Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 10, Num. 4, 2000, pp. 25-27

Australasian Biotechnology, Vol. 10 No. 4, 2000, pp. 25-27

GMOS AND MINING

MINING AND THE LEGAL ISSUES CONCERNING GENETICALLY MODIFIED ORGANISMS

K. Bristow & S. Clague

Corrs Chambers Westgarth, Melbourne and Brisbane

Code Number: au00044

ABSTRACT

Although a variety of biotechnological processes exist in the mining industry, they do not involve genetic modification technology. Whilst GM technology has the potential to be of great use to the mining industry and a greater focus on GM technology could be expected in future, the industry should be aware of the effect that public and environmental concerns surrounding the use of GM organisms may have on the decision to use such technology. Specifically, numerous regulatory requirements will need to be satisfied, each of which can create delays and add to the costs of adopting a technology involving GM organisms.

INTRODUCTION

The deliberate exploitation of biotechnology in the mining sector has a history going back at least to bacterial heap leaching of uranium in the early 1960s. The most commercially advanced biotechnologies at present relate to the biooxidation of refractory ores in the gold, copper, nickel and uranium mining industries, using strains of bacteria either to dissolve part of the ore to release the target metal, or to dissolve the target metal itself.

The biooxidation technologies that are commercially available for use at present do not use genetically modified (GM) bacteria. There are reasons for this that have nothing to do with law. Development of a new bacterial strain using classical techniques is relatively easy when compared with using similar techniques among higher organisms. An example of such a technique is selection, or “enrichment”, by exposing bacteria to physical or chemical conditions that are similar in key respects to the desired operating conditions, over many bacterial generations. To date, it has been difficult or impossible to transform some of the bacterial strains that are suitable for biooxidation technologies, such as Thiobacillus ferrooxidans, using genetic modification (GM) techniques. Where what is needed is a bacterial strain that differs from existing strains in biologically complex ways (such as having maximum growth and activity rates in a substantially higher temperature range), both classical and GM techniques are likely to be inadequate, and the only answer may be bioprospecting for a better species of bacterium.

Over time, practical difficulties to the use of GM techniques may be overcome. Although GM technology will then be more attractive from a technical viewpoint, the commercial success of the technology may be determined by the non-technical issues that arise from the use of GM organisms. For the mining industry, sensitive to perceptions of environmental and public health protection, this could be a politically charged issue.

The legal side of the GM debate is found in the regulatory regimes and requirements that apply to GM organisms. Regulatory regimes can impose substantial delays and costs and in some cases can be a major factor in determining whether or not a project is economically viable and successful. This article examines the GM regulatory regimes which apply in Australia and which are likely to have an impact on mining companies which are considering whether to license, or devote resources to researching, technology involving GM organisms.1

IMPORTATION

If a GM bacterial strain has been developed outside of Australia, it will need to be imported. Importation of viable bacterial strains requires an importation permit to be issued by the Australian Quarantine Inspection Service (AQIS). The permit application asks the applicant to indicate whether the material to be imported is a live GM microorganism. If the answer is yes, the applicant must supply certain technical information about the manner in which the GM organism was created.

AQIS will conduct a risk assessment of any viable bacterial strain to be imported. If the bacterial strain to be imported is a GM strain, AQIS may, when conducting this assessment and when considering whether to grant an importation permit, seek the expert opinion of the Genetic Manipulation Advisory Committee (see below for more details of GMAC). Whether AQIS does so will depend on, among other things, whether the GM strain has been imported into Australia before, the intended use of the GM strain, and AQIS’ initial assessment of the risks posed by the GM strain. A GM strain that is to be released into the environment is much more likely to be referred to GMAC for assessment than a GM strain that is to be used only for small scale, in vitro experimentation.

USE AND RELEASE

The Genetic Manipulation Advisory Committee (GMAC) is the expert scientific advisory body on GM issues in Australia and has issued several sets of guidelines for undertaking work with GM organisms. The GMAC Guidelines are not automatically binding as legislation. However, compliance with them is commonly a condition of receiving Commonwealth funding or receiving the benefit of R&D tax incentives, in relation to projects involving GM organisms. In addition, a failure to comply with substantive requirements in the guidelines could harm a company’s public image and could be used to support a claim of negligence.

Where a mining company is proposing to use GM bacteria in a closed bioreactor system (rather than, for example, using them in a heap leaching operation) the GMAC Guidelines indicate that the company should, among other things:

• have its facility inspected and certified by GMAC as being of a particular physical containment level, and have its manual of operating procedures inspected by GMAC, before commencing work with GM organisms;
• allow GMAC to inspect the facility and operating procedures at any time;
• submit a proposal to GMAC providing details of a proposed project, seeking GMAC’s assessment and advice;
• submit evidence to GMAC, showing that the project presents no significant risk to occupational and public health or to the environment, in order for the facility to be certifiable as complying with “Good Industrial Large Scale Practice”;
• generate and maintain internal records of processes involving genetic manipulation, and medical records for the workers associated with the project, for a specified period of time;
• keep all viable GM organisms in a closed system and check the equipment used for propagating and harvesting such organisms regularly for integrity of containment;
• filter exhaust gases removed from the closed system in accordance with prescribed standards;
• test the “genetic characteristics” of the GM organisms used in the project regularly;
• notify GMAC as soon as possible of significant accidents or incidents that are directly attributable to work with GM organisms;
• notify GMAC immediately of any accidental release of GM organisms;
• appoint a Biological Safety Officer to undertake regular safety audits and supervise a regular testing program for appropriate pieces of equipment;
• establish an Institutional Biosafety Committee (IBC) consisting of people with a specified qualification, which must ensure that company staff are properly trained and informed; and
• provide resources for the IBC to undertake its duties adequately and ensure that adequate supervision by the IBC takes place.

Where a mining company proposes instead to conduct a project involving a deliberate or potential release of GM organisms into the environment, such as a heap leaching operation, additional procedures apply under the GMAC Guidelines. These include the following:

• prior to commencement of the project, the project will be widely publicised by GMAC and there will be a 30-day period in which the public may comment;
• where GMAC considers that the proposed project is likely to have a significant effect on the environment, it will refer the matter to the Minister for the Environment, who may require the preparation of an environmental impact statement or a public environment report;
• the company must notify GMAC as soon as possible if, in the case of a deliberate release, unexpected results arise, such as a possible risk to human health or to the environment; and
• the company must notify GMAC as soon as possible if, in the case of a project involving a potential for release, such a release occurs, or there is any other unexpected problem or untoward incident.

Upon receiving appropriate information, GMAC may however exempt a project involving an intention or potential for release of GM organisms into the environment from the application of the GMAC Guidelines, if the organisms in question are to be inactivated prior to the intended or potential release.

The Gene Technology Bill 2000 which is currently before Federal Parliament will, if enacted, replace the existing non-legislative regime with a new compulsory regime, commencing January 2001. The legislation will provide a mechanism for legal enforcement in all cases, not only where a Commonwealth-funded project or an R&D tax incentive is involved. In practice, it is expected that the proposed regime will be similar in substance to the requirements of the existing GMAC Guidelines.

One difference between the existing and proposed regimes which has received considerable media attention relates to the involvement of the Minister for the Environment. Under the current regime, GMAC must refer a matter to the Minister where it considers that a proposed project is likely to have a significant effect on the environment. As a matter of practice, GMAC refers each proposed “general release” of a GM organism to the Minister, as well as certain other proposed projects which it perceives to involve a particular risk or matter of public concern. GMAC will accept, refuse, or accept only subject to conditions, the proposed project, in accordance with the Minister’s advice. Under the proposed regime, the newly established Office of the Gene Technology Regulator (OGTR) must seek the advice of the Minister in relation to all proposals to release a GM organism into the environment. The OGTR is not however bound by the advice of the Minister, although it must take the Minister’s advice into account when deciding whether to permit the proposed release.

ENVIRONMENTAL PROTECTION AND MINING LEGISLATION

Under State and Territory mineral resources and environmental legislation, a proposal to establish a biooxidation operation involving the use of GM microorganisms may require assessment of the environmental impact of the operation and strategies for minimising the risk of environmental damage.

As an example, the Queensland Mineral Resources Act 1989 allows the Minister for Mines and Energy to require an applicant for a mining lease to prepare an environmental impact statement (EIS) in relation to the proposed mining project’s environmental impacts. Given public sensitivity to the use of GM organisms, it seems likely that the Minister would require the applicant to prepare an EIS for a new project involving the use of GM microorganisms. This would seem particularly likely if the project involves releasing the GM microorganisms into the environment, as with a heap leaching operation.

In addition, whether or not an EIS is required, a mining lease can only be granted if the Minister approves the environmental management overview strategy (EMOS) that must be lodged with the application for the lease. The EMOS must specify strategies for protecting the environment and managing environmental impacts (such as those identified in an EIS), and for progressive and final rehabilitation of the land.

The Minister may decide only to grant the mining lease subject to conditions which the Minister considers necessary, such as to address the environmental impacts of the project. Such a condition may, for example, require the lease holder to take specified precautions and to provide monetary security to ensure the leaseholder rectifies any environmental damage.

If a biooxidation operation were to be established at an existing mine in Queensland, the leaseholder would probably need to seek a variation to the plan of operations for the mine. If so, the leaseholder would also have to submit an environmental audit statement about the plan as amended, stating how it is consistent with the EMOS. Where a GM bacterial strain is involved, it is possible that the Minister may refuse the variation, or accept it only on the condition that the leaseholder take certain precautions and deposit extra security (that is, in addition to the security deposited when the mining lease was granted).

TRANSPORTATION

Transport of “dangerous goods” is regulated by State and Territory legislation, which incorporates the classifications and handling requirements contained in the Australian Dangerous Goods Code (ADG Code). Generally speaking, GM microorganisms are classified as a dangerous good², and accordingly the ADG Code contains a number of requirements in relation to their transportation. (Additional, more stringent requirements apply to microorganisms that are toxic or infectious.)

The key requirements are summarised below:

• Packaging: The GM microorganisms must be transported in three layers of packaging, at least two being watertight, with enough absorbent material between the primary receptacle and the second layer of packaging to absorb the entire contents of the primary receptacle. The packaging must be of a design type which has successfully passed prescribed performance testing.
• Labelling: The packaging must bear appropriate packaging performance and specification markings, as well as labels that are appropriate to the particular microorganisms it contains.

Additional requirements apply to a vehicle carrying GM microorganisms “in bulk” (that is, in containers that are individually greater than 450 litres or 400 kilograms) or carrying GM microorganisms in containers that are in aggregate more than 1,000 litres or kilograms. In such circumstances, the following requirements apply:

• Placarding: The vehicle must bear the prescribed placards that are appropriate to the risks posed by those microorganisms.
• Clean-up insurance: The vehicle must be covered by a policy of insurance or other form of indemnity in respect of, among other things, the costs that would be incurred by or on behalf of a government authority in a clean-up resulting from leakage or spillage of the GM microorganisms from the vehicle. The amount covered by this insurance policy or indemnity must be at least $1 million per event (at least $2.5 million per event if the GM microorganisms are being transported in bulk).

EXPORT

When deciding whether to research and develop a mineral processing technology involving GM organisms, an important consideration may be the attitudes to GM technology of the countries in which potential customers of the technology are located. In some cases, restrictions on import of GM organisms may be limited to agricultural produce. In other cases, the restrictions may be wider but an approval or exemption process may be available. The impact of such policies and the delays encountered in going through such processes should at least be taken into account when assessing the potential market for a technology, before time and money are spent developing it.

CONCLUSION

There are numerous regulatory requirements which apply to the use of GM organisms. Often these requirements do not apply, or apply only in a limited way or in particular circumstances, to the use of organisms that are otherwise identical but were not created using GM technology. This distinction can sometimes seem arbitrary³. The consequence of these regulatory requirements is that, if there are non-GM alternative processes available, the delays and costs involved in complying with the GM-specific requirements is a serious factor to be taken into account by mining companies (in addition to the general public concern with GM technology) when deciding whether to obtain a licence of, or conduct research, into GM technologies, and when planning how to implement that decision.

Keir Bristow is a lawyer in Corrs Chambers Westgarth’s Intellectual Property practice group. He can be contacted by e-mail to the following address: Keir_Bristow@corrs. com.au. Stuart Clague is a lawyer in Corrs Chambers Westgarth’s Planning, Environment and Local Government practice group. He can be contacted by e-mail to the following address: Stuart_Clague@corrs.com.au.

1. For simplicity, this article will assume that the GM organism involved is a strain of bacterium.

2. Under the ADG Code, “genetically modified microorganisms ... which could alter animals, plants, microbiological substances and ecosystems in such a way as cannot occur naturally” are categorised as dangerous goods, unless consent has been obtained for deliberate release of such microorganisms into the environment. This definition is ambiguous in several respects, however, it is probably safest to assume that it was intended to be interpreted broadly. Where permission to release GM microorganisms has been granted, an examination of the specific terms and conditions of that permission may be necessary to determine whether or not the GM microorganisms are a dangerous good for the purpose of transport to the site where they are intended to be released.

3. As an example, T. ferrooxidans experiences a high level of mutation as a result of naturally occurring “insertion sequences” which insert into the bacterial genome, potentially altering or disrupting gene function, and later excise themselves, seemingly at random. If it were possible somehow to identify and “freeze” one or more desirable mutation which resulted from insertion sequences naturally inserting themselves into genes, without using GM technologies, a bacterial strain which carried such mutations would probably not be considered to be GM and as a result would not be subject to the same regulatory requirements as a bacterial strain containing mutations with similar effect but created as a result of the use of GM techniques.

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