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Australasian Biotechnology (backfiles)
AusBiotech
ISSN: 1036-7128
Vol. 10, Num. 1, 2000, pp. 22-25
Untitled Document

Australasian Biotechnology, Vol. 10 No. 1, 2000, pp. 22-25

THE GM ISSUE - AGITATION AGAINST GM FOODS RISES AS BILL DEBATE BEGINS

Code Number: au00009

Protests and marches in city areas in Australia during March against genetically modified foods has highlighted the intensifying clash between those in favour and against the use of biotechnology to alter some of the characteristics of food. Increasing pressure in being placed on supermarket chains, food companies and governments to slow down or stop the sale of genetically modified foods.

Against this background, the new Gene Technology 2000 legislation will be shortly debated in the Federal Parliament.

The Interim Office of the Gene Technology Regulator (IOGTR) has released a draft Gene Technology Bill 2000, together with an explanatory guide, for public comment prior to the introduction of the Bill to Parliament in late March.

Draft regulations which will underpin the legislation are expected to be released soon.

The draft bill was prepared by the Commonwealth Office of Parliamentary Counsel during November and December last year, following consultation based on responses to the discussion paper, Proposed national regulatory system for genetically modified organisms - How should it work?, which was released in October.

The development of the legislation was overseen by central agencies such as Departments of Premier and Cabinet in most States and Territories and by the Commonwealth Department of Health and Aged Care.

In late February and March, the IOGTR, in collaboration with State and Territory officers, has been holding public consultations in every State and Territory which may lead to amendment of the Bill before it is tabled in Parliament.

The legislation targets GM products such as stock feed and cotton trash which are not currently covered by regulatory agencies such as the Therapeutic Goods Administration (TGA) and the Australia New Zealand Food Authority (ANZFA).

The objective of the legislation is to protect public health and safety and to protect the environment by identifying and managing risks posed as a result of gene technology through the regulation of certain dealings with GMOs.

It will regulate all 'dealings' (e.g. research, manufacture, production, commercial release and import) with live viable organisms that have been modified using gene technology, including the progeny of such GMOs which also share a genetically modified trait.

Examples of matters that will be regulated by the legislation include: the growing of crops and animals including fish that have been genetically modified; and laboratory research involving the genetic modification of animals, plants, bacteria and viruses.

The proposed regulatory system is based on three components:

    • exemptions, which will be similar to current GMAC exemptions which involve very low risk;
    • notifiable low-risk dealings, which may proceed provided certain conditions are observed; and
    • licences , which will be required for all other dealings with GMOs.

The licensing system will be based on scientific risk assessment and consultation with expert advisory committees, government agencies and the public, and will take into account matters of national interest and ethical issues.

The legislation will be administered by the Gene Technology Regulator (GTR), who will be appointed by the Governor-General on the advice of the Commonwealth Minister for Health with approval from a majority of States and Territories.

A Ministerial Council comprising one or more Ministers from the Commonwealth and each State and Territory will be established to provide broad oversight of the regulatory framework and guidance on matters of policy that underpin the legislation.

Two advisory groups will be established to advise the GTR: a Gene Technology Advisory Committee which will replace the current Genetic Manipulation Advisory Committee (GMAC) as the expert scientific body on GMOs; and a Gene Technology Community Consultative Group, a broadly-based consultative committee established to provide views to the Ministerial Council and the GTR on new technologies as they emerge, and on the development of the procedural and policy documents which will guide the GTR's decision-making.

It is also proposed that the Australian Health Ethics Committee of the NHMRC will be utilised, with some additional members (to include environmental ethicists and people with a specific knowledge of gene technology), to examine ethical issues and develop ethical guidelines connected to GMOs.

The public will be invited to comment on every application to the GTR where a release of a GMO into the environment is envisaged.

The GTR will have the capacity to commission independent research to monitor any risks posed by GMOs, and will implement a range of monitoring powers which will vary depending on the level of risk. Enforcement powers will include the ability to issue directions, cancel or suspend approvals, seek injunctions and make reports directly to Federal Parliament.

 

PINEAPPLE PROTEST

Protestors from a group known as 'Free Seed Liberation' staged Australia's first raid against a genetically modified plant experiment when they uprooted pineapples being grown at the Queensland Primary Industry's Agricultural Biotechnology Centre in Brisbane in March.

About 100 genetically modified pineapples were pulled out of the ground in the raid. The pineapples are being grown to clone a gene which causes the rotting disease in pineapples known as black heart. The attack has set the experiment back by a year. Security at the laboratory is being reviewed.

The Federal Government intends that the regulatory scheme will be operated on a full cost recovery basis, although there has been strong criticism of this from the research sector, industry and consumer groups. Detailed proposals for cost recovery are currently being developed.

As neither the Commonwealth nor the States and Territories have full legislative power to regulate gene technology, the States and Territories will have to enact their own legislation along similar lines to the draft Bill and an Intergovernmental Agreement will provide for a nationally consistent scheme overseen by the GTR.

The draft Bill and Explanatory Guide are available on the Internet at www.health.gov.au/tga/gene/genetech/ consult.html. The closing date for submissions was 10 March 2000. For further information contact the Interim Office of the Gene Technology Regulator on (02) 6270 4318.

Written comments on the proposed regulatory scheme can be submitted to them at: IOGTR, Mail Drop Point 54, PO Box 100, Woden ACT 2606 fax: (02) 6270 4310 email: iogtr@health.gov.au.

Queries and copies of these documents should be addressed to Neil Ellis, tel (02) 6270 4305, or Neil Smith, tel (02) 6270 4308.

SUMMARY OF LEGISLATION EXPLANATORY GUIDE

We reproduce below a summary of the legislation taken from IOGTR's Explanatory Guide.

Why legislate in relation to GMOs?

While the current administrative arrangements in relation to GMOs have been effective to date, the current system, like any system dealing with cutting edge technology, has to change to remain relevant not only to the science that it oversees but also to the industry that it regulates and the community it protects.

Three key developments necessitate change, and the development of legislation, at this time:

    • The emergence of "gap" GMOs - There is an increasing number of GMOs that are not regulated by existing regulatory agencies. For example, some microorganisms used to decompose toxic substances, ornamental plants modified to enhance particular characteristics and herbicide tolerant crops.
    • The move toward general (commercial) releases - To date in Australia only 3 general releases of GMOs into the environment have been approved. However a number of GMOs are currently the subject of research and are nearing the stage where proponents may seek approval for release into the environment. It is important that an appropriate regulatory system be in place to assess and manage any risks to public health or the environment posed by the GMOs.
    • Community and industry expectations of regulatory systems. As more GMOs are being developed in both research contexts and for commercial sale, both industry and consumers are demanding that there be a regulatory system in place that protects the community and the environment and is balanced, science-based, transparent, developed in close consultation with the community and industry and able to be monitored and enforced.
What are the goals of this regulatory system?

In summary, we are trying to achieve a national regulatory system that:

    • protects public health and safety and the environment by regulating those GMOs that fall between the 'gaps' of existing regulatory systems;
    • builds on the strengths of existing administrative arrangements for contained work with GMOs (the GMAC arrangements) by providing a statutory underpinning for these arrangements;
    • is based on the precautionary approach;
    • provides a clear path to market for those GMOs assessed to be safe;
    • is transparent;
    • is based on a scientific assessment of the risk combined with a consideration of broader issues of national interest and ethics;
    • provides ample opportunity for community involvement in decision-making;
    • is accountable to key stakeholders (including Parliament) and the public;
    • actively minimises the regulatory burden on the individuals and organisations who will seek to use the system;
    • harmonises risk assessments across regulatory agencies in relation to the genetic safety of GMOs and GM products;
    • establishes a regulatory process that is as objective as possible; and
    • is highly nationally uniform, efficient and effective.
What is the object of the legislation?
    • The object of the legislation is to protect the health and safety of people and to protect the environment by identifying and managing the risks posed as a result of gene technology through the regulation of certain dealings with GMOs.
    • Further explanation of the Object of the legislation is provided in Part 1.
What is the scope of the legislation - that is, what will the legislation regulate?
    • The legislation will regulate all 'dealings' (eg. research, manufacture, production, commercial release and import) with live viable organisms that have been modified by techniques of gene technology, including the progeny (or descendants) of such GMOs which also share a genetically modified trait.

Examples of matters that will be regulated by the legislation include: the growing of 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 regulate GM products only where they are not regulated by an existing regulatory agency. Most GM products are regulated by existing agencies such as the TGA (therapeutic goods) and ANZFA (food products). The GM products which are not already covered by an existing national regulatory scheme (so-called "gap products") will be regulated by the GTR under the new legislation.

Examples of "gap products" include: stockfeed and cotton trash.

    • For more information on the scope of the legislation please refer to Part 1 (definitions) and Part 4 (Regulation of dealings with GMOs).

How will the new legislation for GMOs interact with existing legislation?

The new system will operate alongside the existing regulatory systems. The need to minimise any duplication and harmonise requirements across existing agencies will be addressed in three ways:

    • By reducing overlap through careful crafting of the scope of this legislation (to ensure the GTR does not regulate products, or activities, that are the responsibility of other regulators);
    • Through close working relations and exchange of information - legislation will require the GTR to take into account advice of other agencies and they too will be required to take into account the advice of the GTR when considering applications for products that have been genetically modified. A range of administrative arrangements such as shared databases will also be implemented;
    • By harmonising risk assessment - one of the functions of the GTR will be to work with existing regulators to harmonise risk assessment on GMOs and GM products and harmonise data requirements in relation to genetic safety.

How will dealings with GMOs be regulated?

The legislation revolves around systems of prohibitions and approvals. Every dealing with a GMO (as defined in the Bill) will need to be licensed by the Regulator, unless the dealing is a notifiable low risk dealing or the dealing is an exempt dealing.

There are three components to the proposed regulatory system. These components are:

    • Exemptions - where the GTR is confident that a certain dealing (eg contained research involving a very well understood process for studying a GMO) involves a very low risk, the class of dealing with the GMO will be prescribed in the Regulations as exempt. This will mean that no licence is required provided that the dealing remains within the specified parameters. It is expected that all of the current GMAC exemptions will also be exempt under the new system.
    • There will be no exemptions for any dealing that involves a deliberate release into the environment (eg field trials and commercial releases).
    • 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 like "class licences" that are described in the Regulations.
    • The Bill does not allow dealings which involve the deliberate release of a GMO into the environment (eg a field trial or commercial release of a GMO) to be prescribed as low risk notifiable dealings.

    Licences - All other dealings with GMOs (that are not exempt or low risk notifiable dealings) will require licensing 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. The licensing system will also take into account matters of the national interest and ethical issues by building ethical issues into the system at a fundamental level - the point at which all new research is proposed. For more detail on the licensing system and the role of ethics please see specific questions below.

Who will administer the legislative scheme?

The legislative scheme will be administered by an independent statutory office holder - the Gene Technology Regulator or GTR. It is proposed that the GTR will have strong powers to regulate GMOs which will be derived from both the Commonwealth legislation and complementary State and Territory legislation. There will be only one GTR for the whole of Australia.

The GTR will:

    • be appointed by the Governor-General on the advice of the Commonwealth Minister for Health who must have approval for the recommendation from a majority of States and Territories;
    • report directly to Federal Parliament annually, and at any other time as required. The power to report directly to Federal Parliament on any matter is a significant power and one that is vested in a very limited number of statutory office holders;
    • manage his/her own monies as a part of a discrete fund; and
    • be responsible for making all decisions on individual licence applications with no political interference.

Who will oversee the Regulator?

A Ministerial Council comprising one or more Ministers from the Commonwealth and each State and Territory will be established to provide broad oversight of the regulatory framework and guidance on matters of policy that underpin the legislation.

In addition, the GTR will be accountable:

    • to the Federal Parliament (through annual reporting as detailed above);
    • under the Financial Management and Accountability Act 1997 for the management of the GTRs budget; and
    • to applicants, licence holders and the general public through clear, open and transparent decision making processes.
Who will advise the Regulator?

It is proposed that two key advisory groups be established to assist the Regulator:

    • The Gene Technology Advisory Committee will replace the current Genetic Manipulation Advisory Committee (GMAC) as the expert scientific body providing advice to the GTR on GMOs; and
    • The Gene Technology Community Consultative Group will be a broadly based consultative committee established to provide their views to the Ministerial Council and the GTR on new technologies as they emerge, and on the development of the procedural and policy documents which will guide the GTR's decision-making.
How will the ethical considerations be taken into account?

It is proposed that an ethics group be established to specifically examine ethical issues connected to GMOs. Rather than establishing a new committee, it has been suggested that the existing Australian Health Ethics Committee be utilised with some additional members (to include environmental ethicists and people with a specific knowledge of gene technology). This possibility is being explored.

The ethics group would develop ethical guidelines after comprehensive community consultation including consultation with the Gene Technology Community Consultative Group. The Guidelines would be endorsed and issued by the Ministerial Council. They would then be required to be observed by all people researching and developing GMOs. In fact an application for a licence to deal with a GMO could not even be accepted by the GTR if the proposed methodology was inconsistent with ethical guidelines issued by the Ministerial Council on the advice of the ethics committee.

How will the community have input?

Interested members of the community will be:

    • given the opportunity to make comment on every single application to the GTR where a release of a GMO into the environment is envisaged, whether that be a field trial or a new GMO or the general release of a thoroughly tested GMO. There will be a two stage public consultation - the first calling for comments on the application (excluding confidential commercial information) and the second calling for comments on the GTR's risk assessment and risk management plan (for more information refer to Part 6);
    • given a voice through the Gene Technology Community Consultative Group which will provide advice to the GTR and the Ministerial Council on matters of concern in relation to GMOs and on proposed policy guidelines (for more information refer Part 7);
    • invited to review a Register of all approvals (including conditions of those approvals) which will be maintained by the GTR (for more information refer Part 5);

Detailed proposals for the way that costs associated with the regulatory scheme will be recovered will be developed during the early part of 2000.

How will the national scheme be established?

As neither the Commonwealth nor the States and Territories have full legislative power to regulate gene technology, it is envisaged that the Commonwealth Bill will form one part of a co-operative national legislative scheme to regulate GMOs.

It is anticipated that States and Territories will enact their own legislation in similar terms to the Commonwealth Bill. It is also anticipated that an Inter-Governmental Agreement will be negotiated between Commonwealth, State and Territory governments. The Agreement will provide for the establishment of the nationally consistent scheme, the governance arrangements for the system and the arrangements for ensuring national consistency in legislation over time.The effect of the national scheme is that there will be one central national Regulator responsible for all aspects of the regulatory scheme.

The documents can also be viewed on the website www.health.gov.au/ tga/genetech.htm

Copyright 2000 - Australasian Biotechnology

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