Environmental issues raised by the release and use of genetically modified plants and animals in Australia
Environment Australia, December 1999
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The Secretary of Environment Australia was requested by the Secretary to the House of Representatives Standing Committee on Primary Industries and Regional Services (HRSCPIRS) to present a submission to the Parliamentary Committee addressing "the environmental issues raised by the release and use of genetically modified plants and animals in Australia".
The HRSCPIRS Inquiry is clearly concerned with 'access' to those varieties of plants and animals that are used for agricultural primary production. These generally comprise varieties of 'higher' plants that are used for crop production, pastures, horticulture and silviculture (eg cotton, canola, wheat, pasture grasses, eucalypts), and 'higher' animals used for livestock production or in aquaculture (eg cattle, pigs, fish, prawns). The Terms of Reference of the Inquiry do not extend to the consideration of organisms used to protect plant and animal varieties grown for produce, eg viruses, bacteria, and fungi used in pest or disease control.
Our submission is therefore restricted to environmental issues associated with the release and use of genetically modified (GM) 'higher' plants and animals used for primary production. Most examples will be drawn from plants, as these comprise nearly all GMOs currently under development for commercial release in Australia. Use of gene technology and release of genetically modified organisms (GMOs) in the control of pests or diseases (eg Pseudomonas fluorescens, Nucleopolyhedrosis Virus), or in the environmental management, mining and energy sectors, are outside the scope of this inquiry into primary producer access to gene technology. Consequently, our submission will seldom refer to environmental issues raised by release and use of GMOs in pest or disease control or in 'environment biotechnology'.
The scope of the term 'genetic modification' used in this submission is consistent with the draft scope of Australia's future national framework for the statutory regulation of GMOs. This is the scope intended for legislation that will underpin the proposed Office of the Gene Technology Regulator (OGTR). The government's intention to establish the OGTR was announced on 11 May 1999, and the legislation is currently being drafted.
Thus, we apply the term Genetically Modified Organism (GMO) to describe an organism that has been modified by techniques of genetic modification, or derived or developed from such an organism, but does not include a human. An Organism is further defined as a biological entity capable of reproduction or of transferring genetic material (and includes a microorganism). Genetic Modification refers to the altering of the genetic material in an organism by a way that does not occur naturally (for example through processes such as mating or natural recombination or both).
There is already statutory regulation of some GMOs and their products under a complex matrix of Commonwealth statutory instruments (Attachment A) and non-statutory processes. Administering agencies of the most relevant statutory controls are the Australia New Zealand Food Authority (ANZFA), the Therapeutic Goods Administration (TGA) in the Health portfolio, and the National Registration Authority (NRA) and the Australian Quarantine Inspection Service (AQIS) in the Agriculture, Fisheries and Forestry portfolio.
In May the government announced that it would develop an enforceable regulatory system for gene technology that would fill gaps in regulation and address public concerns about safety and ensure that there is no threat to human health or the environment. The present largely voluntary system for controlling the release and use of GM plants and animals used in the open environment in agriculture ('agricultural GMOs') and other GMOs not presently regulated is administered by the Interim Office of the Gene Technology Regulator (IOGTR) in the Health portfolio. The IOGTR functions will be replaced by a consistent national statutory system administered by the Office of the Gene Technology Regulator (OGTR) under new legislation.
This new system is to operate in close collaboration with and complement excisting systems for regulating food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods. New legislation is being developed to cover gaps in the coverage of excisting regulatory authorities.
The EA Submission will not deal in any detail with regulation of the safety of GMOs and their products by the Interim OGTR and already excisting regulatory agencies, because the Standing Committee will doubtless receive their detailed submissions. Nor will we address government policy on the regulation of gene technology to the extent already determined. However, we will comment on regulatory matters yet to be resolved or determined.