A new system for the regulation of genetically modified organisms ("GMOs") in Australia commenced operation on 21 June 2001. The law governs the growing of genetically modified ("GM") crops, the breeding of GM animals, experiments with GMOs and a variety of other dealings with GMOs (whether for medical, agricultural or other purposes). The regime is established by the Gene Technology Act 2000 (Cth) (the "Act") and the Gene Technology Regulations 2001 (Cth) (the "Regulations").

Part A of this article contains a description of the new system. Part B focuses on specific aspects of the law, including: (a) the range of dealings potentially permissible under the Act; and (b) the Regulator’s power to decide whether an activity proceeds.

The principal conclusions are these:

1. (Range of dealings) An extensive range of dealings are potentially permissible under the Act, including the broad release of GMOs into the environment, and the cloning of human beings (where the progeny are not genetically identical to the forbear).
2. (The Regulator decides) The Act establishes the Office of the Gene Technology Regulator (the "Regulator"), which decides whether or not licences to authorise dealings with GMOs should be granted. The Regulator has broad discretion in the exercise of its powers. All tests to be satisfied under the Act with respect to the granting of licences are subjective, to be determined by a value judgment of the Regulator. The Regulator is not required to consult the Ethics Committee or the Community Consultative Committee created by the Act; and whilst the Regulator must consult the expert Technical Advisory Committee, it is free to choose not to follow the committee’s advice.
3. (Merit reviews) Neither the public nor affected stakeholders (such as adjoining farmers) have merit appeal rights to challenge a decision of the Regulator to grant a licence. This is despite the implications of such a licence being significant for such persons. However, proponents whose licence applications are rejected (or approved on unfavourable terms) do have merit appeal rights to the Administrative Appeals Tribunal.
4. (Insurance) There is no requirement that insurance be held by persons who carry out dealings with GMOs. This is a matter that has been left to the discretion of the Regulator.
5. (Geographical coverage) The Act and Regulations do not apply to Norfolk Island (a territory of Australia).

The legislation regulates "dealings" with "genetically modified organisms".

"Dealings" are defined to include:

• conducting experiments with GMOs;
• breeding or growing GMOs;

• using GMOs to manufacture products;
• importing GMOs,

as well as the possession, transportation and disposal of GMOs for any of these purposes.

A GMO, for the purposes of the Act, is any organism whose genetic material has been modified by gene technology. For example, if a gene is added to a plant, or if one of its genes is altered or deleted, and this is done by gene technology (as opposed to by natural means, such as sexual reproduction), then the organism will be a GMO and be regulated by the Act.

The Act does not, as a general rule, regulate products derived from genetically modified organisms ("GM Products"). These products are intended to be regulated by other legislation.

The Act prohibits all dealings with GMOs, unless:

(A) the dealing is authorised by a GMO licence;

(B) the dealing is a notifiable low risk dealing;

(C) the dealing is included in the GMO Register; or

(D) the dealing is an exempt dealing.

GMO licences are the principal form of approval under the Act. The other three types of authorisation are intended to apply only to low risk dealings.

GMO licences are issued by the Office of the Gene Technology Regulator (the "Regulator").

The assessment process applicable to an application for a licence depends on whether or not the proponent intends to release a GMO into the environment.

If it does (as would be the case where GM crops are to be grown in the open) - then a comprehensive assessment procedure applies, involving stakeholder participation. The process is as follows:

1. If the Regulator believes that the proposed dealing "may pose significant risks to the health and safety of people or to the environment", then it must publicly notify the application and invite submissions from the public.
2. The Regulator must prepare a risk assessment and a risk management plan. These are intended to identify risks posed by the dealing and ways in which those risks can be managed.
3. The Regulator must advertise the risk assessment and risk management plan, and invite submissions from the public.
4. The Regulator must seek advice from the States and certain other bodies.
5. The Regulator has 170 days to determine the application.

If the proponent does not intend to release a GMO into the open (as with experiments within a contained laboratory) – then the process involves step 2 above only, and the Regulator has 90 days to determine the application. Such applications do not involve public notification or provide an opportunity for stakeholder submissions.

A licence may only be issued, if the Regulator is satisfied that:

(a) the proposed dealing is able to be managed in such a way as to protect the health and safety of people and the environment;

1. the applicant is a suitable person to hold the licence; and
2. the licence would not be inconsistent with any policy principles published by the Ministerial Council.

The remaining three categories of authorised dealing are not examined in this paper in detail. Broadly:

1. ‘notifiable low risk dealings’ and ‘exempt dealings’ are dealings of a type listed in the Regulations. Such dealings must comply with requirements set out in the Act (e.g. they must be carried out in a contained facility).
2. The final category of dealings are those which the Regulator believes to pose minimal risk to human health and the environment and which the Regulator has listed on a register called the GMO Register.

The Regulator is required to maintain a "Record of GMO and GM Product Dealings". This Record is available to the public and is intended to be a comprehensive record of all dealings in Australia that involve GMOs or GM Products.

The Act permits the Regulator to declare information to be "confidential commercial information" for the purposes of the Act, in which event it will not be included in the Record or otherwise disclosed to the public.

The Regulator must not make such a declaration:

1. if satisfied that the public interest in disclosure outweighs the prejudice that the disclosure would cause; or
2. if the information relates to locations at which field trials involving GMOs are occurring or are proposed to occur. Information regarding the location of field trials must be made public, unless the Regulator is satisfied that significant damage to the health and safety of people, the environment or property would be likely to occur if the locations were disclosed.

The legislation gives broad discretion to the Regulator to decide if, and on what terms, licences should be granted.

To illustrate:

1. all tests to be satisfied under the Act with respect to the granting of licences are subjective, to be determined by a value judgment of the Regulator. Essentially, it up to the Regulator to decide what level of risk is acceptable;
2. there is no requirement for a licencee to hold insurance. Whether or not a licence condition requiring insurance is imposed is a matter for the discretion of the Regulator;
3. whilst the Act creates an expert Technical Advisory Committee to advise on risks posed by potential dealings, it is up to the Regulator to decide whether, and to what extent, it will follow that advice;
4. there is no requirement that licences be limited in duration. This is a matter for the Regulator’s discretion;
5. the Act creates a Community Consultative Committee and an Ethics Committee. However, the Regulator can decide if, and to what extent, these committees are consulted.

In essence, complicated issues such as:

1. the level of risk which is acceptable;
2. the level of precaution which should be taken; and
3. ethical considerations,

are reserved as a value-judgment for the determination of the Regulator.

The Regulator’s discretion could have been limited in any of a number of different ways. For example, the Act could have provided as follows (no doubt, other tests could be formulated by experts):

1. if the proposed dealing may pose significant risks to the health and safety of people or to the environment (a test used elsewhere in the Act (s49)), then the Regulator may not grant a licence for the dealing without the concurrence of the Technical Advisory Committee;
2. the Regulator may not grant a licence permitting a release of a GMO into the environment, if the Technical Advisory Committee advises that there is a material risk the GMO will spread beyond the area the subject of the licence;
3. insurance could have been made mandatory.

The Regulator’s decision to grant a licence cannot be appealed on the merits. In other words, the Regulator’s value judgment (or preparedness to accept risk) cannot be appealed to any more senior body.

This is despite the fact that the Regulator’s decision making is largely unchecked, and that the grant of a licence can have significant implications for people living in the relevant area or for the livelihood of GM-free farmers.

However, applicants have merit appeal rights to the Administrative Appeals Tribunal to appeal any decision by the Regulator to refuse a licence or to issue a licence on conditions opposed by the applicant.

3. Range of potential dealings

All experiments and other dealings with GMOs, whether for scientific, medical or agricultural purposes, require a form of authorisation under the Act.

The Act places no limit on the range of dealings potentially permissible under the Act, with 3 exceptions:

1. The Act prohibits the cloning of a whole human being (section 192B). The Act defines this as "the use of technology for the purpose of producing, from one original, a duplicate or descendant that is, or duplicates or descendants that are, genetically identical to the original".

This prohibition would appear to allow human cloning so long as one genetic difference (no matter how minor) can be shown.

2. The Act prohibits experiments or research putting human cells, or a combination of human and animal cells, into animal eggs (section 192C).

This prohibition is limited to experimentation and research. It does not prevent other dealings with such organisms (such as the breeding of these organisms), where the experimentation or research is done overseas (or on Norfolk Island – which is not covered by the Act or Regulations).

3. The Act prohibits experiments or research that involves putting a combination of human cells and animal cells into a human uterus (section 192D).

Again, this appears to allow the breeding of such organisms - where the research and experimentation is done overseas or on Norfolk Island.

Where public notification is required by the Act, the obligation is to publish a notice in: (a) the Government Gazette; (b) a newspaper circulating in all States (i.e. The Australian); and on the Regulator’s website. These are a surprising choice of publications, given that the Government Gazette is not generally read by the public, The Australian has a limited readership, and few people can be expected to regularly visit the Regulator’s website, unless aware a licence application has been made.

A preferred approach would have been to notify neighbours or to those in the immediate locality of the proposed activity, directly. As it stands, a person is more likely to be notified of a home extension on a neighbouring property, than a proposal to release genetically modified organisms onto adjoining land.

5. The assessment process for licences

The distinction described in Part A between dealings which involve a release of a GMO into the open environment and dealings which do not, is problematic, because a number of dealings may fall somewhere in-between. Taking the following dealings, for example:

1. the growing of GM plants in a greenhouse with an earthen floor (allowing drainage of water into the open environment) or with louvres that periodically open and close;
2. the growing of GM plants in a garden leading off a laboratory, if the garden has a high brick wall surrounding it;
3. an experiment in a laboratory, where waste water leaves via a drainage system into the open environment.

If the Regulator considers these dealings not to involve an intentional release of a GMO into the open environment, then they will not be publicly notified, and will not be subject to stakeholder scrutiny.

Given the risks potentially involved with GMO dealings, it would have been preferable for one assessment process to apply to all licences, and for that system to provide persons likely to be affected and the public at large an opportunity to express concerns and make submissions.

6. Why are GMO Bills also being considered by State and Territory parliaments?

It is unclear whether the Commonwealth has the constitutional power to legislate on GMOs in respect of all dealings, by all persons, all over Australia. According to the Explanatory Memorandum, gaps in constitutional coverage may include dealings with GMOs by certain individuals, State departments and universities who are not involved in cooperative arrangements with corporations or in interstate trade and commerce.

To ensure the Cth’s GMO laws cover the entire country (other than Norfolk Island), it is intended that each State and Territory will pass "mirror legislation", consistent with the Act and Regulations. It is intended that these laws will be centrally administered by the Commonwealth Regulator.

1. The wide range of dealings potentially permissible under the Act;
2. the broad discretion given to the Regulator to license activities to proceed;
3. the absence of objective limits on the risks which can be taken;
4. the lack of supervision of the Regulator; and
5. the inability to appeal the Regulator’s value judgment in deciding to approve a dealing,

make for a permissive (as opposed to a precautionary) scheme; one which places enormous responsibility in the hands of the Regulator.