of, gene technology• Prohibiting a person from dealing with GMOs unless the dealing is

authorised in accordance with the Act• Providing for monitoring and enforcement of the legislation

The Legislation regulates:• All work with GMOs• All who work with GMOs• The facilities in which GMOs are handled

The consequences of non-compliance• Imprisonment for up to 5 years • Fines up to $226,840

4

What is a Genetically Modified Organism

A GMO is defined in the Act as an organism:• That has been modified by gene technology;• That has inherited traits from an organism (the initial organism), being

traits that occurred in the initial organism because of gene technology; or

• Anything declared by the regulations to be a GMO, or that belongs to a class of things declared by the regulations to be genetically modified organisms.

5

Organisms that are NOT GMOs1. A mutant organism in which the mutational event did not involve the

introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species).

2. A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.

3. Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.

4. An organism that results from an exchange of DNA if:

(a) the donor species is also the host species; and

(b) the vector DNA does not contain any heterologous DNA.

6

Organisms that are NOT GMOs5. An organism that results from an exchange of DNA between the donor

species and the host species if:

(a) such exchange can occur by naturally occurring processes; and

(b) the donor species and the host species are micro-organisms that:

(i) satisfy the criteria in AS/NZS 2243.3:2002 (Safety in laboratories, Part 3: Microbiological aspects and containment facilities) jointly published by Standards Australia and Standards New Zealand, for classification as Risk Group 1; and

(ii) are known to exchange nucleic acid by a natural physiological process; and

(c) the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.

7

Techniques that are NOT gene technology1. Somatic cell nuclear transfer, if the transfer does not involve genetically

modified material

2. Electromagnetic radiation-induced mutagenesis

3. Particle radiation-induced mutagenesis

4. Chemical-induced mutagenesis

5. Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human

6. Protoplast fusion, including fusion of plant protoplasts

7. Embryo rescue

8. In vitro fertilisation

9. Zygote implantation

10.A natural process, if the process does not involve genetically modified material

8

Dealings with Genetically Modified Organisms

A “dealing with” a GMO means the following:• Conducting experiments with a GMO• Making, developing, producing or manufacturing a GMO• Breeding or propagating a GMO• Using a GMO to manufacture something that is not a GMO• Growing, raising or culturing a GMO• Importing, transporting or disposing of a GMO• Possessing, supplying or using the GMO for the purposes of a dealing any

of the above

9

Types of DealingsThere are four types of dealings, based on the level of risk to people and the environment:• Exempt dealings• Notifiable Low Risk Dealings (NLRD)

• PC1-NLRD• PC2-NLRD

• Licensed• DNIR - Dealings not involving intentional release into the environment• DIR - Dealings involving intentional release into the environment

10

Exempt DealingsExempt dealings are a category of dealings with GMOs that have been assessed over time as posing a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). Conducted in a certified OGTR PC1 facilities

Examples of Exempt Dealings:Shot-gun cloning using DNA from any organism provided that it is not a pathogen nor a toxin-producing organism in an approved host/vector system Cloning into common laboratory strains of E.coli provided that the donor DNA satisfies certain criteria

NOTE: Application for Exempt dealings is submitted to IBC. No work is allowed before getting approval from IBC.

11

Notifiable Low Risk Dealings (NLRD)These are dealings with GMOs that have been assessed over time as posing low risks, provided certain risk management conditions are complied with. Two types of NLRDs:• PC1 NLRD – conducted in a certified OGTR PC1 facilities

• Example - use of a genetically modified mouse where no selective advantage has been conferred as a result of the modification

• PC2 NLRD – conducted in a certified OGTR PC2 facilities• Examples - use of a replication deficient retroviral vector that can

infect human cells, provided that the DNA can't correct the replication deficiency

• use of transgenic mice that have a selective advantage as a result of the genetic modification

NOTE: Application for NLRD dealings is submitted to IBC. No work is allowed before getting approval from IBC.

12

Licensed Dealings

All dealings with GMOs that are NOT Exempt Dealings and NLRDs are licensed by the OGTR.

Application for licensed dealings is submitted to OGTR through IBC

There are 2 types of licence:• DNIR - not involving the intentional release of a GMO into the environment • DIR - involving the intentional release of a GMO into the environment

For further information on these dealings please contact the IBC or visit the OGTR website - www.ogtr.gov.au

13

Certified OGTR FacilitiesLaboratories certified by the OGTR fall into the following categories based on their physical aspects, personal protective requirements and work practices.

Physical Containment Level 1 (PC1) Facility

Dealings allowed are EXEMPT and PC1-NLRD

Physical Containment Level 2 (PC2) Facility

Dealings allowed are EXEMPT, PC1-NLRD, PC2-NLRD and DNIR

Physical Containment Level 2 (PC2) Animal Facility

Dealings allowed are EXEMPT, PC1-NLRD, PC2-NLRD and DNIR

14

OGTR Certified PC1 Facility – Lab Practice• Comply to MCRI Essential Laboratory Practices – These are displayed

on the outer side of the laboratory doors.

• In addition,

• Work benches, surfaces and equipment where procedures involving GMOs have taken place must be decontaminated when the procedures are completed.

• Any equipment that is, or may be, contaminated with GMOs must be decontaminated prior to being removed from the facility.

15

OGTR Certified PC2 Facility – Lab PracticeComply to MCRI Essential Laboratory Practices

In addition, clean GREEN/BLUE long sleeved lab gowns must be worn at all times. These gowns must be removed when leaving the PC2 facility unless going to an adjoining OGTR facility of the same or higher certification level.

• Long sleeved GREEN/BLUE lab gowns are dedicated for OGTR PC2 facilities

• Except during the entry and exit to the facility, doors of the PC2 facility must be closed

16

PC2 Animal Facility – Lab PracticeEntrance doors into the facility must remain locked when facility personnel are not in attendance.

When not being handled, the GM animals or animals containing GM micro-organisms must be kept in containers or cages designed to prevent the escape of the animals being contained.

All animals or cages/containers of animals must be labelled to enable identification of the animals being contained and to indicate the number of animals in the containers.

Large animals must be clearly marked so they can be readily identified (e.g. with a tattoo, permanent tag, microchip or permanent brand). Some documented system of accounting for the number of animals in the facility must be used.

Animal Carcasses must be returned to the PC2 Animal Facility for sterilisation

17

PC2 Facility – Aerosol containment

Any procedures generating aerosols (cell culture, opening ampoules, pipetting)

or when a biohazard needs to be contained, must be carried out within a

Class II Biological Safety Cabinet

18

Storage of GMOs – PC1 and PC2• GMOs, including organisms containing GMOs, being stored must be wholly

contained inside a sealed, unbreakable primary container.

• GMOs for which the minimum permitted physical containment level is PC2, must be packed inside a sealed, unbreakable secondary container. In the case of a small storage unit, such as a refrigerator, freezer, or cryogenic storage container, the storage unit is permitted to be the secondary container.

• The primary container must be labelled to clearly show the name or other identifier of the GMO being stored.

• A record(s) of GMOs being stored must be maintained and made available to the Regulator upon request.

19

Transport of GMOs – PC1 and PC2GMOs which require containment in a PC1 facility must not be removed from the facility unless they are to be transported to another containment facility certified by the OGTR to at least PC1.

• The external surface of the primary and any required secondary container (for PC2 GMOs) must be decontaminated prior to transport

• GM micro-organisms to be transported, including plants or animals containing GM micro-organisms, must be wholly contained inside a sealed, unbreakable primary container.

• All GM materials to be transported must be labeled.

• Procedures must be in place to ensure that all GMOs or the number of primary containers of cultures of GMOs transported, can be accounted for and that a loss of GMOs during transport, or the failure of delivery, can be detected.

• Access to the GMOs must be restricted during transportation

20

Transport of GM animals• GM animals to be transported must be wholly contained inside a sealed,

unbreakable primary container.

• GM animals must be tagged or labelled so as to indicate that they are GMOs. Large animals, such as pigs, sheep, cattle etc., must be individually tagged (e.g. by microchip, tattoos, ear tags or ear notches). Small animals must be identified by labelling the cage or container, or individually as above.

• After the transport of small animals, containers must be decontaminated, including by ensuring no individual animals are hidden in any bedding or media.

21

Decontamination of GMOs

All GMOs must be decontaminated prior to final disposal. • This includes liquid and solid waste

Decontamination can be effected by: • autoclaving or other heat treatment; • chemical treatment; • incineration; or• by any other method approved in writing by the OGTR.

Refer to MCRI Waste Procedures

22

Loss, spill or escape of GMOs• In the event of the escape, unintentional release, spill, leak, or loss of

GMOs, including failure of the GMOs to be delivered to the recipient:

• efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable

• the incident must be reported to the Regulator as soon as reasonably practicable.

• Applications for Exempt dealing and NLRD dealing can be found on i-know , type in GMO into the search or click on the links below;

• GMO Exempt Dealings• GMO PC1 NLRD application• GMO PC2-NLRD application

23