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Australasian Biotechnology, Vol. 10 No. 1, 2000, pp. 28-29 Regulatory Update - Consultation Draft of Gene Technology Bill 2000 Stuart Clague and Deborah Weekes, Planning, Environment and Local Government Group, Corrs Chambers Westgarth Lawyers Code Number: au00011 Regulation of Dealings with GMOs Central to the operation of the Gene Technology 2000 Act will be the regulation of dealings with GMOs. However, in order to understand the intended operation of the Act, it is necessary to understand a number of key definitions in the Bill. The term "deal with", in relation to GMOs, has been very widely defined to mean:
In addition, the term includes ancillary dealings such as the possession, supply, use, transport or disposal of GMOs for the purposes of, or in the course of, one of the primary dealings mentioned above. The term "genetically modified organism" has been defined to mean an organism that has been modified by gene technology, an organism that has inherited particular traits from a parent organism (being traits that occurred in the parent organism because of gene technology) or anything declared by regulation to be a genetically modified organism. However, the term does not include a human being or an organism declared by the regulations not to be a genetically modified organism. The drafting of this definition reflects the policy that the regulation of GM products should remain with existing regulators (e.g. ANZFA, TGA, NRA). However, the Bill permits GM products for which there is no existing regulator ("gap" GM products) to be declared as GMOs and to therefore become subject to the Act. The term "gene technology" has been defined to mean any technique for the modification of genes or other genetic material but does not include sexual reproduction, natural recombination, selective breeding or any other technique specified in the regulations. Finally, the term "organism" is defined to mean any biological entity that is viable, capable of reproduction or capable of transferring genetic material. Licensing System for Dealings with GMOs The introduction of a licensing system for dealings with GMOs is a key component of the Bill. In the absence of a GMO licence, any dealing with a GMO is an offence unless the dealing is a notifiable low risk dealing or an exempt dealing. In establishing the licensing system, the Bill draws a distinction between the licensing of dealings which involve the deliberate release of GMOs into the environment, (e.g. field trials and the commercial release of GMOs) and those which do not (e.g. contained research with GMOs). In the former case the Regulator may only decide the application after undertaking extensive consultation with the public, GTAC and other agencies in relation to the application and preparing a risk assessment and risk management plan for the proposed dealing. In the latter case, the Bill merely provides that the Regulator may consult with GTAC and other agencies in relation to the application. In each case, after considering the above matters, the Regulator must decide whether to issue the licence, with or without conditions, or to refuse the licence. In making this decision, the Bill requires the Regulator to have regard to:
Further, the Regulator must not issue a licence unless satisfied that the risks posed by the dealing are able to be managed in such a way as to protect the health and safety of people and the environment. In addition, the Regulator must have regard to the national interest. Low Risk Dealings and Exempt Dealings A GMO dealing which is classified as a notifiable low risk (NLR) dealing or an exempt dealing will not be subject to the licensing requirements of the Act. Notifiable low risk dealings are low risk dealings, prescribed by regulation, which do not involve the deliberate release of GMOs into the environment. These dealings will be subject to requirements imposed by regulation. These requirements may relate to matters such as notifying the Regulator of any NLR dealings, the supervision of NLR dealings by Institutional Biosafety Committees and the containment levels of facilities in which NLR dealings are to be undertaken. It is anticipated that NLR dealings will include those dealings which are currently classified as "Category B" dealings under the existing GMAC guidelines. In addition, the Bill provides that certain very low risk dealings may be specified by regulation as exempt dealings. It is anticipated that these will include the existing GMAC exemptions. Confidentiality A person ("the applicant") may apply to the Regulator for protection of confidential commercial information in relation to GMOs. The types of information which are considered to be confidential commercial information are trade secrets, information which has a commercial or other value which will be diminished upon disclosure and information which concerns the lawful commercial or financial affairs of a person or an organisation. A person who is aware of confidential commercial information, because they are performing duties under the Act, may only disclose that information under a court order, with the consent of the applicant or in the course of performing duties under the Act. Review of Decisions The Bill introduces a procedure for merits review of decisions made under the Act. However, this right of review is only available to persons directly effected by a decision and does not extend to third parties. The Bill provides for internal review by the Regulator, in the case of decisions made by a delegate of the Regulator, and for external review by the Commonwealth Administrative Appeals Tribunal, in the case of decisions made personally by the Regulator. In addition, an aggrieved person may make an application for judicial review of decisions made under the Act. This review process is available to third parties which are able to establish sufficient standing. These may include peak environment and industry organisations. Conclusion The consultation draft of the Bill provides a framework for the regulation of dealings with GMOs to ensure that they do not compromise public health or safety or the environment. However, much of the detail of this regime still remains to be spelt out in the regulations and in policy guidelines and codes of practice prepared under the Act. A consultation draft of the proposed regulations is expected to be released in late February 2000. This will allow for a more complete understanding of the new regime. The closing date for submissions to the IOGTR on the Bill is 10 March 2000.
Copyright 2000 - Australasian Biotechnology |
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