Gene Technology Bill 2000

2000

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

HOUSE OF REPRESENTATIVES

GENE TECHNOLOGY BILL 2000

EXPLANATORY MEMORANDUM

(Circulated by authority of the Minister for Health and Aged Care,

the Hon. Michael Wooldridge, MP)

ISBN: 0642 438692

GENE TECHNOLOGY BILL 2000

OUTLINE

This Bill represents a major component of a national scheme established by Commonwealth, State and Territory legislation 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 object of the Bill is to be achieved through a regulatory framework which:

(a) provides an efficient and effective system for the application of gene technology; and

(b) operates in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and genetically modified products (GM products) such as the existing schemes for the regulation of food, therapeutic goods, agricultural and veterinary chemicals and industrial chemicals.

Consistent with its object, the Bill:

(a) establishes a statutory officer, to be known as the Gene Technology Regulator (the Regulator), for the purposes of performing functions and exercising powers under the Bill;

(b) establishes three key Committees (the Gene Technology Technical Advisory Committee, the Gene Technology Ethics Committee and the Gene Technology Community Consultative Group) to provide scientific, ethical and policy advice respectively to the Regulator and/or the Ministerial Council established under an Intergovernmental Agreement on Gene Technology;

(c) prohibits persons from dealing with GMOs unless the dealing with the GMO is:

(i) exempt;

(ii) a notifiable low risk dealing;

(iii) on the Register of GMOs; or

(iv) licensed by the Regulator.

(d) establishes a scheme for the assessment of risks to human health and the environment associated with various dealings with GMOs which includes opportunities for extensive public input; and

(e) provides for a centralised, publicly available database of all GMOs and GM products approved in Australia (the Record of GMOs and GM product approvals).

FINANCIAL IMPACT STATEMENT

In the 1999 Budget, the Federal Government committed $7.6 million over 2 years for the

development of the gene technology legislation and the establishment of the Regulator. Once the Regulator is established, it is intended that the costs incurred by the Regulator as a result of fulfilling his/her functions under the legislation be 100% cost recovered from the users of the regulatory regime (for example, those seeking a license under this Bill). The fees and charges levied, in order to recover the costs of the regulatory system, will be prescribed in regulations made under this Bill and the Gene Technology (Licence Charges) Bill 2000. Regulations will be made following an independent analysis of the costs associated with the legislative scheme, extensive consultation with stakeholders and the preparation of a Regulation Impact Statement detailing the costs, benefits and impacts of the proposed charges.

REGULATION IMPACT STATEMENT

1. Background 1. Background

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Scope of this Regulation Impact Statement (RIS)

In early 1999, the Commonwealth Government agreed that:

§ a national regulatory system for the control of GMOs and the use of gene technology be developed to replace the existing administrative system;

§ the regulatory system would be managed by an independent statutory office holder (the Gene Technology Regulator); and

§ the Regulator would derive power from both Commonwealth and State and Territory legislation.

Given past Government consideration of alternatives to a national regulatory system, (including through consideration of relevant RISs), this RIS focuses on the costs and benefits of each component of the proposed regulatory scheme, as reflected in the Gene Technology Bill 2000. Government also provided some direction on various components of the scheme and where such direction was provided this has been noted in this RIS.

This RIS provides a high level of qualitative analysis about the costs and benefits of the proposed regulatory scheme. In the absence of much of the detail of the regulatory scheme (to be addressed in regulations) it has not, however, been possible to undertake a detailed quantitative costing of the scheme.

The Interim Office of the Gene Technology Regulator (the IOGTR), will be commissioning an independent analysis of the costs associated with the Commonwealth component of the regulatory system. The study will:

* provide a quantitative analysis of each of the components of the regulatory system as set out in the Bill and the draft regulations;

* include modelling of options for fees and charges to recover costs; and

* include an analysis of the expected throughput of the regulatory system in the first five years, to assist cost projections and cost-recovery modeling.

The independent costings of the scheme, the options for cost recovery and the proposed fees and charges (for inclusion in regulations made under the legislation) will be subject to extensive consultation with governments, industry and other stakeholders. This will occur before Government makes any regulations prescribing fees and charges in relation to the scheme.

Regulations prescribing the fees and charges (made under the Gene Technology Bill 2000 and the Gene Technology (Licence Charges) Bill 2000) will be subject to a separate RIS.

Separate RISs will also accompany the Gene Technology (Consequential Amendments) Bill 2000 and any Codes of Practice developed under the Gene Technology Bill 2000. Each State and Territory will be responsible for the production of a RIS in relation to the jurisdiction specific legislation to be developed in support of the Commonwealth Bill.

What is gene technology?

Gene technology involves the modification of organisms by the direct incorporation or deletion of one or more genes to introduce or alter a specific characteristic or characteristics. Organisms created using gene technology techniques are commonly referred to as "genetically modified organisms (GMOs). GM products are things (other than a GMO) derived or produced from a GMO.

There are a variety of applications of gene technology including:

§ research, for example, basic research in biology and medicine with micro-organisms and transgenic animals (primarily mice at this point in time, however, sheep are also used);

§ agricultural applications for example, genetic modification of crops to incorporate pesticide resistance or herbicide tolerance, or the slowing of the ripening process in fruit and flowers by inhibiting the action of certain genes;

§ production of therapeutic goods for example the modification of micro-organisms to produce therapeutic products such as insulin;

§ bio-remediation for example, the use of micro-organisms to decompose toxic substances and clean-up industrial sites or environmental accidents; and

§ industrial uses for example, the production of enzymes for use in paper pulp production.

A range of sectors currently utilise gene technology in Australia:

(1) for research and development purposes:

§ Universities and other public research institutes; and

§ State and Commonwealth agencies (such as CSIRO and State government agriculture departments).

(2) for commercial purposes:

§ Industry including biotechnology companies, pharmaceutical companies and agricultural companies; and

§ Primary Producers, currently for agricultural cropping, but potentially in relation to commercial stock ventures also. For example, in 1991 a company

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developed a pig with superior commercial qualities, in particular more rapid growth to sale weight and better meat characteristics.

What are the potential benefits of gene technology to Australia?

Proponents of gene technology identify a range of benefits to be derived from the various applications of gene technologies in relation to agriculture, health and the environment.

* Agricultural benefits

Proponents of gene technology believe that gene technology advances in primary production will allow Australia to maintain or improve existing production efficiency and thus maintain Australia's share of world markets, through:

§ increased productivity and yield leading to reduced 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 chemical sprays, with less exposure of farm workers.

While some of these benefits can be derived from the application of other technologies, gene technology is more precise than other conventional techniques (such as mutagenesis and some conventional cross breeding) and produces results more quickly than can be achieved through, for example, selective breeding. Gene technology therefore holds the potential to realise benefits more quickly and cost effectively than other techniques.

Gene technology also produces changes to the characteristics of agricultural products that are not possible through other techniques.

* Health benefits

The Australian health sector is already utilising gene technology as a diagnostic tool and for disease prevention and treatment as well as to conduct research into the cause of disease.

Biopharmaceuticals already in use in Australia, include cytokines, enzymes, hormones, monoclonal antibodies, blood coagulation factors, and a Hepatitis B vaccine. These GM products have advantages such as improved efficacy, greater availability, cheaper production, reduced allergenicity and reduced risks of transmission of infectious agents.

Biotechnology can also provide safer food. An example includes the reduction of food contaminants, allergens and natural toxic compounds in foods, minimising adverse health effects such as allergic reactions and food poisoning.

* Environmental benefits

Gene technology also promises benefits for the environment including:

§ reduced use of chemicals/pesticides, reduced ground water contamination, reclaiming of polluted or salt-affected land;

§ increased agricultural productivity reducing the need for land clearing, thus protecting biodiversity;

§ production of biodegradable plastics and biodiesel; and

§ bio-remediation.

What are the possible 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 concern in the community about the unintended effects the use of the technology may have on the health of the Australian community and the environment.

While the possible "costs" of gene technology vary considerably between types of GMOs and GM products, possible risks identified to date include:

§ increased health risks associated with allergenicity in genetically modified foods;

§ possible unknown long term or inter-generational consequences that may not be able to be adequately addressed once the GMO is widely used;

§ risk to Australia's capacity to maintain diverse farming practices because of the impact of contamination to traditional or organic crops through the use of genetically modified crops in surrounding areas (that is, increased monoculture in farming practices);

§ the impact of plants with disease resistance and herbicide tolerance on pest management;

§ increased use of agricultural chemicals associated with genetically modified herbicide tolerant crops resulting in increased environmental damage;

§ possible increase in the ecological competence of crop species and a resultant increase in the potential of those crops to become weeds or pests;

§ the potential for GM animals, such as pigs, containing a growth hormone

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gene to escape and become feral; and

§ the potential for the grazing behaviour of livestock containing a modified rumen bacteria (designed to detoxify poisonous plants which the animals might graze) changing the grazing behaviour of these animals such that they cause environmental damage.

In addition, there are broader, non-scientific concerns that have been expressed about the use of the technology including ethical, social and moral concerns relating to the impact of `humans playing God' by using gene technology.

How is gene technology currently regulated? How is gene technology currently regulated?

A range of GMOs and GM products are currently regulated in Australia:

§ Foods (including genetically modified or GM foods) are regulated under State and Territory Food Acts with the role of developing food Standards resting with the Australia New Zealand Food Authority (ANZFA) under the Australia New Zealand Food Authority Act 1991 (Cth).

§ Therapeutic goods (including genetically modified therapeutic goods) are regulated under the Therapeutic Goods Act 1989 (Cth), administered by the Therapeutic Goods Administration (TGA) within the Commonwealth Department of Health and Aged Care.

Human gene therapy (both clinical research and marketing of products for human gene therapy) is also regulated by the TGA. The National Health and Medical Research Council (NHMRC) also supervises research involving human gene therapy through its Gene and Related Therapies Research Advisory Panel (GTRAP).

§ Agricultural and veterinary (agvet) chemicals (including GM agvet chemicals) are regulated through a national scheme administered by the National Registration Authority (NRA). Regulation centres around the Agricultural and Veterinary Chemicals (Code) Act 1994 (Cth) and related legislation in all jurisdictions which controls the post-sale use of agvet chemicals.

§ Industrial chemicals are regulated through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth) and accompanying State/Territory legislation.

§ Imports/exports are regulated under the Quarantine Act 1908 (Cth), the Imported Food Control Act 1992 (Cth) and the Export Control Act 1982 (Cth) administered by the Australian Quarantine and Inspection Service (AQIS). The Australian Customs Service (ACS), under the Customs Act 1901 (Cth), has a general border control role which it undertakes with the assistance of AQIS. Other regulatory agencies also rely on the ACS to provide primary control of imports and exports.

The role of the Genetic Manipulation Advisory Committee

The Genetic Manipulation Advisory Committee (GMAC) is a non-statutory expert advisory body reporting to the Commonwealth Department of Health and Aged Care. GMAC's membership includes a wide range of experts in fields such as molecular biology, ecology, plant genetics, agriculture and biosafety engineering.

GMAC provides advice to the aforementioned regulators about the biosafety and environmental implications of GMOs. GMAC also receives advice and information from the other regulatory agencies and from Environment Australia.

In addition, since 1975, GMAC (and its predecessors, the Academy of Science Committee on Recombinant DNA and the Recombinant DNA Monitoring Committee) has scrutinised the development and use of novel genetic manipulation techniques in Australia.[1]

Each proposal (whether intended as a research and development project or for the commercial release of a GMO) is considered by GMAC on a case by case basis and judged on the individual merits of the application.

To February 2000, GMAC has assessed:

§ 5164 proposals for small scale contained work. Small scale genetic manipulation work is mostly directed at basic research in biology and medicine and is conducted within contained laboratories. Most small scale work is carried out by Universities and other research organisations.

§ 40 proposals for large scale contained work, such as the production of: hormones, growth factors and vaccines; enzymes for trials in patients with enzyme deficiencies; and enzymes for use in paper pulp production. Most large scale contained work is carried out by commercial organisations (38 of the proposals were from commercial organisations and 2 of the proposals were from Universities)

§ 236 proposals for field trials of GMOs. Most field trials have been for genetically modified plants, with the majority being for cotton or canola. The remainder were for micro-organisms such as bacteria, viruses and yeast. Most field trials are run by commercial companies (44%) or the CSIRO (37%). Of the remainder, 11% of the field trials have been conducted by Universities and 8% by State government agencies.

§ 8 applications for general (commercial) release of GMOs. Three of these have been approved to date: Bt cotton (which was subsequently regulated by the

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NRA); a violet carnation; and a carnation with improved vase life. In addition, the NRA has approved, with the advice of GMAC, the release of a genetically modified plant pesticide (in 1989) and a salmonella vaccine (in 1992).

What are the shortcomings of the current system of controls?

While GMAC has provided reliable scientific advice regarding any risks posed by the application of gene technology and how such risks should be managed, the major weaknesses of the existing system relate to the fact that as an administrative system there is: insufficient capacity for independent legally enforceable auditing and monitoring; insufficient capacity for the imposition of penalties or other action in the event of a breach; and inadequate transparency of decision making.

The problems with the current administrative system, and the necessity for the introduction of a legislative scheme at this time, are discussed in further detail in Section 2. Problems of this RIS.

What decisions have been made by governments about the future regulation of gene technology?

Given the potential risks to the environment and to human health and safety generated by the increased use of gene technology, State and Territory and Commonwealth Governments have been working together for a number of years, to identify options for improving the administrative system of controls over gene technology in Australia. Options examined include:

§ retaining a GMAC-style administrative system with some minor adjustments;

§ implementing a co-regulatory approach based on the observance of codes of practice and standards, developed cooperatively between industry and government; and

§ the implementation of a more comprehensive legislative system.

RISs were developed for each of these options and in late 1998 and early 1999, the Commonwealth Government (and a number of State and Territory Governments) endorsed the development of a national regulatory system of controls over GMOs and the use of gene technology. The national regulatory system was to comprise both Commonwealth and State and Territory legislation.

Given past Government consideration of alternatives to a national regulatory system, (including consideration of relevant RISs), this RIS focuses on analysing the regulatory impact of the Commonwealth component of the national regulatory system: the Gene Technology Bill 2000.

What does this legislative package propose?

The Bill forms a major part of a nationally consistent legislative scheme (relying on Commonwealth legislation and legislation in all States and Territories). The Bill is designed to protect the health and safety of people, and protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

Key components of the Gene Technology Bill 2000 include provisions which:

(a) Provide for the legislation to form part of a national legislative scheme, complemented by consistent legislation in each jurisdiction;

(b) Define the scope of the legislation. The legislation applies to:

* all dealings with GMOs (live, viable organisms that have been modified by techniques of gene technology); and

* dealings with GM products that are not regulated by existing regulators.

(c) Establish the Gene Technology Regulator as an independent statutory office holder with responsibility for implementing the legislation;

(d) Establish three key advisory Committees. The Gene Technology Technical Advisory Committee, the Gene Technology Ethics Committee and the Gene Technology Community Consultative Group will, respectively, provide scientific, ethical and policy advice to the Regulator and/or the Ministerial Council (comprising Ministers from each State and Territory and the Commonwealth and established under an Intergovernmental Agreement on Gene Technology) in relation to GMOs;

(e) Prohibit persons from "dealing with"[2] GMOs unless the "dealing" is:

* exempt.

* a notifiable low risk dealing;

* licensed; or

* on the Register of GMOs.

The type of regulation applied in relation to each of the categories is based on an assessment of the risks posed by the proposed dealing with a GMO.

(f) Provide for the certification of facilities to certain containment levels and the accreditation of organisations assessed by the Regulator to have a properly constituted and maintained Institutional Biosafety Committee;

(g) Establish a publicly available database of all approvals of GMOs and GM products in Australia;

(h) Establish comprehensive auditing, monitoring, inspection and enforcement

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powers that can be adapted to individual circumstances on a case by case basis; and

(i) Provide that approvals granted by GMAC prior to the date the new legislation takes effect will be recognised under the new regulatory system until such time as the prior approval expires, or for a period of two years after the date of effect of the legislation, whichever is sooner.

Each of the components of the scheme are addressed in more detail in Part 4 - Options and Impact Analysis of this RIS.

What are the estimated costs of the new legislative scheme?

Throughout the period of development of the new regulatory system for GMOs, and particularly since May 1999, States, Territories and the Commonwealth have recognised that it will not be possible to fully cost the regulatory system until:

§ the Commonwealth Bill is agreed by the Federal Government and the regulations under that Bill are developed;

§ the model State legislation is drafted; and

§ the Intergovernmental Agreement on Gene Technology, which underpins the legislative system and details the respective roles of the Commonwealth and States and Territories in the scheme, is entered into.

As detailed in Part 1 - Background of this RIS, the IOGTR will commission an independent analysis of the costs associated with the Commonwealth component of the regulatory system. The study will be conducted in two stages, over a period of seven months, with a real-time of approximately four months:

Part 1 will:

§ be conducted in the period April - May 2000;

§ be based on the Bill as agreed by the Federal Government and introduced into Parliament, and the draft Regulations released for public comment in April;

§ provide a quantitative analysis of each of the components of the regulatory system as set out in the Bill and the draft Regulations;

§ include initial modelling of options for fees and charges to recover costs; and

§ include an analysis of the expected throughput of the regulatory system in the first five years, to assist cost projections and cost-recovery modelling.

Part 2 will:

§ be conducted in the period July - August 2000;

§ refine the quantitative costs of the regulatory system, based on amendments to the Bill agreed by Parliament, and the final regulations; and

§ include final modelling of options for cost recovery, based on the analysis of expected throughput.

It is anticipated that the final report will be delivered in September 2000, at which time extensive consultation will be undertaken with governments, industry and stakeholders, regarding the proposed costings and levying of fees and charges. Regulations, including an accompanying RIS, will then be developed detailing the fees and charges regime.

2. Problem

GMOs and GM products present a range of possible health and environmental risks to the community. These risks vary depending on the particular activity proposed to be undertaken and the particular GMO or GM product.

While the level of knowledge about possible risks is growing in the community, there remains inadequate information available to the community and consumers. Individuals may also have difficulty in assessing and processing available information to help them make informed choices about what levels of possible risk they consider to be acceptable to their health and safety.

In addition, there are possible risks to public health and the environment that may not be properly taken into account by either the industry involved with GMOs or GM products, or the consumers, or users of GMOs or GM products.

There are difficulties in relying upon industry to provide the necessary information and make appropriate risk assessment and management decisions. This is because, in an objective aggregate sense, it may not be in their best interests to draw the possibility of risk to the attention of prospective consumers and the community generally. Equally, consumers might discount the usefulness of industry provided information on that basis.

There is, therefore, a case for government intervention to assess and manage the risks and to provide information to consumers and the community.

Given the growth in gene technology, the current government intervention is, however, inadequate.

When established, the GMAC administrative system was designed to deal with research into GMOs, or utilisation of GMOs, conducted within contained facilities.

Currently in Australia, the application of gene technology is quite different, as there has been an emergence of GMOs which do not fall within the legislative

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mandate of existing regulators. Also, there is an increasing shift from work being conducted in laboratories to GMOs being released into the environment either for the purposes of field trials or for commercial release.

The current system lacks credibility in meeting the broad concerns of the community about the risks posed by not having in place, sufficient mechanisms to ensure adequate openness and transparency in its risk assessment and management roles, nor sufficient enforcement capabilities. This lack of credibility (particularly in relation to the assessment and management of GMOs for release into the environment) may also harm the ability of industry to market GMOs and GM products assessed as safe. In addition, unnecessary costs may be generated through less than optimal coordination between regulators in the current system.

Activities with GMOs and GM products that are currently unregulated

Examples of `gap' GMOs which are currently overseen by GMAC under administrative arrangements but which are not regulated under any 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);

§ the use of GM viruses and GM vaccines.[3]

In addition, certain GM products (that is, things derived or produced from a GMO) also fall outside the mandate of existing product regulators. For example, stockfeed produced from genetically modified agricultural crops.

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 proponent's compliance with GMAC advice or to enforce compliance with that advice.

3. Objectives of Government action in this area

What are the objectives of Government action in this area?

The objective of Government action 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 through regulating certain dealings (or activities) with GMOs.

Against the Government's broad goal, and to address the shortfalls in the current regulatory arrangements, the Government's objectives are to:

§ pursue an efficient and cost effective approach;

§ continue a science based approach to the assessment of risks but including capacity for formal consideration of broader issues such as ethics;

§ avoid unnecessary duplication with existing regulators and provide for better coordination of the activities of all regulators involved in the approval of GMOs and GM products;

§ provide to industry a more streamlined and certain pathway for seeking and gaining approval to deal with GMOs and GM products that can be managed safely;

§ increase enforceability of the arrangements for managing risk;

§ achieve greater transparency and accountability; and

§ be more responsive to stakeholders and community views.

4. Options and Impact Analysis

This section sets out the various options for each of the key components of the Gene Technology Bill 2000. As numerous components of the Bill are examined, for ease of reference, an assessment of the impacts (including the costs and benefits of each option) has also been included in this section.

In terms of the impacts of the Bill and the scheme it will support, the groups most likely to be significantly affected by the initiative are:

§ government - including Commonwealth, State/Territory and local governments;

§ business - including large, medium and small commercial enterprises, universities and researchers and users of gene technology (including primary producers);

§ consumers; and

§ community members.

Options and Impact Analysis of key components of the proposed legislation

a) National scheme legislation

Option 1 - A co-operative nationally consistent regulatory scheme

It is anticipated that the Gene Technology Bill 2000 will be complemented by consistent legislation in each jurisdiction to form a national regulatory scheme. It is also anticipated that an Intergovernmental Agreement on Gene Technology (IGA) will be negotiated between the Commonwealth, State and Territory governments. The IGA will provide for the establishment of the

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nationally consistent scheme, the governance arrangements for the system and the arrangements for ensuring national consistency of the various pieces of legislation over time. The effect of the national scheme will be that there is one central national regulator responsible for all the day-to-day aspects of the regulatory scheme.

Option 2 - Discrete legislation in each jurisdiction

Each jurisdiction could enact discrete legislation regulating GMOs, effectively creating a gene technology regulatory body in each State and Territory. To provide some degree of national consistency, for example on the matter of standards, this could also be complemented by an IGA.

Option 3 - Commonwealth legislation

The Commonwealth could rely on its broad constitutional powers to enact legislation to regulate GMOs. While the Commonwealth could regulate all imports, activities by corporations or individuals engaged in interstate trade and commerce, there would be some `gaps' in constitutional coverage. Those `gaps' would include the dealings with GMOs by certain individuals, State departments and Universities who were not involved in co-operative arrangements with corporations, or in interstate trade and commerce. These `gaps' would either remain unregulated or would be subject to additional legislation enacted by States and Territories.

Impacts of Option 1 - A co-operative nationally consistent regulatory scheme

On Government - The overall costs to Australian governments of administering one centralised scheme are likely to be much lower than the costs of administering discrete schemes in each jurisdiction as economies of scale can be realised. The differences between jurisdictions (for example, unique flora or fauna) can be taken into account in the decision-making processes of the central Regulator to ensure that the unique environments in various Australian regions are protected. The IGA, underpinning the legislative scheme, will reduce the possibilities of inconsistent amendments being made to the complementary legislation in each jurisdiction.

On Business - A single national system will minimise costs to businesses that conduct activities across a number of jurisdictions, as they will only need to understand and comply with one set of rules, as opposed to different rules in each jurisdiction. Costs to businesses that only operate within one jurisdiction should also be reduced as the result of economies of scale being realised through the central administration of the scheme.

On the Community - Consistency of decision-making across Australia will provide greater protection of public health and safety and the environment and therefore lift public confidence regarding the use of gene technology in Australia. During consultations on the draft legislation, community members strongly supported a consistent national scheme. They considered it important that one standard for risk assessment of public health and safety and the environment be applied across Australia (taking into account any unique conditions in each jurisdiction) and that different standards should not be applied in different jurisdictions.

On Consumers - One of the potential advantages of minimising structural costs (and having one centralised national regulator) is to enable any cost-savings which may be generated through centralised regulation of GMOs to be passed onto consumers as lower prices.

Impacts of Option 2 - Discrete legislation in each jurisdiction

On Government - Overall costs would be higher as each jurisdiction would need to establish a regulatory agency. This would allow Governments in each jurisdiction to establish the level of protection demanded by their industry and constituents. This would be unlikely to be uniform and could easily mean that some GMOs considered safe for release in certain jurisdictions would not be considered safe in others. These impacts could, however, be reduced if Governments agreed to implement an IGA to underpin the legislation enacted in each jurisdiction and provide for some level of national consistency.

On Business - Significant costs and time delays would be incurred with business having to comply with differing requirements (for example, for data packages) and assessment processes in each jurisdiction. Different requirements in each jurisdiction could also lead to "forum shopping" by businesses who may seek to gain approval for GMOs in the jurisdiction with minimal (or least costly) regulatory requirements. As detailed above an IGA could mitigate some of these effects.

Impact of mutual recognition legislation - If an exemption for GMOs and GM products was made under mutual recognition legislation, the impact on businesses would be significant as approvals to sell GMOs or GM products would be needed in each jurisdiction. Costs would also be increased for supermarkets and businesses in the distribution chain, as a result of some products being allowed to be sold in certain States and not in others.

There could also be some labour force restrictions whereby a company or individual's licence to undertake dealings may not be transferable between jurisdictions. If the mutual recognition legislation operated in respect of GMOs and GM products, (enabling the sale of GMOs or GM products throughout Australia and the recognition of licences throughout Australia) the impact on business would be minimal. Given the commitment of jurisdictions to a national scheme at this time, it is not possible to project whether an exemption would

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be sought under mutual recognition legislation should this option be adopted.

On the Community - There would be no assurance of consistency of decision making across Australia. This could undermine the community's confidence in the quality of government regulation.

On Consumers - Aside from any increased costs which industry may pass on to consumers, the impact on consumers would depend on the operation of mutual recognition legislation. As detailed above, if an exemption for GMOs and GM products was made under mutual recognition legislation, the impact on consumers could be significant with products being available in some jurisdictions and not others.

Impacts of Option 3 - Commonwealth legislation

On Governments - If this approach is adopted, it would still be necessary for each State and Territory to introduce legislation to ensure complete coverage of all dealings with GMOs. This is because the Commonwealth does not have comprehensive constitutional coverage in respect of GMOs. As such the impacts detailed at Option 2 would also apply to this option.

On Business - If States and Territories did not legislate to fill the `gaps' in the Commonwealth coverage of dealings with GMOs, there would be potential for an `uneven playing field' to emerge as certain enterprises and research institutes would be caught by the Commonwealth legislation, while others might escape regulatory oversight entirely. Some businesses would thus continue to reach acceptable standards while others would not be regulated. Over time, this could produce distorted business practices and also endanger both the community and the environment as well as the good reputation of businesses involved in GM research and commercial activities. If States and Territories legislate to fill the `gaps' in Commonwealth coverage of dealings with GMOs, the same impacts on business that are identified at Option 2 would also apply to this option.

On the Community - Community confidence in the regulatory system could be reduced, given the `gaps' in coverage of the legislation. Refer to the impacts on the community in relation to Option 2, if States and Territories legislated to fill the `gaps' in Commonwealth coverage.

On Consumers - Refer to the impacts on consumers in relation to Option 2.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. The advantages over other options are that this Option:

§ increases national consistency of regulation;

§ provides a more streamlined and certain pathway for businesses seeking approval for dealings with GMOs;

§ minimises the costs of compliance to government and business that operate in more than one jurisdiction;

§ minimises inefficiencies and distortions in the market place as the result of differing levels of regulation in different jurisdictions; and

§ minimises discrepancies between jurisdictions and potential gaps or loopholes in legislative coverage that could further undermine community confidence in the safe management of GMOs.

b) Scope of the Act including interface with existing regulators

Option 1 - the Bill operates as a `gap filler' regulating all dealings with live, viable GMOs and also GM products not regulated by existing regulators.

The proposed Bill regulates all "dealings" (including research, manufacture, production, propagation, commercial release and import) with live viable GMOs that have been modified by techniques of gene technology, including the progeny (or descendants) of such GMOs which also share a genetically modified trait. This recognises that at present most of the "gaps" in legislative oversight exist in relation to dealings with live viable organisms[4]. Examples include laboratory research involving the genetic modification of animals, plants, bacteria and viruses and the growing of crops, animals and fish.

The legislation will also regulate GM products (non-live or non-viable products) where they are not regulated by an existing regulatory scheme. This recognises that most GM products are regulated by existing regulatory agencies (for example, GM medicines, foods and chemicals) but that there may be some products that are not currently regulated (for example, stock feed).

Option 2 - The Bill creating a `super-regulator' or `one stop shop'

Under this approach, the legislation would establish a `one stop shop' for the regulation of GMOs and GM products. All GMOs and GM products would be comprehensively regulated by a single agency regardless of whether the GMOs or GM products were also therapeutic goods, foods, agricultural and veterinary chemicals or industrial chemicals.

Impacts of Option 1 - the Bill as a `gap filler'

On Government - This option recognises the roles of each of the existing regulators and the desirability of assessing GM products along with their non-GM counterparts under the relevant regulatory framework . For example, GM therapeutic goods are most appropriately assessed for safety, quality and efficacy under the therapeutic goods scheme, with advice on the genetic safety of the medicine being provided by the Regulator.

The Regulator will act as a centralised area of expertise on genetic safety and

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will make advice available to other regulators of GM products. This reduces costs to government by eliminating the need for each regulatory agency to establish a centre of expertise on gene technology. There will, however, be some cost to government as a result of the need for the regulatory agencies to work closely together to harmonise requirements in relation to the assessment of risks posed by gene technology.

On Businesses - In some cases, businesses will require approval from a number of regulators in order to market a GM product. For example, GM crops will be regulated as they are growing in the field by the Regulator and also by ANZFA if they are intended to enter the food chain. Additional costs could be incurred by industry if data requirements and assessment of genetic safety is not harmonised between the Regulator and existing regulators. A number of mechanisms have been utilised in this Bill and the Gene Technology (Consequential Amendments) Bill 2000[5] to create a system that is as seamless as possible, thereby minimising compliance costs to industry. For example, the legislation requires:

§ exchange of information between regulators;

§ the Regulator to hold a centralised database of all approvals for GMOs and GM products; and

§ the Regulator to work with other agencies to harmonise data requirements, assessment and standards in relation to risks posed by gene technology.

The legislation also enables pre-approval conferencing between the proponent and relevant regulators to improve understanding of the regulatory requirements and reduce duplication of effort.

On the Community and Consumers - This option ensures that all aspects of production, manufacture, sale etc of GMOs and GM products are regulated and that there are no `gaps' in regulatory coverage. The system also ensures that the Regulator either directly regulates, or provides advice to other regulators, on all GMOs and GM products. Furthermore, the Regulator will establish a comprehensive database of all GMOs and GM products. During consultations, community members expressed the importance of a comprehensive regulatory system being able to provide a high level of re-assurance to the community, that any risks posed by the use of gene technology are properly assessed.

Impacts of Option 2 - The creation of a `super-regulator' or `one stop shop' for the approval of all GMOs and GM products.

On Government - The establishment of a `super-regulator' would require significant time and resources to reform all of the existing national regulatory schemes. This is not a simple process as each of the schemes depends on legislation at the Commonwealth level and in States and Territories. In addition, the skills which already exist within the TGA, ANZFA, NRA, NICNAS and AQIS would need to be duplicated, at least to some extent, in the new `super-regulator' for GMOs. The uncertainty associated with wholesale changes, may also generate unforeseen costs as the result of de-stabilising the operations of the existing regulators.

On Business - The benefits of the `super-regulator' would lie primarily in the more streamlined approach to GMOs and GM products under which an approval would only be required from one regulator. This would deliver some benefits by reducing the time taken to assess at least some GMO applications and data packages. The disadvantage would be that GM products would be assessed entirely separately from their non-GM counterparts even when the effect of the genetic modification was minimal. This could lead to significant discrepancies in the costs of compliance (and hence, costs of marketing) between GM products and their non-GM counterparts. Complete reform of existing systems and the establishment of a `super-regulator' would also take considerable time, meaning that the existing administrative processes would remain in place for considerably longer period of time.

On the Community - A `super-regulator' may provide more transparency and certainty for community members who have serious concerns regarding gene technology. Community concerns and input about the impacts of GMOs on human health and safety and the environment could have maximum effect as they would be focused into a single system.

On Consumers - As a result of the differing regulatory treatment of GM products and their non-GM counterparts, there may be distortions in the market place manifested in inconsistent pricing of like products.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. The advantages of this option are that it:

§ recognises the role of existing regulators and ensures that any live and viable GMOs are directly regulated by the Regulator and that any GM products that are not regulated by existing agencies are regulated by the Regulator;

§ ensures that like products are treated in a similar way (reducing market distortions) while also ensuring that any risks posed by gene technology are considered in all cases;

§ minimises duplication by implementing strategies to improve the

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interface between regulators; and

§ can be implemented without delay.

c) Management of the gene technology scheme

In early 1999, the Federal Government considered a number of alternatives relating to the management of the scheme including the establishment of a statutory office holder, a statutory board or ongoing management of the scheme by GMAC. A RIS was prepared on these issues for consideration by Government.

On the basis of the information available, including the RIS, Government endorsed the establishment of a statutory office holder. It was considered that a statutory office holder who reported directly to Parliament, is the final decision maker on individual applications, is responsible for a discrete fund of monies and is responsible for regular public reporting, would:

§ provide a high level of independence, transparency and accountability; and

§ not incur the level of costs associated with a statutory board flowing from the need to frequently bring together a group of officials to make decisions and delays resulting from the greater potential for disagreements on matters of everyday administration.

As a government decision has already been taken on this issue, the impacts of alternative options are not explored in detail in this RIS.

d) Provision of expert advice to the Regulator to inform decision-making

Option 1 - The establishment of a Gene Technology Technical Advisory Committee, a Gene Technology Community Consultative Group and a Gene Technology Ethics Committee to provide expert advice to the Regulator and the Ministerial Council overseeing the national legislative scheme.

Option 2 - The Regulator seeks expert and community advice on an ad hoc basis through, for example, forums rather than through the establishment of statutory committees.

Impacts of Option 1 - Establishment of a range of expert Committees

On Government - Significant resources, including a well-staffed secretariat, will be required to establish and service the Committees. The major advantage of the expert Committee structure is that it would enable the Regulator to access necessary advice to inform decision-making and the development of policy to underpin the regulatory system. This improves the rigour, transparency and accountability of the system and ensures that it remains fully cognisant of community views and the latest scientific developments.

On Business - As the system is proposed to be cost-recovered from the users of the system (applicants and licence holders), industry will bear the costs of establishment and operation of the Committees. It is, however, anticipated that increased consumer and community confidence in the regulatory system as a result of the involvement of Committees in the assessment of applications and development of policy, will translate into greater acceptance of GMOs and GM products in the market place.

On the Community - The community and consumers have an opportunity for input into the regulatory system at both a policy level (through the Gene Technology Community Consultative Group) and on a case by case basis through the proposed assessment process (please refer below). This affords a level of transparency and accountability.

On Consumers - It is possible that increased costs incurred by business as a result of funding the operation of the Committees may be passed on to consumers through increased product prices.

Impacts of Option 2 - Seeking expert and community advice on an ad hoc basis

On Government - This option would reduce the resource implications associated with establishment and management of the Committees. However, in making his or her decisions the Regulator would not be able to rely upon the timely input of scientists who were experts in the required fields. Nor would the Ministerial Council have ongoing access to community views about gene technology to inform the development of policy.

On Business - This option would be cheaper to administer, with associated benefits for industry from a cost-recovery perspective.

On the Community and Consumers - This would reduce the transparency in the system as it would not be clear exactly who the Regulator might seek advice from on any given application or issue. There would also be no assured opportunity for community input into policy making. Community members, some of whom are already concerned about the relationship between Government and business in this area, may become more cynical. This would potentially have a dramatic impact on the credibility of the regulatory system over time. This in turn may effect the willingness of business to market GMOs and GM products reducing consumer choice.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. Although probably more costly than ad hoc sources of advice, the establishment of expert committees in the

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legislation will deliver a range of benefits including higher quality and more transparent decision-making. Mechanisms have been included in the legislation to ensure the costs of establishing and maintaining the Committees will not "blow out" including, requirements that the Committees provide advice at the request of the Ministerial Council or the Regulator. This ensures that the work of the Committees can be prioritised and that unnecessary expenses are not incurred.

e) The regulation of dealings with GMOs

Option 1 - A system utilising a range of regulatory tools (including licensing) commensurate with the risk posed by certain dealings with GMOs.

The Bill proposes that all dealings with GMOs will be prohibited unless the dealing with the GMO is:

§ exempt from the requirements of the legislation (on the basis of the negligible risk posed by the dealing with the GMO. Exemptions will be prescribed in regulations);

§ a notifiable low risk dealing (on the basis that the work is to occur within a contained facility and does not present any significant risks. Notifiable low risk dealings will be prescribed in regulations and will rely on self-assessment by researchers with the assistance of IBCs. The Regulator will, however, provide independent oversight of assessments);

§ licensed (either as dealings involving, or not involving, release into the environment); or

§ entered on the Register of GMOs (following a period of licensing, monitoring of any risks and a determination that the GMO no longer requires licensing based on the ability to successfully manage minimal risk posed by the dealings with the GMO).

This system recognises:

§ that different types of dealings with GMOs present varying levels of risk, and that different levels of assessment and regulatory oversight are appropriate in relation to each. Similarly, varying levels of community involvement and statutory timeframes for assessment will be detailed in the Bill and the regulations, based on the level of risk of the proposed dealings; and

§ that any risks to public health and safety and the environment which may be associated with dealings with GMOs should be identified through a transparent process before those dealings are undertaken.

Option 2 - Status quo: Assessment based on the current GMAC model.

Option 3 - Regulation focusing on post-market monitoring and exclusion rather than pre-market regulation

Impacts of Option 1 - A system utilising a range of regulatory tools based on the level of risk posed by the proposed dealing with the GMO.

On Government - A licensing system is relatively resource-intensive to establish and maintain. However, Government resources will be directed towards higher risk activities (for example, any application involving an intentional release into the environment). A self-assessment and notification scheme is adopted in relation to low risk contained research activities (notifiable low risk dealings - as described above). This reduces resources expended by Government in relation to low risk activities. Various types of GMOs could move between categories over time, as better information becomes available about exactly what risks are posed by certain GMOs.

On Business - The proposed system reflects a sliding scale of regulatory oversight based on risk. Thus, paperwork burden and compliance will be kept to a minimum for low-risk activities. Higher risk activities will, however, incur additional costs, commensurate with the level of risk posed by the dealing. Such costs will be in excess of the costs currently incurred by industry in relation to the assessment of higher risk activities by GMAC (under administrative arrangements). Statutory data requirements, costs of applying for a licence and timeframes for assessment will be detailed in regulations made under the Bill providing a high level of statutory certainty for industry. Such regulations will be subject to extensive consultation and a further RIS.

On the Community - This is expected to engender a high level of community confidence that risks associated with a GMO will be identified and appropriately regulated by the Regulator. There will be extensive opportunity for community involvement in `higher risk' applications involving the release of GMOs into the environment. Costs, in particular in terms of time, will be incurred by community members who wish to contribute to the Regulator's assessment of proposals involving release of a GMO into the environment. The community can be confident that GMOs cannot be trialled in the field or released into the environment without a thorough assessment by the Regulator.

On the Consumer - Comprehensive regulatory oversight of GMOs will reassure consumers that any products available in the market place have been assessed as safe. This may increase consumer acceptance of such products and lead to an increased variety of goods bought to market by industry. Costs carried by industry in relation to the preparation of a comprehensive application for a licence to deal with a GMO, as well as the Regulator's costs of assessment, may be passed on to consumers as increased costs of GMOs and GM

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products which proceed to market.

Impacts of Option 2 - Assessment based on the current GMAC model

On Government - This approach would incur minimal costs to government as it would utilise the existing GMAC processes. This approach has the potential to undermine community confidence in the system, if it is perceived to continue the disadvantages of the existing system. Such as, insufficient transparency, accountability for decision making and lack of regulatory certainty.

On Business - This approach would be likely to have a minimal impact on business in terms of costs. During consultations, however, industry did not endorse this approach and expressed the benefit of comprehensive assessment of risks being undertaken by Regulator with advice from GMAC.

On the Community and Consumers - During community consultations, the community expressed a very strong desire for an independent regulator to undertake risk assessments and risk management with advice from a range of stakeholders including a scientific body.

Impacts of Option 3 - Regulation focusing on post-market monitoring and exclusion rather than pre-market regulation

On Government - This would involve some costs to government, through the need to work closely with industry and the community in developing the standards which would be applied by industry. Government would also incur costs related to post market monitoring and the removal of any unsafe GMOs from the marketplace. These costs could be offset by lower pre-market approval costs.

On Business - This option would involve minimal cost to industry but like Option 2 would be unlikely to engender sufficient community confidence to enable the marketing of GMOs and GM products.

On the Community - During consultations, the community expressed concerns that GMOs present unique risks which must be independently assessed before they are marketed. They considered that post-market monitoring and exclusion measures would be inadequate to deal with a situation where environmental or public health risks are identified after the event, and when it may not be possible to withdraw the product easily (for example in the case of a crop).

On Consumers - Consumers (in particular, primary producers utilising GM seed) would have increased access to GMOs.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. Community consultations (please refer Part 6 - Consultation) have demonstrated that only a comprehensive system utilising prohibitions and licensing for higher risk activities can deliver the type of comprehensive testing, backed up with appropriate sanctions for non-compliance, which the Australian community considers is merited by the potential risks posed by GMOs to public health and safety and the environment. The proposed system minimises the regulatory burden to industry by adopting a sliding scale of regulatory oversight based on risk. Higher requirements are placed on higher-risk activities, such as commercial releases of GMOs. A more streamlined approach is adopted for lower risk activities such as research in contained facilities.

To illustrate the practical effect of the Bill on some of the groups who will utilise the legislation, case studies have been included in respect of the impact of the legislation on: dealings with exempt GMOs; notifiable low risk dealings; higher risk work with GMOs within laboratories or other contained facilities; and work involving release of GMOs into the environment.

g) Certification of facilities and accreditation of organisations

Option 1 - Certification of facilities and accreditation of

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organisations by the Regulator.

The proposed legislation provides for the Regulator to:

§ Certify facilities: The Regulator may require, as a condition of licence, that certain work with GMOs is only conducted in facilities of a certain assessed containment level. The requirements for certification to Physical Containment (PC) levels 2, 3 and 4 would be spelt out in guidelines issued by the Regulator (just as they are currently spelt out in guidelines issued by GMAC). The guidelines would be subject to consultation and a RIS. The Regulator would directly certify laboratories to PC level 3 and 4 (at present there are 24 facilities certified to these levels by GMAC) and would utilise IBCs to assist in the monitoring of PC level 2 facilities.

§ Accredit organisations: At present IBCs operate within institutions undertaking gene technology work. Currently, there are 92 IBCs operating in Australia. The IBCs oversee work occurring within institutions and provide information and advice to researchers and to GMAC. Under the new system it is intended that this system be continued through the accreditation of organisations. An Organisation will be accredited by the Regulator if the Organisation can establish to the satisfaction of the Regulator that the Accredited Organisation has established and will maintain an IBC in accordance with guidelines issued by the Regulator. The IBCs will not provide a regulatory role but they will continue to: assist organisations to understand regulatory requirements; and provide advice to the Regulator regarding the work occurring at an institutional level.

Option 2 - Third party (and/or industry) certification and accreditation.

This approach would involve the Regulator setting standards for accreditation of institutions and certification of facilities. Compliance with such standards would then be monitored by third parties or industry (accredited by the Regulator).

Impacts of Option 1 - Certification of facilities and accreditation of organisations by the Regulator.

On Governments - The proposed system simply formalises existing administrative arrangements which Governments have acknowledged as operating effectively. Costs related to administration of the certification and accreditation system should be minimal, as guidelines issued by the Regulator will be based on the existing GMAC guidelines in relation to IBCs and the containment of facilities.

On Business - No additional costs, or delays, should be incurred by business. Business is currently required to have facilities certified to certain containment levels by GMAC. Similarly, the establishment and maintenance of IBCs is the responsibility of organisations, overseen by GMAC. The proposed legislation simply formalises an existing administrative practice. Guidelines and standards will provide a high level of certainty for applicants for certification or accreditation. The accreditation process also recognises the value of a co-regulatory approach in relation to low risk activities undertaken within laboratories.

On the Community - The community can be confident that work within institutions is being carried out in line with standards set by the Regulator. The standards set by the Regulator will be on the public record, monitored and enforced.

On Consumers - There should be negligible impacts as most of the work undertaken in certified facilities is research work.

Impacts of Option 2 - Third party (and/or industry) certification and accreditation.

On Governments - This approach would minimise the resources associated with the Regulator directly accrediting organisations and certifying facilities. However, costs would be incurred to recruit and audit third party industry assessors. The small number of organisations requiring accreditation (presently 92) and facilities to be certified by the Regulator (presently 24) would probably not justify the costs of recruiting and accrediting third party assessors and auditors to undertake this role.

On Industry - Industry noted that in the area of gene technology (unlike food regulation) there are few organisations that would be appropriately skilled, and independent, to undertake audits of containment facilities or organisations. Industry would also incur costs on two levels: costs as the result of the Regulator accrediting assessors and auditors; and costs imposed by such assessors and auditors for the work undertaken on behalf of the Regulator. Given the small number of organisations to be accredited and facilities to be certified it is also likely that the charges levied by third parties for providing such a service would be as great, if not greater, than the charges the Regulator would levy for provision of the same service.

On the Community - During consultations the community strongly opposed this model. They felt that at this early stage in the development of GMOs, certification and accreditation must be undertaken directly by the Regulator to ensure sufficient independence and proper oversight. It was, however, recognised that over time, it may be possible to utilize third party auditors, particularly if the number of organisations undertaking gene technology increased dramatically.

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On Consumers - No significant impacts are foreseen

Conclusion and recommended option:

The Bill reflects a preference for Option 1. This option offers a co-regulatory approach under which institutions will largely continue `business as usual' with the advantage, for public confidence and the credibility of the system, of ultimate oversight by the Regulator.

h) Database of GMOs and GM products

Option 1 - Establishment of a centralised database of all GMOs and GM products approved in Australia

The Bill proposes the establishment of a publicly accessible central database including information about all approvals of GMOs and GM products in Australia. It is proposed that the database include all relevant information (including any conditions of licence) excluding confidential commercial information. The Regulator will make an assessment of whether information is confidential commercial information on a case by case basis and in accordance with legislated criteria.

Option 2 - The status quo

GMAC currently maintains a database, available on the GMAC website, that contains summary information about field trials and general releases. The GMAC database does not include information about approvals in relation to contained work or approvals of GM products by other regulators (such as TGA and ANZFA).

Impacts of Option 1 - A centralised database of all GMOs and GM products

On Governments - Costs will be incurred as the result of establishing and maintaining a comprehensive database of all GMO approvals. Such a database will, however, assist governments to discharge responsibilities including under international obligations and in terms of accountability to the public. All relevant Commonwealth agencies and State Territory Governments will also have access to the database (including confidential commercial information) which will assist them in any related decision making by State based regulatory authorities.

On Business - The draft legislation ensures that legitimate confidential commercial information provided by applicants is able to be protected. This provides benefits to industry by ensuring that information with a commercial value (including intellectual property) or information that may cause harm to an applicant if it were released (for example, information that may provide an unfair advantage to competitors) is protected.

On the Community - The database enables community members interested in gene technology, to easily access, through a singe national database, comprehensive information about GMOs and GM products. This will help to empower community members wishing to actively engage in the development of policies on gene technology.

On Consumers - Increased information available to consumers to assist them to make informed choices in the market place.

Impacts of Option 2 - The status quo

On Governments - No significant impact

On Business - No significant impact

On the Community and Consumers - A disadvantage of this approach is that community members are not provided with comprehensive information about GMOs and GM products. This would reduce the capacity of the community to contribute to the debate surrounding gene technology and may lead to distrust in the regulatory system as it would be perceived to be hiding information from the community.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. In order to instill public confidence in the regulatory system and enable research and commercial applications of gene technology to proceed, it is essential that as much information as possible is made available to the community, while at the same time protecting legitimately confidential commercial information. Option 1 realizes these benefits at minimal cost.

i) Monitoring and enforcement

Option 1 - Utilisation of a combination of industry auditing, independent monitoring and auditing, inspections and power to give directions requiring remedial action to be taken.

The proposed Bill provides for a combination of:

§ Auditing by licence holders and Accredited Organisations. It would be a condition of licence that people undertaking dealings with GMOs regularly report to the Regulator about compliance with licence conditions. In addition, a statutory condition would require reporting of any additional information regarding risks to public health and safety and the environment. Similarly, Accredited Organisations would report to the Regulator about ongoing

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maintenance of an IBC;

§ Independent auditing and monitoring by the Regulator. The legislation empowers the Regulator to undertake regular monitoring and/or `spot-audits' as necessary and commensurate with the level of risk posed by the dealings being undertaken and the history of compliance of the licence holder. This ensures that the level of oversight remains commensurate with the risk. Auditing and monitoring may be undertaken by the Regulator in relation to licensing, notifiable low risk dealings, certified facilities and Accredited Organisations;

§ Inspections. The legislation provides for inspections (including search, seizure etc) where a suspected breach has occurred;

§ Enforcement action - the legislation provides for a number of options to deal with breaches of the legislation including variation, suspension or cancellation of licence/accreditation/certification, the issue of directions, reporting of breaches directly to Parliament and criminal penalties; and

§ Remedial action. The Regulator has a statutory right to recover costs incurred as a result of the need to issue directions to a licence holder to remediate following a breach of condition in order to protect public health and safety and avoid damage to the environment.

Option 2 - Industry-based monitoring and reporting to the Regulator including the use of third party auditors

Impacts of Option 1 - A combination of industry auditing, independent monitoring and auditing, inspections and issue of directions.

On Government - The Bill provides flexibility for the Regulator to undertake any necessary monitoring to ensure that the legislation is being observed and that public health and safety and the environment is being protected.

On Business - Costs will be incurred to business to comply with conditions of licensing determined by the Regulator and to undertake internal auditing and reporting of results to the Regulator. However, compliance costs will be commensurate with the level of risk associated with the particular dealings with GMOs being undertaken. Further, compliance costs will be minimised over time for those businesses that demonstrate a strong record of compliance with the legislation (as the result of decreased audit and inspection by the Regulator on the basis of the proven record of ability to mange the dealings with the GMO appropriately).

Some of the costs of the system (eg. licensee audits) are likely to be met by end-users of the system such as farmers in the form of an increased price for seed and other GMOs.

On the Community - Extensive monitoring and enforcement powers provides the community with confidence that the Regulator can take appropriate and rapid action to address any problems which may arise.

On Consumers - Consumers may be required to make a contribution to the monitoring and enforcement system through higher prices for products which contain GMOs.

Impacts of Option 2 - Industry-based monitoring and reporting to the Regulator

On Government - This would minimise the resources expended by the Regulator. The Regulator could accredit and oversee the auditors, but would not be required to be involved in auditing and monitoring on a case by case basis.

On Business - If industry undertook their own monitoring and auditing, costs (both financial and paperwork burden) would be minimised. Industry would, however, incur similar costs whether the auditing and monitoring was undertaken by third party auditors or by the Regulator directly. Concern has also been expressed, particularly by researchers, that any third party auditors would need skills in the relevant area (most likely people active within the industry itself) and that utilisation of such people may raise conflicts of interest and the potential for disclosure of information with a significant commercial value.

On the Community - During consultations, the community strongly opposed this approach. Given the potential risks posed by GMOs and the fact that the industry is in its infancy in Australia, community members expressed the importance of industry being overseen by an independent regulator. It was considered that industry oversight or third party oversight could result in a reduction in monitoring, lower standards, and inadequate reporting of adverse effects or breaches of the legislation.

On Consumers - As for Option 1.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. While this option will be more expensive to establish and maintain, the Regulator will need to have an effective range of powers to audit, monitor and enforce the legislation. This will help to ensure that risks to public health and the environment are properly addressed. Following review of the legislation in 5 years time, the use of third party auditors may be considered, particularly if the use of gene technology is more extensive in Australia, history of compliance is strong and community acceptance of GMOs has increased.

j) Transitional period and Grandfathering of existing GMAC approvals

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Option 1 - Grandfathering of existing approvals

The proposed Bill provides that once the new legislative system takes effect, approvals previously granted by GMAC may continue in force until they expire or for a period of two years whichever is the sooner. After a maximum of two years, all dealings with GMOs must be re-assessed and regulated by the Regulator.

Option 2 - No grandfathering

Under this alternative all dealings with GMOs would be required to be licensed by the Regulator from the first day of operation of the new legislation regardless of whether or not the work had been previously approved by GMAC.

Impacts of Option 1 - Grandfathering of existing approvals

On Governments - This provides the Regulator with a two year period during which to reassess any approvals made by GMAC. If a grandfathering provision was not included the Regulator would need to re-assess thousands of existing approvals as soon as the legislation takes effect. This would have a significant impact on the overall available resources of the Regulator during the first 6-12 months of operation, and might detract from other activities such as working towards harmonising data requirements and risk assessments with other agencies, and the preparation of guidelines and codes of practice.

On Business - This minimises costs to industry associated with having to re-apply for assessment having already undergone an assessment by GMAC during the interim period prior to commencement of the legislation. Industry will, however, have to comply with statutory conditions of licence prescribed in the Bill. These relate to reporting of adverse effects, granting of permission for the Regulator to enter premises to undertake inspections and informing persons covered by the licence of any relevant conditions. These statutory conditions are unlikely to impose any additional costs of compliance on industry as, under current administrative arrangements, GMAC expects observance of such requirements. Should additional information become available regarding risks, the Regulator may also impose additional conditions following notification to the licence holder and the provision of opportunity for comment.

On the Community and Consumers - During consultations, the community recognised the benefits of grandfathering existing approvals but supported an approach whereby after a certain defined period of time, all dealings with GMOs would be approved by the Regulator and entered on a central database.

Impacts of Option 2 - No grandfathering

On Governments - This would have significant resource implications for the Regulator who would be required to reassess thousands of applications during a very short period of time.

On Business - This would impose large costs on industry. A significant administrative and paperwork burden would be imposed on industry (in particular researchers) if they were required to re-apply for licensing of all existing approvals at the time of commencement of the legislation. In addition to the costs of having to resubmit applications for ongoing research and other work, all work would need to cease until approvals had been granted by the Regulator. This might also produce a situation where some very low risk GMOs could not be used for a period of time, which would be extremely disruptive in particular for laboratory work.

On the Community and Consumers - No significant impact.

Conclusion and recommended option:

The Bill reflects a preference for Option 1. This approach minimises the impact on industry while ensuring that after a certain period of time, all work will have been assessed by the Regulator, unless it is exempt or a notifiable low risk dealing.

6. Consultation

a) The consultation process

Consultation on the proposed regulatory scheme for GMOs commenced in 1998 and has involved a number of stages.

Stage 1

In November 1998, a paper prepared by the Commonwealth State Consultative Group on Gene Technology (CSCG) and entitled "Regulation of Gene Technology" was circulated for public consultation. Consultations were held throughout Australia seeking views about the broad policy principles that might underpin the new regulatory scheme. Some of the general features of the system of regulation were also discussed. As a result of these consultations, the CSCG agreed to a set of policy principles which the CSCG has used to guide it in developing the proposed regulatory system.

Stage 2

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On the basis of the agreed policy principles, the CSCG worked to develop proposals for the operational details of the new regulatory system.

The CSCG prepared a discussion paper entitled "Proposed national regulatory system for genetically modified organisms - How should it work?". This document sets out the proposed approach to regulating GMOs, including the proposed scope and form of the legislation, the proposed management structures, the proposed system of regulation and the proposed mechanisms for maintaining transparency, accountability and community involvement in the system over time. The discussion paper was:

* advertised in a range of national, States and Territory and regional newspapers;

* direct-mailed to over 2,500 individuals and organisations including the groups referred to below as well as all MPs and Senators in Federal Parliament; and

* posted on the website of the IOGTR, which is the Branch of the Commonwealth Department of Health and Aged Care which is facilitating the development of the legislation.

Invitations to attend targeted consultations were sent to approximately 2,500 individuals and organisations across Australia: Vice Chancellors of all Universities where research involving GMOs is conducted; all IBCs; State/Territory Inter-Departmental Committees; 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; industry groups; retailers and food industry groups; and primary producers.

The targeted consultations were held in all States and Territories during November and December 1999. More than 200 written submissions were received on the Discussion Paper.

At each session, participants were asked how they felt the legislation could be more streamlined and reduce the impact on business, while maintaining the integrity of the system in terms of protecting public health and safety and the environment.

A number of issues were raised by participants relating to the cost and benefits to industry of the proposed legislation. Many of these issues were reflected in the draft legislation released in late December 1999.

Stage 3

In December 1999 an early draft of the Gene Technology Bill 2000 and an accompanying Explanatory Guide were released for public consultation.

Once again, a call for public submissions was made in newspapers in all jurisdictions, on the IOGTR website and direct mailed to over 2,500 individuals.

Public forums were also held in all capital cities and also in Tamworth, Rockhampton and Albury-Wodonga. Over 750 people attended the public consultations and more than 160 written submissions were received.

During public consultations, officers from the IOGTR explained the impact of various parts of the draft Gene Technology Bill 2000 and sought comment on ways that the proposed legislative system could be improved and any negative impacts minimised. The public forums gave rise to many suggestions for change and a range of options were discussed.

A summary of views elicited from the main affected parties as a result of consultation is described below. Please note that this summary does not attempt to summarise all of the views of all of the parties involved in consultations on the draft Gene Technology Bill 2000. Rather it emphasises areas of support and dissention in relation to options proposed in this RIS and areas where costs and benefits of various approaches were raised.

(a) National scheme legislation

This element of the legislation was widely supported during consultations. Stakeholders from all sectors (general community, industry including research institutions) supported the maximum degree of national uniformity possible. Many stakeholders expressed strong concerns about a lack of uniformity emerging overtime and stressed the importance of putting structures in place for ensuring a high level of consistency over time.

(b) Scope of the Act including interface with existing regulators

Many community groups and individuals supported the Regulator being a `one-stop shop' regulating all GMOs and GM products. Such groups articulated the advantages of a `one-stop' shop as:

§ providing a streamlined assessment process requiring approval from only one regulator;

§ providing greater opportunity for community input; and

§ addressing the perceived problems with the existing regulatory systems.

Others supported the gene technology legislation regulating the `gaps' with capacity to provide advice to the regulators where they consider GM products. It was considered that:

§ A `one stop shop' would create inefficiencies, as areas of expertise in each of the NRA, TGA, NICNAS and ANZFA would have to be duplicated by the

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Regulator;

§ A `one-stop shop' assumes that the `GMO-ness' of a product is its key characteristic. In relation to most GM products the major risks posed do not relate to the genetically modified qualities of the product but from other qualities and the proposed application of the product. For example, in relation to therapeutic goods, the fact that the good has been derived from a GMO is of minor consequence compared to the general safety, quality and efficacy of the various constituents of the drug; and

§ Administrative arrangements could be put in place to improve the interface between existing regulators without the need to overhaul the entire system of existing regulation in relation to products. For example, the paperwork burden of dealing with several different regulators should be minimised over time. For instance, through the harmonisation of data requirements across the various systems.

(c) Management of the gene technology scheme

Stakeholder consultations demonstrated strong support for the creation of an autonomous regulator of gene technology, independent of the political process. Provided this could be achieved, most stakeholders did not express a preference for whether the legislation was administered by a single statutory office holder or a statutory board.

Some community and environmental groups supported the involvement of Ministers in decision making on individual applications, however, this was not supported by all environmental/consumer groups nor at all by industry groups, researchers, primary producers and government agencies.

(d) Provision of expert advice to the Regulator to inform decision-making

The establishment of a Gene Technology Technical Advisory Committee (based on the current GMAC) to provide scientific advice to the GTR, was strongly supported by all stakeholders. Many stakeholders did, however, emphasise the importance of stringent conflict of interest and disclosure of interest provisions applying in respect of Committee members (this will be addressed in the regulations).

The establishment of a Gene Technology Community Consultative Group received a mixed response from stakeholders. While most people supported the establishment of a broadly based community group there was a range of views expressed regarding the role of the group. Some community representatives and environmental groups considered that the Group should be involved in decision making on individual cases while this was strongly opposed by industry, Universities and primary producer groups.

The Gene Technology Ethics Group was supported by most stakeholders. Industry, consumer, environmental, primary producer and other groups acknowledged the need for the legislative system to be underpinned by ethical guidelines prepared by a properly constituted ethics committee and considered by the Ministerial Council for endorsement. Concern was expressed however, regarding the precise terms of reference of such a group and the types of ethical issues that would be considered.

In relation to all of the Committees, industry emphasised the need for prioritisation of the work of the Committees in order to keep costs to a minimum and in order to ensure that the costs of the Committees do not blow-out.

(e) The regulation of dealings with GMOs

All stakeholders strongly supported an approach whereby the level of regulation applied to particular dealings with GMOs was commensurate with the level of risk posed by the particular dealings. There was considerable support in the community for the way that GMAC has dealt with research involving GMOs. There was also a strong call from researchers that the existing system be maintained as far as possible, in relation to contained work so that unnecessary costs were not incurred in relation to work that is largely low risk. The assessment process proposed in relation to notifiable low risk dealings and dealings with GMOs that do not involve a deliberate release into the environment was generally supported. It was seen as a streamlined way for dealing with low risk activities, based on the current GMAC processes, but with capacity for more comprehensive assessment where necessary.

In relation to the regulation of higher risk activities involving release into the environment, the proposed licensing system was generally supported.

There was particular support for the assessment process involving two stages of public consultation. Many researchers and industry groups emphasised the importance of retaining some flexibility in the assessment process. As such, small scale low risk field trials would not be subject to the same level of public consultation (and expense) as higher risk proposals. Industry also emphasised the need for the regulations to detail statutory timeframes and data requirements for applications, to provide some level of certainty to applicants.

It should be noted, however, that many individual members of the community felt strongly that there is insufficient information about the risks that GMOs may pose. As such, they considered that there should be a moratorium on the release of GMOs into the environment.

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(f) Certification of facilities and accreditation of organisations

The proposed approach to the certification of facilities reflects the current process adopted by GMAC but with additional capacity to take action where an organisation undertakes research in facilities that are not certified or in facilities that have been certified but the conditions of certification are not met. This approach was broadly supported.

With respect to Accredited Organisations, there was broad support for basing the new system on the existing GMAC system. The following points were made:

§ researchers and IBC members, emphasised the importance of the overarching organisations taking responsibility for the IBCs (in particular in terms of adequate resourcess and the indemnification of individual voluntary committee members);

§ Universities and other institutions (including companies) emphasised the important role IBCs play and the costs incurred by the organisation to maintain the system of IBCs. It was felt that these expenses should not be overlooked; and

§ recognising the closeness of the relationship between IBCs and their parent organisations, many people emphasised the importance of the Regulator providing independent oversight of the IBCs (through the system of accreditation of organisations).

(g) Database of GMOs and GM products

The centralised database of GMOs and GM products was strongly supported. Industry and Universities emphasised the importance of the legislation including provisions for the protection of confidential commercial information. Existing regulators favoured the establishment of a database that interacted with databases of existing regulators so that the transfer of information between regulators was as streamlined and cost efficient as possible.

(h) Monitoring, enforcement and remediation

Consultations provided strong support for the Regulator to have a range of options for monitoring and enforcing the system. Several stakeholders also noted that:

§ the Regulator should develop guidelines regarding the regularity of monitoring and auditing for various classes of dealings with GMOs in order to provide some certainty of costs to industry; and

§ the use of third parties may reduce the effectiveness of the feedback loop which would be critical to inform the Regulator's future decisions (for example, the Regulator needs to know what is happening in the field after approval, to inform his future decisions on similar GMO applications).

(i) Transitional period and Grandfathering of existing GMAC approvals

This was universally supported. Researchers and Universities, in particular, noted that the impact of not having grandfathering provisions would be significant, as it would not only delay research but also impose significant additional costs on researchers.

8. Implementation and review

Implementation

The regulatory system is expected to be fully operational by 3 January 2001.

It is proposed that certain parts of the Bill (for example, those creating the Regulator and advisory Committees) will be commenced in advance of the prohibitions and licensing provisions. This would allow the Regulator to commence critical activities (for example, the development of application guidelines) prior to the actual commencement of the scheme.

Review Review

It is proposed that the new legislative scheme will be comprehensively reviewed after 5 years to make any necessary changes to the system. It is proposed that the process for review of the system be included in the IGA on Gene Technology.

The IGA will also contain provisions for agreement by Ministers of any necessary changes to the Acts and regulations during the initial 5 year period, with the agreement of the States and Territories

Much of the day-to-day impacts of the new scheme will be through regulations (for example, the Licence Charges Regulations are still to be developed) and Guidelines and Codes of Practice (for example, what information must be presented to the Regulator in conjunction with the application). The impacts of these associated aspects will be separately assessed.

9. Competition Principles Agreement Statement

Where proposals maintain or establish restrictions on competition, the Competition Principles Agreement requires the responsible agency to establish that:

§ the benefits to the community outweigh the costs; and

§ the Governments' objective can only be achieved by restricting

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competition.

The Gene Technology Bill 2000 restricts competition by requiring new entrants into the market to seek a licence from the Regulator for their proposed dealings with GMOs. Institutions wishing to conduct GMO research must also gain accreditation from the Regulator before undertaking those activities. Accreditation will be granted where an organisation can establish that they have, and will maintain, a properly constituted IBC in accordance with guidelines issued by the Regulator.

These requirements restrict competition to the extent that:

§ the Regulator is the only person able to grant such licences and accreditations. The assessment of risk is not open to competition;

§ they increase regulatory barriers to entry into the field of dealings with GMOs and GM products;

§ they create a disadvantage for firms dealing with GMOs and GM products who wish to compete in markets where the non-GM counterpart products have not had to incur the additional costs of regulation by the Regulator; and

§ a fee will attach to the granting of licences and accreditation.

Do the benefits to the community outweigh the costs?

As detailed throughout this RIS, the major benefits of the legislation include:

§ For the community at large - Assurances that all GMOs used in Australia have been comprehensively assessed by an independent Regulator as being safe in terms of the health of people and the impact on the environment. Public confidence in the regulation of GMOs also has positive downstream effects for industry, manifesting in increased consumer acceptance of GMOs assessed to be safe. For consumers this also translates to increased consumer choice in relation to GMOs and GM products and potential access to a broader range of products with improved quality or health benefits;

§ For industry - The proposed regime establishes a clear and efficient assessment process for GMOs ensuring a high level of regulatory certainty. Industry has emphasised the need for an efficient, rigorous, regulatory system that ensures the proposed assessment of all GMOs in order to enable the benefits of gene technology to be captured for the Australian community.

The overall cost impact of these restrictions would include:

§ some diminution of GMOs and GM products coming into the market which are judged to pose unacceptable risks to health or the environment or to raise unacceptable ethical concerns;

§ possible impact on research, if charges are levied by the Regulator in relation to applications to undertake research with GMOs. This may reduce the long term benefits of research to the community and may hinder the development of GMOs for the public good which lack commercial attractiveness; and

§ in markets where GMOs and GM products were competing with non-GM products, the regulatory costs disadvantage may result in less than optimal market share for the GMOs and GM products. This would be offset by increased marketability as a result of increased consumer confidence in the products coming to market. The GMOs and GM products could also rely on any cost or quality advantages produced from gene technology.

Given the substantial benefits to the community, in terms of the protection of health and safety and the environment, and to industry, in terms of providing a pathway to market for GMOs judged to be safe, it is anticipated that the benefits will outweigh the costs of regulation.

As described in Part 1 - Background, a comprehensive independent analysis of the costs of the full regulatory system (including the regulations) will be undertaken between April and September 2000. The analysis of costs will be subject to extensive consultation with Governments, industry and other stakeholders.

The regulatory scheme will also be the subject of ongoing monitoring (regarding its effectiveness in meeting its objectives including cost efficiency) and a comprehensive review after 5 years. The review will be directed at ensuring the legislation maximises benefits while minimising costs.

Can the Governments objective only be achieved through restricting competition?

As detailed in Part 1 - Background to this RIS, an administrative scheme (based around the Genetic Manipulation Advisory Committee) has been operating for a number of years providing oversight in relation to research with GMOs, field trials involving GMOs and the commercial release of GMOs not regulated under existing regulatory schemes.

This administrative scheme was based on voluntary compliance by industry and as such did not restrict competition. However, as outlined in Part 2 - Problems of this RIS, there are a number of problems associated with continuing a voluntary administrative scheme of this nature (including regulatory uncertainty, an inability to enforce conditions and compliance with GMAC requirements etc).

Governments' examined a range of options for addressing these problems as detailed in Part 1 - Background of this RIS.

The approach adopted, whereby high risk dealings must be licensed by the Regulator and undertaken within accredited organisations (who have an IBC) is

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the only option that ensures:

§ a comprehensive assessment of the risks posed to public health and safety and the environment in relation to dealings with GMOs;

§ assessment by an independent regulator with access to advice from a range of sources. The potential risks that may be posed by dealings with GMOs are sufficiently great that their assessment and management cannot be left to industry self-regulation;

§ responsibility for ensuring that the dealings are managed safely rests with an identified organisation (the licence holder);

§ regulatory certainty for industry in terms of timeframes, assessment processes, protection of confidential commercial information;

§ a high level of transparency and stakeholder involvement in decision making;

§ capacity for enforcement in the case of a breach. The consequences of a breach of licence may be severe and as such the Regulator needs to have a range of enforcement options open to them;

§ ensures that risks are effectively communicated to consumers and others to allow them to make informed decisions on the basis of all the facts. Effective risk assessment and communication by the Regulator reduces potential imbalance in the market place. This occurs where, for example, information is unavailable to one party (ie consumers/the public).

GENE TECHNOLOGY BILL 2000

NOTES ON CLAUSES

PART 1 - PRELIMINARY

Clause 1 - Short title

This is a formal provision that specifies the short title of the Act as the Gene Technology Act 2000.

Clause 2 - Commencement

Sub-clause 2(1) provides that clauses 1 and 2 of the Act commence on the day on which the Act receives Royal Assent.

Sub-clauses 2(2) and (3) enable various provisions of the Act to commence at a date to be fixed by Proclamation. If any provisions of the Act do not commence within six months of Royal Assent, those provisions commence on the first day after the end of that period.

The effect of these provisions is to enable different parts of the Act to commence at different times. For example, to assist with transitional arrangements it may be desirable to commence the provisions of the Act establishing the Regulator and the advisory committees before the prohibition and licensing provisions commence. This would enable those bodies to prepare necessary technical guidelines in advance of the licensing provisions taking effect.

Clause 3 - Object of Act

This clause provides that the object of this Bill is to protect the health and safety of people, and to protect the environment, by identifying risks posed by, or as a result of, gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).

The terms "environment", "gene technology", "dealings" and "genetically modified organisms" are defined in clause 10.

Clause 4 - Regulatory framework to achieve object

This clause makes it clear that it is intended that the object of the Bill be achieved through a regulatory system that will be based on an efficient and effective system of assessment. Furthermore, the regulatory framework is to operate in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and genetically modified (GM) products. For example:

* foods (including GM foods) are regulated under State and Territory food Acts with the role of developing food Standards (for consideration by the Australia New Zealand Food Standards Council) resting with the Australia New Zealand Food Authority under the Australia New Zealand Food Authority Act 1991;

* therapeutic goods (including GM therapeutic goods) are regulated under the Therapeutic Goods Act 1989 administered by the Therapeutic Goods Administration;

* agricultural and veterinary chemicals (including GM agricultural and veterinary chemicals) are regulated through a national scheme administered, in cooperation with all States and Territories, by the National Registration Authority under the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals (Code) Act 1994; and

* industrial chemicals are regulated through the National Industrial Chemicals Notification and Assessment Scheme under the Industrial Chemicals (Notification and Assessment) Act 1989 and accompanying State/Territory legislation.

The Bill will also operate alongside current import arrangements for GMOs (which are administered by the Australian Quarantine and Inspection Service in

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accordance with the Quarantine Act 1908) and in conjunction with existing State and Territory legislation which may also effect the use of GMOs (for example, general biological control legislation, environment legislation and fisheries legislation).

Clause 5 - Nationally consistent scheme

This clause notes that it is intended that this Bill form a component of a nationally consistent scheme for the regulation, by the Commonwealth, States and Territories, of certain dealings with GMOs. It is expected that each State and Territory will enact its own gene technology legislation to complement, or apply, the Commonwealth legislation within its own jurisdiction. It is also expected that an Intergovernmental Agreement on Gene Technology (the Gene Technology Agreement) will be signed by the Commonwealth, States and Territories to ensure the national system maintains a high degree of consistency over time.

Clause 6 - Act to bind the Crown

Sub-clause 6(1) provides that the Bill will bind the Crown in each of its capacities.

Sub-clause 6(2) provides that the Crown may not be prosecuted for a criminal offence against this Bill or regulations.

Clause 7 - External Territories

This clause provides that the Bill will have application in every external Territory, excluding Norfolk Island. Therefore, the legislation will cover, for example, the Indian Ocean Territories (Cocos and Christmas Islands), Macquarie and Heard Islands, the Australian Antarctic Territory and the Jervis Bay Territory. Norfolk Island has advised that a decision on the application of this Bill to Norfolk Island will be postponed pending the outcome of consultations on Norfolk Island.

Clause 8 - Offences

This clause describes how the criminal offences established by the Bill will operate.

Sub-clause 8(1) provides that Chapter 2 of the Criminal Code Act 1995 (the Criminal Code) applies to all offences against the Bill. This means that where it is alleged an offence has been committed under the Bill, it will be necessary for the prosecution to establish a fault element (for example, intent or recklessness), except where the necessity to establish fault in relation to an element of the offence is explicitly excluded in the Bill.

Sub-clause 8(2) provides that, if a maximum penalty is specified at the foot of a clause or sub-clause of this Bill then the offence referred to in the clause or sub-clause is punishable, on conviction, by a penalty not exceeding that maximum.

PART 2 - INTERPRETATION AND OPERATION OF ACT

DIVISION 1 - Simplified outline

Clause 9 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - Definitions

Clause 10 - Definitions

This clause sets out a number of definitions for words and phrases used in the Bill. These definitions determine the meaning that is to be attributed to certain words or phrases whenever they are used in the Bill or regulations. Key definitions, which are essential to defining the scope of the legislation and describing how it will be administered, include:

"deal with", which, in relation to a GMO, is defined to mean:

(a) conduct experiments with the GMO;

(b) make, develop, produce or manufacture the GMO;

(c) breed the GMO;

(d) propagate the GMO;

(e) use the GMO in the course of manufacture of a thing that is not the GMO;

(f) grow, raise or culture the GMO; and

(g) import the GMO;

and also includes the possession, supply, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (g).

"environment" includes:

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(a) ecosystems and their constituent parts; and

(b) natural and physical resources; and

(c) the qualities and characteristics of locations, places and areas.

It is intended that the definition of environment include all animals (including insects, fish and mammals), plants, soils and ecosystems (both aquatic and terrestrial).

"gene technology" is defined to cover any technique for the modification of genes or other genetic material, but does not include:

(a) sexual reproduction;

(b) homologous recombination; or

(c) any other technique specified in the regulations for the purposes of this paragraph.

"genetically modified organism" is defined as:

(a) an organism that has been modified by gene technology;

(b) an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or

(c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

(d) a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic gene therapy; or

(e) an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be a genetically modified organisms.

The ability to prescribe things to be genetically modified organisms in regulations (under (c) of the definition of a GMO) ensures there is capacity to regulate GM products that are not regulated by existing regulatory agencies. An example of such a `gap' product is GM stockfeed.

Human beings are excluded from the definition of a GMO to ensure that a person who has undergone somatic cell gene therapy (for example, treatment for cancer) is not a GMO (as defined in this legislation), thus requiring the person to be licensed for the rest of their lives because they have been modified by techniques of gene technology. The conduct of human gene therapy will, however, continue to be regulated by the TGA and, in the case of research involving human trials, also overseen by the National Health and Medical Research Council. The Gene Technology Regulator would also be involved if the work involves a live or viable GMO (presenting possible occupational health and safety or environmental risks).

"GM product", which is defined as a thing (other than a GMO) derived or produced from a GMO.

Clause 11 - Meaning of intentional release of a GMO into the environment

Clause 11 describes the circumstances in which a dealing will be considered to involve an intentional release into the environment. The clause provides that a dealing with a GMO involves the intentional release of the GMO into the environment if the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment. This definition is intended to cover field trials of GM crops and animals and any commercial release of a GMO into the environment.

This definition is important for identifying the appropriate assessment path to be applied in relation to the dealing with the GMO. The process for approval of dealings with GMOs (as described in Part 5) varies depending on whether the dealing is to occur under conditions of containment or whether the dealing involves a deliberate release of the GMO into the environment. This flexibility has been built into the scheme because of the potential for different, or more serious, risks developing in relation to public health and safety and the environment from dealings involving a release into the environment, thereby necessitating a more comprehensive public consultation and risk assessment process.

Clause 12 - Meaning of corresponding State law

Sub-clause 12(1) provides that a corresponding State law means a State law that is declared by the relevant Commonwealth Minister (the Minister), by notice in the Gazette, to correspond to this Bill and the regulations, including such a law as amended from time to time.

Sub-clause 12(2) provides that the Minister may, under certain circumstances, revoke a Gazette notice which is declared under sub-clause 12(1). These circumstances include: if the Minister is requested by the State concerned to revoke the notice; or the State law has been amended otherwise than as agreed by a majority of the members of the Ministerial Council (where that majority includes the Commonwealth); or amendments to the State law have been agreed by a majority of the members of the Ministerial Council (where that majority includes the Commonwealth) and the State law has not been amended in

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accordance with that agreement within a reasonable period after the agreement.

DIVISION 3 - Operation of Act

Clause 13 - Operation of Act

This clause describes the consitutional powers on which this legislation is based. It specifies that the Bill applies to things done by: constitutional corporations; a person that may cause the spread of diseases or pests; and the Commonwealth and Commonwealth authorities. It also provides that the Bill covers things done in the course of constitutional trade or commerce and for purposes relating to the collection, compilation, analysis and dissemination of statistics. It further provides that the Bill applies to things authorised by the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution (which contains the `incidental' power) in relation to the aforementioned matters.

This clause ensures that the Bill has broad coverage in all jurisdictions until such time as each State and Territory enacts corresponding State laws at which time this legislation will "wind-back" in respect of specified bodies and things (thereby recognising the role, powers and functions of States and Territories). This "wind-back" of the Commonwealth law is described in clause 14.

Clause 14 - Wind-back of reach of Act

This clause provides for a "wind-back" of the reach of this Bill, where States or Territories have enacted corresponding State laws.

This clause provides that, once a State or Territory enacts a corresponding State law (as defined in clause 12) and the State has given a notice to the Minister stating that this clause is to apply (a "wind-back notice"), this Bill will "wind-back" its operation in respect of:

(a) dealings with GMOs that would only have been regulated under this Bill as a result of the application of the power in relation to limiting the spread of pests and diseases; and

(b) dealings with a GMO undertaken by a higher education institution or a State agency, and by persons authorised to undertake the dealing by a licence held by a higher education institution or State agency.

Clause 15 - Relationship to other Commonwealth laws

This clause clarifies that this Bill is not intended to "cover the field" in respect of GMOs. This clause makes it clear that the provisions of the Bill are in addition to, and not in substitution for, the requirements of any other law of the Commonwealth, whether that law has been passed or made before or after the commencement of the Bill.

DIVISION 4 - Provisions to facilitate a nationally consistent scheme

Subdivision A - General provisions

Clause 16 - State laws may operate concurrently

Sub-clause 16(1) provides that the Bill is not intended to exclude the operation of any State law, to the extent that the State law is capable of operating concurrently with the Bill, other than a State law prescribed by the regulations for the purposes of this section.

Sub-clause 16(2) provides that the Governor-General may prescribe a State law under sub-clause 16(1) only if there is no corresponding State law in effect in relation to that State. In addition, the Governor-General must be satisfied that either: the State law relates specifically to dealings with GMOs; or for the purposes of a decision under the State law as to whether or not a licence, authority or approval is granted under the State law, the State law distinguishes between dealings with GMOs and dealings with other things.

The intention of these provisions is to ensure that existing and future State legislation (such as general environmental, fisheries, and land management legislation) continues to operate concurrently with this Bill, provided it is capable of doing so. However, where State legislation is enacted that is inconsistent with the national scheme of regulation for GMOs, or effectively establishes a dual licensing regime, there is capacity for such laws to be prescribed as not operating concurrently with this Bill.

Clause 17 - Conferral of functions on Commonwealth authorities and officers

Sub-clause 17(1) provides that a corresponding State law may confer functions, powers and duties on: the Regulator or another officer of the Commonwealth; a Commonwealth authority; and any of the Committees established under the legislation (the Gene Technology Technical Advisory Committee, the

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Gene Technology Ethics Committee and the Gene Technology Community Consultative Group).

Sub-clause 17(2) empowers an authority, officer or body on whom a function, power or duty is conferred, under sub-clause 17(1), to perform the function or duty, or exercise the power.

Sub-clauses 17(3), (4) and (5) have been included to enable corresponding State laws to empower the Regulator to include matters on the GMO Register, or vary matters already on the Register and enter information on the Record of GMO and GM Product Dealings, in accordance with a corresponding State law.

Sub-clause 17(6) provides that the Regulator may annotate the GMO Register or Record of GMO and GM Product Dealings to identify which entries on the Register or Record relate to decisions made by the Regulator under a corresponding State law.

Clause 18 - No doubling-up of liabilities

Sub-clause 18(1) provides that if an act or omission is an offence against the Bill and is also an offence against a corresponding State law, and the offender has been punished for the offence under the corresponding State law, then the offender is not also liable to be punished for the offence under the Bill.

Sub-clause 18(2) provides that, if a person has been ordered to pay a pecuniary penalty under a corresponding State law because of certain conduct, the person is not liable to a pecuniary penalty under the Bill for the same conduct.

This clause establishes that there be no `double jeopardy' under the Bill or a corresponding State law.

Clause 19 - Review of certain decisions

This clause provides the capacity for the Administrative Appeals Tribunal to review decisions made under a corresponding State law, for example, where the `wind-back' of this Bill has taken effect (in accordance with clause 14) and the decision by the Regulator is made under State legislation.

Sub-clause 19(2) provides that a decision of the Regulator is a `reviewable State decision' where the State law provides for review by the Administrative Appeals Tribunal and where the decision is declared in the regulations to be a `reviewable State decision'.

Sub-clause 19(3) provides that for the purposes of this clause the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment of the Commonwealth.

Clause 20 - Things done for multiple purposes

This clause provides that licences, certificates and other things issued or done under the Bill remain valid although they may have been done for the purposes of a corresponding State law.

Subdivision B - Policy principles, policy guidelines and codes of practice

Clause 21 - Ministerial Council may issue policy principles

Sub-clause 21(1) enables the Ministerial Council to issue policy principles in relation to ethical issues relating to dealings with GMOs and to other matters relating to dealings with GMOs which are detailed in the regulations. The Regulator will be required to observe such principles and must not issue a licence under the legislation if he or she considers that to do so would be inconsistent with a policy principle issued by the Ministerial Council.

Sub-clause 21(2) sets out the criteria which must be satisfied before the Ministerial Council. The Ministerial Council must be satisfied that adequate consultation on the proposed principle has occurred in accordance with the requirements of clause 22.

Sub-clause 21(3) clarifies that regulations made describing issues in relation to which policy principles may be made, may relate to matters beyond public health and safety and the environment (such as cultural matters), but that the principles must not detract from the protection of public health and safety and the environment. For example, policy principles could not be made in relation to trade if the effect of the principles were to override the primary object of the Bill which is the protection of the health and safety of people and the environment.

Sub-clause 21(4) specifies that these policy principles are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.

Clause 22 - Consultation on policy principles

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This clause describes the consultation process that must be observed before the Ministerial Council may issue a policy principle under clause 21. The clause provides that the policy principles must be developed in consultation with each of the three Committees established under the legislation (the Gene Technology Technical Advisory Committee, the Gene Technology Ethics Committee and the Gene Technology Community Consultative Group). The clause also requires consultation with the Regulator and appropriate Commonwealth and State agencies. Consultation must also be undertaken with industry, environmental, consumer and other groups, as determined by the Ministerial Council.

The clause does not describe who will be responsible for developing the draft policy principles, as this will vary depending on the subject matter of the policy principles. For example, it is anticipated that policy principles related to ethical matters would be developed by the Gene Technology Ethics Committee, while other policy principles may be developed by the Regulator or the Gene Technology Community Consultative Group. Once drafted and following extensive consultation, the proposed policy principles would be put to the Ministerial Council for consideration and issuing.

Sub-clause 22(2) anticipates that the Ministerial Council will issue more detailed guidelines regarding consultation processes, and provides that where such guidelines are issued, they must be observed by the Committees or other bodies developing policy principles.

Clause 23 - Ministerial Council may issue policy guidelines

This clause allows the Ministerial Council to issue policy guidelines in relation to matters relevant to the functions of the Regulator. Such policy guidelines are distinguishable from policy principles (described in clause 21) as these guidelines will not be binding on the Regulator. The Regulator will, however, be required to take such guidelines into account when deciding on an application for a licence under the legislation.

Clause 24 - Ministerial Council may issue codes of practice

This clause allows the Ministerial Council to issue codes of practice in relation to gene technology.

Sub-clause 24(2) describes the requirements for consultation which must be met before the Ministerial Council may issue a code of practice. The Regulator must develop the codes of practice in consultation with the three committees established under the legislation (the Gene Technology Technical Advisory Committee, the Gene Technology Ethics Committee and the Gene Technology Community Consultative Group). The Regulator must also consult with Commonwealth and State agencies, regulatory agencies and industry, environmental, consumer and other groups as determined by the Commonwealth and the States.

It is intended that such codes of practice will form the basis for certain conditions imposed under a licence (under clause 62). Given the legislative intent of the codes of practice, sub-clause 24(3) provides that codes of practice are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.

PART 3 - The Gene Technology Regulator

Clause 25 - Simplified outline

This clause gives a simplified outline of the Part.

Clause 26 - The Gene Technology Regulator

This clause establishes the Regulator. The Regulator will be a statutory office holder with significant independence. This position is expected to be akin to the Auditor General, Commonwealth Ombudsman, and the Chief Executive Officer of the Australian Radiation Protection and Nuclear Safety Agency.

Clause 27 - Functions of the Regulator

This clause sets out the functions of the Regulator. The Regulator will be responsible for:

(a) performing functions in relation to GMO licences as set out in Part 5. Part 5 describes the process for initial consideration, assessment and decision making in relation to applications for licences under the Bill;

(b) developing draft policy principles and policy guidelines as requested by the Ministerial Council;

(c) developing codes of practice;

(d) issuing technical and procedural guidelines in relation to GMOs;

(e) providing information and advice to other regulatory agencies about GMOs and GM products;

(f) providing information and advice to the public about the regulation of

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GMOs;

(g) providing advice to the Ministerial Council about the operations of the Regulator and the Gene Technology Technical Advisory Committee; and about the effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments of relevant legislation;

(h) undertaking or commissioning research in relation to risk assessment and the biosafety of GMOs;

(i) promoting the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies;

(j) monitoring international practice in relation to the regulation of GMOs;

(k) maintaining links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia; and

(l) performing such other functions as are conferred on the Regulator by this Bill, the regulations or any other law.

Clause 28 - Powers of the Regulator

This clause clarifies that the Regulator has power to do all things necessary or convenient to be done in connection with the performance of the Regulator's functions.

Clause 29 - Delegation

This clause allows the Regulator to delegate the Regulator's powers or functions to Commonwealth officers and State and Territory officers where the functions of such officers relate directly or indirectly to GMOs or GM products. This is important so that, with their agreement, Commonwealth and State officers can be enlisted to assist the Regulator in, for example, undertaking monitoring activities. While the Regulator will be responsible for assessing applications and issuing licences, the Regulator may need to delegate some functions to, for example, officers of the Australian Quarantine and Inspection Service to enable them to inspect imported GMOs at Australia's border to ensure compliance with any licence issued by the Regulator.

Sub-clause 29(2) requires that delegates comply with any directions issued by the Regulator.

Clause 30 - Independence of the Regulator

This clause entrenches the Regulator's independence and discretion in relation to the exercise of his or her powers or functions. It specifically provides that the Regulator may not be directed by anyone in respect of whether or not a particular application for a GMO licence is issued or refused, nor in respect of conditions to which a particular GMO licence may be subject.

PART 4 - REGULATION OF DEALINGS WITH GMOS

DIVISION 1 - Simplified outline

Clause 31 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - Dealings with GMOs must be licensed

Clause 32 - Person not to deal with a GMO without a licence

This clause describes the central prohibition in this legislation. It provides that a person is guilty of an offence if:

(a) the person deals with a GMO knowing that it is a GMO; and

(b) the person knows that the dealing with the GMO is not authorised by a GMO licence or is reckless as to whether or not the dealing is so authorised; and

(c) the person knows that the dealing is not a notifiable low risk dealing (as described in clause 74) or is reckless as to whether or not the dealing is a notifiable low risk dealing; and

(d) the person knows that the dealing is not an exempt dealing (as specified by the regulations) or is reckless as to whether or not the dealing is an exempt dealing; and

(e) the person knows the dealing is not included on the GMO Register (as established under clause 76) or is reckless as to whether or not the dealing is included on the GMO Register.

A person must not, therefore, deal with a thing they know to be a GMO without a licence authorising that dealing, unless the dealing is a notifiable low risk dealing, has been specifically exempted from the application of the legislation under the regulations, or has been placed on the GMO Register.

The note at the end of sub-clause 32(1) alerts readers to Chapter 2 of the Criminal Code which sets out the principles of criminal responsibility which must be met for a successful prosecution. Chapter 2 of the Criminal Code sets out the "mental" or "fault" elements that are necessary for the prosecution to establish in relation to an offence (such as intent or recklessness).

Sub-clause 32(2) describes the maximum penalties that may be imposed in relation to an offence under sub-clause 32(1). If the offence is an aggravated

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offence (as defined in clause 38 as being an offence that causes significant damage, or is likely to cause significant damage, to the health and safety of people or the environment) the penalty is 2,000 penalty units. This equates to $220,000 for an individual and $1.1 million for a body corporate (the Crimes Act 1914 provides that a penalty unit is currently equivalent to $110).

In any other case, the maximum penalty is 500 penalty units which equates to $55,000 for an individual and $275,000 for a body corporate.

Sub-clause 32(3) defines "exempt dealing" to be a dealing specified in the regulations as an exempt dealing

Sub-clause 32(4) provides that regulations may exempt all dealings with a GMO, a class of GMOs, a class of dealings with a GMO or class of GMOs, or one or more specified dealings with a GMO or with a specified class of GMOs. A class of dealings or a class of GMOs may be defined by a range of matters. For example, an exempt class of dealings with a GMO may be limited by the type of GMO, who deals with the GMO, how the GMO is dealt with and whether the GMO is regulated under existing legislation.

Clause 33 - Person not to deal with a GMO without a licence--strict liability offence

This clause describes the same offence as clause 32 but enables strict liability to apply in respect of the offence. This means that a smaller penalty (200 penalty units in the case of an aggravated offence and 50 penalty units in any other case) may be applied in relation to lesser offences without the need to establish all of the fault elements of the offence.

While it is necessary to establish that the person dealt with the GMO knowing that it was a GMO, the fact that they dealt with the GMO without a licence or without the dealing being a notifiable low risk dealing, exempt dealing or dealing on the GMO Register, is sufficient. It will not be necessary to establish that they knowingly or recklessly dealt with the GMO without approval under the legislation.

Clause 34 - Person must not breach conditions of a GMO licence

Sub-clause 34(1) provides that a holder of a GMO licence is guilty of an offence if they intentionally do something, or fail to do something, that they know will result in a breach of a condition of licence or that they do being reckless as to whether or not the action or omission will contravene the licence.

Sub-clause 34(2) establishes a similar offence for persons covered by a GMO licence who do something, or fail to do something, which results in a breach of a condition of licence. However, in this case it is also necessary for the prosecution to establish that the person had knowledge of the conditions of licence. By contrast, in relation to offences committed by holders of a licence (under sub-clause 34(1)) it is assumed that all licence holders would necessarily have knowledge of the conditions of a licence.

Sub-clause 34(3) describes the maximum penalties that may be imposed in relation to an offence under sub-clauses 34(1) and (2). If the offence is an aggravated offence (as defined in clause 38 as being an offence that causes significant damage, or is likely to cause significant damage, to the health and safety of people or the environment), the penalty is 2,000 penalty units. This equates to $220,000 for an individual and $1.1 million for a body corporate (the Crimes Act 1914 provides that a penalty unit is currently equivalent to $110). In any other case, the maximum penalty is 500 penalty units, which equates to $55,000 for an individual and $275,000 for a body corporate.

Clause 35 - Person must not breach conditions of a GMO licence--strict liability offence

This clause describes the same offences as clause 34 but enables strict liability to apply in respect of the offences. This means that a smaller penalty (200 penalty units in the case of an aggravated offence and 50 penalty units in any other case) may be applied in relation to lesser offences (such as a breach of more minor conditions of licence) without the need to establish all of the fault elements of the offence.

Under this clause, if a licence holder breaches a condition of licence, it is not necessary to establish that they did so knowingly or recklessly in order for the penalty to be applied.

If a person covered by a licence breaches a condition of licence, provided it can be established that they had knowledge of the conditions of licence, it is not necessary to establish that they breached the condition of licence knowingly or recklessly in order for the penalty to be applied.

Clause 36 - Person must not breach conditions on GMO Register

This clause provides that a person is guilty of an offence if the person deals with a GMO knowing that it is a GMO, and the dealing is in breach of a condition specified on the GMO Register (described in Part 6, Division 3) relating to the dealing.

Recognising that dealings with GMOs are only entered on the GMO Register after a period of licensing and after the Regulator is satisfied that any risks are minimal and that it is no longer necessary for the GMO to be licensed directly, the penalty for breach of any condition is smaller than the penalties for breach of a condition of licence. Sub-clause 36(1) provides that the maximum penalty is 50 penalty units.

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Sub-clause 36(2) provides that the person must have dealt with the GMO knowing that it is a GMO. However, strict liability applies in relation to establishing that the dealing is on the GMO Register and that the dealing contravened a condition on the Register.

Clause 37 - Offence relating to notifiable low risk dealings

Notifiable low risk dealings are described in clause 74. Notifiable low risk dealings are categories of dealings with GMOs that are low risk dealings. For example, research with low risk GMOs occurring within facilities that are entirely contained. The types of dealings which are notifiable low risk dealings will be set out in regulations, along with any conditions that must be complied with in respect of such dealings.

Sub-clause 37(1) provides that a person is guilty of an offence if they deal with a GMO knowing that it is a GMO, that the dealing is a notifiable low risk dealing, and that the dealing has been undertaken in contravention of the regulations (which describe the conditions to be observed). The maximum penalty is 50 penalty units.

Sub-clause 37(2) provides that strict liability applies in relation to establishing that the dealing is a notifiable low risk dealing and that the dealing was not undertaken in accordance with the conditions prescribed in the regulations.

Clause 38 - Aggravated offences--significant damage to health or safety of people or to the environment

This clause describes the concept of an "aggravated offence", as referenced in clauses 32, 33, 34 and 35. An aggravated offence is one that causes significant damage, or is likely to cause significant damage, to the health and safety of people or to the environment. This recognises that some offences against the Bill are potentially more serious than others (given the possible significant consequences that may flow from an action), and that in the event of such serious offences there should be higher penalties.

Sub-clause 38(2) provides that in order to prove an aggravated offence, the prosecution must prove that the person who committed the offence intended his or her conduct to cause significant damage to the health and safety of people, or to the environment or that the person was reckless as to whether his or her conduct would cause such significant damage.

PART 5--LICENSING SYSTEM DIVISION 1-- Simplified outline Clause 39 - Simplified outline This clause gives a simplified outline of the Part.

DIVISION 2 - Licence applications DIVISION 2 - Licence applications Clause 40 - Person may apply for a licence Clause 40 - Person may apply for a licence

This clause describes the requirements for applying to the Regulator for a licence to undertake certain dealings with GMOs.

Sub-clause 40(2) provides that the licence applicant must apply in writing and must provide all of the information requested by the Regulator and prescribed in the regulations. The applicant will be required to provide the Regulator with all of the information that is necessary to support the assessment of the application including information about potential risks associated with the proposed dealings and how the applicant proposes to manage any such risks.

Sub-clause 40(3) requires that the application specify whether any of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment. This is important as it determines the assessment process applied in relation to the application.

Sub-clause 40(4) clarifies that an application may be made in respect of one dealing, one or more specified dealings, or in respect of a class of dealings with specified GMOs or classes of GMOs.

Sub-clause 40(5) clarifies that the applicant may apply for authorisation for the dealings with the GMO to be undertaken by a named person, a class of persons or all persons.

Sub-clause 40(6) provides that the application must be accompanied by an application fee if such an application fee is prescribed in the regulations.

Clause 41 - Application may be withdrawn

This clause allows the applicant to withdraw a licence application at any time before the licence is issued.

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Sub-clause 41(2) provides that the application fee is not refundable if the applicant withdraws the application.

Clause 42 - Regulator may require applicant to give further information

This clause enables the Regulator to require an applicant for a licence to give the Regulator such further information in relation to the application as the Regulator requires. The request for further information must be by notice in writing and may specify the period within which information is to be provided.

Clause 43 - Regulator must consider applications except in certain circumstances

This clause enables the Regulator to undertake an initial "screening" of an application before he or she accepts the application. As part of this initial screening, the Regulator looks at whether:

* the application contains the required information, including any further information previously requested by the Regulator;

* the application indicates whether it involves a deliberate release into the environment or not (as this will be important for determining the assessment process undertaken);

* it is accompanied by the requisite application fee; and

* the application is inconsistent with a policy principle issued by the Ministerial Council under clause 21.

If the application is inadequate on any of these grounds, the Regulator may refuse to undertake any further consideration of the application.

Sub-clause 43(3) provides that the Regulator must issue the licence or refuse to issue the licence within any statutory timeframe described in the regulations.

Clause 44 - Regulator may consult with applicant

This clause allows the Regulator to consult with the applicant on an application before considering that application. This provides capacity for the Regulator to hold `pre-conferences' with applicants to assist their understanding of the regulatory requirements. If the application relates to a GMO that will also require approval from an existing regulator or regulators at some point during the life cycle of the GMO or its products, the Regulator may also involve these other relevant regulators to ensure an effective and efficient interface between the relevant regulatory agencies.

Clause 45 - Regulator must not use certain information in considering licence application

This clause provides that, where a person provides confidential commercial information in support of a licence application, the Regulator must not use that information to consider a licence application by another person unless the first person has given written consent for the information to be used.

This clause is intended to combat the `free rider' effect, where it would be possible for a second applicant to minimise the resource implications of a licence application by referring to, or using, information already made available to the Regulator in support of another application.

Whilst the Regulator may not consider the information submitted by the first party in relation to an application by a second party (without the written permission of the first party) this does not preclude the Regulator from utilising resources generated by the Regulator in relation to the first application (eg literature searches) in considering the second application. Further, the Regulator may use information he or she learns about risk in respect of the first application, to aid consideration of the second.

DIVISION 3--Initial consideration of licences for dealings not involving intentional release of a GMO into the environment

Clause 46 - Applications to which this Division applies

This clause provides that Division 3 applies to an application for a GMO licence where the Regulator is satisfied that none of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment. This would include, for example, applications in respect of dealings with GMOs within a contained laboratory.

The term `intentional release of a GMO into the environment' is defined in clause 11.

Clause 47 - What the Regulator must do in relation to application

This clause sets out the steps that the Regulator must take in assessing an application and before a decision on the application is made.

Sub-clause 47(1) provides that before issuing a licence, the Regulator must prepare a risk assessment and risk management plan in relation to the GMO and the proposed dealings in the licence application. The risk assessment must take into account any risks posed to health and safety of people or the

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environment, by the proposed dealing with the GMO. The risk management plan must take into account how any such risks may be managed so as to protect the health and safety of people and the environment.

Sub-clause 47(4) provides that the Regulator may consult the States, the Gene Technology Technical Advisory Committee, relevant Commonwealth authorities and local councils, as well as any other person, on any aspect of the application.

DIVISION 4 - Initial consideration of licences for dealings involving intentional release of a GMO into the environment

Clause 48 - Applications to which this Division applies

This clause provides that Division 4 applies where the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence involves the intentional release of a GMO into the environment. For example, this Division applies to small-scale experimental trials of GMO crops conducted in fields or waterways and applications for commercial release of a GMO, for example, large scale growing of crops for commercial sale.

The term `intentional release of a GMO into the environment' is defined in clause 11.

Clause 49 - Dealings that may pose significant risks to the health and safety of people or the environment

This clause describes the process that the Regulator must follow, and the matters the Regulator must consider, where at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or the environment.

Recognising that applications for licences involving the intentional release of GMOs into the environment may be varied, and that the risks posed by applications also vary, it is important that the Regulator have the capacity to apply an assessment process appropriate for considering the risks posed by the particular application. For example, the risks posed in relation to an application seeking authorisation to hold two genetically modified cows in a double-fenced holding pen are very different to the risks that may be posed by the extensive growing of genetically modified crops in open fields. While both involve the deliberate release of a GMO into the environment, this clause enables the Regulator to apply a higher level of public scrutiny to applications which pose greater potential risks.

Sub-clause 49(1) requires that the Regulator inform stakeholders and the community of the receipt of all applications relating to dealings that may pose significant risks to the health and safety of people or to the environment via a wide publication of a notice in respect of the application. The Regulator must provide public notification of such applications by notice in the Gazette, by advertisement in a newspaper circulating nationally and by notice on the Regulator's website. The Regulator may also choose to notify receipt of such an application through other means, such as direct mailing individuals and organisations who have registered an interest in receiving such information from the Regulator.

Sub-clause 49(2) sets out the matters that the Regulator must have regard to in determining whether the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or the environment. The Regulator must, for example, consider the potential for spread of the GMO, the scale of the proposed dealings, and the effects of the genetic modification on the properties of the organism.

Sub-clause 49(3) sets out certain requirements for the content of the public notification in respect of the application. The notice must: state that an application has been made; state that a person may request further information about the application; invite written submissions on the application; and specify the closing date for submissions (being no earlier than 30 days after the date on which the notice was published). The Regulator may however decide on a longer period of consultation.

Clause 50 - Regulator must prepare risk assessment and risk management plan

Sub-clause 50(1) provides that, before issuing a licence, the Regulator must prepare a comprehensive risk assessment and risk management plan. The risk assessment would:

* identify any hazards to public health and safety or the environment associated with the dealing, based on objective information;

* estimate the probabilities of hazards occurring; and

* estimate the risk that is a function of the above two factors.

Following the estimation of risk, a risk management plan would identify measures for managing any risks identified in order to reduce the probability of hazards occurring. The risk management plan may provide that the risks cannot be managed and, as such, a licence should not be granted. Alternatively the plan could set out conditions that would be necessary for the risks to be effectively managed.

It is intended that the Regulator will issue detailed guidelines regarding the process for risk assessment and risk management, following extensive public consultation on these matters.

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Sub-clause 50(2) clarifies that, regardless of the Regulator's initial consideration regarding the risks of the proposed dealings and whether or not a first round of public consultation was therefore necessary, the Regulator must prepare a comprehensive risk assessment and risk management plan (such assessments and plans must then be notified publicly under clause 52).

Sub-clause 50(3) provides that, in preparing a risk assessment and risk management plan, the Regulator must seek advice from a range of parties, including the Gene Technology Technical Advisory Committee, the States, the Commonwealth Environment Minister, prescribed Commonwealth agencies and relevant local councils.

Clause 51 - Matters Regulator must take into account in preparing risk assessment and risk management plan

Sub-clause 51(1) details a range of matters which must be considered by the Regulator in preparing the risk assessment. Those matters include the risks posed by the proposed dealings, submissions made to the Regulator, and any advice provided by the Gene Technology Technical Advisory Committee and Commonwealth, State and local government agencies.

Sub-clause 51(2) details the range of matters which must be considered by the Regulator in preparing the risk management plan. Those matters include the means of managing any risks to the health and safety of people and the environment posed by the proposed dealings, submissions made to the Regulator, and any advice provided by the Gene Technology Technical Advisory Committee, the Commonwealth Environment Minister and Commonwealth, State and local government agencies. Regulations may also prescribe other matters to be taken into account by the Regulator in preparing the risk assessment or risk management plan.

Sub-clause 51(3) provides that, in ascertaining the best means of managing the risks associated with the GMO, the Regulator is not limited to considering submissions or advice made or given to him or her, and may inform him or herself through other means such as independent research.

Clause 52 - Public notification of risk assessment and risk management plan

This clause describes the process the Regulator must follow after having prepared a draft risk assessment and risk management plan. The Regulator must notify the public stating that a risk assessment and risk management plan has been prepared. The notice must: inform people that they are able to request a copy of the risk assessment and risk management plan (in accordance with clause 54); invite written submissions on the risk assessment and risk management plan; and specify the closing date for submissions (which may not be earlier than 30 days after the notice was published).

The Regulator must publish the notice in the Government Gazette, a newspaper circulating in all States and on the Regulator's website. The Regulator may also supplement this notification by, for example, direct mailing all persons who have registered an interest in receiving notification of applications and placing advertisements in the papers of regional areas affected by the application.

Sub-clause 52(3) also requires the Regulator to seek the views of the Gene Technology Technical Advisory Committee, the States, Commonwealth agencies prescribed in regulations, the Commonwealth Environment Minister and such local councils as the Regulator considers appropriate.

Clause 53 - Regulator may take other actions

This clause allows the Regulator to take other actions to determine whether the range of dealings proposed by the application do indeed pose risks to the health and safety of people or the environment. These actions may include a public hearing.

Sub-clauses 53 (2) - (4) set out certain requirements in relation to public hearings, including the capacity for the Regulator to give directions restricting the publication of evidence given at a public hearing (sub-clause 53(3)) and a penalty where such directions are contravened.

Clause 54 - Person may request copies of certain documents

This clause clarifies that when a person requests a copy of a licence application or risk assessment or risk management plan, the Regulator must provide the person with the information, excluding any confidential commercial information and any information about the applicant's relevant convictions (within the meaning of clause 58).

DIVISION 5 - Decision on licence etc.

Clause 55 - Regulator must make a decision on licence and licence conditions

This clause provides that, after taking the steps required in Division 3 or 4 of part 5 in relation to an application for a GMO licence, the Regulator must decide whether or not to issue a licence. If the Regulator decides to issue a licence, he or she may impose conditions in relation to the dealings with the GMO.

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Clause 56 - Regulator must not issue the licence unless satisfied as to risk management

Sub-clause 56(1) provides that the Regulator must not issue the licence unless he or she is satisfied that any risks posed by the proposed dealings are able to be managed in such a way as to protect the health and safety of people and the environment.

Sub-clause 56(2) specifies the matters that the Regulator must have regard to in making a decision under sub-clause 56(1) as including: a risk assessment; the risk management plan; any submissions received on the risk assessment and risk management plan; and any policy guidelines in force under clause 23 (as issued by the Ministerial Council).

Clause 57- Other circumstances in which Regulator must not issue the licence

This clause sets out the other circumstances in which the Regulator must not issue the licence. These circumstances include:

(a) where the issue of the licence would be inconsistent with a policy principle issued by the Ministerial Council under clause 21; and

(b) where the Regulator is not satisfied that the applicant is a suitable person to hold the licence. Matters that the Regulator must take into account when determining an applicant's suitability are described in clause 58.

Clause 58 - Matters to be taken into account in deciding whether a person is suitable to hold a licence

This clause allows the Regulator to consider a range of matters in deciding whether a natural person or a corporation is suitable to hold a licence.

Sub-clause 58(1) specifies that, in relation to a natural person, the Regulator must have regard to any relevant conviction of the person, and any revocation or suspension of a licence or permit relating to the health and safety of people or the environment which is or was held by the person under a law of the Commonwealth, a State, or a foreign country. The Regulator must also consider the capacity of the person to meet the conditions of the licence. This may include, for example, a consideration of the person's financial viability, personal skills and experience, and any other matters that may influence the capacity of the applicant to fulfill any conditions of licence imposed by the Regulator.

Sub-clause 58(2) specifies that, for a body corporate, the Regulator must have regard to any relevant conviction of the body corporate, and where there is a relevant conviction, whether the offence was committed at a time when any person who is presently a director, officer or shareholder of the corporation was a director, officer or shareholder. This sub-clause also requires the Regulator to consider any revocation or suspension of a licence or permit relating to the health and safety of people or the environment which is or was held by the corporation under a law of the Commonwealth, a State, or a foreign country. The Regulator must also consider the capacity of the corporation to meet the conditions of the licence.

Sub-clause 58(3) clarifies the meaning of a `relevant conviction'. Not only must the offence have related to a law concerning the health and safety of people or the environment, but the offence must have been committed within the period of 10 years immediately before the making of the application for the licence, and the offence must have been punishable by a fine of $5,000 or more, or by a term of imprisonment of one year or more.

Sub-clause 58(4) clarifies that the clause does not affect the operation of Part VIIC of the Crimes Act 1914, which relieves persons of disclosing spent convictions in certain circumstances.

Clause 59 - Notification of licence decision

This clause requires that the Regulator provide a written notification to the applicant of the Regulator's decision, including any conditions imposed.

Clause 60 - Period of licence

This clause specifies that a licence issued under the Bill remains valid either until the end of a specified period, or until it is cancelled or surrendered.

Sub-clause 60(2) provides that a licence is not in force during any period of suspension.

DIVISION 6 - Conditions of licences

Clause 61 - Licence is subject to conditions

This clause provides that licences may be subject to a range of conditions, including conditions set out in clauses 63, 64 and 65, conditions prescribed by the regulations and conditions imposed by the Regulator at the time of issuing the licence or at any time thereafter.

Clause 62 - Conditions that may be prescribed or imposed

Sub-clause 62(1) enables the Regulator to impose conditions in relation to the GMO that relate to the `full life-cycle' of the GMO, including any products derived from that GMO.

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Sub-clause 62(2) lists some of the possible licence conditions which may be imposed. Licence conditions may, for example, relate to: limiting the scope of the dealings authorised by the licence, the purposes for which the dealings may be undertaken, and the geographic area in which the dealings authorised by the licence may occur; labeling of the GMO; limiting the dissemination or persistence of GMO in the environment; and contingency planning in respect of unintended effects of the dealings authorised by the licence.

Clause 63 - Condition about informing people of obligations

Sub-clause 63(1) makes it a condition of a licence that the licence holder inform any person covered by the licence, and to whom a particular condition of the licence applies, of several matters. These are: the particular conditions applying to the person (including any variations of conditions); the cancellation or suspension of the licence; and the licence-holder's surrender of the licence.

Sub-clause 63(2) allows the Regulator or the regulations to specify particular requirements for the way that people covered by a licence must be informed of their obligations by the licence holder.

Sub-clause 63(3) notes that such requirements may include measures relating to labelling, packaging, conducting training and providing information in relation to the dealings with the GMO.

Sub-clause 63(4) makes it a condition of licence that, where requirements for informing people covered by a licence have been prescribed or specified, the licence holder must comply with those requirements.

Clause 64 - Condition about monitoring and audits

This clause requires that, where a person is authorised to deal with a GMO, and a particular licence condition applies to that dealing, the person authorised to deal with the GMO must allow the Regulator (or his or her delegate) to enter premises where the dealing is being undertaken, for the purposes of auditing or monitoring the dealing.

This condition enables the Regulator to undertake routine or "on-the-spot" auditing and/ or monitoring of licensed dealings with GMOs to ensure that any conditions imposed are being complied with and that the activity with the GMO is being conducted safely. The auditing and monitoring powers of the Regulator (provided for by this clause) are also supplemented by the inspection powers of inspectors in the case of a possible breach of the legislation. Part 11 of the Bill describes these additional powers of inspection.

Clause 65 - Condition about additional information to be given to the Regulator

This clause makes it a condition of a licence, and therefore compels the licence holder, to provide information to the Regulator in the following circumstances:

* where he or she becomes aware of additional information as to any risks to the health and safety of people or to the environment associated with the dealings authorised by the licence; or

* where he or she becomes aware of any contraventions of the licence by a person covered by the licence; or

* where he or she becomes aware of any unintended effects of the dealings authorised by the licence.

Sub-clause 65(2) specifies that the licence holder is taken to have become aware of additional information as to risks if he or she was reckless as to whether such information existed. The licence holder is also taken to have become aware of contraventions or unintended effects of the licence if he or she was reckless as to whether such contraventions had occurred or unintended effects existed.

Clause 66 - Person may give information to Regulator

This clause provides that a person covered by a licence may inform the Regulator if he or she becomes aware of additional information as to any risks associated with the dealings authorised by the licence that may pose risks to the health and safety of people or to the environment. A person who becomes aware of any contraventions of the licence by a person covered by the licence, or becomes aware of any unintended effects, may also provide such information to the Regulator.

Clause 67 - Protection of persons who give information

This clause provides that civil proceedings may not be brought against a person who has given information to the Regulator because another person has suffered loss, damage or injury as the result of the disclosure of information to the Regulator. This clause does not, however, affect any rights a person may have against an informer who published the information more broadly than just to the Regulator - this clause only provides protection in respect of civil proceedings in relation to the disclosure of the information to the Regulator.

DIVISION 7 - Suspension, cancellation and variation of licences

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Clause 68 - Suspension and cancellation of licence

This clause gives the Regulator the power to suspend or cancel a licence. This power may be exercised by the Regulator by giving written notice to the licence holder. The grounds for the exercise of this power are listed in this clause and include: suspected breach of a licence condition; suspicion that an offence has been committed against the Bill; or where the Regulator becomes aware of new information about the risks associated with the licensee's dealings, and he or she is satisfied that the licensee does not have adequate measures to deal with those risks.

Clause 69 - Surrender of licence

This clause allows a licence holder to surrender a licence, with the consent of the Regulator.

Clause 70 - Transfer of licences

This clause allows for a licence to be transferred from the licence holder to a `transferee' provided that certain requirements are met.

Sub-clause 70(1) provides that a licence holder and the person to whom it is proposed that the licence be transferred (the transferee) may jointly apply to the Regulator for the licence to be transferred.

Sub-clause 70(2) specifies that the application must be in writing and must include information specified by the Regulator and/or prescribed in the regulations.

Sub-clause 70(3) requires that, in deciding whether to approve the transfer of the licence, the Regulator must be satisfied that any risks posed by the dealings will continue to be managed in such a way as to protect the health and safety of people, and the environment.

Sub-clause 70(4) also requires that the Regulator decide whether the transferee is a `suitable person' to hold the licence. The criteria described in clause 58 would be used by the Regulator in making such an assessment.

Sub-clause 70(5) requires that the Regulator provide written notice of his or her decision to the licence holder and the transferee.

Sub-clause 70(6) sets out the effect of a transfer. The transfer takes effect on the date specified in the written notice provided to the licence holder and the transferee by the Regulator and the licence continues in force under clause 60 subject to the same conditions as in force immediately before the transfer. The Regulator may however subsequently vary the conditions of licence (if necessary) in accordance with clause 71.

Clause 71 - Variation of licence

This clause allows the Regulator to vary a licence where he or she is satisfied that any variation will have the effect of ensuring that any risks to the health and safety of people and the environment are properly managed.

Sub-clause 71(2) provides that the Regulator's discretion to vary the licence is limited. The Regulator must not vary a licence so as to authorise dealings involving the intentional release of a GMO into the environment if the application for the licence was originally considered under Division 3 (which deals with licence applications where there is to be no release of the GMO into the environment).

Sub-clause 71(3) allows the Regulator to vary a licence in a number of ways, including: by imposing additional licence conditions; removing or varying conditions; or by extending or reducing the authority granted by the licence.

Sub-clause 71(4) provides that the Regulator must not vary a licence if to do so would mean that any risks posed by a dealing authorised by the licence could not be properly managed so as to ensure the continued protection of the health and safety of people and the environment.

Clause 72 - Regulator to notify of proposed suspension, cancellation or variation

Sub-clauses 72(1), (2) and (3) specify that the Regulator must give written notice of a proposed suspension, cancellation, or variation of a licence to the licence holder. The notice must state the Regulators intentions regarding the suspension, cancellation or variation of the licence. The notice may also require the licence holder to give the Regulator specified information which is relevant to the proposed changes to the licence, and may invite the licence holder to make a written submission to the Regulator about the proposed suspension, cancellation or variation. The licence holder must be given at least 30 days in which to provide the requested information or make a written submission.

Sub-clause 72(4) requires that the Regulator consider any submission made by the licence holder in making the decision to suspend, cancel or vary the licence.

Sub-clause 72(5) clarifies that the requirements set out in this clause are not necessary where the suspension, cancellation or variation has been requested by the licence holder.

Sub-clause 72(6) waives the formal requirements for notification to the licence holder where the Regulator considers that the suspension, cancellation or variation is necessary in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.

PART 6 - REGULATION OF NOTIFIABLE LOW RISK DEALINGS AND DEALINGS ON THE GMO REGISTER

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DIVISION 1 - Simplified outline

Clause 73 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2--Notifiable low risk dealings

Clause 74 - Notifiable low risk dealings

This clause allows regulations to be made which declare a particular dealing with a GMO to be a `notifiable low risk dealing' for the purposes of this Bill. These would be low risk dealings in contained facilities that the Regulator determines to be low risk on the basis of experience and previous risk assessments of the class of dealings.

Sub-clause 74(2) provides that a notifiable low risk dealing can never involve the intentional release of the GMO into the environment. That is, dealings with GMOs may only be prescribed in the regulations as notifiable low risk dealings if the dealings are carried out within contained facilities.

Sub-clauses 74(3) specifies the matters to be considered by the Regulator before regulations are made prescribing notifiable low risk dealings. Relevant considerations include: whether the GMO is `biologically contained' (because it is not able to survive or reproduce without human intervention); whether the dealing involves minimal risk (taking into account the properties of the GMO as a pathogen or pest and its capacity to produce toxic proteins); and whether proposed conditions will be adequate to manage any risk associated with the proposed dealing.

Sub-clause 74(4) provides that where regulations are made prescribing certain dealings as notifiable low risk dealings, the regulations may be expressed to apply to a single dealing, a class of dealings or all dealings with a GMO or a class of GMOs.

Clause 75 - Regulation of notifiable low risk dealings

Sub-clause 75(1) allows regulations to be made which regulate one notifiable low risk dealing, or a specified class of notifiable low risk dealings.

Sub-clause 75(2) specifies that the regulations may contain certain conditions which must be complied with by persons undertaking notifiable low risk dealings, including requirements in relation to: the class of person who may undertake notifiable low risk dealings; notification of the dealings to the Regulator; the need for supervision by an Institutional Biosafety Committee; and the containment level of facilities in which such dealings are undertaken. The role of Institutional Biosafety Committees, set up within Accredited Organisations, is explained in more detail in Part 7, Division 3.

DIVISION 3--The GMO Register

Clause 76 - GMO Register

This clause establishes the GMO Register, which is to be kept in a computerised form and maintained by the Regulator.

As described in this Division, the purpose of the GMO Register is to enable certain dealings with GMOs to be undertaken without the requirement for a licence to be held by a named individual or organisation. Dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time, and once the Regulator is satisfied that the dealings with the GMO are sufficiently safe that they can be undertaken by anyone without the GMO being dependent on oversight by a licence holder).

For example, a company who wished to market a flower that had been genetically modified to extend vase life, would initially apply for a licence to do so. If any risks posed by the flower could be managed, the Regulator would grant the applicant a licence subject to, as a minimum, conditions requiring provision of any further information about risks or unintended effects by the licence holder and a requirement that the Regulator be allowed to enter premises to undertake auditing and monitoring. After a period of time (for example, 5 years), the Regulator could re-examine the licence and determine that, on the basis of the absence of risks posed by the flower, it is no longer appropriate for the flower to be subject to the licensing regime and that the flower should be entered on the Register, enabling unrestricted use.

Clause 77 - Contents of Register

This clause provides that, where the Regulator determines that a dealing with a GMO is to be included in the GMO Register, the Register must contain: a description of the dealing with the GMO; and any condition(s) to which a particular dealing with a GMO is subject.

Clause 78 - Regulator may include dealings with GMOs on GMO Register

Sub-clause 78(1) provides that the Regulator may place a GMO on the Register where the dealing with the GMO is, or has previously been, authorised by a GMO licence.

Under sub-clause 78(2), a determination to place something on the GMO Register may be made on application by a GMO licence holder, or on the initiative of the Regulator.

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Sub-clause 78(3) provides that a determination takes effect on the day specified in the determination. Further, in the circumstances whereby a licence holder has applied to have certain licensed dealings with GMOs entered on the Register, the date specified in the determination must not be before the licence ceases to be in force. That is, the licence must "run its course" before the dealing with the GMO may be placed on the Register.

Sub-clause 78(4) provides that a determination to include a GMO dealing on the GMO Register is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.

Clause 79 - Regulator not to make determination unless risks can be managed

This clause prevents the Regulator from placing a dealing with a GMO on the Register unless the Regulator is satisfied that any risks posed by the dealing are minimal, and that it is not necessary for the persons undertaking the dealing to hold, or be covered by, a GMO licence in order to protect the health and safety of people and the environment.

In making a determination to place a dealing on the GMO Register, the Regulator must have regard to all available information about the possible need for a licence, including: any data about adverse effects posed by the dealing; any other information as to risks associated with the dealing of which the Regulator is aware; and whether there is a need for the dealing to be subject to conditions. The Regulator may also have regard to any other matters the Regulator considers relevant.

Clause 80 - Variation of GMO Register

This clause allows the Regulator to vary the GMO Register by written determination so as to: remove a dealing from the GMO Register; revoke or vary conditions to which the dealing is subject; or impose additional conditions on the dealing. A written determination varying the GMO Register in any of these ways is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.

Clause 81 - Inspection of Register

This clause requires the Regulator to permit any person to inspect any part of the GMO Register.

PART 7 - CERTIFICATION AND ACCREDITATION

DIVISION 1 - Simplified outline

Clause 82 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - Certification DIVISION 2 - Certification Clause 83 - Application for certification This clause allows a person to apply to the Regulator for certification of a facility to a particular containment level. The application must be in writing, must contain such information as the Regulator requires, and be accompanied by the appropriate application fee (as prescribed by the regulations).

Certification of a facility to a certain containment level will be required of any organisation who wishes to undertake notifiable low risk dealings, or who holds a licence for dealings with GMOs where the licence includes a condition that the work with the GMO be conducted in a facility certified to a particular containment level.

The containment levels to which the Regulator may certify a facility will be documented in guidelines issued by the Regulator (as described in clause 90).

Clause 84 - When the Regulator may certify the facility This clause allows the Regulator to certify the facility to a specified containment level where the facility meets the requisite containment standards, which are to be specified in guidelines issued by the Regulator under clause 90.

Clause 85 - Regulator may require applicant to give further information This clause allows the Regulator to request an applicant for certification of a facility to provide the Regulator, within a specified period, with additional

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information to assist the Regulator's consideration of the application.

Clause 86 - Conditions of certification

This clause provides that the certification of a facility is subject to several types of conditions: those imposed by the Regulator at the time of certification; those imposed after certification as a variation to the original certification; and any conditions prescribed in the regulations.

Clause 87 - Variation of certification

This clause allows the Regulator to vary the certification of a facility, by notice in writing, to the holder of the certification. The Regulator has a discretion to impose additional conditions or remove or vary the conditions originally imposed.

Clause 88 - Suspension or cancellation of certification

This clause allows the Regulator to suspend or cancel the certification of a facility where the Regulator believes that, on reasonable grounds, a condition of the certification has been breached.

Clause 89 - Regulator to notify of proposed suspension, cancellation or variation

Sub-clause 89(1) requires that, before suspending, cancelling or varying a certification, the Regulator will provide written notice to the holder of the certification. The formal requirements of the notice are specified in sub-clause 89(2), and include the requirement that (within a designated period) any relevant information be provided by the holder of the certification to the Regulator, and a requirement to invite the holder of the certification to make a written submission concerning the proposed suspension, cancellation or variation.

Sub-clause 89(3) requires that the notice provided to the holder of certification must specify the period in which the holder of certification must give information or make submission. The period must not be less than 30 days.

Sub-clause 89(4) provides that the Regulator must consider any written submissions made to him or her.

Sub-clauses 89(5) and (6) exclude the requirements of this clause where the suspension or variation is requested by the holder of the certification, or where the Regulator considers that the action is necessary to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.

Clause 90 - Guidelines

This clause allows the Regulator to issue technical or procedural guidelines (for example, about the requirements for the certification of facilities to specified containment levels) and to vary or revoke those guidelines by written instrument.

DIVISION 3 - Accredited organisations

Clause 91 - Application for accreditation

This clause enables a person to apply to the Regulator for accreditation of an organisation. The application must be in writing, and contain such information as the Regulator requires.

It is anticipated that the regulations will provide that notifiable low risk dealings may only occur within accredited organisations. Similarly, the Regulator may impose as a condition of licence, a requirement that the work be conducted within an accredited organisation. As described in this Division, an organisation will be accredited if it can establish to the satisfaction of the Regulator that it has a properly constituted Institutional Biosafety Committee (operating in accordance with guidelines issued by the Regulator).

The role of Institutional Biosafety Committees will be to provide day to day advice and assistance to, and oversight of, people undertaking dealings with GMOs within organisations. Regulatory responsibility will continue to rest with the Regulator (including responsibility for independent monitoring and auditing of the dealings with GMOs). The Institutional Biosafety Committee will, however, play an important role in ensuring the safety of dealings with GMOs and in providing assistance and advice both to applicants and licence holders and also to the Regulator.

Clause 92 - Regulator may accredit organisations

Sub-clause 92(1) enables the Regulator to accredit an organisation (by written instrument).

Sub-clause 92(2) provides that in making the decision whether to accredit the organisation, the Regulator must have regard to matters such as: whether the organisation has established, or proposes to establish, and whether it will be able to maintain, an Institutional Biosafety Committee and; whether the organisation has, or will have, appropriate indemnity arrangements for Institutional Biosafety Committee members. The Regulator may also take into account any other matters specified in guidelines issued by the Regulator.

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Clause 93 - Regulator may require applicant to give further information

This clause enables the Regulator to require an applicant for accreditation of an organisation to give the Regulator, within a designated period, relevant further information in relation to the application.

Clause 94 - Conditions of accreditation

This clause specifies that the conditions to which accredited organisations are subject are: those imposed by the Regulator at the time of accreditation; those imposed by the Regulator later by variation; and those prescribed by the regulations.

Clause 95 - Variation of accreditation

This clause gives the Regulator power to vary the organisation's accreditation, at any time, by notice in writing.

Sub-clause 95(2) allows the Regulator to impose additional conditions or remove or vary conditions that were originally imposed.

Clause 96 - Suspension or cancellation of accreditation

This clause enables the Regulator to suspend or cancel the accreditation of an organisation if the Regulator believes, on reasonable grounds, that a condition of the accreditation has been breached.

Clause 97 - Regulator to notify of proposed suspension, cancellation or variation

This clause provides that the Regulator must provide notice in writing of the proposed suspension, cancellation or variation to the holder of the accreditation. The notice may request relevant information and invite a written submission from the holder of the accreditation, within a designated timeframe. The Regulator must consider any written submissions made to him or her.

Sub-clauses 97(5) and (6) exclude the requirements of the clause where the suspension, cancellation or variation is requested by the holder of the accreditation, or where the Regulator considers that the action is necessary to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.

Clause 98 - Guidelines

This clause enables the Regulator to issue guidelines containing requirements that must be met in order for an organisation to be accredited.

Sub-clause 98(2) provides that such guidelines may relate to, but are not limited to, the establishment and maintenance of Institutional Biosafety Committees.

Sub-clause 98(3) also allows the Regulator to vary or revoke the guidelines by written instrument.

PART - THE GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE, THE GENE TECHNOLOGY COMMUNITY CONSULTATIVE GROUP AND THE GENE TECHNOL OGY ETHICS COMMITTEE

DIVISION 1 - Simplified outline

Clause 99 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - The Gene Technology Technical Advisory Committee

Clause 100 - The Gene Technology Technical Advisory Committee

This clause establishes the Gene Technology Technical Advisory Committee as a committee comprising up to 20 part-time members appointed by the Minister.

The Minister must appoint a chair to the Committee and before appointing any members must consult a range of stakeholders including: the States; the Regulator; scientific, consumer, health, environmental and industry groups as considered appropriate by the Minister; and any Ministers the Minister considers appropriate.

Sub-clause 100(5) lists the areas of experience required on the Gene Technology Technical Advisory Committee, and specifies that the Minister must not appoint a person as a member of the Committee unless the Minister is satisfied that the person has skills or experience in one or more of a range of scientific and technical areas.

The areas of expertise to be reflected on the Committee include: molecular biology; ecology; plant, microbial, animal or human genetics; virology; entomology; agricultural or aquacultural systems; biosafety engineering; public health; occupational health and safety; risk assessment; clinical medicine; biochemistry; pharmacology; plant or animal pathology; botany; microbiology; animal biology; immunology; toxicology; and any other areas specified by the regulations.

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Sub-clause 100(6) provides that the Minister must also appoint a layperson as a member of the Committee. The Minister need not be satisfied that the person has skills or experience in an area mentioned in sub-clause 100(5).

Sub-clause 100(7) provides that, in appointing the members of the Committee, the Minister must ensure, as far as is practicable, that among the members as a whole there is a broad range of skills and experience in the areas mentioned in sub-clause 100(5).

Sub-clause 100(8) also provides that the Minister must not appoint a member to chair the Committee unless a majority of jurisdictions agree to the appointment.

Clause 101 - Function of the Gene Technology Technical Advisory Committee

This clause specifies that the function of the Gene Technology Technical Advisory Committee is to provide advice, on the request of the Regulator, or of the Ministerial Council, on a range of matters which include:

(a) gene technology, GMOs and GM products;

(b) applications made under the Bill;

(c) the biosafety aspects of gene technology; and

(d) the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes.

Clause 102 - Expert advisers

This clause allows the Minister to appoint one or more `expert advisers' to the Gene Technology Technical Advisory Committee. These advisers may be appointed on an ad hoc or continuing basis and will be expected to supplement the expertise of the Committee where this is necessary in relation to the consideration of particular applications. The expert advisers will play a supporting role to the Committee and will not have voting rights on the Committee.

Clause 103 - Remuneration

Sub-clause 103(1) requires that members of the Gene Technology Technical Advisory Committee, and expert advisers to the Committee, are to be remunerated at a rate set by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, members are to be paid the remuneration as prescribed in the regulations.

Sub-clause 103(2) specifies that members of the Committee and their expert advisers are to be paid the allowances that are prescribed in the regulations.

Sub-clause 103(3) provides that this clause is subject to the Remuneration Tribunal Act 1973.

Clause 104 - Members and procedures

This clause enables regulations to be made prescribing a range of matters relating to the members of the Gene Technology Technical Advisory Committee, and to expert advisers, such as: terms of appointment; resignation; disclosure of interests; termination of appointment; and leave of absence.

Sub-clause 104(2) states that regulations may also be made on matters relating to the operation of the Committee, such as: procedures for convening meetings of the Committee; the constitution of a quorum for a meeting of the Committee; the way in which matters are to be resolved by the Committee; Committee records; and reporting requirements.

Sub-clauses 104(3) and (4) provide that, where no regulations have been made to guide the operations of the Committee, the Regulator may determine how the Committee must operate and, in the absence of such a determination by the Regulator, the Committee may operate in the way it determines.

Clause 105 - Subcommittees

This clause allows the formation of subcommittees to assist in the performance of the Committee's functions, and provides for the making of regulations to deal with the constitution and operation of such subcommittees.

DIVISION 3 - The Gene Technology Community Consultative Group

Clause 106 - The Gene Technology Community Consultative Group

This clause establishes the Gene Technology Community Consultative Group, to be known as the Consultative Group.

Clause 107 - Function of Consultative Group

This clause provides that the function of the Consultative Group is to provide advice, on the request of the Regulator or the Ministerial Council, on matters of general concern in relation to GMOs, and on the need for (and content of) policy principles, guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GMO products.

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Clause 108 - Membership

This clause specifies that the Minister is to appoint up to 12 members of the Consultative Group on a part-time basis, including one of the members as chair.

Sub-clause 108(2) provides that, prior to appointing a member of the Consultative Group, the Minister must consult: the Regulator; the States; such scientific, consumer, health, environmental and industry groups as the Minister considers appropriate; and such other Ministers as the Minister considers appropriate.

Sub-clause 108(3) provides a list of areas of experience for members of the Consultative Group. It specifies that, with two exceptions, the Minister must not appoint a person as a member of the Consultative Group unless the Minister is satisfied that the person has skills or experience pertaining to gene technology in one or more of the following areas: environmental issues; consumer issues; the impact of gene technology on the community; issues relevant to the biotechnology industry; issues relevant to gene technology research; public health issues; issues relevant to primary production; and issues relevant to local government. Regulations may also be made prescribing additional areas of skill or experience.

It is not intended that the appointees to the Consultative Group be scientific experts in gene technology. Rather, it is expected that they will be able to speak to certain issues that are relevant to gene technology (such as environmental or consumer issues).

Sub-clause 108(4) specifies that the Consultative Group must include: a person who is a member of the Gene Technology Technical Advisory Committee (to provide scientific assistance to the Group); and a person who is a member of the Gene Technology Ethics Committee (to assist with advice on ethics issues).

Sub-clause 108(6) requires that the Minister not appoint a chair for the Consultative Group unless a majority of jurisdictions have agreed to that appointment.

Clause 109 - Remuneration

This clause provides that members of the Consultative Group are to be paid remuneration as determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, members are to be paid the remuneration that is prescribed by the regulations.

Sub-clause 109(2) specifies that members of the Consultative Group are to be paid allowances as prescribed.

Sub-clause 109(3) provides that this clause is subject to the Remuneration Tribunal Act 1973.

Clause 110 - Regulations

This clause enables regulations to be made prescribing a range of matters relating to the members of the Consultative Group, such as: terms of appointment; resignation; disclosure of interests; termination of appointment; and leave of absence.

Sub-clause 110(2) states that regulations may also be made on matters relating to the operation of the Consultative Group such as: procedures for convening meetings of the Consultative Group; the constitution of a quorum for a meeting of the Consultative Group; the way in which matters are to be resolved by the Consultative Group; records; and reporting requirements.

Sub-clauses 110(3) and (4) provide that, where no regulations have been made to guide the operations of the Consultative Group, the Regulator may determine how the Consultative Group must operate and in the absence of such a determination by the Regulator, the Consultative Group may operate in the way it determines.

DIVISION 4 - The Gene Technology Ethics Committee

Clause 111 - The Gene Technology Ethics Committee

This clause establishes the Gene Technology Ethics Committee (the Ethics Committee) as a Committee of up to 12 part-time members, including a chair.

Sub-clause 111(4) requires that before appointing a member of the Ethics Committee, the Minister must consult: the Regulator; the States; such scientific, consumer, health, environmental and industry groups as the Minister considers appropriate; and such other Ministers as the Minister considers appropriate.

Sub-clause 111(5) also requires that the Minister not appoint a person as a member of the Ethics Committee unless the Minister is satisfied that the person has skills or experience in one or more of the following areas: ethics and the environment; health ethics; applied ethics; law; religious practices; population health; agricultural practices; animal health and welfare; issues of

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concern to consumers in relation to gene technology; and environmental systems.

Sub-clause 111(6) also requires that the Ethics Committee include: a person who is a member of the Gene Technology Technical Advisory Committee; and a person who is a member of the Australian Health Ethics Committee who also has expertise in medical research.

Sub-clause 111(7) provides that the Minister must not appoint a member to chair the Ethics Committee unless a majority of jurisdictions agree to the appointment.

Clause 112 - Function of the Gene Technology Ethics Committee

This clause provides that the function of the Ethics Committee is to provide advice, on the request of the Regulator or of the Ministerial Council, on: ethical issues relating to gene technology; the development of codes of practice in relation to ethics in respect of conducting dealings with GMOs; and the development of policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons.

Clause 113 - Expert advisers

This clause allows the Minister to appoint one or more expert advisers to the Ethics Committee. These advisers may be appointed on an ad hoc or continuing basis and will be expected to supplement the expertise of the Committee where this is necessary in relation to the consideration of particular matters. The expert advisers will play a supporting role to the Committee and will not have voting rights on the Committee.

Clause 114 - Remuneration

This clause requires that a person who is a member of the Ethics Committee or an expert adviser be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the member is to be paid the remuneration that is prescribed in the regulations.

Sub-clause 114(2) provides that a person who is a member of the Ethics Committee or an expert adviser is to be paid the allowances that are prescribed in the regulations.

Sub-clause 114(3) provides that this clause is subject to the Remuneration Tribunal Act 1973.

Clause 115 - Members and procedures

This clause enables regulations to be made prescribing a range of matters relating to the members of the Ethics Committee, such as: terms of appointment; resignation; disclosure of interests; termination of appointment; and leave of absence.

Sub-clause 115(2) states that regulations may also be made on matters relating to the operation of the Ethics Committee, such as: procedures for convening meetings of the Committee; the constitution of a quorum for a meeting of the Committee; the way in which matters are to be resolved by the Committee; records; and reporting requirements.

Sub-clauses 115(3) and (4) provide that, where no regulations have been made to guide the operations of the Ethics Committee, the Regulator may determine how the Committee must operate and, in the absence of such a determination by the Regulator, the Committee may operate in the way it determines.

Clause 116 - Subcommittees

This clause allows the Ethics Committee to establish subcommittees, with the Regulator's consent, to assist in the performance of its functions.

Sub-clause 116(2) specifies that matters relating to the constitution and operation of such subcommittees may be prescribed by regulations.

PART 9 - ADMINISTRATION

DIVISION 1 - Simplified outline

Clause 117 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - Appointment and conditions of Regulator

Clause 118 - Appointment of the Regulator

This clause provides that the Regulator is to be appointed by the Governor-General for a term specified in the instrument of appointment, being a term not less than three years and no more than five years.

Sub-clause 118(3) provides that the Regulator holds office on a full-time basis.

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Sub-clause 118(4) provides that a person must not be appointed as the Regulator unless a majority of jurisdictions agree to the appointment.

Clause 119 - Termination of appointment

Sub-clause 119(1) provides that the Governor-General may terminate the appointment of the Regulator for misbehavior or physical or mental incapacity.

Under sub-clause 119(2), the Governor-General must terminate the Regulator's appointment if the Regulator does any of the things listed in paragraphs 119(2)(a) to (d) inclusive. This includes: being absent from duty (except on leave of absence) for 14 consecutive days, or for 28 days in any period of 12 months; becoming bankrupt; compounding with his or her creditors; assigning his or her remuneration for the benefit of his or her creditors; failing to disclose interests as required under clause 120; or engaging in employment outside the duties of his or her office without the Minister's approval.

Sub-clause 119(3) further provides that the Governor-General must not terminate the Regulator's appointment on the grounds of misbehavior or physical or mental incapacity (in accordance with sub-clause 119(1)) without the agreement of a majority of jurisdictions.

Sub-clause 119(4) provides that if the Regulator is either, an eligible employee for the purposes of the Superannuation Act 1976 or a member of the superannuation scheme established by deed under the Superannuation Act 1990, the Governor-General may, with the Regulator's consent, retire the Regulator from office on the grounds of physical or mental incapacity.

Sub-clauses 119(5) and (6) set out the circumstances in which the Regulator is taken to have been retired from office on the grounds of invalidity under the Superannuation Act 1976 and the Superannuation Act 1990.

Clause 120 - Disclosure of interests

This clause provides that the Regulator must give written notice to the Minister of all financial or other interests that the Regulator has prior to, or that he or she acquires during, tenure as the Regulator, that could conflict with the proper performance of the Regulator's functions under the Bill and regulations.

Clause 121 - Acting appointment

Sub-clause 121(1) permits the Minister to appoint a person to act as the Regulator if, firstly, there is a vacancy in that office, whether or not an appointment has previously been made to the office, or, secondly, during any period, or all periods, when the Regulator is absent from duty or from Australia or is, for any reason, unable to perform the duties of the office.

Sub-clause 121(2) provides that anything done by a person purporting to act as the Regulator under this provision is not invalid merely because:

(a) the occasion for the appointment had not arisen;

(b) there was a defect or irregularity in connection with the appointment;

(c) the appointment had ceased to have effect; or

(d) the occasion to act had not arisen or had ceased.

Clause 122 - Terms and conditions

This clause provides that in respect of matters not specifically provided for by this Bill, the Regulator holds office on such terms and conditions (if any) as are determined by the Governor-General.

Clause 123 - Outside employment

This clause provides that the Regulator must not engage in any paid employment outside the duties of the office without the Minister's written approval.

Clause 124 - Remuneration

This clause establishes the basis for determining the Regulator's remuneration and allowances.

Sub-clause 124(1) provides that the Regulator is to be paid the remuneration that is determined by the Remuneration Tribunal. Where no determination of that remuneration by the Tribunal is in operation, the Regulator is to be paid the remuneration prescribed by the regulations.

Sub-clause 124(2) provides that the Regulator is to be paid such allowances as are prescribed by the regulations.

Sub-clause 124(3) provides that this clause has effect subject to the Remuneration Tribunal Act 1973.

Clause 125 - Leave of absence

Sub-clause 125(1) provides that the Regulator has the recreation leave entitlements determined by the Remuneration Tribunal.

Sub-clause 125(2) enables the Minister to grant the Regulator leave of absence, other than recreation leave, on such terms and conditions as the Minister determines. The terms and conditions may include those relating to remuneration.

Clause 126 - Resignation

This clause provides that the Regulator may resign by giving the Governor-General a written notice of resignation.

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DIVISION 3 - Money

Clause 127 - Regulator may charge for services

This clause provides that the Regulator may charge for services provided by, or on behalf of, the Regulator in the performance of the Regulator's functions.

Clause 128 - Notional payments by the Commonwealth

As the Bill applies to the Crown in all its capacities including the Crown in right of the Commonwealth, sub-clause 128(1) has been included to clarify that fees and charges under this Bill and regulations, and charges levied under the Gene Technology (Licence Charges) Act 2000 are notionally payable by the Commonwealth (or parts of the Commonwealth).

Sub-clause 128(2) provides that the Minister for Finance and Administration may give written directions for the purposes of this clause, including directions relating to the transfer of amounts within, or between, accounts operated by the Commonwealth.

Clause 129 - Gene Technology Account

This clause sets up the Gene Technology Account, which is a Special Account for the purposes of the Financial Management and Accountability Act 1997.

Clause 130 - Credits to Account

Sub-clause 130(1) sets out the amounts that must be transferred to the Gene Technology Account. These include: monies appropriated by the Parliament for the purposes of the Account; amounts equal to amounts received by the Commonwealth under the Gene Technology (Licence Charges) Act 2000; amounts equal to fees received by the Commonwealth under sub-clauses 40(6) and 83(3); amounts equal to amounts received by the Commonwealth in connection with the performance of the Regulator's functions; and amounts recovered by the Commonwealth under sub-clause 146(5) and 158(4), to the extent that they are referable to costs paid out of the Account.

Sub-clause 130(2) provides that the purposes of the Account are to make payments to further the object of the Bill, as set out in clause 3, and to make payments connected to the performance of the Regulator's functions under this Bill under regulations made under the Bill, or under a corresponding state law.

Clause 131 - Recovery of Amounts

This clause provides that the following amounts may be recoverable in a court as debts due to the Commonwealth:

(a) amounts payable to the Commonwealth under the Gene Technology (Licence Charges) Act 2000;

(b) fees payable to the Commonwealth under this Bill, the regulations or a corresponding State law; and

(c) amounts payable to the Commonwealth in connection with the performance of the Regulator's functions.

Clause 132 - Purposes of Account

This clause describes the circumstances under which the Regulator can expend money credited to the Account.

DIVISION 4 - Staffing

Clause 133 - Staff assisting the Regulator

This clause provides that staff necessary to assist the Regulator are to be persons engaged under the Public Service Act 1999 and are to be made available by the Secretary of the Department for this purpose. This does not preclude the Regulator undertaking his or her own recruiting to ensure that he or she attracts suitably skilled and qualified employees. Technically however, the staff would be employed under the certified agreement of the relevant Secretary, their positions being funded by the Regulator.

Clause 134 - Consultants

This clause enables the Regulator to appoint suitably qualified and experienced consultants to assist the Regulator.

Sub-clause 134(2) provides that the Regulator may determine the conditions of engagement of such consultants.

Clause 135 - Seconded officers

This clause provides that the Regulator may be assisted in the performance of his or her functions or powers, by officers seconded from other Commonwealth Departments or authorities or State agencies, with the agreement of such agencies.

DIVISION 5 - Reporting requirements

Clause 136 - Annual Report

This clause requires the Regulator to prepare and give to the Minister, as soon as practicable after the end of each financial year, an annual report on the operations of the Regulator during the year.

Sub-clause 136(2) requires the Minister to cause a copy of the Report to be tabled before each House of Parliament within 15 sitting days of the day on which the report was given to the Minister.

The Regulator must also provide a copy of the annual report to each State.

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Clause 137 - Reports to Parliament

Sub-clause 137(1) provides that the Regulator may, at any time, cause a report about matters relating to the Regulator's functions to be tabled in either House of Parliament.

Sub-clause 137(2) requires the Regulator to give a copy of such a report tabled in Parliament to the Minister and to each State.

DIVISION 6 - Record of GMO and GM Product Dealings

Clause 138 - Record of GMO and GM Product Dealings

This clause provides that the Regulator must maintain a comprehensive record of GMO and GM product dealings, to be known as `the Record'. This Record would be likely to take the form of a computerised database.

In relation to GMO licences, sub-clause 138(3) requires that the Record contain certain information (other than confidential commercial information) in relation to every GMO licence which has been issued. That information shall include details such as: name of licence holder; persons covered by the licence; and any licence conditions.

In relation to notifiable low risk dealings, sub-clause 138(4) requires that the Record contain the following information (other than confidential commercial information): the name of the person who notified the dealing; and relevant particulars of the dealing as prescribed in regulations.

In relation to GM products, sub-clause 138(5) requires that the Record contain details of approvals of GM products made by other regulators and notified to the Gene Technology Regulator. Under the Gene Technology (Consequential Amendments) Bill 2000 certain GM products will be notified to the Regulator under the following pieces of legislation:

* the Agricultural and Veterinary Chemicals (Administration) Act 1992;

* the Australia New Zealand Food Authority Act 1991;

* the Industrial Chemicals (Notification and Assessment) Act 1989;

* the Therapeutic Goods Act 1989.

Sub-clause 138(6) provides that the Record must also include a description of each dealing on the GMO Register, including any conditions to which the dealing is subject.

Sub-clause 138(7) and (8) provide that the record maybe kept in a computerised form and that information must be entered on the record, by the Regulator, as soon as reasonably practicable.

Clause 139 - Inspection of Record

This clause requires that the Regulator permit any person to inspect any part of the Record. It is, however, also intended that the Record be available on the Regulator's website.

DIVISION 7 - Reviews of notifiable low risk dealings and exemptions

Clause 140 - Regulator may review notifiable low risk dealings

This clause allows the Regulator, at any time, to consider whether a dealing with a GMO should become a notifiable low risk dealing, or whether an existing notifiable low risk dealing should no longer be recognised as such. This enables the legislation to respond to changes in technology and to any additional information that becomes available regarding the risks of certain dealings with GMOs, or the absence thereof.

Sub-clause 140(2) requires that, in making these decisions, the Regulator must consider the matters in sub-clause 74(2) and sub-clause 74(3). These sub-clauses require the Regulator to consider matters, such as: whether the proposed dealings involve an intentional release into the environment; whether the GMO can be biologically contained; whether the GMO is a pathogen or pest; and whether any risks can be managed with minimal, or no, conditions.

Clause 141 - Regulator may review exemptions

This clause allows the Regulator, at any time, to consider whether a dealing with a GMO should be an exempt dealing, and whether an existing exemption should no longer be such.

Clause 142 - Regulator may give notice of consideration

This clause enables the Regulator to place a public notice, at any time, calling for submissions from the public about what dealings with GMOs should be removed or added to the list of notifiable low risk dealings or exemptions, including submissions on any reasons for the proposed change. This clause also sets out the matters that the Regulator must include in a public notice, and a requirement for the Regulator to also notify the States, the Gene Technology Technical Advisory Committee, and prescribed Commonwealth agencies.

Clause 143 - What Regulator may do after consideration

This clause allows the Regulator, after completion of the process outlined at clause 140, to recommend to the Ministerial Council that:

* a dealing be declared a notifiable low risk dealing, or

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* an existing declaration under regulations be withdrawn, where the dealing should no longer be a notifiable low risk dealing; or

* a dealing be exempted; or

* an existing exemption be retained or removed.

The Regulator is required to advise the Ministerial Council because it will be the Ministerial Council who agree any changes to the national legislative scheme, and who make recommendations to each of the Parliaments to adopt such changes.

Clause 144 - Regulator not required to review matters

This clause clarifies that the requirement to review notifiable low risk dealings or exemptions is at the discretion of the Regulator.

PART 10 - ENFORCEMENT PART 10 - ENFORCEMENT

Clause 145 - Simplified outline

This clause gives a simplified outline of the Part.

Clause 146 - Regulator may give directions

This clause provides that, if a licence holder or a person covered by a licence is not acting in compliance with the legislation, and their actions are likely to cause, or are causing harm to the health and safety of people or to the environment, then the Regulator may give written directions to the person directing them to do things necessary to ensure compliance or to bring the person back into compliance with the legislation. If the person does not take the necessary action within the period of time specified by the Regulator, the Regulator may take the necessary steps, or arrange for the necessary steps to be taken, to ensure compliance with the legislation.

This provision effectively enables a "clean-up" or remediation to be undertaken, either by the Regulator or via the direction of the Regulator, where, for example, a condition of licence has been breached resulting in the accidental release of a GMO, and there is a need to re-contain the GMO.

The clause further provides that if costs are incurred by the Regulator in taking steps to bring the activity back into compliance with the legislation, such costs may be recovered from the licence holder or the person covered by the licence (as applicable).

This clause should also be read in conjunction with clause 158, which enables an inspector to take immediate action where there is an imminent risk of danger to health and safety of people or to the environment. In such circumstances, the inspector can take such steps as are necessary without first giving written notice to the licence holder or applicant requiring them to take the necessary steps. Such action, by the inspector or others, is also cost recoverable from the offending party.

Clause 147 - Injunctions

If a person has engaged, or is engaging, or is proposing to engage in any conduct that is or would be an offence against the Bill or regulations, sub-clause 147(1) provides that the Federal Court may grant an injunction, on application by the Regulator or any other aggrieved person, to restrain that person from engaging in that conduct.

Likewise, if a person has refused or failed, or is refusing or failing, or is proposing to refuse or fail, to do any thing, and such a refusal or failure is or would constitute an offence against this Bill, then the Federal Court may, on application by the Regulator or any other aggrieved person, grant an injunction requiring the person to do the thing.

Sub-clause 147(3) provides that the Court's powers to grant injunctions under this section may be exercised whether or not it appears to the Court that the person intends to engage, or to continue to engage, in conduct of that kind, and whether or not the person has previously engaged in conduct of that kind.

Sub-clause 147(4) empowers the court to discharge or vary any injunction granted under this section, and sub-clause 147(5) enables the Court to grant an interim injunction pending the determination of an application for an injunction under sub-clause 147(1).

Sub-clause 147(6) makes it clear that the powers of the Court set out under this section are in addition to, and not in derogation of, any of the other powers of the Court.

Clause 148 - Forfeiture

Sub-clause 148(1) states that if a court convicts a person of an offence against this Bill or regulations, or makes an order under section 19B of the Crimes Act 1914 in respect of a person charged with an offence against this Bill, then the court may, on application by the Commonwealth, order forfeiture to the Commonwealth of any substance or thing used, or otherwise involved in the commission of the offence.

Sub-clause 148(2) provides that a thing ordered by a court to be so

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forfeited becomes the property of the Commonwealth, and may be sold or otherwise dealt with in accordance with the directions of the Regulator.

Sub-clause 148(3) states that, until the Regulator gives such a direction, the thing must be kept in such custody as the Regulator directs. "Thing" is widely defined in clause 11 to refer to something that also includes a substance, and a thing in electronic or magnetic form.

PART 11 - POWERS OF INSPECTION

DIVISION 1 - Simplified outline

Clause 149 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - Appointment of inspectors and identity cards

Clause 150 - Appointment of inspectors

Sub-clause 150(1) enables the Regulator to appoint, by instrument in writing, appropriate officers to be inspectors for the purposes of exercising all the powers under this Part. The persons the Regulator may appoint as inspectors are Commonwealth employees or State or Territory employees.

Sub-clause 150(2) requires a person appointed as an inspector to comply with any directions of the Regulator when exercising powers or performing functions in that capacity.

Clause 151 - Identity card

Sub-clauses 151(1) and 151(2) require the Regulator to issue an identity card, in a form prescribed by the regulations, to every person appointed as an inspector. The identity card must have a recent photograph of the inspector.

Sub-clause 151(3) provides that it is an offence for a person who ceases to be appointed as an inspector to fail to return his or her identity card to the Regulator, as soon as practicable. The offence attracts a maximum penalty of $110.

Sub-clause 151(4) requires the inspector to carry his or her identity card at all times when exercising powers or performing functions as an inspector.

DIVISION 3 - Monitoring powers

Clause 152 - Powers available to inspectors for monitoring compliance

Sub-clause 152(1) confers powers upon an inspector to enter any premises and to exercise any or all of the powers set out in clause 153 for the purposes of establishing whether or not the Bill or regulations are being complied with.

Sub-clause 152(2) provides that an inspector may only enter premises under this clause if: he or she has the consent of the occupier of the premises; or where the inspector has obtained a warrant under clause 172 to make that entry; or where the occupier of the premises is a licence holder, or a person covered by a licence, and the entry is at a reasonable time.

Clause 153 - Monitoring powers

This clause describes the monitoring powers that an inspector may exercise for the purposes of finding out whether the Bill or regulations have been complied with. Some of these powers may be exercised without a warrant and others require a warrant.

DIVISION 4 - Office-related powers

Clause 154 - Searches and seizures related to offences

This clause sets out the powers of an inspector who enters and conducts searches of premises to obtain evidence of a commission of an offence, and the circumstances under which those powers may be exercised.

Sub-clause 154(1) states that the powers under this clause may be exercised if an inspector has reasonable grounds for suspecting that there may be evidential material on any premises.

Sub-clause 154(2) provides that an inspector may enter premises, either with the consent of the occupier or under a warrant issued under clause 173, to do any of the things described in sub-clause 154(3) and clause 155, including, if the entry is under a warrant, seizing the evidential material if the inspector finds it on the premises.

Sub-clause 154(3) provides that if, in the course of searching for a particular thing at premises in accordance with a warrant, an inspector finds something else that he or she believes on reasonable grounds to be evidential

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material which the inspector also reasonably believes must be seized to prevent its concealment, loss or destruction, or use in the commission or continuation of an offence against this Bill or regulations, then the warrant is taken to authorise the inspector to seize that thing.

Clause 155 - Offence-related powers of inspectors in relation to premises

This clause sets out the general powers inspectors may exercise under paragraph 154(2)(b). These include the power to: search premises and any thing found on premises for evidential material; to inspect, examine, take measurements of, conduct tests on, or take samples of the evidential material; take photographs or other forms of recordings of the premises or the evidential material; and take onto the premises such equipment and materials as the inspector requires for the purposes of exercising powers in relation to the premises.

Clause 156 - Use of equipment at premises

This clause provides that an inspector may operate equipment at the premises to see whether evidential material is accessible, if he or she believes that the equipment may be operated without damaging it.

Sub-clause 156(2) provides that, if evidential material is so accessible, the inspector may seize equipment or any disk, tape or other associated device, or operate the equipment, in order to obtain the evidential material, or to copy such evidential material to another storage device, and remove it from the premises.

Sub-clause 156(3) is intended to facilitate the seizure of printouts or duplicate discs wherever possible, rather than the original material. It provides that an inspector may seize equipment under paragraph 156(2)(a) only if it is not practicable to put the material into documentary form or to copy it to a storage device, or if possession by the occupier of the equipment could constitute an offence.

Sub-clause 156(4) provides that an inspector may seize equipment under paragraph 156(2)(a) or documents under paragraph 156(2)(b), only if the inspector entered the premises under a warrant.

DIVISION 5 - Expert assistance

Clause 157 - Expert assistance to operate a thing

This clause provides that an inspector may secure the thing (for example, certain equipment) by locking it up or guarding it, if he or she believes on reasonable grounds that evidential material may be accessible by operating the thing at the premises, but that expert assistance is needed to operate the thing and the evidential material may be destroyed or otherwise interfered with if the thing is not secured in the meantime. This is necessary to ensure that where, for example, the equipment is more sophisticated than expected and cannot be accessed or moved, the opportunity to obtain expert assistance and to preserve evidential material is not lost.

Sub-clause 157(2) requires the giving of notice to the occupier in cases where equipment may be secured for a period not exceeding 24 hours.

Sub-clause 157(3) allows the thing to be secured for either 24 hours or until the thing is operated by an expert, whichever happens first.

Sub-clause 157(4) allows an inspector to apply to a magistrate for an extension of the time needed for securing the equipment if he or she believes, on reasonable grounds, that the expert assistance will not be available within the 24 hour period. The occupier must be given notice under sub-clause 157(5) that the inspector intends to apply for an extension, and the occupier has a right to be heard in relation to the application.

DIVISION 6 - Emergency powers

Clause 158 - Powers available to inspectors for dealing with dangerous situations

Sub-clause 158(1) describes the circumstances in which an inspector may exercise powers under this clause. These are where the inspector has reasonable grounds for suspecting that there may be, on any premises, a particular thing that is not in compliance with the requirements of the Bill or regulations, and where it is necessary to exercise the powers under this clause to avoid an imminent risk of death, serious illness, serious injury or to protect the environment.

Sub-clause 158(2) provides that, in such circumstances, an inspector may, without a warrant or the consent of an occupier: enter premises; search the premises for the thing; secure the thing if the inspector finds it on the premises until a warrant is obtained to seize the thing; if the inspector believes on reasonable grounds that a person has failed to comply with any requirements of the Bill or regulations in relation to the thing, require the person to take such steps, or arrange for such steps to be taken, as the inspector considers necessary for the person to comply with the Bill or the regulations; and take such steps in relation to the thing as the inspector considers appropriate.

Sub-clause 158(3) requires the inspector to exercise his or her powers under sub-clause 158(2) only to the extent necessary for the purposes of avoiding an imminent risk of death, serious illness, serious injury or serious damage to the environment.

Sub-clause 158(4) provides that, where the Regulator incurs costs as the result of the inspector taking steps, or arranging for steps to be taken, under paragraph 158(2)(e), the Regulator can recover any costs incurred as a result of taking such steps.

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DIVISION 7 - Obligations and incidental powers of inspectors

Clause 159 - Inspector must produce identity card on request

This clause makes it clear that an inspector cannot exercise any of the powers under this Part in relation to premises unless he or she produces his or her identity card upon being requested to do so by the occupier of those premises.

Clause 160 - Consent

This clause provides that, before obtaining consent from a person to enter premises (under paragraphs 152(2)(a) or 154(2)(a)), the inspector must inform the person that he or she may refuse consent.

Sub-clause 160(2) clarifies that any consent given by a person to enable entry to premises by the inspector must be voluntary.

Clause 161 - Details of warrant to be given to occupier etc.

This clause provides that, if a warrant in relation to premises is being executed, a copy of the warrant must be made available to the occupier of the premises or another person who represents the occupier, where the occupier or their representative are present at the premises. The inspector responsible for the execution of the warrant must identify himself or herself. Sub-clause 161(3) provides that the copy need not include the signature of the Magistrate who issued the warrant.

Clause 162 - Announcement before entry

This clause provides that, before an inspector enters premises under a warrant they must announce that they are authorised to enter and give any person at the premises an opportunity to allow entry to the premises, unless there are reasonable grounds to believe that immediate entry to the premises is required to ensure the safety of a person or to prevent serious damage to the environment, or so that the effective execution of the warrant is not frustrated.

Clause 163 - Compensation for damage

This clause provides that if damage is caused to a thing as a result of it being operated as mentioned in clauses 153 or 156 and the damage resulted from insufficient care being exercised by the inspector either in selecting the person to operate the equipment or by the person operating it, compensation is payable to the owner.

Compensation is payable out of money appropriated by the Parliament. In determining the amount payable, regard is to be had as to whether the occupier (or his or her employees and agents) had provided any warning or guidance as to the operation of the thing. This is to minimise compensation in cases where there has been a deliberate programming of software to destroy or cause damage if not accessed in a particular manner, or where the occupier failed to mitigate damage by providing warning or guidance.

DIVISION 8 - Power to search goods, baggage etc.

Clause 164 - Power to search goods, baggage etc.

This clause empowers an inspector to search goods and baggage taken off ships or aircraft travelling from a place outside Australia to Australia or from a place outside an external Territory to that Territory. Failure or refusal to answer a question relating to such goods or baggage is punishable by up to 30 penalty units, which equates to $3,300 for individuals and $16,500 for a body corporate.

This clause has been included to enable inspectors (who may be officers of the Australian Quarantine and Inspection Service appointed as inspectors under this legislation) to search goods and baggage imported into Australia.

Clause 165 - Seizure of goods

This clause provides that an inspector may seize any goods if there is a reasonable suspicion that the goods have been used, or otherwise involved, in the commission of an offence against the Bill or the regulations, or that the goods will provide evidence of an offence against the Bill or the regulations.

DIVISION 9 - General provisions relating to search and seizure

Clause 166 - Copies of seized things to be provided

This clause provides that if an inspector seizes, under a warrant, documents, film, computer files or storage devices etc, the inspector must, on request of

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the occupier or their representative who is present when the warrant is executed, give a copy of the thing or the information seized to the occupier or their representative as soon as practicable after the seizure.

Sub-clause 166(2) provides that this clause does not apply where the thing seized was seized under paragraphs 156(2)(b) or (c), or where possession by the occupier of the thing seized could constitute an offence.

Clause 167 - Occupier entitled to be present during search

This clause provides that occupiers or their representatives may choose to observe the searching of the premises providing they do not impede the conduct of the search in any way. The right to search does not preclude inspectors from searching 2 or more areas of the premises at the same time.

Clause 168 - Receipts for things seized

This clause provides that receipts are to be issued to occupiers for things seized. Under this provision, it will be possible for the items to be listed on the same receipt. It is not envisaged that inspectors would be required to identify absolutely every item individually where those items can be adequately identified by a class description.

Clause 169 - Retention of seized things

This clause describes when things seized under this Part of the Bill must be returned. Unless a court has ordered otherwise, or it is forfeited or forfeitable to the Commonwealth, the seized thing must be returned where the reason for its seizure no longer exists, or where it will not be used as evidence, or after 60 days have expired from the day it was seized.

Sub-clause 169(2) provides that an inspector must take reasonable steps to return the thing to the person from whom it was seized after the 60 days referred to in sub-clause 169(1), unless proceedings in which the seized thing will be used have been brought against an offender within the 60 day limit and the proceedings have not finished, or an extension of time for the retention of the seized thing has been granted by a magistrate, or returning the thing could cause an imminent risk of death, serious illness, serious injury or serious damage to the environment, or an inspector is otherwise authorised to dispose of it pursuant to some law or court order.

Sub-clause 169(3) provides that where the seized thing is returned, it may be returned unconditionally or on such terms and conditions as the Regulator sees fit.

Clause 170 - Magistrate may permit a thing to be retained

This clause describes how an inspector may apply to a magistrate for an order to retain a seized thing beyond the 60 day retention period (or before the end of a period specified in an order of a magistrate) where proceedings in respect of which the thing may afford evidence have not commenced.

Sub-clause 170(2) provides that if the magistrate is satisfied that it is necessary for an extension of time to be granted to enable an inspector to investigate whether or not an offence has been committed against the Bill or to enable the evidence to be secured for the purposes of a prosecution, the magistrate may grant an extension for such period as is specified in an order. Before making an application under this section, an inspector must take reasonable steps to establish who has an interest in the retention of the seized goods and, if practicable, notify such persons.

Clause 171 - Disposal of goods if there is no owner or owner cannot be located

This clause provides that the Regulator may dispose of a thing seized under this Part, in a manner the Regulator considers appropriate, if there is no owner of the thing or the Regulator has made reasonable efforts to locate the owner and cannot locate the owner.

DIVISION 10 - Warrants

Clause 172 - Monitoring warrants

This clause enables a magistrate to issue a warrant that permits more than one inspector to enter the same premises for the purposes of establishing whether the Bill and regulations have been complied with.

Sub-clause 172(3) provides that the magistrate must not issue the warrant unless the inspector or some other person has given the magistrate any information the magistrate requires concerning the grounds on which the issue of the warrant is being sought.

Sub-clause 172(4) describes the matters that must be contained in a warrant issued by a magistrate under this clause. For example, the warrant must: authorise the inspectors to enter the premises and exercise powers under clause 153; state when the entry is authorised to be made; specify the day on

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which the warrant ceases to have effect; and state the purpose for which the warrant is issued.

Clause 173 - Offence-related warrants

This clause describes how an inspector may apply to a magistrate for a warrant under this clause in relation to premises for the purposes of identifying and/or seizing evidence.

Sub-clause 173(1) provides that an inspector may apply to a magistrate for a warrant in relation to premises.

Sub-clause 173(2) enables the magistrate to issue a warrant if he or she is satisfied, by information given under oath, that there are reasonable grounds for suspecting that there is, or there may be within the next 72 hours, evidential material in or on the premises in relation to which an application for a warrant is being made.

Sub-clause 173(3) prevents the magistrate from issuing a warrant unless the inspector or some other person has given to the magistrate, either verbally or by affidavit, such further information (if any) as the magistrate should require concerning the grounds on which the issue of the warrant is being sought.

Sub-clause 173(4) prescribes what must be included in a warrant. The warrant must include the name of one or more inspectors and it must authorise all those named to enter the premises and exercise the powers set out in sub-clause 154(3) and in clause 155, and to seize the evidential material. The warrant must also state whether the entry is authorised to be made at any time during the night or day, or whether entry is restricted to specified hours of the day or night. The warrant must also specify when the warrant ceases to have effect (being a day not later than a week after the issue of the warrant), and also state the purposes for which the warrant is being issued.

Clause 174 - Offence-related warrants by telephone, telex, fax etc.

This clause sets out the circumstances in which a warrant may be obtained over the telephone or by telex, facsimile or other electronic means.

Sub-clause 174(1) provides that, in urgent cases where an inspector considers it necessary, the inspector may apply to a magistrate for a warrant under clause 173 either by telephone, telex, facsimile or other electronic means.

Sub-clause 174(2) provides that the magistrate may require communication by voice to the extent that it is practicable in the circumstances.

Sub-clauses 174(3) and (4) require the inspector to prepare any information mentioned in sub-clause 173(2) setting out the grounds on which the warrant is sought. The inspector may apply for the warrant before the information is sworn, where this is necessary in the circumstances.

Sub-clause 174(5) provides that, if the magistrate is satisfied that there are reasonable grounds for issuing the warrant (after having considered relevant information), the magistrate may issue the same warrant that the magistrate would issue under clause 173 as if the application for the warrant had been made under that clause.

Sub-clause 174(6) provides that, if the magistrate completes and signs the warrant for the inspector, the magistrate must inform the inspector what the terms of the warrant are, the day on which and the time at which the warrant was signed, the day on which the warrant ceases to have effect (being a day not more than a week after the magistrate completes and signs the warrant), and must record on the warrant the reasons for granting the warrant. The inspector must also complete a form or warrant in the same terms as the warrant completed and signed by the magistrate, and must write on the form the name of the magistrate and the day on which and the time at which the warrant was signed.

Sub-clause 174(7) requires the inspector to send to the magistrate the form of warrant completed by the inspector under this clause, and the information required to be prepared when the inspector applied for the warrant over the telephone, the information prepared must have been duly sworn. The inspector is required to send this to the magistrate not later than the day after the expiry or the execution of the warrant, whichever is the earlier day.

Sub-clause 174(8) provides that when the magistrate receives these documents, the magistrate must attach them to the warrant, completed and signed, and deal with the documents in the same way the magistrate would have dealt with the information if the application for the warrant had been made under clause 173.

Sub-clause 174(9) provides that a form of warrant completed in accordance with sub-clause 174(6) is authority for any entry, search, seizure or other exercise of power that the warrant signed by the magistrate authorises.

Sub-clause 174(10) states that, in any proceedings where the court must be satisfied that the exercise of a power was authorised by this clause, and the warrant signed by the magistrate authorising the exercise of that power cannot be produced, the court must assume, unless the contrary is proved, that the exercise of the power was not authorised by such a warrant.

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Sub-clause 174(11) states that any reference in this Part to a warrant under clause 173 is taken to include a warrant signed by a magistrate under this clause.

Clause 175 - Offences relating to warrants

This clause sets out offences in relation to an application for a warrant.

Sub-clause 175(1) provides that it is an offence, attracting a maximum penalty of imprisonment for 2 years or 120 penalty units, if a person makes a statement, when applying for a warrant, that he or she knows to be false or misleading in a material particular.

Sub-clause 175(2) sets out other actions that attract a maximum penalty of 2 years imprisonment or 120 penalty units. These include:

(a) a person stating in a document purporting to be a form of warrant under clause 174 the name of a magistrate who was not the magistrate that issued the warrant;

(b) stating, for the purposes of clause 174, on the form of warrant something that, to the person's knowledge, departs in a material particular from the form authorised by the magistrate;

(c) purporting to execute or present to another person a document purporting to be a form of warrant under clause 174 when the person knows it had not been approved by the magistrate under that clause or where it departs in a material particular from the terms authorised by a magistrate under clause 174; or

(d) giving to a magistrate a form of warrant under clause 174 that was not the form of warrant the person purported to execute.

DIVISION 11 - Other matters

Clause 176 - Part not to abrogate privilege against self-incrimination

This clause clarifies that nothing in this Part affects the right of a person to refuse to answer a question, give information, or produce a document on the ground that the answer to the question, the information or the production of the document, might tend to incriminate him or her, or make him or her liable to a penalty.

Clause 177 - Part does not limit power to impose licence conditions

This clause makes it clear that the powers exercisable under this Part in no way affect the ability of the Regulator to impose licence conditions. For example, the Regulator may impose additional conditions relating to auditing and monitoring requirements.

PART 12 - MISCELLANEOUS

DIVISION 1 - Simplified outline

Clause 178 - Simplified outline

This clause gives a simplified outline of the Part.

DIVISION 2 - Review of decisions

Clause 179 - Meaning of terms

This clause sets out a table describing those decisions under the Bill that are subject to review by the Administrative Appeals Tribunal (reviewable decisions), and those persons who are able to seek review in relation to reviewable decisions (eligible persons).

Clause 180 - Notification of decisions and review rights

This clause provides that, as soon as practicable after making a reviewable decision under the Bill, the Regulator must notify each eligible person in writing. The notification must include information about the terms of the decision, the reasons for the decision and a statement setting out the review rights of the person.

Sub-clause 180(2) provides that, if the Regulator fails to properly notify eligible persons of their review rights (under sub-clause 180(1)), this does not affect the validity of the decision.

Clause 181 - Internal review

This clause provides that an eligible person may apply to the Regulator for an internal review of a reviewable decision within 30 days after the decision came

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to the notice of the applicant, or within some further period, if any, specified by the Regulator.

If a person seeks internal review by the Regulator, the Regulator must conduct such a review personally and may affirm, vary or revoke the original reviewable decision. If the Regulator revokes the original reviewable decision, the Regulator may make such other decisions as the Regulator considers appropriate.

A person may not seek internal review of a reviewable decision if the Regulator personally made the original decision (as opposed to a delegate of the Regulator having made the original decision).

Clause 182 - Deadlines for making reviewable decisions

This clause provides that, if a person applies to the Regulator for internal review of a reviewable decision and the Regulator does not notify the applicant of the Regulator's decision within any time period set out in the Bill or regulations for the Regulator to advise the applicant of the outcome of the internal review, then the Regulator is taken to have rejected the application for internal review.

Clause 183 - Review of decisions by Administrative Appeals Tribunal

This clause provides that an eligible person may apply to the Administrative Appeals Tribunal in relation to a reviewable decision if they have exhausted their rights of internal review (under clause 181), or if the original reviewable decision was made personally by the Regulator and, as such, there is no opportunity for internal review.

DIVISION 3 - Confidential commercial information

Clause 184 - Application for protection of confidential commercial information

This clause provides that a person may apply to the Regulator for a declaration that specified information to which this Bill relates is confidential commercial information for the purposes of this Bill. Such an application must be made in writing in the approved form.

Clause 185 - Regulator may declare that information is confidential commercial information

This clause describes the circumstances in which the Regulator must declare information to be confidential commercial information for the purposes of the Bill.

Sub-clause 185(1) sets out the criteria in relation to which the Regulator must be satisfied before they can declare information to be confidential commercial information. The person applying for a declaration must satisfy the Regulator that the information in the application for declaration is: a trade secret; information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or other information that concerns the commercial or financial affairs of a person, organisation or undertaking which if disclosed, could unreasonably affect the person, organisation or undertaking.

Sub-clause 185(2) enables the Regulator to consider the public interest and, if satisfied that the public interest in disclosure outweighs the prejudice that the disclosure would cause to any person, the Regulator may refuse to declare that the information is confidential commercial information.

Sub-clauses 185(3) and (4) provide that the Regulator must give the applicant written notice of his or her decision about the application and that, if the Regulator refuses to declare the information to be confidential commercial information, the Regulator must, nevertheless, continue to treat the information as confidential commercial information until such time as any review rights under clauses 181 (internal review) and 183 (review before the Administrative Appeals Tribunal) have been exhausted.

Clause 186 - Revocation of declaration

This clause enables the Regulator to revoke a declaration made under clause 185 if the Regulator is satisfied that the information no longer meets the criteria set out in sub-clauses 185(1)(a), (b) or (c), or that the public interest in disclosure of the information outweighs the prejudice that disclosure would cause to any person. As for a decision made under clause 185, the revocation of a declaration does not take effect until any review rights have been exhausted.

Clause 187 - Confidential commercial information must not be disclosed

This clause provides that a person who has access to confidential commercial information must not disclose such information unless: it is in the act of carrying on the course of their duties under the Bill; or is in relation to a Court order; or they have received the consent of the person who applied to have the information declared as confidential commercial information.

This provision enables the Regulator to provide confidential commercial information to Commonwealth agencies or authorities, State agencies and the Gene Technology Technical Advisory Committee but ensures that such agencies may

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not disclose the information outside their organisations unless compelled to by court order or with the consent of the person who applied to have the information treated as confidential commercial information.

Notes following sub-clauses 187(1) and 187(2) clarify that for the purposes of the Freedom of Information Act 1982, confidential commercial information (information to which sub-clause 187(1) or 187(2) applies) is information to which section 38 of the Freedom of Information Act 1982 applies.

DIVISION 4 - Conduct by directors, employees and agents

Clause 188 - Conduct by directors, employees and agents

This clause provides for the determination of the elements of an offence when it involves a body corporate, including extending liability to ostensible agents of a body corporate.

Clause 189 - Meaning of terms

This clause defines terms used in clause 188 of the Bill, including "the state of mind of a person", "a director of a body corporate", "engaging in conduct" and "an ancillary offence".

DIVISION 5 - Transitional provisions

Clause 190 - Transitional provision - dealings covered by Genetic Manipulation Advisory Committee advice to proceed

This clause provides for transitional arrangements in relation to dealings with GMOs approved prior to the commencement of the Bill. The clause only covers matters previously approved by the Genetic Manipulation Advisory Committee.

The effect of sub-clauses 190(1) and (2) is that if a dealing with a GMO received advice to proceed from the Genetic Manipulation Advisory Committee before the commencement of the licensing provisions of this Bill, then that dealing is deemed to be licensed under this Act. The licence is taken to be subject to any conditions imposed by the Genetic Manipulation Advisory Committee `s advice to proceed.

The `deemed' licence continues in force until the period ending at the earliest of the following times: the time the advice to proceed expires, at the end of two years beginning when this Bill received Royal Assent, or when the licence is cancelled or surrendered.

If, at the time when the licence ceased to be in force, the licence holder wished to continue the dealings with the GMO, the licence holder would need to apply to the Regulator for another licence.

Sub-clause 190(3) defines the terms "advice to proceed" and "transition period".

Clause 191 - Regulations may relate to transitional matters

This clause provides that regulations may be made in relation to transitional matters arising from the enactment of this Bill.

DIVISION 6 - Other

Clause 192 - False or misleading information or document

This clause provides that a person must not give false or misleading information, or produce a document that is false or misleading in a material particular, in connection with any application made to the Regulator under this Bill or the regulations, or in compliance or purported compliance with this Bill or the regulations. The penalty for knowingly providing such false or misleading information or documents is 60 penalty units (which equates to $6,600 for an individual and $33,000 for a body corporate) or 1 year imprisonment.

Clause 193 - Regulations

This clause empowers the Governor-General to make regulations prescribing matters required or permitted to be prescribed by the Bill, or necessary or convenient to be prescribed for carrying out or giving effect to the Bill.

Sub-clause 193(2) clarifies that, without limiting the matters that may be prescribed in regulations by the Governor-General, regulations may be made requiring a person to comply with codes of practice or guidelines issued under this.

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FOOTNOTES:
[1] GMAC oversees any work involving the construction and/or propagation of viroids, viruses, cells or organisms of novel genotype produced by genetic manipulation which are either: unlikely to occur in nature; are likely to pose a hazard to public health or to the environment.

[2] "deal with" is defined to include, in relation to a GMO, conducting experiments with, making, developing, producing, manufacturing, breeding, propagating, using in the course of manufacture of a thing, growing, raising, culturing or importing.

[3] While the TGA regulates the safety, quality and efficacy of vaccines (and GTRAP also oversees clinical trials utilising viruses), they do not regulate occupational health and safety risks to the producer of the vaccine or virus nor do they examine any environmental risk which may be associated with the use of the GM vaccine. At present advice on

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these issues is provided by GMAC.

[4] It should, however, be noted that GMAC currently oversee these activities under administrative arrangements.

[5] Note that a separate RIS has been prepared to accompany the Gene Technology (Consequential Amendments) Bill 2000