Embryonic stem-cell research and new biotechology laws

In the context of the GTA, a GMO is defined as:

• an organism that has been modified by Gene Technology;
• an organism that has inherited particular 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 of the GTA to be a GMO.

An "organism" is any biological entity capable of reproduction or capable of transferring genetic material. However, a GMO does not include:

• a human being, who has been modified by Gene Technology only by way of somatic cell gene therapy; or
• an organism declared by the regulations not to be a GMO, or that belongs to a class of organisms declared by the regulations not to be a GMO.

Accordingly, research involving the genetic modification or manipulation of human body parts, tissue, fluid, reproductive material or cells is regulated by the GTA. This is likely to include genetic modification of embryonic stem cells and organisations currently undertaking such research must ensure that they meet the requirements to do so under the Act.

When can an organisation conduct GMO research?

The GTA permits organisations to deal with GMOs only if the dealing is:

• under a licence;
• a Notifiable Low Risk Dealing ("NLRD");
• exempt under the regulations; or
• is included on the GMO Register.

Licence to Deal with a GMO

Under the GTA, an organisation must apply to the GTR for a licence to undertake certain dealings with a GMO. There are essentially 2 forms of dealings capable of licence, namely:

• intentional release of a GMO into an environment; and
• non-intentional release of a GMO into an environment.

Upon receipt of any licence application for a proposed dealing with a GMO, the GTR will prepare a risk management plan and risk assessment. In some instances the GTR may seek advice in the preparation of the risk assessment and risk management plan from the States, the Gene Technology Technical Advisory Committee and other appropriate bodies.

Notifiable Low Risk Dealings ("NLRDs")

In essence, NLRDs include:

• dealings which do not involve the intentional release of a GMO into the environment; or
• any GMO declared by the regulations to be a NLRD.
• The GTA requires the GTR to determine whether a dealing with a particular GMO is a NLRD. When doing so, the GTR must consider a number of factors including:
• whether the GMO is biologically contained so that it is not able to survive or reproduce without human intervention; or
• whether the dealing with the GMO would involve minimal risk to the health and safety of people and to the environment.