This chapter summarises key aspects of the Gene Technology Bill 2000. While we urge you to examine the whole Guide, we also understand that some people will only require an overview of the Bill.
The views of stakeholders and the feedback received to date on key issues are reflected in Chapter 4 (Parts 1-12) as part of the detailed explanation of the various parts of the Bill.
3.1 What is the object of the Gene Technology Bill 2000?
This Bill is a major component of a national scheme to protect the public health and safety of people and to protect the environment from risks associated with gene technology. The scheme will operate by identifying and assessing risks posed by, or as a result of, gene technology, and by managing any risks through the regulation of certain dealings with genetically modified organisms (GMOs). The national scheme will be established by Commonwealth, State and Territory legislation.
3.2 What does the Gene Technology Bill 2000 do?
The Bill does six key things. It:
- establishes a statutory officer, the Gene Technology Regulator (the GTR) to administer the legislation and make decisions under the legislation;
- establishes a scientific committee, an ethics committee and a community committee to advise the GTR and the Ministerial Council on gene technology;
- prohibits persons from dealing with GMOs (e.g. research, manufacture, production, commercial release and import) unless the dealing is:
- a notifiable low risk dealing (that is, contained research work which has been demonstrated to pose minimal risk to workers, the general public or the environment);
- on the Register of GMOs; or
- licensed by the GTR.
- establishes a scheme to assess the risks to human health and the environment associated with various dealings with GMOs, including opportunities for extensive public input;
- provides for monitoring and enforcement of the legislation; and
- creates a centralised, publicly available database of all GMOs and GM products approved in Australia (the Record of GMO and GM product dealings).
(a) The Gene Technology Regulator
The legislative scheme will be administered by the Gene Technology Regulator(GTR). The GTR will:
- be an office holder with significant independence – similar to the Auditor- General and the Tax Commissioner;
- be appointed by the Governor-General only with the agreement of the majority of all jurisdictions;
- administer the legislation and assess any risks posed by GMOs;
- inform and advise other regulatory agencies, States and Territories and the public about GMOs and GM products;
- promote harmonised risk assessments for GMOs and GM products by regulatory agencies;
- monitor and enforce the legislation; and
- report to Parliament annually, and at any other time such a report is warranted, and will copy any such report to the States and Territories.
(b) The Committees
The legislation establishes three key advisory groups to assist the GTR and the Ministerial Council on Gene Technology:
- The Gene Technology Technical Advisory Committee (the scientific committee) will replace the current Genetic Manipulation Advisory Committee (GMAC). The committee will provide scientific and technical advice to the GTR or the Ministerial Council on matters including: gene technology, GMOs and GM products, and applications made under the legislation.
- The Gene Technology Community Consultative Group (the community committee) will be a broadly based consultative committee established to provide views to the Ministerial Council and the GTR on: community concerns regarding gene technology and the need for, and content of, policy guidelines and codes of practice to the development of the procedural and policy documents which will guide the GTR’s decision-making.
- The Gene Technology Ethics Committee (the ethics committee) will provide advice to the GTR and the Ministerial Council on the ethics of gene technology, appropriate ethics guidelines and any necessary prohibitive directives.
(c) The prohibitions
- The legislation will regulate all ‘dealings’ (e.g. research, manufacture, production, commercial release and import) with live viable organisms that have been modified by techniques of gene technology, including the progeny (or descendents) of such GMOs which also share a genetically modified trait.
Growing crops and animals (including fish) that have been genetically modified; and laboratory research involving the genetic modification of animals, plants, bacteria and viruses.
- The legislation will also regulate some GM products, but only where the products are not regulated by an existing agency. On the whole, GM products are already regulated by agencies such as the TGA (therapeutic goods) and ANZFA (food products). The GM products which are not already covered by an existing national regulation scheme will be regulated by the GTR under the new legislation. An example is stock feed derived from a GM crop such as cotton.
- The legislation revolves around a system of prohibitions and approvals. Every dealing with a GMO will need to be licensed by the GTR, unless the dealing is an exempt dealing, a notifiable low risk dealing or on the Register of GMOs.
- Exemptions – where the GTR is confident that a certain dealing involves a very low risk, the class of dealing with the GMO will be recorded in the regulations as exempt (e.g. contained research involving a very well understood process for creating and studying a GMO). This will mean that no licence is required, provided that the activity remains within the specified parameters. There will be no exemptions for any release of a GMO into the environment (e.g. field trials and commercial releases). This reflects the current approach under the GMAC system.
- Notifiable low risk dealings – the regulations will also set out categories of dealings with GMOs which are very low risk and which may proceed provided that certain conditions spelt out in the regulations are observed. This will include requirements that the specified dealings be undertaken only in contained facilities, overseen by Institutional Biosafety Committees and notified to the GTR. These will be similar to “class licences” and the conditions under which such dealings will operate will be clearly set out in the regulations.The Bill does not allow dealings which involve the intentional release of a GMO into the environment to be prescribed as a notifiable low risk dealing.
- Licences – all dealings with GMOs (that are not exempt or low risk notifiable dealings) will need to be licensed by the GTR. The licensing system will be based on rigorous scientific risk assessment and extensive consultation with expert advisory committees, Government agencies and the public.
- Register of GMOs – dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time. Dealings will not be entered onto the Register until the GTR is satisfied that the dealings are sufficiently safe that they can be undertaken by anyone, and that safety does not depend on oversight by a licence holder.
(d) Risk assessmentTop of page
Taking a hypothetical case, such as an application for the field trial of a genetically modified crop, this is a summary of the steps that would be taken by the GTR to assess the application.
Stage 1 – The applicant provides the GTR with a full data package containing all information required by regulations and explanatory guidelines. For example, the applicant provides information about: the parent organism; the characteristics of the GMO (including the methods used for modification, the vectors used etc); the new traits of the GMO (including the stability of the new organism); any health impacts of the GMO (including any increased toxic or allergenic effects); the proposed release (including information about the receiving environment); potential environmental impacts; proposed monitoring techniques; methods or procedures to minimise the spread or persistence of the GMO; and contingency planning in the case of any unexpected effects of the GMO.
Stage 2 – The GTR undertakes a preliminary check of the information to ensure that all relevant information has been included in the application and makes an initial assessment of whether the activity may have a significant impact on the environment.
The GTR also checks to make sure that the application is consistent with policy principles. Policy principles are issued by the Ministerial Council, on the advice
of the ethics committee or the community group. If the application is inconsistent
with a policy principle (including any ethical guidelines issued by the Ministerial Council) or animal welfare legislation, the GTR must refuse to accept the application.
Stage 3 – If the GTR considers that the proposed dealing with the GMO may have a significant impact on the environment, the GTR calls for public submissions on the possible risks and means of managing the risks. The GTR would advertise in newspapers and in the Commonwealth Gazette, place notices on the GTR’s website, and direct-mail all persons on the GTR’s mailing list. The GTR also seeks advice on possible risks from the Commonwealth Environment Minister, the scientific committee, the States and Territories, relevant Commonwealth agencies and local councils.
Stage 4 – The GTR prepares a comprehensive risk assessment and risk management plan, based on the information provided by all parties and information generated by the GTR. In preparing the plan the GTR considers:
- advice from the scientific committee;
- information provided by State, Territory and local governments about any local or regional environmental issues;
- advice provided by the Commonwealth Environment Minister and State
- Environmental Protection Agencies;
- advice provided by health agencies, including the potential health effects of the GMO;
- advice provided by members of the public;
- the data provided by the applicant – if necessary, the GTR may also commission independent verification of such data;
- information generated by the Office of the GTR (including literature searches and any independent research conducted).
Stage 5 – For all releases of GMOs into the environment (both low risk and higher risk), the GTR conducts a round of public consultation on the draft risk assessment and risk management plan (which is a draft determination). Again, the draft risk assessment and risk management plan would be advertised in newspapers, on the GTR’s website, in the Gazette and direct-mailed to all interested persons. This second round of consultation enables public scrutiny of the draft decision to ensure that the GTR has taken into account all relevant matters and has undertaken a comprehensive assessment of the application.
Stage 6 – The GTR makes a decision on the application and if the application is approved, applies conditions to manage any risks. For example, conditions may be applied about where the crop may be grown, measures for limiting the spread of the GMO, how the crop must be disposed of and the type and level of monitoring of the crop that is required.
(e) The monitoring and enforcement of conditions
One of the benefits of a legislative scheme is the capacity to properly monitor activities involving GMOs and to enforce compliance, where necessary, with the conditions that the GTR imposes.
The GTR will:
- have the capacity to commission independent research to monitor any risks posed by GMOs;
- implement a range of monitoring activities which will vary depending on the level of risk posed by the proposed dealing (for example, the GTR may require regular reporting, auditing, routine inspections or a combination of these depending on the level of risk posed by the dealing and the history of compliance with the legislation);
- be able to appoint inspectors with significant powers to investigate suspected breaches of the legislation; and
- possess a broad range of enforcement powers, including the ability to issue directions, cancel or suspend approvals, seek injunctions and make reports directly to Federal Parliament.
(f) The central database of GMOs
The legislation establishes a centralised and publicly available database for the recording of all approvals of GMOs and GM products (the Record of GMO and GM Product dealings).
The database will include information about:
- all licences issued by the GTR, including details of the licence holder, persons covered by the licence, dealings authorised by the licence and licence conditions; and
- all notifications given to the GTR by other regulators about GM products approved for sale in Australia. For example, if the Therapeutic Goods Administration approves a genetically modified medicine for sale in Australia this must be entered in the database.