Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 10, Num. 5, 2000, pp. 33-35

Australasian Biotechnology, Vol. 10 No. 5, 2000, pp. 33-35

BIOTECHNOLOGY REGULATORY NEWS

PROPOSED NEW GENE TECHNOLOGY REGULATORY REGIME

Gaye Middleton, Mallesons Stephen Jaques, Brisbane

Code Number: au00054

INTRODUCTION

The Australian Federal government has proposed a new regime for the regulation of gene technology in Australia in a package of three complementary pieces of legislation. The most important of these pieces of legislation is the Gene Technology Bill 2000 (“the Bill”). The Gene Technology (Consequential Amendments) Bill 2000 and the Gene Technology (Licence Charges) Bill 2000 are designed to assist in implementing the reforms proposed by the Bill.

Following a public consultation process, the Bill was passed by the House of Representatives on 30 August 2000, and has been introduced into the Senate. The Federal government aims to have the new regulatory regime for gene technology operational by 3 January 2001 to replace the existing regulatory regime overseen by the Genetic Manipulation Advisory Committee (“GMAC”).

The Bill was introduced by the Australian Federal government in response to the following developments:

1. The need to legislatively regulate gene technology that is currently not regulated by legislation, known as “gap technology”, including herbicide resistant crops and genetically modified ornamental plants.
2. The expected increase in the number of general releases of GMOs into the environment as advances are made in gene technology research.
3. Community and industry expectations regarding the regulatory system for gene technology, which require transparency and fairness of the regulatory process and public consultation, particularly in relation to sensitive areas such as genetically modified food.

The primary object of the Bill is to protect the health and safety of people and to protect the environment by:

1. identifying risks posed by or as a result of gene technology; and
2. managing those risks by regulating dealings with GMOs.

The Bill seeks to achieve these objects through a regulatory framework which:

1. provides an efficient and effective system for the application of gene technologies; and
2. operates in conjunction with existing Australian Federal and State regulatory schemes regarding GMOs and genetically modified products.

The Gene Technology Regulator (“GTR”) is a new public office to be established under the Bill. The GTR’s functions include:

1. licensing dealings with GMOs;
2. developing draft policy guidelines and codes of practice relating to GMOs;
3. issuing technical and procedural guidelines relating to GMOs;
4. advising other regulatory agencies regarding GMOs and genetically modified products;
5. advising the public about regulation of GMOs; and
6. advising the Australian Commonwealth and the States regarding the operations of the GTR and the Gene Technology Technical Advisory Committee (“GTTAC”), and regarding the effectiveness of legislative regulation of GMOs.

There will also be a Ministerial Council established under an intergovernmental agreement between the Federal government and all of the Australian States and Territories, which will issue policy principles regarding ethical issues relating to dealings with GMOs and other prescribed matters in consultation with the GTR and other government and non-government groups. The Ministerial Council may also issue policy guidelines relating to the functions of the GTR and codes of practice relating to gene technology.

The GTR and the Ministerial Council will be advised by:

1. GTTAC, the successor of GMAC, regarding scientific, technical and policy matters;
2. the Gene Technology Community Consultative Group regarding matters of general concern regarding GMOs and related policy guidelines and codes of practice; and
3. the Gene Technology Ethics Committee regarding ethical issues relating to gene technology and related codes of practice and policy principles.

Under the Bill, persons who deal with GMOs must be licensed unless the dealing in which they are involved is an exempt dealing or a notifiable low risk dealing. A “GMO” or “genetically modified organism” is defined by the Bill as:

1. an organism that has been modified by gene technology; or
2. an organism that has inherited traits resulting from gene technology from its parent organism; or
3. anything declared by regulation to be a GMO¹,

but does not include:

4. a human being, if that human being is only covered by the definition because that human being has undergone somatic cell gene therapy; or
5. organisms or classes of organisms declared not to be GMOs by regulation.

A “GM Product” is defined as a thing other than a GMO derived or produced from a GMO.

The following organisms have been declared by the draft Gene Technology Regulations 2000 not to be GMOs:

1. mutant organisms in which the mutational event did not involve the introduction of any foreign nucleic acid;
2. recombinant organisms formed by integration of a mobile genetic element that occurs naturally in the species concerned into chromosomal or extrachromosomal DNA sequences;
3. organisms resulting from the fusion of two animal cells that are unable to form viable whole animals;
4. organisms resulting from protoplast fusion involving only non-pathogenic bacteria or non-pathogenic yeast; and
5. plants formed by embryo rescue, in vitro fertilisation, zygote implantation or protoplast fusion.

Under the Bill, to “deal with” a GMO means to:

1. conduct experiments with the GMO;
2. make, develop, produce or manufacture the GMO;
3. breed the GMO;
4. propagate the GMO;
5. use the GMO in the course of manufacturing a thing that is not the GMO;
6. grow, raise or culture the GMO; or
7. import the GMO,

and includes possession, supply, use, transport or disposal of a GMO in the course of such a dealing.

All dealings with GMOs which involve the intentional release of those GMOs into the environment must be licensed. “Exempt dealings” and “notifiable low risk dealings” will be those classes of dealings prescribed as such by the regulations under the Bill.²

Exempt dealings are those classes of dealings classified as involving a very low risk. It is anticipated that all dealings with GMOs that are currently exempted from GMAC will be exempt dealings under the Bill.

In determining whether a dealing is a notifiable low risk dealing, the following factors will be considered by the GTR:

1. whether a GMO will be biologically contained because it is not able to survive or reproduce without human intervention;
2. whether a dealing with a GMO involves minimal risk to the health and safety of people and to the environment, because the GMO is not a dangerous pathogen or a serious pest and does not produce toxic proteins; and
3. whether minimal conditions are necessary to manage any such risk.

Before a notifiable low risk dealing can be legally conducted, that dealing must be assessed by an Institutional Biosafety Committee (“IBC”), and notification of that dealing and a copy of the IBC’s assessment given to the GTR. Notifiable low risk dealings must:

1. be conducted in at least physical containment level 2 as prescribed by the GTR;
2. be supervised and its details recorded by the assessing IBC; and
3. if it involves human pathogens, be conducted only in accordance with the recommendations for vaccination given in Australian Standard AS/NZS 2243.3:1995 (Safety in laboratories: microbiology).

All dealings with GMOs that are not exempt dealings or notifiable low risk dealings must be licensed under the new regulatory system. The licensing system, to be administered by the GTR, is divided into two procedures. One procedure is for dealings which involve the intentional release of a GMO into the environment, while the other procedure is for those dealings that do not involve the intentional release of a GMO into the environment.

As currently happens, applications under the Bill to license dealings which involve the intentional release of GMOs into the environment will undergo a public consultation process. However, unlike the current system, the public consultation process will be more detailed, and will involve two stages instead of one.

The first stage of public consultation requires the GTR to publish notice of all applications to license dealings involving the intentional release of GMOs into the environment in the Federal government gazette, in a newspaper circulating generally in all Australian States and on the GTR website (if any). That notice must invite written submissions from the public as to whether or not a particular application for a licence should be successful, and stating that interested persons may seek further information about such an application. Members of the public must be given at least 30 days from the date of publication of the notice in which to make submissions.

Before granting a licence for the intentional release of GMOs into the environment, the GTR must prepare a risk assessment and risk management plan in relation to the proposed dealing. In doing so, the GTR must seek advice from GTTAC, the States and relevant Commonwealth and State regulatory bodies, and take into account submissions made by members of the public in relation to a particular application. Once the risk assessment and risk management plan have been prepared, the GTR must notify the public of that fact by publishing a further notice in the Federal government gazette, in a newspaper circulating generally in all Australian States and on the GTR website (if any), and invite requests for further information and written submissions. Members of the public must be given at least 30 days to make a submission regarding the risk assessment and risk management plan.

For applications to obtain a licence for dealings that do not involve intentional release of GMOs into the environment, the GTR must prepare a risk assessment and risk management plan, but there is no public consultation process. It is also optional for the GTR to seek advice from GTTAC, the States and relevant Commonwealth and State regulatory bodies when making a decision regarding such applications.

Following consideration of a licence application and compliance with any public consultation requirements, the GTR must decide whether or not to issue a licence for a particular dealing with GMOs. The GTR must not issue a licence if the GTR is not satisfied that any risks posed by the proposed dealing can be managed in such a way that the health and safety of people and the environment are protected. In making this decision, the GTR must have regard to:

1. the risk assessment, the risk management plan and submissions in relation to them;
2. whether the licence would conflict with relevant policy guidelines and codes of practice; and
3. whether the applicant is a suitable person to hold the licence, having regard to:

1. relevant convictions for offences committed by the person;
2. past revocations or suspensions of a licence or permit held by that person under a law of any country or Australian States relating to the health and safety of people or the environment; and
3. the capacity of the applicant to meet the licence conditions.

Once the GTR has decided whether or not to license a particular dealing with GMOs, the GTR must notify the applicant in writing of that decision. Conditions may be imposed on the grant of a GMO licence.³ All licences issued by the GTR will be recorded by the GTR in the Record of GMO and GM Product Dealings, which will be available for public inspection. Licences will be transferable subject to the approval the GTR.

It will be a federal criminal offence not to comply with the licensing provisions proposed under the Bill, punishable by a fine of $55,000, or $220,000 for an aggravated offence. Other proposed enforcement measures include:

1. the issue of compliance directions by the GTR to licence holders in breach of the legislation or the terms of their licence;
2. granting of injunctions to restrain offences against the legislation; and
3. forfeiture to the Federal government of any thing used or otherwise involved in the commission of an offence.

The Bill proposes to establish a national uniform scheme for regulating gene technology in Australia. The GTR will be a national, central administrator for regulating dealings with GMOs. It is envisaged that each Australian State and Territory government will enact legislation which mirrors the Bill.

Once appropriate State and Territory legislation is enacted, the Federal government proposes to “wind back” the operation of the Bill, so that State and Territory legislation continues to regulate dealings with GMOs by higher education institutions, State agencies and individuals which would only be covered by the Bill due to the Federal government’s Constitutional power to legislate in relation to quarantine matters. State and Territory laws will operate concurrently with the Federal legislation. However, persons convicted of an offence under State or Territory legislation will not be prosecuted for the same offence under the Federal legislation.

It is also proposed that, by means of an intergovernmental agreement signed by the Australian Federal, State and Territory governments, a national scheme will be established for regulating dealings with GMOs, administrating that scheme, and maintaining a consistent national regulatory framework.

In addition, the Gene Technology (Consequential Amendments) Bill 2000 provides for amendments to existing Federal regulatory systems relating to GMOs. These amendments require the administrators of those regulatory schemes to:

1. advise the GTR of applications made under any of those schemes of the application for approval under those schemes of a substance or thing constituted by or containing a GM Product;
2. consider any advice given the GTR in relation to such applications; and
3. notify the GTR whether or not approval has been granted for that substance or thing so that, where appropriate, it can be entered on the Record of GMO and GM Product Dealings.

These amendments ensure that existing regulators of GM Products have access to the GTR’s advice on genetic safety and that the Record of GMO and GM Product Dealings is comprehensive for all such dealings in Australia.

A copy of the draft legislation referred to in this paper and accompanying explanatory memoranda is available on the Internet at http://www.aph.gov.au/

Copyright 2000 - Australasian Biotechnology