2.1 What is gene technology?
For over 100 years, we have been using techniques for altering the properties (or genes) of living things through methods such as selective breeding, plant cloning or grafting and the use of microbial products in fermenting. The principle of altering various organisms is not new but gene technology provides new methods for doing so.
Gene technology is, in many ways, more precise than previous techniques and allows, for the first time, transfer of a single gene from one organism to another. It involves modifying organisms by adding or deleting one or more genes to create or change specific characteristics. Organisms created using gene technology are often called “genetically modified organisms” (GMOs). Some people also call them “genetically manipulated organisms” or “genetically engineered organisms”.
2.2 How is gene technology used?
Gene technology has a wide range of applications including:
- In research, for example, basic research in biology and medicine with microorganisms and animals;
- Agricultural applications , for example, genetic modification of crops to incorporate pest resistance or herbicide tolerance, or the slowing of the ripening process in fruit and flowers;
- Production of therapeutic goods, for example, the modification of microorganisms to produce products such as insulin;
- In medicine, for example, the identification and treatment of genetic disease;
- Bio-remediation, for example, using micro-organisms to decompose toxic substances and clean-up industrial sites or environmental accidents; and
- Industrial uses, for example, producing enzymes for use in paper pulp production.
2.3 What are the potential benefits of gene technology to Australia?
Supporters of gene technology identify a range of potential benefits from applications of gene technology in relation to agriculture, health and the environment:
- Some agricultural benefits include:
- higher productivity and yield leading to lower or stable prices for consumers;
- more efficient use of agricultural and veterinary chemicals;
- savings in energy inputs to farm production;
- recovery of degraded land; and
- reduced use of chemical sprays, with less exposure of farm workers.
- Some health benefits include:
- using gene technology for research into the cause of diseases, as a diagnostic tool and for preventing and treating diseases;
- improved biopharmaceuticals (including cytokines, enzymes, hormones, monoclonal antibodies, blood coagulation factors, and vaccines) with advantages such as improved efficacy, greater availability, cheaper production, reduced allergenicity and reduced risks of transmission of infectious agents; and
- potentially safer food with fewer food contaminants, allergens and natural toxic compounds.
- Some environmental benefits include;
- lower use of chemicals/pesticides, reduced ground water contamination, reclaiming of polluted or salt-affected land;
- higher agricultural productivity reducing the need for land clearing, thus protecting biodiversity;
- producing biodegradable plastics and biodiesel; and
2.4 What are the potential risks of the technology?
The very characteristics of gene technology which produce many of the benefits (such as the ability to introduce genes from one species into a different species) are also those that cause concerns in the community. These concerns are related to potential unintended effects on the health of people or the environment.
Possible risks identified to date include:
- higher risks of allergic reactions to genetically modified food;
- unknown long term consequences that we may not be able to reverse or fix once the GMO is widely used;
- contamination of traditional or organic crops by neighbouring genetically modified crops;
- more agricultural chemicals used on genetically modified herbicide tolerant crops, possibly resulting in increased environmental damage;
- crops so strong that they become weeds or pests;
- GM animals such as pigs, which contain a growth hormone gene, escaping and becoming feral;
- effects of insect-resistant crops on non-target insects, such as butterflies; and
- transfer of genes for herbicide tolerance from GM crops to related species resulting in herbicide-resistant weeds.
2.5 Why is legislation needed for GMOs?
For the past 12 years, the use of gene technology has been overseen by the Genetic Manipulation Advisory Committee (GMAC). GMAC is a committee of experts (in fields such as molecular biology, ecology, plant genetics, agriculture and biosafety engineering) which reports to the Commonwealth Minister for Health. The system overseen by GMAC has no legislative backing; compliance with GMAC guidelines and GMAC recommendations is voluntary.
GMAC also plays an important role advising the existing regulators (such as the Therapeutic Goods Administration, the Australia New Zealand Food Authority and the National Registration Authority for Agricultural and Veterinary Chemicals) about the safety of GMOs as products (such as food, therapeutic goods and agricultural, veterinary and industrial chemicals).
While GMAC has provided reliable scientific advice about the risks posed by gene technology, and how to manage such risks, the system is not backed up by legislation. This means there is no legally enforceable way to audit or monitor the use of gene technology or penalise breaches.
Another important reason why legislation is needed is that the range of applications for gene technology is changing very rapidly. Certain GMOs are now being developed which do not fall neatly within the mandate of the existing regulators. Also, more GMOs are approaching the commercialization stage when the producers of the GMOs will be seeking to release the GMO into the environment, either for the purposes of field trials or for commercial release.
Examples of activities with ‘gap’ GMOs which are currently overseen by GMAC but are not regulated under existing legislation include:
- the growing of GM agricultural crops;
- the growing or breeding of GM animals or fish;
- the use of GM micro-organisms designed to decompose toxic substances (bio-remediation); and
- the use of GM viruses and GM vaccines.
To date, GMAC has provided advice directly to proponents on these ‘gap’ GMOs. However, as a result of the administrative nature of the GMAC system, governments have had limited capacity to either monitor proponents’ compliance with GMAC advice, or to enforce compliance with that advice.
The objective of the gene technology legislation is to protect the health and safety of people and to protect the environment by identifying risks posed as a result of gene technology and by managing those risks. It does this be creating laws for certain dealings (or activities) with GMOs.
The Government’s objectives also include:
- an efficient and cost effective approach regulating gene technology;
- continuing a science-based approach for risk assessment, but also including capacity for formal consideration of broader issues such as ethics;
- avoiding unnecessary duplication between the activities of the new GTR and existing regulators, and to generally improve the coordination between all regulators involved in the approval of GMOs and GM products;
- creating a more streamlined and certain pathway for industry seeking approval for GMOs and GM products that can be managed safely;
- enforceability of the arrangements for managing risk;
- greater transparency and accountability; and
- better ability to respond to stakeholder and community views.
2.6 Where did the ideas in the legislation come from?
For some time, public servants from the Commonwealth and all States and Territories have been working together to develop ways to regulate GMOs and GM products. This work has taken place through a group of Commonwealth, State and Territory officials - the Commonwealth State Consultative Group on Gene Technology (CSCG).
The Bill developed in four stages:
1. Policy principles to underpin the legislative scheme Top of page
In November 1998, a paper entitled Regulation of Gene Technology was circulated for limited public consultation. Officials traveled to each jurisdiction hearing views about the broad policy principles and some of the features of the system of regulation that people wanted. As a result of these consultations, the CSCG agreed a set of policy principles to guide development of the regulatory system.
2. Operational detail to inform the drafting of the legislation
On the basis of the agreed policy principles and the first round of consultation, officials worked together to fill in the details about how the regulatory system should work. They looked at what sort of legislation was appropriate, how decisions would be made, how GMOs would be regulated and how the public would be kept informed and be able to provide input to the scheme.
In October 1999, the discussion paper “Proposed national regulatory scheme for genetically modified organisms – How should it work?” was:
- advertised in a range of national, State and Territory and regional newspapers;
- made available to 2,500 individuals and organisations notified by directmail;
- provided to all MPs and Senators in Federal Parliament; and
- posted on the website of the Interim Office of the Gene Technology Regulator.
- Vice Chancellors of all Universities where research involving GMOs is conducted;
- all Institutional Biosafety Committees who currently oversee work with GMOs;
- all State/Territory Inter-Departmental Committees who are currently looking at issues related to GMOs including the proposed legislation;
- consumer groups, including the Australian Consumers Association and the Consumers Health Forum;
- environmental groups, including the Australian Conservation Foundation and Friends of the Earth;
- health professional groups, including the Australian Medical Association, and the Public Health Association of Australia;
- industry groups and companies, including the Australian Proprietary Medicines Association and AVCARE;
- retailers and food industry groups, including Woolworths, Goodman Fielder, and the Australian Supermarkets Association; and
- primary producer groups, including the Pork Council of Australia, the Australian Meat Council, Meat and Livestock Australia, State/Territory Farmers Associations, the Australian Poultry Industries Association, Australian Cotton CRC, and Dairy Farmers Associations.
received on the discussion paper.
Information received from face-to-face consultations and written submissions was invaluable for indicating the types of issues that individuals and organisations felt should be addressed by the legislation (as well as those that people felt should be addressed in different ways).
3. The draft Commonwealth Gene Technology Bill
On the basis of input provided by non-government stakeholders and the general community, as well as officers from Commonwealth agencies and States and Territories, a consultation draft of the Gene Technology Bill was prepared by the Commonwealth Office of Parliamentary Counsel during November and December 1999. The Bill was also prepared having regard to international precedents particularly in Canada, New Zealand, the United States of America and the European Community.
4. Consultation on the draft Commonwealth Gene Technology Bill
The draft of the Gene Technology Bill (green cover) was released, along with a plain language explanatory guide, for public comment in late December 1999. Invitations to comment on the Bill and attend public consultations were sent to 2,500 individuals and organisations. Advertisements were also placed in newspapers in all States and Territories inviting people to attend the public forums. Public forums were held in all capital cities and three regional centres (Albury-Wodonga, Tamworth and Rockhampton) during February and March 2000 to provide an opportunity to discuss issues.
The enormous interest in gene technology was reflected both in the number of people attending the forums, and in the valuable input we received. A wide range of interested parties provided written submissions including:
- consumer groups;
- environmental groups;
- organic Farmers;
- traditional Farmers;
- representatives of the agriculture industry;
- representatives of the gene technology industry;
- representatives of the food industry; and
- Commonwealth and State governments as well as local councils.
On the basis of these consultations, a number of changes were made to the draft Bill to reflect the issues and comments raised by the community. Where possible, this guide indicates those changes or where a re-think was necessary because of the strength of stakeholder sentiment about particular matters.
2.7 What happens now?
From July 2000 onwards:
The legislation will be considered by Federal Parliament. The legislation will be referred to a Senate Committee (the Community Affairs References Committee) for an inquiry into the legislation.
While the legislation is in Parliament, up-to-date information regarding the status of the legislation, and also details of the debates on the legislation, can be found on the Parliament House webpage.
In July 2000:
The government will release draft Commonwealth Gene Technology Regulations, to be made under the Gene Technology Bill 2000 when it becomes law.
People indicated that it is often difficult to understand how the legislation will work by simply looking at the draft Bill because a lot of the administrative detail is included in the regulations. An early draft of the regulations will therefore be made available for public comment.
The IOGTR will conduct national consultations on the draft regulations in late August 2000. The consultations will be advertised in newspapers in each jurisdiction and also on the IOGTR website and direct-mailed to all persons on the IOGTR/GMAC mailing list.
Between July 2000 and September 2000
Model State legislation will be released for public comment. The model state legislation will be substantially similar to the Commonwealth legislation (for more detail regarding the model State legislation please refer to Chapter 8).
The Gene Technology Intergovernmental Agreement which underpins the legislative scheme will also be released (for more detail regarding the Agreement please refer to Chapter 9).
Pending the passage of the legislation through Federal Parliament in 2000, the government expects that the new legislative system will be fully operational by 3 January 2001.
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