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Australasian Biotechnology, Vol. 11 No. 6, 2001, pp. 27-29 BIOTECHNOLOGY LAW DEVELOPMENTS IN BIOTECHNOLOGY LAW - GENE TECHNOLOGY ACT 2000 John Lee Lawyer, IP and Biotechnology Group, Gilbert & Tobin, 2 Park Street, Sydney, NSW 2000 Code Number: au01071 1. Introduction Australia’s recent adoption of a comprehensive regulatory regime to cover research into and use of genetically modified organisms (GMOs) has already resulted in some debate about disclosure requirements. The regime is established under the Gene Technology Act 2000 (the Act) and, since it came into force on 21 June 2001, some major industry participants have sought to avoid disclosure of the location of GM crop trials by having them classified as confidential1. Companies involved in GM research are concerned that the disclosure requirements of the Act may jeopardise their research and endanger the properties of farmers who have agreed to conduct GM trials. The strict new regime is a response to growing concern about public safety issues arising from the increased use of GMO’s in the fields of research, agriculture and industry. There was concern that these issues were not being addressed by the previous voluntary guidelines. The following is a summary of the scope of the new regime and the key issues that researchers and investors in the GM industry should to be aware of. 2. Summary of Key Points of the Act
3. The significance of GMOs A GMO can be described as an organism whose genetic make up has been altered by any artificial technique capable of modifying genetic material (the definition in the Act is set out in paragraph 6 below). Scientists have been aware of techniques for genetic modification for some time but it is only relatively recently that the huge potential benefits of GM technology in terms of applications for health, food production and primary industry have been recognised. By altering the genetic make up of organisms, their utility and characteristics can be enhanced. For example GM crops may demonstrate increased resistance to herbicides or enhanced yields over non-modified variants.
However, there is still widespread public concern about the use of GMO’s. This arises because this field of science is still in its infancy and the long-term effects of producing and releasing GMO’s into the environment on a large scale are unknown. There is concern for example about possible allergic and other physical reactions to GM food which may not emerge for some time. There are also economic and ecological concerns relating to maintaining traditional farming methods alongside GM methods, and there are fears about the impact genetic modification will have as it ripples through the food chain (ie cattle grazing on GM crops). Nevertheless, the government recognises that the very significant potential benefits of GM research should not be jeopardised by safety concerns which can be alleviated by implementing proper safeguards. In introducing the Act, the Australian Government has taken a proactive stance to strictly regulate the production and use of GMO’s. The new regulatory regime will have a significant impact on industry participants who will need to ensure they understand their obligations to avoid potential liability for non-compliance. 4. Previous Regulation The existing laws in Australia relating to genetic modification are mostly endproduct specific:
5. Voluntary Regulation of GMO’s The Genetic Manipulation Advisory Committee (GMAC) was established in 1987 and more recently the Interim Office of the Gene Technology Regulator (IOGTR) was established within the Department of Health and Aged Care. The IOGTR works with GMAC to assess community safety and environmental protection aspects of gene manipulation practices that are not covered by any of the other existing regulators. To date researchers and companies dealing with GMOs have generally adhered to this voluntary system, however they have not been under any legal obligation to comply with the advice of GMAC or the IOGTR. 6. Scope of the New Regime The new regime, which is intended to complement the existing regulations set out in paragraph 4 above, is mandatory. Any company or individual dealing with GMO’s will now be subject to the compulsory licensing and approval scheme administered by the new GTR. A GMO is defined in the Act as:
Gene technology means:
Dealing with GMO’s for the purpose of the Act includes:
The definitions are wide enough to encompass any purposeful or industrial application of GMOs and any experimental trial. Human beings have been expressly excluded from the definition of genetically modified organisms. It was considered that to include humans in the definition would be to subject people who have undergone gene therapies to the compulsory licensing system - an obviously undesirable consequence. Human gene therapy will continue to be regulated by the Therapeutic Goods Administration, and any research involving human trials will be overseen by the National Health and Medical Research Council.5 It is an offence under the Act for a person to knowingly engage in conduct which will result in the cloning of a human being, that is, the creation of a whole duplicate or descendant of a human being with identical genes.6 7. The Gene Technology Regulator The GTR, is to be the main regulator for any dealings with GMOs. The GTR will develop policy principles and guidelines for dealing with GMOs, issue licences for certain dealings, and provide information and advice to the public and other government agencies. The Act emphasises the independence of the GTR,7 and the position has been likened to that of the Auditor General or the Commonwealth Ombudsman.8 An Acting GTR, Ms Liz Cain, has been overseeing the regime since its inception in June. On 30 September, the Federal Health Minister announced the appointment of a permanent GTR, Dr Sue Meek. Dr Meek, who is at present Executive Director of the Science and Technology Division of the West Australian Department of Commerce and Trade, will take up her new appointment in December 2001. The Act establishes three committees to assist the GTR in administering the Act and developing policy.9 (i) The Technical Advisory Committee, consisting mainly of members with specialist expertise in medical and biological disciplines.10 (ii) The Community Consultative Committee, made up of members with relevant experience in issues of environmental and public safety,11 and (iii) The Ethics Committee, including members with experience in fields such as environmental ethics, law and animal health and welfare.12 8. The Licensing Procedure Subject to certain exemptions13, the Act prohibits dealing with GMO’s without a licence. The licensing procedure is stringent, and prospective licensees will need to carefully prepare the relevant documentation and supporting information in order to expedite the process. A complete and accurate application setting out detailed background information about the applicant, the precise scope of the proposed dealings, potential environmental impacts, perceived benefits and risk management strategies is more likely to be accepted. Given their significant investment in research, industry participants may wish to take professional advice in the preparation and submission of licence applications to ensure all proposed dealings are covered and enhance the prospect of success. The form a licence will take will depend on the scope of the application. For example, the application may be in respect of all dealings with one specific GMO, or with GMOs in a specific class. The licence can authorise persons specified in the application, or all persons.14 There are no formal requirements for the application to disclose information about potential risks of proposed dealings.15 However, the GTR is empowered to require an applicant to furnish further information in order to assist the decision making process, and can refuse to consider an application if this is not complied with.16 If the applicant proposes dealings that do not involve the intentional release of GMOs into the environment, the GTR will prepare a risk assessment and management plan for that application.17 In preparing this assessment, the GTR will consider the scope of dealings that such a licence would authorise and the associated health, safety and environmental risks. The GTR may consult relevant State or Commonwealth authorities, the Technical Advisory Committee, and any other person the GTR considers appropriate. 9. Release of GMO’s into the Environment The GTR’s role is more comprehensive when an applicant seeks a licence covering the right to release GMO’s into the environment. The GTR must firstly notify the public that the application has been made and invite written submissions on whether the licence should be issued. The GTR will then prepare a risk assessment and management plan. In addition, consultation with the States, the Technical Advisory Committee, relevant Commonwealth agencies, the Environment Minister and any appropriate local council is compulsory for these applications. The results of this consultation process must be taken into account in the preparation of a risk assessment and risk management report. The GTR may also consider it appropriate to hold a public hearing in order to determine the licence application.18 Once the GTR has considered the licence application he or she must make a decision whether to grant a licence and on what terms. An applicant can seek review of a decision to refuse a licence or a decision to impose particular conditions on a licence.19 10. Licence conditions Every licence will be subject to three main conditions:
Additionally, the GTR has a discretion to prescribe further licence conditions which curb the risk of the particular dealing. Licences are transferable subject to approval of the GTR and the GTR may vary the terms or conditions of a licence. The licence conditions impose strict obligations on licence holders to carefully monitor and to provide information about their GMO dealings. Consequently licence holders will need to have in place effective monitoring and management procedures and practices. Documentation, records and any experimental data or reports should be maintained and available for inspection. Any new information that comes to light concerning risk profiles or unintended developments must be recorded so that it can be notified to the GTR. 11. Enforcement and Penalties The GTR has wide powers under the Act to monitor compliance with licence conditions, and with the Act in general.22 There are provisions for inspectors to search premises, conduct tests and take samples. If the GTR is satisfied that there has been a breach of licence conditions, the licence holder, or a person covered by the licence may be charged,23 penalties may be imposed and the licence may be suspended or cancelled.24 The Act empowers the GTR or any other person effected by an existing or threatened breach of the Act to seek an injunction in the Federal Court. 12. Record of GMO Dealings The Act establishes a public register, the Record of GMO and GM Product Dealings.25 This will record the details of licensed dealings including the licence holder, the scope of dealings and any conditions of the licence. This information, which includes maps of the specific location of GM crop trials, is publicly available but the Act enables a licence holder to apply to have information classified as confidential.26 If the GTR is satisfied that the information is a trade secret, is commercially sensitive, or that disclosure would prejudice the provider or impact on the environment, the GTR may declare that it is confidential. Within days of the Act coming in to force, several different GM research organisations had made applications to have some 87 crop trial sites classified as confidential. However, on 8 August 2001, the Acting GTR rejected all the applications for confidentiality on the basis that none had provided sufficient evidence to satisfy the stringent eligibility criteria imposed by the Act. The applications were initiated due to concerns that the positions of individual farmers may be jeopardised by publication of GM crop sites. However, the GTR considered these concerns had largely been dealt with and rejection of the confidentiality applications was seen by the GTR to be in keeping with the spirit of the regime - to provide a transparent system for regulating gene technology. Only one applicant, the University of Western Sydney, has appealed the GTR’s decision on confidentiality to the prescribed review body, the Administrative Appeals Tribunal.27 13. Conclusions The new regulatory framework is a proactive step, establishing a stringent regime to monitor dealings with GMOs. While recognising the significant potential benefits of GM research and applications, the Act attempts to regulate GMO dealings in a way which will allay public health and safety concerns. It imposes strict obligations on any person or company who wishes to deal with GMOs, requiring them to obtain a licence prescribing the scope of their dealing and to maintain information and records about their activities. To enhance transparency, a public record of all GMO dealings is established providing detailed information about the scope of existing dealings. Through the submissions process, the public can also have input into the determination of licence applications. Not surprisingly, the introduction of legislation in a previously unregulated field has caused concern amongst those engaged in the GM industry as well as the general public. It is a world first in attempting to balance the undoubted benefits of GMO research with needs of public and environmental safety. Provided that industry participants and investors are aware of and adhere to their obligations under the new regime and provided that the public and interest groups take the opportunity to be actively involved in its administration, the new regime may succeed in meeting this objective. Glossary
Notes
Copyright 2001 - AusBiotech |
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